Cardiac Implantable Electronic Devices (CIEDs)

AP19‐­00018

Transvenous lead extractions in patients with cardiac implantable electronic device: Ramathibodi experience

Titaya Sukhupanyarak, Kanchit Likittanasombat, Pakorn Chandanamattha, Tachapong Ngarmukos, Sirin Apiyasawat

Ramathibodi, Thailand

Introduction:

In Thailand, the efficacy of transvenous lead extractions in patients with cardiac implantable electronic device was limited.

Methods:

The retrospectively study with patients who was received transvenous lead extraction in Ramathibodi hospital during 1 January 2006 until 31 December, 2017. Clinical data and ablation procedure were classified.

Result:

The with patients who was received transvenous lead extraction in Ramathibodi hospital 29 patients, male 48 (72.7%) patients, mean age 57.14 + 19.29 years old, Indication of lead extraction due to infection was 34 (51.5%) patients. The efficacy of treatment 66 (100%) patients. The complication was cardiac tamponade 2 (3%) patients.

Conclusion:

Transvenous lead extraction was effective treatment and low complication.

AP19‐­00020

A case of suspected the lead fracture from a sudden increase of the battery impedance

Seigo Yoshida, Kenta Iida, Ryou Gotou, Nobuhiko Hagimoto, Susumu Adachi

Shuuwa General Hospital, Japan

Introduction:

A case is 69 years old female who had a dual‐­chamber pacemaker that had been implanted in March 2007 for a high‐­grade atrioventricular block. The generator was St. Jude Medical Identify ADxXLDR5386 and the ventricular lead was the same company's IsoFlex S1646.

Methods:

When she received a regular pacemaker check in June 2015, a battery impedance was 3.3 kohms. However, 12 months later, in June 2016, a sudden increase in the battery impedance was recognized that was 15.8 kohms. The pacemaker exchange was performed immediately.

Result:

In the examination of the ventricular lead at the time of the exchange, A threshold of the ventricular lead fluctuated significantly from measurement to measurement. A lead fracture was suspected from a fluoroscopic image and decreasing a ventricular lead impedance and sensitivity. An additional insertion of a new ventricular lead was accomplish after confirming that a existing vein was not obstructed. Also from a generator inspection by the manufacturer, a rapid increase in the battery impedance was interpreted to result from a high output pacing accompanying the Autocapture setting caused by the threshold fluctuation due to the lead fracture.

Conclusion:

We report because there are few reports of the sudden increase of the battery impedance caused by the lead fracture.

AP19‐­00024

Removal of Leadless pacemaker using double snare catheter

Tadashi Yamamoto

Hokkaido Cardiovascular Hospital, Japan

Introduction:

A 90‐­years‐­old man, with a known history of Atrial fibrillation, hypertension, diabetes mellitus type2 and dementia, was diagnosed as having bradycardia of atrial fibrillation and received a permanent single‐­chamber pacemaker in the left prepectoral area 30 years ago. However, he had lead fractures twice in the left side, and a pacemaker was inserted in the right prepectoral area 15 years ago, and there were three leads in his body. At the time of the new admission to our hospital, a physical examination revealed adherence of skin to the device with overt erosion on the right side of his upper chest. A cardiovascular examination was unremarkable. No evidence of infective endocarditis was observed. He was performed an operation of exchange pacemaker generator on the right chest 2 month before in our hospital. We diagnose an infection of pacemaker generator and decided to extraction the generator. As temporary pacemaker was implanted, the generator was extracted. At that time, blood culture was negative. Therefore, a leadless pacemaker was decided to implant in his right ventricle 2 week after the operation. Three days later after the leadless pacemaker implantation, he got high fever and chest pain. We diagnose acute pneumoniae with chest CT images and blood examinations. However, some examinations showed not only pneumonia but also leadless pacemaker infection. In blood culture, MRSA was positive, and vegetation on the leadless pacemaker was observed by a transesophageal echocardiography. We treated with conservative antibiotic therapy and removal of pacemaker leads and leadless pacemaker.

Methods:

We decided to removal of infected Micra about 4 months after implantation. We introduced a catheter transfemoral vein (Micra introducer: 23 Fr inner diameter, 27 Fr outer diameter, Medtronic Inc). Then we loaded a pair of 7 mm/175 cm snare (Amplatz goose neck, MERITMEDICAL) and introducer catheter (7Fr 98 cm, XEMEX) to grab the head and the tail of the Micra, which was released from the septal myocardium while pushing the septal and pulling back the Micra.

Result:

Micra was safely removed from the right ventricle (RV). No fibrosis and vegetation involving tines or body of Micra was observed. Echocardiogram after the operation excluded pericardial effusion.

Conclusion:

The infected Micra about 4 months after implantation was able to extract from the RV because the leadless pacemaker was implanted on the septal wall of RV. If Micra was deployed at apex of RV, thin wall thickness of RV was difficult to extract it due to get higher risk of RV rupture.

AP19‐­00032

Early experience of leadless pacemaker implantation in a single Japanese center

Motomi Tachibana, Kimikazu Banba, Kensuke Matsumoto, Masahisa Arimichi, Atsushi Hirohata

Sakakibara Heart Institute, Japan

Introduction:

The leadless pacemaker (Micra Transcatheter Pacing System ;Micra TPS) is recognized as a viable alternative to transvenous single chamber pacemaker system. The safety and efficacy have been reported in western countries. However, the studies with Micra TPS in Japanese have not well been known. The present study aimed to evaluate the safety and efficacy of Micra implantation in our institution.

Methods:

Twenty seven patients implanted Micra TPS in our institution from September 2017 to January 2019 were recruited. We investigated retrospectively the efficiency of Micra implantation.

Result:

The mean age and BMI of study patients was 85 years‐­old, and 21 kg/m², respectively. Sixteen patients (59.2%) had dementia, and 3 (11.1%) showed chronic obstructive lung disease. Antithrombotic agents were administered in 12 patients (44.4%). The primary disease of the patients was as follows, Sick sinus syndrome (n = 12, 44.4%), atrioventricular block (n = 8, 29.6%), and Bradycardia atrial fibrillation (n = 7, 25.9%). Twenty‐­six patients (96.3%) were successfully implanted Micra TPS without complication. One patient (3.7%) needed reoperation next day after the operation due to dislodgement. Within 30 day after operation, the pacing threshold became worse than just after implantation in 3 patients (11.1%).

Conclusion:

The Micra TPS implantation is likely to be alternative to transvenous single chamber pacemaker. However, it is necessary to pay attention to the threshold especially during the early phase of postoperative period.

AP19‐­00036

The effect of direct to patient communication on patient compliance with automated managed remote monitoring (RM) of cardiac implantable electronic devices (CIEDs)

Kevin Campbell, Rebecca Revell

PaceMate/Biocynetic, United States

Introduction:

Remote monitoring of CIED patients is accepted as standard of care according and this has been published in consensus statements in 2015. Prior studies have indicated that comprehensive remote monitoring of devices can decrease hospitalizations, improve outcomes, and decrease mortality. The amount of data generated by CIEDs can easily overwhelm device clinics and automation of the clinic workflow with software has positively impacted this process and improved patient compliance. However, patients often require reminder phone calls, help with troubleshooting and many prefer a human contact when managing their devices at home. We hypothesize that Software based automated remote monitoring, when utilized with active patient communication via telephone calls, can improve patient compliance and reduce monitor disconnects.

Methods:

A subset of 5981 patients enrolled in the PaceMate automated remote monitoring system that had CIEDs requiring manual transmissions were considered over a 50‐­day period. Prior to the initiation of the study, patients were managed with both automation as well as personal telephone support (including transmission reminder calls, calls for missed transmissions, and calls for disconnected monitors) through a centralized communication center. During the 50‐­day study period, no telephone reminders were made. After 50 days, a roster of non‐­compliant patients was generated from the vendor lists of disconnected monitors, missed transmissions and “no scheduled” transmissions.

Result:

In our sample, after 50 days of eliminating human telephonic patient communication from 16 different clinic settings, there was a mean reduction of patient transmission compliance of 41%. Of the 5981 patients enrolled, 2457 patients were found to have missed transmissions at the end of the study period. The Median decrease in compliance was 29% and the IQR for the decrease was 39.5%

Conclusion:

These results demonstrate the importance of incorporating direct to patient communication protocols in the management of CIED patients followed with automated remote monitoring software solutions. Automation with software certainly improves workflow and increases the ability of clinicians to process large amounts of data in an efficient and timely fashion. However, direct to patient communication is still needed in order to maximize the potential benefits of remote monitoring. The disruption of remote monitoring data flow can lead to missed alerts involving heart failure diagnostics, clinically actionable arrhythmias or significant device or lead malfunction. Our study suggests that adding direct to patient communication to a robust automated remote monitoring software system can significantly improve patient compliance and likely will lead to improved patient outcomes.

TABLE 1 Change in Compliance without direct‐­to‐­patient communication

Clinic	Number of patients	Non‐complaint after 50 days	% decrease in compliance without direct to patient communication
A	63	34	54%
B	331	274	83%
C	1682	334	20%
D	83	58	70%
E	502	41	8%
F	112	71	63%
G	508	142	28%
H	80	26	33%
I	155	115	74%
J	251	114	45%
K	765	385	50%
L	199	151	76%
M	29	29	100%
N	967	610	63%
O	131	68	52%
P	123	5	4%
Totals	5981	2457	Mean = 41%

AP19‐­00037

Automation of remote monitoring of cardiac implantable electronic devices (CIEDs): The clinical implications of after‐­hours data management

Kevin campbell

PaceMate/Biocynetic, United States

Introduction:

Remote monitoring and follow up of data generated by CIEDs can be a complex and time‐­consuming process. Data flow 24 hours a day, 7 days a week and, as a result, data transmissions occur at times when devices clinics are closed. The aim of this study was to characterize after‐­hours transmissions by percentages of overall transmissions and by clinical urgency.

Methods:

CIED device transmission data from patients enrolled in automated remote follow up using PaceMateTM remote monitoring software over a 12‐­month period were examined. Transmissions were classified as GREEN (normal), YELLOW (abnormal needing MD review) and RED (urgent action required) by PaceMateTM software and confirmed by IBHRE certified PaceMate technicians.

Result:

There were 66 702 transmissions received from 9379 patients with 9379 devices (1 CIED per person). The transmission rate by device type ranged from 1.8 to 15.3 with a mean of 7.1 transmissions/device over the study period. Overall, 75.3% of transmissions occurred after usual business hours, 41.1% on weekday nights and 34.2% on weekends. There were 377 transmissions classified as RED alerts (0.6% of all transmissions) and 75.3% of RED alerts occurred after hours: 47.8% on weekday evening and 27.6% on weekends. There were 17323 transmissions classified as YELLOW alerts (26.0% of all transmissions) and 75.0% of these alters occurred after hours: 48.8% on weekday evenings and 33.7%% on weekends.

Conclusion:

Three‐­quarters of all transmissions from remote monitoring of CIEDs occurred after hours. These data take a great deal of staff labor to process manually and may be taking time away from other important clinical activities during usual hours. Importantly, 75% of all RED and all YELLOW alert transmissions also occurred after hours. The combined total of RED and YELLOW alerts represented almost 18000 transmission, 27% of all transmissions, and, on average, 1.9 transmissions per patient. This high volume of potentially clinically significant and actionable after‐­hours events puts patients at risk for missed or delayed clinical response without an automated, systematic way to process them.

AP19‐­00038

Percutaneous dual chamber pacemaker implantation via transhepatic approach in a patient with Ebstein's anomaly after Glenn operation and tricuspid valve replacement

Fang Yuan, Wan Ke, Jiang Lingyun

Sichuan University, West China Hospital, China

Introduction:

A 62‐­year‐­old woman with Ebstein's Anomaly was admitted with exertional dyspnea. The 24‐­hours electrocardiogram monitoring showed junctional escape rhythm without P waves at a heart rate of 33 beats per minute and Mobitz type II block. Implantation of a permanent pacemaker was recommended. She had a history of Glenn operation and tricuspid valve replacement two years ago. Contrast‐­enhanced computed tomography showed that the superior vena cava was connected to the right pulmonary artery (Panel A).

Methods:

Given subclavian vein hindered, transhepatic venous route would be a reasonable approach. The procedure was performed with the patient under conscious sedation. Under ultrasound guidance, the middle hepatic vein was successfully punctured and catheterized for lead access. Two guide wires were advanced into the right atrium via the hepatic vein via. A ventricular lead was screwed into the inferior wall of the right ventricle, the atrial lead was inserted in the right atrium.

Result:

After confirming acceptable capture threshold, the leads were connected to a dual chamber pacemaker, and the generator was placed in a pocket under the fascia of the rectus abdominis muscle (Panel B). No complications such as local liver injury, hematoma and hepatic vein thrombosis were observed. During the 6‐­month follow‐­up, there was no hepatic dysfunction and dislocation of electrode.

Conclusion:

The trans‐­hepatic route may be considered as a viable route for pacemaker implantation in such case which subclavian vein route isn't feasible.

AP19‐­00041

“Stubborn right ventricle” ‐­ How did we overcome the challenge?

Nishan De Vas Goonewardane, Suresh Kottegoda

Sri Jayawardenepura General Hospital, Sri Lanka., Sri Lanka

Introduction:

56‐­year‐­old patient without significant co‐­morbid disease was diagnosed to have symptomatic sinus node dysfunction and consented for a dual chamber pacemaker. He did not suffer from background ischaemic heart disease, ECHO assessment was normal with structurally normal heart, preop investigations showed normal electrolytes, calcium, and creatinine. Was not on any medication of significance.

Methods:

Pre pectoral pocket creation and subclavian vein puncture was uneventful. During procedure RV lead was manipulated to multiple positions through the introducer sheath but failed to achieve pacing despite good sensing thresholds over 5 mV. Lead, connector cable, programmer connections were adjusted but was in vain. Ultimately, we decided to insert a 5FR Temporary pacemaker wire through the subclavian vein access which was an innovative move. Due to its easier manoeuvrability, with lot of effort we found an atypical location near anterior free wall of RV where pacing is possible albeit with high amplitudes. Position fluorosaved and PPM lead parked in exact location and actively screwed. RA too was silent so we reverted to single chamber pacing.

Result:

Immediate recovery was uneventful. Post PPM programming in 6 weeks showed improved pacing and sensing function and intact placement. Sensing was 12 mV, pacing threshold 1.2V, and impedance 786 Ohms.

Conclusion:

This is the first occasion we have faced an electrically silent Right ventricle endocardium. We managed to get over the problem with innovative strategy and flexible decision making. It is very rare to have a silent RV when there are no scars around. Cardiac MRI will be useful to screen any myocardial disease followed by myocardial biopsy if needed.

AP19‐­00044

Incidence and predictors of pacemaker induced left ventricular dysfunction in patients with right ventricular pacing

Raghav Bansal, Neeraj Parakh, Anunay Gupta, Rajnish Juneja, Nitish Naik, Rakesh Yadav, Gautam Sharma, Ambuj Roy, Sunil K Verma, Vinay K Bahl

Holy Family Hospital, India

Introduction:

Asynchronous activation of left ventricle (LV) due to chronic right ventricular (RV) pacing has been known to predispose to LV dysfunction. The predictors of LV dysfunction remain to be prospectively studied. This study was designed to follow up patients with RV pacing to look for development of LV dysfunction and identify predictors of LV dysfunction.

Methods:

Three hundred sixty three patients undergoing dual chamber and single chamber ventricular implants were enrolled and followed up. Baseline clinical parameters; paced QRS duration and axis; RV lead position by fluoroscopy; LV ejection fraction (LVEF) by simpson's method on transthoracic echocardiography (TTE); intraventricular dyssynchrony (spetal‐­posterior wall contraction delay) and interventricular dyssynchrony (aorto‐­pulomnary ejection delay) on TTE were recorded. The patients were followed up at 6‐­12 monthly interval with estimation of LVEF and pacemaker interrogation at each visit. Pacemaker induced cardiomyopathy (PiCMP) was defined as a fall in ejection fraction of 10% as compared to the baseline LVEF. Patients developing PiCMP were compared to other patients to identify predictors.

Result:

The mean age of study population was 59.8 years, 68.3.

Conclusion:

Incidence of PiCMP with RV pacing was found to be 13.8% over a mean follow up of 14.5 months. Burden of right ventricular pacing and interventricular dyssynchrony were identified as the most important predictors for the development of PiCMP.

TABLE 1 Baseline patient characteristics expressed for the entire cohort and cohort stratified by the presence or absence of Pacemaker induced cardiomyopathy (PiCMP)

Characteristic	Entire cohort (n = 254)	Cohort with PiCMP (n = 35)	Cohort without PiCMP (n = 219)	P value
Age (years)
<60 years	95 (37.4%)	11 (31.4%)	84 (38.3%)	.432
≥60 years	159 (62.6%)	24 (68.6%)	135 (61.6%)
Sex (% males)	68.9%	65.7%	69.4%	.661
Diabetes	33.5%	25.7%	34.7%	.295
Hypertension	30.7%	40%	29.2%	.199
CAD	15.7%	14.3%	15.9%	.798
Type of pacing
1 VVIR	127 (50.0%)	19 (54.3%)	108 (49.3%)	.585
2 DDDR	127 (50.0%)	16 (45.7%)	111 (50.7%)
Site (Other excluded)
1 Apical	144 (56.7%)	21 (60%)	123 (56.2%)	.353
2 Non‐­Apical	104 (40.9%)	11 (31.4%)	93 (42.4%)
Mid septum	54 (21.2%)	6 (17.1%)	48 (21.9%)
RVOT	50 (19.7%)	5 (14.3%)	45 (20.5%)
pQRSd
<150 msec	160 (63.0%)	18 (51.4%)	142 (64.8%)	.127
>150 msec	94 (37.0%)	17 (48.6%)	77 (35.2%)
Baseline LVEF	58% ± 7.3%	60% ± 8.0%	58% ± 7.1%	.400
% pacing
<60%	96	12	67	.002
≥60%	158	23	152
Aorto‐­pulmonary ejection delay (msec)	30.2 ± 20.6	42.3 ± 19.1	28.3 ± 20.2	.001
Septal posterior wall activation delay (msec)	51.5 ± 35.6	60.3 ± 33.1	50.0 ± 35.8	.665
FU LVEF	55% ± 8.0%	45% ± 10%	56% ± 6.3%	–

TABLE 2 Multivariate analysis for identification of predictors of PiCMP

Characteristic	Hazard ratio	P value	Confidence intervals
Age (years)	1.35	.433	0.63‐­2.91
Sex (% males)	0.84	.662	0.39‐­1.79
Diabetes	0.65	.298	0.29‐­1.46
Hypertension	1.61	.202	0.77‐­3.37
CAD	0.87	.798	0.32‐­2.41
Dual vs Single chamber	0.819	.585	0.40‐­1.67
Site (Apical vs Non‐­Apical)	1.44	.355	0.66‐­3.14
pQRSd (≥150 msec vs < 150 msec)	1.74	.130	0.85‐­3.57
Baseline LVEF	1.63	.405	0.51‐­5.21
% pacing (<60% vs > 60%)	4.26	.004	1.59‐­11.41
Aorto‐­pulmonary ejection delay (mesec)	3.15	.002	1.52‐­6.55
Septal posterior wall activation delay (msec)	1.41	.666	0.29‐­6.83

AP19‐­00051

Single chamber leadless pacemaker implantation for the treatment of cardioinhibitory vasovagal syncope ‐­ a United Kingdom perspective

Michael Chi Yuan Nam, Christopher Pepper, Christopher Rinaldi, Matthew Bates, Andrew Thornley, Riyaz Somani, Khalid Abozguia, Stuart Harris, Archana Rao, Michala Pedersen, Janet McComb, Ewen Shepherd, Oliver Segal, Richard Schilling, Amir Zaidi, Paul Roberts

Bournemouth Hospital ‐­ UK, United Kingdom

Introduction:

The use of pacemakers in the treatment of cardioinhibitory vasovagal syncope is controversial with a mixed message from the limited evidence base. Single chamber leadless pacemakers have been shown to be an effective alternative option to conventional pacemakers, but their benefit within the context of cardioinhibitory vasovagal syncope is unknown. This study examines the use of leadless pacemakers in a cardioinhibitory vasovagal population in the United Kingdom.

Methods:

Observational data on 32 patients implanted with the Micra Transcatheter Pacemaker System for vasovagal syncope are presented. Data was collected on implant indications, implant procedure and follow up data from 12 centres across the United Kingdom that had elected to use a Micra leadless pacemaker in this patient population.

Result:

32 patients aged 37 ± 14 years (range 18‐­64 years) with 62% of the patients being female were recruited to the study. Vasovagal syncope was diagnosed clinically and with the support of Holter ambulatory cardiac monitoring, tilt table testing and implantable loop recorders. The duration of symptoms was 8 ± 8 years with an average frequency of syncope being 4 ± 6 times/year. The mean longest documented R‐­R interval was 13 ± 7 seconds. The Micra pacemaker was successfully implanted in all patients with a major complication rate of 3.1%. Patients were followed up for 404 ± 237 days (range 63‐­928 days). At follow up 28 (87%) patients were free from symptoms.

Conclusion:

This observational study suggests that the use of a single chamber leadless pacemaker in the treatment of cardioinhibitory vasovagal syncope might be a reasonable clinical option.

AP19‐­00053

Diabetes attenuates response to cardiac resynchronization therapy and worsens prognosis in heart failure: results from the Prospective Evaluation of Asian with CRT for Heart Failure study

Eugene Tan

National University Heart Centre Singapore, Singapore

Introduction:

The association of diabetes with cardiac resynchronization therapy (CRT) response and cardiovascular outcomes in Asian patients with heart failure (HF) are unclear. This study aims to investigate the effects of diabetes on CRT response and cardiovascular outcomes in Asian HF patients.

Methods:

Consecutive Asian HF patients receiving CRT were enrolled in the Prospective Evaluation of Asian with CRT for Heart Failure (PEACH) registry from 2011 to 2017. Only patients with paired echocardiograms pre‐­ and post‐­CRT were included in the study CRT response and super‐­response was defined as decrease in end‐­systolic volume index ≥ 15% and ≥ 30%, respectively. Primary endpoint was time to composite of HF‐­hospitalization and all‐­cause mortality.

Result:

Among 161 patients followed for 3.3 ± 1.5 years (age 6.7 ± 11.2 years, 22% females, mean QRS duration 154.3 ± 22.4 milliseconds, 83% left bundle branch block), 84 (52%) were CRT responders and 57 (35%) were super‐­responders. Responders were more likely non‐­diabetic (Responders: 62% non‐­diabetic vs 43% diabetic, P = .01; Super‐­responders: 46% non‐­diabetic vs 26% diabetic, P = .008). Of 82 (51%) patients with diabetes (mean HbA1c 8.0 ± 2.1%, mean duration 7.6 ± 4.6 years), 35 (43%) achieved CRT‐­response, of which 32 (91% of diabetic responders) were super‐­responders. Diabetic patients were more likely to have ischaemic heart disease (80% vs 59%, P = .004), chronic kidney disease (60 vs 28%, P < .001), retinopathy (11% vs 0%, P = .002) and peripheral vascular disease (15% vs 1%, P = .002). However, LV dimensions and LVMI were similar in the presence or absence of diabetes. Diabetic patients were at least 56% less likely to achieve reverse remodelling with CRT (CRT response: AOR 0.44, 95% CI 0.20‐­0.98; Super‐­response: AOR 0.42, 95% CI 0.18‐­0.97). Diabetic non‐­responders had a higher baseline HbA1c than diabetic responders (8.5 ± 2.3% vs 7.4 ± 1.6%, P = .02), and a larger proportion in the highest quartile of lead separation (38% vs 14%). However, insulin use (23% vs 38%, P = .14), duration of diabetes (7.7 ± 4.2 vs 7.5 ± 5.0 years, P = .69) and mean LVMI (154.1 ± 42.9 vs 150.3 ± 48.5, P = .43) did not differ between diabetic responders and diabetic non‐­responders respectively. The extent of CRT‐­response correlates with higher event‐­free survival (CRT response: AHR 0.5, 95% CI 0.30‐­0.81; super‐­response: AHR 0.27, 95% CI 0.14‐­0.52).

Conclusion:

The extent of reverse remodelling post CRT is the strongest predictor of event free survival. However, diabetes is detrimental to the CRT recipient by attenuating reverse remodelling, inducing end organ dysfunction and is independently associated with worsened clinical outcomes among Asian HF patients.

AP19‐­00069

Initial experience of subcutaneous implantable cardioverter defibrillators in Thailand

Titaya Sukhupanyarak, Thachapong Ngamukos, Sirin Apinyasawat, Pakorn Chandanamattha

Ramathibodi, Thailand

Introduction:

Background: The subcutaneous implantable cardioverter‐­defibrillator (S‐­ICD) was safety and feasibility in worldwide. However, in Thailand, the study of S‐­ICD was small and limited.

Methods:

Method: The Retrospective study between 1 November 2015 and 30 September 2018 in Ramathibodi hospital, Thailand. The patient who implant S‐­ICD was enrolled.

Result:

Result: 7 patients were enrolled in the study. 4 were male (57%), mean age 34 years old (range 23‐­69) mean BMI 25 kg/m2 (range 16‐­47). The S‐­ICD was implanted for primary prevention 4 patients (57%). Clinical indications included Brugada syndrome (3 patients), Non ischemic cardiomyopathy (2 patients), RVOT VT (1 patient) and idiopathic ventricular fibrillation (1 patient). There was hematoma 1 patient. After a mean follow‐­up of 16 months (range 1‐­34 months), one patient underwent one successful appropriate shock for treatment and one patient underwent one inappropriate therapy.

Conclusion:

Conclusion S‐­ICD is a safety and feasible treatment of VT in Thai population.

AP19‐­00072

Safety and performance of a novel two lead cardiac resynchronization therapy system

Naushad Shaik, Michael Drucker, Christopher Pierce, George Thomas, Shane Gillett

BIOTRONIK, United States

Introduction:

Novel two lead BIOTRONIK CRT‐­D (DX) devices provide a floating atrial dipole in lieu of a dedicated atrial lead to collect atrial sensing diagnostics and can offer several advantages compared to conventional three lead devices, including a reduction in procedural complexity and re‐­ intervention risk. When implanted with an LV lead, these combine for a two lead CRT system. The goal of the research presented herein is to evaluate CRT‐­DX system safety and performance compared with a conventional three lead CRT‐­D system at 3 and 6 months post‐­implant.

Methods:

A total of 126 subjects from the QP ExCELs study (NCT02290028), were selected to identify 63 matched pairs (each DX subject paired with a CRT‐­D control) with demographic characteristics based on age, gender, NYHA class, LVEF and heart failure etiology. All patients had a standard CRT‐­D indication with de novo implantation or an upgrade from an existing ICD or pacemaker. System performance data was obtained from routine, daily remote transmissions, and system performance differences were assessed by taking a 14‐­day average of the mean differences between each subject pair at 3 and 6 months post‐­implant. All adverse events utilized QP ExCELs case report forms and were evaluated through 6 months post‐­implant.

Result:

Subjects were 65% male with a mean age of 67 years and LVEF of 25%. Sixty percent of the subjects were NYHA class III with the remainder NYHA class II. System performance characteristics are provided in the attached table. A total of 2 adverse events were identified as related or possibly related to the RA or RV lead in both the CRT‐­DX and in the conventional CRT‐­D cohorts. Two RV/RA lead dislodgements occurred in the CRT‐­D cohort, compared to 1 RV lead dislodgement in the CRT‐­DX cohort. One occurrence of oversensing in the RA dipole due to excess noise was identified in the CRT‐­ DX cohort. All four of these events were resolved with a lead revision. Additionally, 4 implant‐­related events were identified as occurring in the conventional CRT‐­D cohort, compared with 2 implant‐­related events in the CRT‐­DX cohort. No pulse generator‐­related adverse events were identified in either cohort.

Conclusion:

The results suggest similar safety and performance in both the CRT‐­DX and conventional three‐­lead CRT‐­D systems over a duration of 6 months post‐­implant, despite the DX lead utilizing one fewer lead.

	RA Sensing Amplitude (Δ ± SD) (mV)	RV Pacing Threshold (Δ ± SD) (V)	Shock Impedance (Δ ± SD) (Ohms)
DX cohort minus 3 lead cohort (N = 63)
3 months post‐­ implant	0.27 ± 2.65	−0.05 ± 0.25	5.14 ± 13.82
6 months post‐­ implant	0.22 ± 2.61	−0.05 ± 0.24	4.17 ± 17.30
	Total Count of Pulse Generator Adverse Events	Total Count of Implant‐­related Adverse Events	Total Count of RA/RV lead Adverse Events
DX Cohort	0	2	2
3 Lead Cohort	0	4	2

AP19‐­00075

The change of QRS duration in patients upgrading to cardiac resynchronization therapy from a pacemaker or implantable cardioverter defibrillator

Tomoyuki Kabutoya, Yasushi Imai, Takafumi Okuyama, Ayako Yokota, Hiroaki Watanabe, Tomonori Watanabe, Takahiro Komori, Kazuomi Kario

Jichi Medical University, Japan

Introduction:

Heart failure patients with a pacemaker or implantable cardioverter defibrillator (ICD) have frequently underwent upgrade operation to cardiac resynchronization therapy (CRT). The characteristics of electrocardiograms in such patients have not been established.

Methods:

We enrolled 15 patients who were upgraded to CRT from a pacemaker and a control group of age‐­ and gender‐­matched patients (15 patients with pacemakers). We also enrolled 17 patients who were upgraded to CRT‐­defibrillators (CRT‐­D) from ICDs and a control group of age‐­ and gender‐­ matched patients (17 patients with ICDs). We evaluated the QRS duration and QTc duration of all patients at baseline and at CRT implantation or at the exchange of the generator.

Result:

Among the patients with a pacemaker, the QRS duration and QTc duration were significantly higher in the upgrade group compared to the control group (QRS duration:175 ± 37 vs 141 ± 29 milliseconds, P = .013, QTc duration 504 ± 39 vs 470 ± 31 milliseconds, P = .015). Among the patients with an ICD, the QRS duration was significantly higher in the upgrade group compared to the control group (163 ± 28 vs 134 ± 40 milliseconds, P = .026), but the QTc duration was similar in both groups (P = .35). The change of QRS was similar between the upgrade group and control group among the patients with a pacemaker (6.7 ± 14.1 vs 3.3 ± 28.8 milliseconds, P = .68) and among the patients with an ICD (8.3 ± 44.0 vs 6.5 ± 25.8 milliseconds, P = .91). The change of QRS was associated with a decrease in QRS duration after CRT implantation among the patients with CRT‐­D from ICDs (r = 0.65, P = .012).

Conclusion:

Prolongation of the QRS duration at baseline, but not the QRS change, was associated with upgrading to CRT. If the QRS duration of a patient with a pacemaker or ICD is wide, CRT implantation might be considered.

AP19‐­00077

A case of CRT implantation using by MediGuide technology

Tomoyuki Kabutoya

Jichi Medical University, Japan

Introduction:

MediGuide technology has applied 3D visualization and navigation by Ensite Velocity System to a pre‐­recorded 2D X‐­ray image to create a real time navigation and ablation without use of fluoroscopy.

Methods:

We implanted cardiac resynchronization therapy (CRT) using by MediGuide technology.

Result:

A 75 years old underwent VVI pacemaker implantation due to bradycardia with atrial fibrillation 6 years ago. He had felt dyspnea, and left ventricular (LV) ejection fraction was reduced to 26% assessed by echocardiography. His Holter ECG and interrogation of pacemaker revealed no evidence of ventricular tachycardia. He underwent CRT upgrade implantation. We introduced a sheath using by fluoroscopy. After recording of 2D X ray, and we introduce CS catheter using by livewire and MediGuide. We confirm coronary vein branch using by contrast agents and fluoroscopy, and introduce LV lead using by MediGuide system. We successfully perform CRT upgrade, his symptom was improved, and LV ejection fraction assessed by echocardiography improved to 36%, and LV systolic volume reduced from 118.2 mL to 87.7 mL.

Conclusion:

MediGuide technology was useful to adding LV lead during CRT upgrade operation for reduction of fluoroscopy.

AP19‐­00083

Venovenous loop with use of indigenous snare for placement of the left ventricular lead during cardiac resynchronization therapy T

Muni Venkatesa Reddy, Saurabh Deshpande, Shishir Roul, Ameya Udyavar

INDIANRAILWAY MEDICAL SERVICES, India

Introduction:

Placement of the left ventricular (LV) lead in the postero‐­lateral vein during cardiac resynchronization therapy (CRT) implantation can be challenging at times. The rate of failure of LV lead placement is 2.4%‐­5%. These difficult cases are addressed with use of long sheaths, extra stiff wire support, balloon anchors, coronary sinus venoplasty, use of goose neck snare, jailed catheter technique & trans septal lead placement. We hereby present a case with very tortuous lateral vein anatomy in which we used “an indigenous snare” which was made from regular hardware used for coronary angioplasty procedures. We formed a venovenous loop of the guide wire and then could achieve a desired and stable position of LV lead with good right ventricular (RV) and LV lead separation

Methods:

52‐­year‐­old hypertensive and diabetic male with old coronary artery disease, with history of coronary artery bypass (CABG) surgery done in past, presented with NYHA class III symptoms. He was optimal medical management. He was planned for cardiac resynchronization therapy (CRT). During left ventricular (LV) lead implantation, there was difficulty in negotiation into desired lateral vein due to local stenosis and unfavorable angle. When balloon dilatation failed to position the lead in place, it was planned to form a venovenous loop for implantation of LV lead. We passed the coronary guidewire from Coronary Sinus (CS) Lateral vein, Collateral Vein, Middle Cardiac Vein, CS, Right Atrium (RA), Superior Vena Cava (SVC). Then, we prepared an “indigenous snare” from a coronary balloon and a workhorse 0.014” coronary guidewire. The distal end of 1st coronary wire was caught with the help of the indigenous snare and exteriorized to form a venovenous loop. The LV lead was then passed into the lateral vein over this venovenous loop. It could be negotiated at the desired distal position and it remained stable after removal of the guidewire.

Result:

There was a very good separation of RV and LV leads as confirmed in orthogonal views on fluoroscopy. The patient has improved post procedure in terms of symptoms, shortening of QRS on ECG and improvement in ejection fraction on follow up of more than 10 months

Conclusion:

In cases with difficult anatomy of CS and lateral vein, it is possible to get a good LV lead position even without use of any special hardware like dedicated snares. This will help get improved success rate with CRT procedures and avoid need for thoracotomy with epicardial lead placement.Images from A to F. (A) Selective Venogram with CS catheter and super‐­ selective headhunter catheter. (B) Passage of coronary guidewire from CSà Lateral Veinà Collateral Veinà Middle Cardiac Veinà Coronary Sinusà RAà SVC. (C) Preparation of the indigenous snare with coronary balloon and a guidewire. (D) The indigenous snare. (E) Tracking of LV lead over the venovenous loop. (F) Final lead position of the three leads. Good separation of RV and LV leads

AP19‐­00092

Permanent ventricular‐­side His bundle pacing achieved by the approach of radiographic landmarks in bradycardia patients

Min Gu, Yiran Hu, Wei Hua, Hui Li, Shu Zhang

Fuwai Hospital, CAMS&PUMC, China

Introduction:

His bundle pacing is a physiological pacing therapy, but His bundle pacing in ventricular side (vHBP) is not well investigated. This study was to investigate the feasibility of permanent vHBP implantation guided by the radiographic marker of the tricuspid valve annulus (TVA).

Methods:

Permanent vHBP was attempted in 30 patients (50% men, age 64 ± 15 years) with symptomatic bradycardia and indicated for pacemaker implantation. The TVA revealed by right ventriculography was used as an anatomic landmark for localizing the site for vHBP under the TVA. Procedural feasibility, vHBP pacing parameters, the effect of vHBP lead on tricuspid valve function, and procedure‐­related complications were evaluated.

Result:

Permanent vHBP was successfully achieved under the TVA in 28 of 30 patients (93.3%). The vHBP threshold was 1.00 ± 0.42V@1 milliseconds (range: 0.4‐­1.9V@1 milliseconds) at implant and remained stable (0.97 ± 0.41V@1 milliseconds, P = .643) after median 6 months follow‐­up. Permanent nonselective vHBP was implemented in 92.9% (26/28) of patients, in which the capture threshold for His bundle and local myocardial tissue were 1.03 ± 0.43V@1 milliseconds and 1.05 ± 0.73V@1 milliseconds, respectively. Two patients had selective vHBP, each with capture threshold 0.7V@1 milliseconds. There were no procedure‐­related complications or significantly worsening tricuspid regurgitation during follow‐­up.

Conclusion:

Permanent vHBP, mostly nonselective, was purposely achieved with a 93.3% success rate and with a low and stable pacing threshold in bradycardia patients. Location of the TVA revealed by right ventriculography can be used as a landmark to identify the site of vHBP, making implantation outcome almost predictable.

AP19‐­00096

A case series of per cutaneous extraction of leads in patients with infected cardiac implantable electronic devices with spectranetics extraction tools

Vishal Pawal, Ameya Udyavar, Hasmukh Ravat

FORTIS HOSPITAL, MULUND WEST, MUMBAI., India

Introduction:

Endocarditis, lead ex plantation or lead/pocket infection in cardiac implantable electronic devices (CIEDs), either permanent pacemaker, implantable cardioverter defibrillators (ICD) or cardiac re synchronization therapy (CRT) device is a disease associated with high mortality. The increasing number of patients with CIEDs explains the rising frequency of endocarditis and lead infection. We present 7 cases of CIEDs related infection & our initial experience with per cutaneous extraction of leads with lead locking devices & Tight Rail Rotating Mechanical Dilator sheath.

Methods:

Skin incision was taken and dissection was done up to the generator & the generator was ex planted. Spectranetics Lead locking device (LLD) (Phillips, San Diego, California) was passed till the tips of leads after cutting off their hubs & was locked. In our cases, RV lead was found stuck proximally at the level of the subclavian ‐­ SVC junction & distally at the level of tricuspid annulus & RV posterior wall. 10/11F dilator sheath was passed over the lead to dilate it over the subclavian region so that it could be free of the adhesions. 11F/13F Tight Rail Rotating Mechanical Dilator sheath was passed over the lead. The adhesions along the length of lead, at the level of tricuspid annulus and RV wall were cut off with the help of the dilator sheath and activated rotating blades. Subsequently the leads were withdrawn with gentle traction.

Result:

Seven cases (3 pacemakers, 2 CRT and 2 ICD devices) underwent per cutaneous extraction of total 13 leads (7 RV, 5 RA and 1 CS lead). Mean age was 54 ± 23 years, with 43% males & 57% females. 5 cases had pocket site infection & 2 had externalization of the pacemaker lead & generator. In 5 cases single skin incision (at generator) & in 2 cases two skin incisions (at generator & leads) were taken. We observed resistance during the lead extraction at subclavian‐­SVC junction in 7, tricuspid annulus in 4 & RV wall in 3 cases. All the leads were extracted successfully without any complications. Primary wound closure was done in 5 & secondary closure in 2 cases.

Conclusion:

Per cutaneous extraction of leads needs technical skills & familiarity with various hardware devices used in the procedure. With availability of various tools such as lead locking devices & mechanical dilator sheaths has improved success rate of this procedure. The series documents successful lead extraction of the leads with extraction tools & successful healing of their wounds.(A) External wound with leads abutting out of skin. (B) Resistance at subclavian‐­ svc junction on fluoroscopy. (C) Resistance at RV posterior wall/tricuspid annulus on fluoroscopy. (D) Extracted lead with tissue

AP19‐­00099

Difference in acute effect of His‐­bundle pacing and conventional right ventricular septum pacing on left ventricular regional wall motion

Masao Takahashi, Taichi Watabe, Kazunari Taniguchi, Hisanori Sanuki

kyushu rosai hospital moji medical center, Japan

Introduction:

There is continued debate regarding the optimal ventricular pacing site for the management of bradyarrhythmias. Previous studies demonstrated conventional right ventricular pacing has adverse effect on cardiac systolic function such as left ventricular (LV) dyssynchrony and LV regional asynergy. Although there are some reports that His‐­bundle pacing (HBP) is less likely to cause electrical and mechanical LV dyssynchrony compared to other ventricular pacing sites, the effect of HBP on LV regional wall motion is well unknown. The purpose of present study is to evaluate and compare the effect of HBP and conventional right ventricular septum pacing (RVSP) on LV regional wall motion by speckle tracking echocardiography.

Methods:

Totally 16 patients newly implanted with dual‐­chamber pacemaker were enrolled. Nine patients underwent successful HBP (all cases were non‐­selective HBP), 7 patients underwent conventional RVSP. All atrial leads were placed in right atrial appendage. 12‐­lead electrocardiogram and echocardiography were conducted at 1 week after pacemaker implantation during own beats and ventricular pacing with atrio‐­ventricular synchronization, respectively. LV was divided in American Society of Echocardiography recommended 16 segments and the longitudinal strain (LS) of each segment was calculated by speckle tracking echocardiography.

Result:

QRS width during RVSP was significantly longer than during HBP (152 ± 9 milliseconds vs 124 ± 24 milliseconds, P = .01). LS value during RVSP in 4 segments was significantly smaller than during own beats (septum‐­base; 9.1 ± 3.9% vs 16.3 ± 3.7%, P = .0006, septum‐­mid; 12.0 ± 3.3% vs 18.4 ± 5.0%, P = .001, inferior‐­base; 13.7 ± 2.7% vs 19.1 ± 3.2%, P = .004, inferior‐­mid; 15.7 ± 3.5% vs 18.6 ± 4.1%, P = .005). However, there was no significant difference in the LS value between during HBP and during own beats in all 16 segments.

Conclusion:

It was suggested that HBP may minimize LV regional asynergy caused by ventricular pacing for the management of bradyarrhythmias.

AP19‐­00100

Transaxillary sub‐­pectoral approach for cosmetic placement of implantable cardioverter defibrillators

Corey Smith, Andrew Hopkins

St George Hospital, Australia

Introduction:

Implantable cardioverter defibrillators (ICD) are occasionally required in young patients. Particularly if body mass index (BMI) is low the standard infraclavicular placement may have an untoward cosmetic impact due to the incision scar or visible protrusion of the device. An alternative approach may allow an improved cosmetic outcome.

Methods:

Implant technique: Under general anaesthesia the patient is prepped and draped with the left arm abducted to 90 degrees. A 5 cm incision is made in the axilla parallel to the lateral border of pectoralis major. The subcutaneous tissue is dissected down to reach the pectoralis major fascia and a submuscular pocket is created with blunt dissection. Venous access can be performed from within the pocket or percutaneously by Seldinger technique and tunneling the wires into the pocket. Leads are placed in a standard fashion and the generator is secured to the fascia. A Jackson‐­Pratt drain is placed in the pocket. The deep tissues are closed in two layers and interrupted sutures used to close the skin.

Result:

We performed this technique for a 39 year old woman (BMI 21) referred for ICD implantation following a ventricular fibrillation cardiac arrest due to dilated cardiomyopathy. She expressed strong concern over the cosmetic appearance of a visible scar or device. The procedure was performed by the cardiologist in the catheterisation laboratory with anaesthetic support for general anaesthesia. There were no operative complications. The patient was discharged on postoperative day two. Lead parameters were stable on follow‐­up and the wound healed well. The patient reported satisfaction with the result.

Conclusion:

This technique has previously been described having been performed in conjunction with plastic surgeons, as our case shows a transaxillary sub‐­pectoral ICD can safely be performed by the cardiologist in the catheterisation laboratory. The postoperative appearance is nearly imperceptible. This may result in improved satisfaction, especially for young female patients.

AP19‐­00102

Atrial tachycardia masquerading as high ventricular rate event in a patient with sick sinus disease and a DDD pacemaker

Saurabh Deshpande, Ameya Udyavar

Jag Jivan Ram Western Railway Hospital, Mumbai Central, Mumbai, India., India

Introduction:

Tachy‐­Brady syndrome is a form of sick sinus disease in which atrial tachycardia (AT) or atrial fibrillation (AF) may occur intermittently with bradycardia. These events, post pacemaker implant need to be detected correctly so that they can be treated for rate control and anticoagulation. Pacemakers are designed with algorithms to detect high atrial rates and then mode switch to a non‐­ tracking mode. Here, we present a case of a patient with DDD pacemaker who had multiple episodes of atrial tachycardia. However, the device detected 5 of these episodes as high V‐­rate episodes instead of high A‐­rate episodes. This misinterpretation can have clinical implications for the patient. We explain why this can occur in the device and how it was troubleshot (in the absence of specialised algorithms), by adjusting the post‐­ventricular atrial blanking period (PVAB)

Methods:

A 66‐­year‐­old male, known diabetic and hypertensive, with a significant sinus pauses and syncope underwent a dual chamber DDD pacemaker (SJM Accent DR) implantation. He was asymptomatic on follow up; but routine pacemaker interrogation showed 17 episodes of mode switch and 5 high V‐­rate episodes. On interrogation of the high V‐­rate episodes, it was seen that patient had atrial tachycardia during these episodes; but the marker strip did not detect consecutive A‐­beats. Undersensing of atrial electrogram (EGM) was ruled out as some of the low amplitude EGMs were properly annotated. The atrial beats before the QRS were properly annotated as AR as they fell in the PVARP. It was found that the atrial beats following after the QRS were not detected as they fell in the PVAB. This undercounting of the atrial EGMs led to labeling these 5 episodes as high V‐­rate events. The SJM Accent pacemaker done not have specialized algorithms like Blanked flutter search (Medtronic), 2:1 Lock‐­in protection (Biotronik) and Atrial Flutter response (BSC) which would prevent this. The default PVAB and PVARP values in this device are 110 and 275 milliseconds. The PVAB was reduced to 80 milliseconds subsequently, after which the mislabeling by the device was corrected. Reducing the PVAB further is not advisable as this might pick up the QRS as atrial activity causing double counting resulting in a “false” mode switch. There is an inverse relationship between the duration of the PVAB and the detection of atrial arrhythmias. Shortening the PVAB in this case allowed us to troubleshoot the problem in this case

Result:

N/A.

Conclusion:

In patients with DDD pacemakers, detailed interrogation of high V‐­rate episodes and analysis of the EGMs and their annotations should be carried out to prevent AT from being detected as VT. This can have clinical implications for the patient in means of treatment and prognosis. Careful adjusting of the PVAB can help prevent this problem

AP19‐­00103

The presence of a His‐­Bundle potential predicts optimal pacing configuration

Seth Goldbarg, Joonhyuk Kim

New York Presbyterian/Queens, United States

Introduction:

Direct His‐­bundle (HB) pacing offers advantages over traditional pacing. However, a frequent disadvantage is that a higher pacing output is often required to capture the HB. It was noted anecdotally that the presence of a HB potential during device implant and interrogation may be associated with lower unipolar pacing threshold compared to bipolar pacing.

Methods:

Patients who had undergone implant of a direct His‐­bundle pacemaker were assessed during routine device interrogation visits. The intracardiac electrogram on the HB lead was inspected for the presence of a HB potential. Then, the HB pacing threshold was determined in both unipolar and bipolar configurations, with electrocardiographic guidance to accurately assess HB capture threshold. The first 10 patients with a HB potential and the first 10 patients without a HB potential were included for assessment.

Result:

Patients with a HB potential on the HB lead had an average unipolar HB pacing threshold of 1.325 V at 1 milliseconds and an average bipolar HB pacing threshold of 1.325 V at 1 milliseconds; no difference was noted. The patients without a HB potential on the HB lead had an average unipolar HB pacing threshold of 1.075 V at 1 milliseconds and an average bipolar HB pacing threshold of 1.4 V at 1 milliseconds; the unipolar pacing threshold was on average 0.325 V lower compared to bipolar pacing (23% reduction).

Conclusion:

In patients with a HB potential on the HB lead during device interrogation, capture threshold was similar in either unipolar or bipolar pacing configurations. However, when no HB potential is noted on the HB lead during device interrogation, the unipolar pacing threshold was found to be 23% lower compared to bipolar pacing. This finding may relate to variations in anatomical HB type or differences in fibrous sheath thickness; further study to determine whether a unipolar pacing configuration is preferable when a his potential is not present are needed.

AP19‐­00111

Lead‐­related complications in patients undergoing ICD/CRT‐­D upgrade in real life practice: the DECODE registry experience

Paolo De Filippo, Vincenzo Russo, Francesco Zanon, Maria Lucia Narducci, Endrj Menardi, Massimo Zoni Berisso, Attilio Pierantozzi, Alberto Bandini, Pasquale Notarstefano, Gennaro Miracapillo, Carlo Ferretti, Leonardo Calò, Attilio Del Rosso, Paolo Sabbatani, Valerio Zacà, Giulio Boggian, Valeria Carinci, Giulia Bottoni, Maurizio Malacrida, Paola Ferrari, Cristina Leidi, Mauro Biffi

Ospedale Papa Giovanni XXIII, Italy

Introduction:

Complications threaten lead addition while upgrading ICD/CRT‐­Ds, as learnt by the REPLACE registry experience. We aimed at understanding the extent and the mechanism of lead‐­related adverse events (AEs) in a contemporary cohort of ICD/CRT‐­D upgrade recipients in a large real‐­world population.

Methods:

Detect long‐­term complications after ICD replacement (DECODE) was a prospective, single‐­ arm, multicenter cohort study aimed at estimating medium‐­ to long‐­term complications in 983 consecutive patients who underwent ICD/CRT‐­D replacement/upgrade from 2013 to 2015. We prospectively analyzed all clinical and device‐­related data of these patients at 12‐­month follow‐­up. In this work we analyzed the reason for ICD/CRT‐­D upgrade, the occurrence and mechanism of lead related AEs at 12 months follow‐­up.

Result:

We analyzed 179 consecutive patients who underwent device upgrade (median age 70 years, 78% male, 57% ischemic, 25% CRT‐­D): 84 (47%) due to lead failure, 85 (47.5%) for clinical reasons, and 10 (5.5%) for clinical reasons plus lead failure. Lead failure was more common in CRT‐­D recipients (44/460, 9.5%) than in ICD recipients (40/523, 7.6%). In 40 ICD recipients, RV coil failure was the most common cause of lead addition (38/40 patients, 95%), atrial lead failure occurring in 2 (5%). In 44 CRT‐­D recipients, lead failure was reported for the RV lead in 25/44 (56.8%), LV lead in 20/44 (45%), and atrial lead in 1/44 (2.2%). Loss of RV sensing occurred in 100% of RV lead failures, while loss of LV capture occurred in 90% of LV lead failures. Sensing issues for RA lead were present in 3 cases. The lead addition procedure was burdened by AEs in 22/179 patients (12.2%), specifically 9/44 (20%) CRT‐­ D and 13/135 (9.6%) ICD. AEs occurred in 12/70 (17%) patients with RV lead failure (12 required repeated surgery), in 13/103 (12.6%) patients with LV lead procedures (8 required repeated surgery), and in none of the 12 patients with atrial lead procedures.

Conclusion:

RV lead loss of function is the leading cause of ICD/CRT‐­D upgrade due to lead failure. RV lead addition is associated to repeated surgery after upgrading more commonly than LV addition. Technologic development in ICD/CRT‐­D should focus on electronic recovery of sensing and detection to minimize repeated surgery, that is associated to infection.

AP19‐­00112

Predictors of major adverse events over 12 months after ICD/CRT‐­D replacement/upgrade in a contemporary large world population: insight to the DECODE registry

Paolo De Filippo, Endrj Menardi, Ernesto Ammendola, Maria Lucia Narducci, Quintino Parisi, Francesco Zanon, Michele Manzo, Giuseppe Stabile, Domenico Potenza, Massimo Zoni Berisso, Fabio Quartieri, Valerio Zacà, Matteo Bertini, Davide Saporito, Fabio Lissoni, Vittorio Calzolari, Gianluca Zingarini, Giulia Bottoni, Maurizio Malacrida, Paola Ferrari, Giovanni Malanchini, Mauro Biffi

Ospedale Papa Giovanni XXIII, Italy

Introduction:

Cardiac Implantable Electronic Device (CIED) surgery is threatened by serious complications both during the procedure and during follow‐­up. The factors associated to attenuated clinical benefit over long term follow‐­up are poorly understood. To evaluate type and extent of Adverse Events (AEs) and potential predictors of major AEs over 12 months after ICD/CRT‐­D replacement/upgrade in a contemporary Italian population.

Methods:

Detect long‐­term complications after ICD replacement (DECODE) was a prospective, single‐­ arm, multicenter cohort study aimed at estimating medium‐­ to long‐­term complications in a large population of patients (pts) who underwent ICD/CRT‐­D replacement/upgrade from 2013 to 2015. The endpoint for this analysis is death from any cause, procedure‐­related infection, and surgical actions/hospitalizations necessary to treat the AEs.

Result:

We included 983 consecutive pts (median age 71 years, 76% male, 55% ischemic, 47% CRT‐­ D). During a mean follow‐­up duration of 353 ± 49 days, 7% of the pts died. A total of 104 AEs occurred in 70 (7.1%) pts. 43 (4.4%) pts needed at least one surgical action to treat the AEs. A total of 23 (2.3%) pts had infective AEs (CIED related in 12 pts, due to other causes in 11). Mortality was unrelated to the occurrence of overall AEs, or of CIED‐­related AEs, or of surgical actions/hospitalizations needed to correct AEs. The endpoint was reached by 109 (11%) pts over 12‐­month follow‐­up (97 pts had a single event, and 12 pts had two events). The median time to the endpoint was 137 [50‐­254] days. On multivariate Cox regression analysis adjusted for baseline confounders, ischemic cardiomyopathy (HR = 1.86, 95% CI: 1.18 to 2.91; P = .0076), hospitalization prior to the procedure (2.34, 1.35 to 4.05; 0.0025) and anticoagulation (1.91, 1.25 to 2.92; 0.0032) were associated with the endpoint during follow‐­ up.

Conclusion:

Evaluation of the patient's profile may assist in predicting vulnerability and should prompt reconsideration of the procedure by deferring at a more stable clinical status, and carefully individualized in the setting of upgrades and anticoagulation management.

AP19‐­00122

Superior vena cava syndromes as a late complication of pacemaker implantation: Two rare cases

Meidianaser Putra, Hauda El Rasyid

Residence of Cardiology Department, Indonesia

Introduction:

Superior vena cava syndrome is a rare complication of pacemaker lead implantation, especially as a late complication. It is induced by endothelial disruption from repeated mechanical trauma by pacemaker lead. The real incidence of central venous stenosis due to pacemaker implantation is uncertain and is likely to be underestimated. The management is still debatable. Rule of oral anticoagulant is not clear yet

Methods:

Case I: A 65 years old man presented with swollen of the left sided neck and shortness of breath since 1 month before admission. ICD was implanted 3 years earlier, caused by type I Brugada syndrome. MSCT result showed stenosis at superior vena cava at level of brachiocephalic trunk. Patient has been given medication warfarin 2 mg od, bisoprolol 2,5 mg od, candesartan 8 mg od, and have a good compliance. After 5 months of follow up, symptoms were relieved.

Result:

Case II: A 54 years old man presented with shortness of breath since 6 months before admission. PPM was implanted 3 years earlier, caused by TAVB and advanced heart failure and had been suggested to CRT procedure. During CRT procedure, the LV lead could not implanted properly because stenosis at left SVC. After ballooning and nitroglycerin intra‐­axillary vein, left SVC still stenosis, the procedure was postponed because of a long time procedure and high dose of radiation. Patient has been given medication metoprolol 12,5 mg bd, furosemide 40 mg od, telmisartan 80 mg od, warfarin 2 mg od, clopidogrel 75 mg od. After 3 months of follow up, patient getting better.

Conclusion:

Stenosis of SVC due to complication of pacemaker lead implantation is rare. Treatment of SVC stenosis is individualized and there are no established guidelines at the present time. In this serial case, warfarin has been proven in improving SVCs symptoms.

Keywords : superior vena cava syndromes, superior vena cava stenosis, pacemaker, warfarin

AP19‐­00123

Survival after transvenous lead extraction due to infective indications

Antonio Curnis, Giampiero Maglia, Francesca Salghetti, Manuel Cerini, Davide Fabbricatore, Michela Raffo, Vincenzo Maiolo, Daniele Giacopelli, Luca Bontempi

Spedali Civili Università di Brescia, Italy

Introduction:

Although in case of infected devices a complete removal is recommended, data on long‐­ term prognosis after transvenous lead extraction (TLE) are scant.

Methods:

We analysed characteristics and survival of patients who underwent TLE in our centre due to infective indications between November 2013 and April 2018.

Result:

Among 480 TLE procedures, 277 (58%) cardiac implantable device (35% pacemaker, 24% ICD and 37% CRT) recipients had a Class I indication for infection. Complete procedural success was achieved in 272 (98%) patients and no intra‐­ or early post‐­procedure major complications occurred. During a median follow‐­up of 21 (7‐­33) months, there were 43 (15.5%) deaths. The most frequently reported causes of death were heart failure (37%), sepsis (19%) and acute kidney failure (12%). Deceased patients were older (median age 77 vs 72 years, P = .001), with higher prevalence of atrial fibrillation (58% vs 38%, P = .021) and kidney disease (60% vs 33%, P = .001) than survivors. The Kaplan‐­Meier estimates of death rates were 12.4% (95% Confidence Interval [CI]: 8.6%‐­17.8%) and 24.2% (95% CI, 18.0%‐­31.9%) at 1 and 3 years, respectively. Using Cox regression model adjusted by baseline patient characteristics, the presence of vegetations on endocardial leads was associated with increased risk of all‐­cause mortality (Hazard Ratio: 2.46, 95% CI: 1.29‐­4.68, P = .006).

Conclusion:

Despite complete removal, CIED device infection is associated with high long‐­term mortality. The presence of vegetations seems a sign of worse prognosis suggesting that early TLE to limit their formation should be suggested.

AP19‐­00124

Pulmonary embolism in lead‐­related infective endocarditis with large vegetations

Luca Bontempi, Giampiero Maglia, Francesca Salghetti, Manuel Cerini, Davide Fabbricatore, Michela Raffo, Vincenzo Maiolo, Daniele Giacopelli, Antonio Curnis

BIOTRONIK Italia, Italy

Introduction:

Transvenous lead extraction (TLE) in cardiac implantable electronic device patients with infective endocarditis and large vegetations is controversial due to the risk of embolization.

Methods:

All consecutive patients referred to our centre for TLE due to infection and with evidence of large vegetations (>10 mm), underwent pre‐­ and post‐­procedure computed tomography (CT) scanning to assess pulmonary embolism.

Result:

A total of 11 patients (73% males, mean age 62 ± 8 years) implanted with pacemaker or implantable cardioverter defibrillator were included in the study. In the largest longitudinal diameter, the mean size of vegetations on endocardial leads was 20 ± 8 mm. Pre‐­procedural CT scanning identified 8 (72%) patients with one or more significant pulmonary emboli with an overall mean size of 20.2 ± 12.2 mm. All patients underwent successful complete TLE with 28 leads extracted using locking styles (45%) or laser sheath (55%). The mean fluoroscopy time was 17.5 ± 22.8 minutes without difference between those with or without pre‐­procedural pulmonary embolism. There were no intra‐­ or early post‐­procedure major complications. The post‐­procedure CT scanning confirmed the presence of silent pulmonary emboli in 6 (54%) patients with a mean size of 22.5 ± 3.5 mm. There was no evidence of different distribution of emboli among the lungs lobes. Patients with or without post‐­procedure pulmonary embolism had similar hospitalization stay (21.0 ± 10.8 days).

Conclusion:

In high‐­volume centres, TLE of infected leads with large vegetations is feasible. In our cohort, the prevalence of pulmonary embolism is high both before than after the procedure, but neither procedure outcome nor hospital stay were affected by this complication.

TABLE 1 Assessment of pulmonary embolism by pre‐­ and post‐­ procedural CT scanning

	Pre‐­procedural CT	Post‐­procedural CT
Number of patients	11 (100%)	11 (100%)
Presence of pulmonary embolism	8 (72%)	6 (54%)
Number of per‐­patient significant pulmonary emboli
1	2 (18%)	0 (0%)
2	1 (9%)	1 (9%)
3	1 (9%)	0 (0%)
>3	4 (36%)	5 (45%)
Size of pulmonary embolism, mm	20.2 ± 12.2	22.5 ± 3.5
Location of pulmonary embolism*
Right lung, upper lobe	5 (45%)	3 (27%)
Right lung, middle lobe	2 (18%)	0 (0%)
Right lung, lower lobe	4 (36%)	3 (27%)
Left lung, upper lobe	4 (36%)	1 (9%)
Left lung, lower lobe	3 (27%)	4 (36%)

*A patient could have more than one lung lobes involved.

AP19‐­00143

Outcomes of transvenous lead extraction with preoperative pericardial drainage in subacute and delayed lead perforation patients: A single‐­center experience

Xu Zhou, Xuebin Li

Peking University, China

Introduction:

The management of cardiac perforation by an implanted lead of a cardiac implantable electronic device is controversial. This study evaluated (a) the outcomes of percutaneous lead extraction and (b) the safety and feasibility of a prophylactic pericardial drain with a percutaneous subxiphoid puncture in high‐­risk patients.

Methods:

The medical records of all patients diagnosed with cardiac perforation by a pacing or defibrillator lead in Peking University People's Hospital from January 2008 to January 2019 were reviewed. To describe the results in a homogeneous cohort, we excluded the following subjects: (a) patients with acute cardiac perforation, (b) patients who underwent surgical repair, and (c) patients whose perforating lead was abandoned. Clinical characteristics, details of the device features, outcomes and complications related to transvenous lead extraction procedures, and follow‐­up data were collected.

Result:

Thirty‐­nine (16 men; mean age 67 ± 15 years) patients with subacute and delayed lead perforation managed by transvenous lead extraction (TLE) were included. With surgical backup, all culprit leads were removed completely by TLE without major complications. Simple traction with or without locking stylet was sufficient in majority of the patients (94.8%). Eight patients with a high risk of haemopericardium underwent percutaneous subxiphoid pericardial puncture prior to TLE (Group A); the remaining patients were assigned to Group B. The mean dwell time of perforating leads in Group A was longer than that in Group B (1084 ± 327 vs 97 ± 331 days, P = .02). The success rate of the pericardial puncture itself was 100%. All patients showed no evidence of new‐­onset or worsening pericardial effusion during the procedure and hospital stay. During the follow‐­up period (14 ± 12 months), one patient died of multiple organ failure, and one patient had a newly implanted ventricular lead extracted because of an elevated pacing threshold.

Conclusion:

In patients with subacute or delayed lead perforation, percutaneous lead extraction with surgical backup is a safe and effective management approach. Prophylactic pericardial drainage with percutaneous subxiphoid puncture might be considered in patients at high risk of perioperative pericardial bleeding.

FIGURE 1 The percutaneous subxiphoid pericardial puncture. (A) The needle was advanced to the heart silhouette; (B) With the contrast restricted to the heart silhouette, the tip of needle was correctly positioned in the pericardial sac; C:The long guidewire crossed multiple cardiac chambers along the cardiac silhouette in LAO projection. LAO: Left anterior oblique

FIGURE 2 The imaging test of lead perforation. (A) Chest x‐­ray demonstrating RV perforation by a PM lead; B:RV lead perforation suspected on AP

FIGURE 3 The distribution of lead dwell time in Group A and Group B chest X‐­ray; (C) RV lead perforation confirmed by fluoroscopy image(same patient with B)showing lead dislocation outside the border of the heart; (D) RV lead shown on chest CT; E and F: lead perforation confirmed by chest CT and corresponding reconstruction(AP view). RV, right ventricular; AP, antero‐­posterior; CT, computerized tomography

TABLE 1 Baseline characteristics of patients with lead perforation

Variables	All subjects (n = 39)	Group A (n = 8)	Group B (n = 31)	P value
Age, years	67 ± 15	70 ± 14	67 ± 16	.54
Male sex	16 (41.0)	4 (50.0)	12 (38.7)	.42
BMI, kg/m2	23.9 ± 2.3	23.0 ± 1.7	24.2 ± 2.4	.19
Symptoms
Chest pain	22 (56.4)	1 (2.6)	21 (53.8)	.01
Syncope	2 (5.1)	2 (5.1)	0 (0)	.06
Dyspnoea	6 (15.4)	2 (5.1)	4 (10.3)	.58
Diaphragmatic stimulation	2 (5.1)	0 (0)	2 (5.1)	1.00
Comorbid conditions
Hypertension	14 (35.9)	10 (25.6)	4 (50.0)	.30
CAD	5 (12.8)	3 (37.5)	2 (6.4)	.06
DM	1 (2.6)	1 (12.5)	0 (0)	.17
NICM	1 (2.6)	1 (12.5)	0 (0)	.17
Medications
Aspirin	6 (7.7)	3 (37.5)	3 (9.7)	.09
Warfarin	2 (5.1)	2 (25)	0 (0)	.03
LVEF (%)	63 ± 10	58 ± 14	65 ± 9	.07
INR	1.2 ± 0.4	1.1 ± 0.5	1.2 ± 0.4	.36
Perforation categories
Subacute	28 (71.8)	1 (12.5)	27 (87.1)	.01
Delayed	11 (28.2)	7 (87.5)	4 (12.9)	.01
Perforation site
RVA	34 (87.2)	4 (50.0)	30 (96.8)	.01
RVFW	4 (12.8)	4 (50.0)	1 (3.2)	.02

Abbreviations: BMI, body mass index; CAD, coronary artery diseases; DM, diabetes mellitus; NICM, nonischaemic cardiomyopathy; INR, international normalized ratio; LVEF, left ventricular ejection fraction; RVA, right ventricular apex; RVOT, right ventricular outflow tract; RVFW, right ventricular free wall.

TABLE 2 Characteristics of CIEDs and extraction

Characteristic	All subjects (n = 39)	Group A (n = 8)	Group B (n = 31)	P value
Lead type
PM	37 (94.9)	6 (75.0)	31 (100)	.04
ICD	2 (5.1)	2 (25.0)	0 (0)	.04
Active fixation	25 (64.1)	6 (75.0)	19 (61.3)	.39
Passive fixation	14 (35.9)	2 (25)	12 (38.7)	.39
Lead dwell time, days	300 ± 638	1084 ± 327	97 ± 331	.02
Extraction tools
Standard stylet	21 (53.8)	1 (12.5)	20 (64.5)	.01
Locking stylet	16 (41.0)	6 (75.0)	10 (32.3)	.04
Snare	2 (5.2)	1 (12.5)	1 (3.2)	.38

Abbreviations: CIED, cardiac implantable electronic devices; PM, pacemaker; ICD, implantable cardioverter defibrillator.

TABLE 3 Clinical characteristics, device parameters and procedure information of patients with prophylactic pericardial drainage (Group A)

Patient #	Age	Gender	Device	Symptoms	Time since implant	Lead dwell time	Fixation	Site of perforation	Anesthesia	Tools
1	88	Male	PM	Chest pain	48 months	48 months	Active	RV Free wall	General	Locking stylet
2	46	Male	PM	Syncope	84 months	84 months	Active	RV Free wall	Local	Snare
3	64	Female	ICD	None (Inappropriate shock)	–	6 months	Active	RV apex	Local	Locking stylet
4	69	Male	CRT‐­D	None (Pacing failure)	–	8 months	Active	RV apex	Local	Locking stylet
5	89	Male	PM	None (Pacing failure)	60 months	60 months	Passive	RV apex	Local	Locking stylet
6	64	Female	PM	Chest pain	50 months	60 months	Active	RV Free wall	Local	Locking stylet
7	69	Male	PM	Chest pain	36 months	36 months	Passive	RV apex	Local	Locking stylet
8	74	Female	PM	Dyspnea (pleural effusion)	12 months	12 months	Active	RV apex	Local	Locking stylet

AP19‐­00147

Predictors of venous occlusion following cardiac implantable device implantation

Eiji Fukuhara, Takanao Mine, Hideyuki Kishima, Masaharu Ishihara

Hyogo College of Medicine, Japan

Introduction:

Additional insertion of leads may be necessary in leads complication after Cardiac Implantable Device implantation. If the vein on the implantation side of the device is occluded, the lead cannot be inserted and the lead is added to the opposite side. However, it is not known in detail whether it is occluded. Therefore, we studied vein angiography on both sides at the time of exchanging, lead revision, or device upgrade and checked for occlusion.

Methods:

104 patients who showed bilateral contrast venography before generator change, lead revision, or device upgrade were studied (61 male, 72 ± 13 years, 61 Pacemaker, 28 Implantable Cardioverter Defibrillator, 15 Cardiac Resynchronization Therapy). Clinical factors and blood samples were obtained before procedure.

Result:

Venous total occlusion was observed 15/104 patients (14%). 1 of the 15 patents had venous total occlusion on the opposite side from Device implantation side. Number of leads (P = .0127) was significantly associated with higher risk of venous occlusion, whereas anticoagulation therapy (P = .0376) significantly reduced incidence of venous occlusion. On multivariate analysis, number of leads (P = .0202, OR 2.7800 for 1 increase in number of leads) were associated with venous occlusion.

Conclusion:

In this study, only 1 patient (1%) was admitted to venous total occlusion on the opposite side from device implantation side. At the time of adding the lead, it is necessary to consider occlusion on the opposite side.

AP19‐­00159

Retrieval of leadless pacemaker embolizes to the lungs

Nobuhiro Nishiyama, Masahiro Morise Morise, Hideomi Fujiwara, Takanobu Yamada, Chinatsu Komiyama, Mitsuhiko Ohta, Yo Fujimoto, Takahide Kodama

Toranomon Hospital, Japan

Introduction:

Case.

Methods:

Case.

Result:

The patient is a man with pacemaker using unipolar lead. Because ERI, we elected to proceed with placement of a leadless pacemaker (Micra). The Micra was deployed successfully, and had 3 of the 4 tines engaged. I cut and pulled the tether out of the system. And then the pacing threshold became unstable. We decided to remove the device, by using a snare and a steerable introducer. Snaring the retrieval head was challenging because the head was too close to septum. Using an electrode catheter, we attempted to turn the device in some other direction, so that the retrieval head was accessible. In the next instant, the Micra had dislodged and embolized to the left pulmonary artery. We snared 2 of the 4 tines (Figure 1), the device was gently pulled to the right atrium. Finally, we snared the retrieval head with another snare and successfully retrieved without any complications. (Figure 2)

Conclusion:

Case.

AP19‐­00176

Acute and chronic effectiveness of ADDs in Patients with permanent HBP

Lan Su, Weijian Huang, Dongjie Liang

the First Affiliated Hospital and Key Lab of Cardiovascular Disease of Wenzhou, Wenzhou Medical Uni, China

Introduction:

Studies have reported that antiarrhythmic drugs can affect pacemaker parameters, but whether they have impact on parameters and conduction after His bundle pacing (HBP) is still lack of research. A prospective study to monitor the influence of antiarrhythmic drugs (ADDs) on pacing parameters and conductivity of His bundle during and after HBP, and assess the impact of drugs on the safety of His bundle pacing.

Methods:

Patients (N = 100)who met the pacing indication with QRS < 120 milliseconds were enrolled. Propafenone, lidocaine and adenosine were injected intravenously according to body weight immediately after implantation of 3830 lead in HBP. Betaloc, amiodarone and digoxin were taken orally for 1 month after operation. The parameters of bipolar pacing and sensing vector before and after treatment were measured, including threshold (pulse width 0.5/1.0 milliseconds), sensing and impedance, and His‐­V wave conduction (HVC) of His lead under 130 bpm pacing. Baseline data in Table 1

Result:

The results showed that there was no influence on the parameters of His lead before and after treatment according to body weight (P > .05), as shown in Table2.

Conclusion:

There is no influence on the parameters and H‐­V conduction of HBP before and after the use of antiarrhythmic drugs.

TABLE 1 Baseline data

N	100
Male	66 (66%)
Age	68.28 ± 10.74
NYHA
Class I	54 (54%)
Class II	34 (34%)
Class III‐­IV	12 (12%)
Hypertension	50 (50%)
Coronary heart disease	16 (16%)
Ischemic cardiomyopathy	1 (1%)
Myocardial infarction	1 (1%)
Sick sinus syndrome	32 (32%)
Atrial fibrillation with slow ventricular rate	28 (28%)
AV block with sinus rhythm	40 (40%)
First degree AVB	25 (15%)
Second degree AVB	12 (12%)
Third degree AVB	3 (3%)
QRS duration (<120 milliseconds)	90.38 ± 12.76
LVEDd (mm)	51.4 ± 11.27
LVEF (%)	54.19 ± 15.85

TABLE 2 Parameters results before and post ADDs intervention

	Sensing‐­bipolar	Captured His bundle threshold of bipolar pacing at 1.0 milliseconds	Captured His bundle threshold of bipolar pacing at 0.5 milliseconds	Impedance‐­bipolar	Pacing at 0.5 milliseconds in HVC > 130 bpm 1:1 conduction
lidocaine (n = 20)
Before treatment	3.73 ± 2.25	0.95 ± 0.59	1.08 ± 0.55	521.45 ± 88.02	1.14 ± 1.04
After treatment	3.38 ± 2.02	0.99 ± 0.61	1.09 ± 0.59	504.1 ± 76.3	1.28 ± 1.05
P‐­value	0.079	0.504	0.779	0.124	0.178
ATP (n = 20)
Before treatment	3.59 ± 1.61	0.8 ± 0.49	0.96 ± 0.5	515.41 ± 69.16	1.24 ± 0.89
After treatment	3.54 ± 1.68	0.88 ± 0.53	1.01 ± 0.53	516.71 ± 70.4	1.16 ± 1.07
P‐­value	0.694	0.157	0.157	0.725	0.539
Propafenone (n = 10)
Before treatment	6.88 ± 6.56	0.51 ± 0.15	0.73 ± 0.22	653.71 ± 148.83	0.74 ± 0.09
After treatment	7.85 ± 6.76	0.51 ± 0.16	0.6 ± 0.14	614.57 ± 117.11	0.63 ± 0.09
P‐­value	0.748	1	0.243	0.234	0.533
Amiodarone (n = 20)
Before treatment	3.45 ± 3.05	1.21 ± 0.47	1.69 ± 0.25	519.9 ± 146.99	1.50 ± 0.86
After treatment	4.02 ± 4	1.29 ± 0.59	1.82 ± 0.34	459.8 ± 55.23	1.55 ± 0.66
P‐­value	0.198	0.457	0.459	0.209	0.570
Digoxin (n = 10)
Before treatment	3.18 ± 2.06	0.65 ± 0.29	1.14 ± 0.31	467.14 ± 61.22	1.0 ± 0.21
After treatment	2.73 ± 2.83	0.67 ± 0.27	1.16 ± 0.28	448 ± 41.69	0.89 ± 0.18
P‐­value	0.401	0.939	0.956	0.49	0.560
Metoprolol (n = 20)
Before treatment	5.76 ± 5.09	0.69 ± 0.21	1.09 ± 0.72	463.33 ± 61.88	0.84 ± 0.78
After treatment	6.04 ± 5.67	0.53 ± 0.08	1.13 ± 0.82	458.37 ± 58.02	0.75 ± 0.84
P‐­value	0.771	0. 511	0.456	0.631	0.520

AP19‐­00190

Impact of transcranial electrical stimulation on implantable defibrillators

Takashi Sasou, Yusaku Nishikawa, Takakehiro Gotou, Masahiro Tomita, Yuma Tsumagari, Saki Kimura, Masako Yamada

Mie University Hospital, Japan

Introduction:

In late years high voltage, the transcranial mark electrical stimulation (BR‐­MSEP) device using the high‐­frequency pulse are developed and are used frequently as perioperative monitoring. treatment using the electrical stimulation and the laboratory procedure diverge into many branches now. However, there are not an implantation type heart device (CIED) in individual treatment and testing and the guidelines for the real handling in examination and the clinic of the electromagnetic interference (emi) despite ten minutes because there are various electrical stimulation methods and devices. Using muscle equivalence agar manikin, we examined the effect that BR‐­MSEP gave to an implantable cardioverter defibrillator (ICD).

Methods:

We made muscle equivalence AGAR manikin with the electric characteristics similar to the muscle and changed the distance (0, 10, 20, 30 cm) from ICD lead to BR‐­MSEP electrode, output (0, 10, 100, 200, 300, 400, 500, 600 V) of BR‐­MSEP and evaluated the presence of the electromagnetic interference in ICD under conditions of 32 ways in total.

Result:

An electromagnetic interference was found under conditions of 24 ways. If output of BR‐­MSEP was 100 (V) or more, we showed an electromagnetic interference from ICD lead regardless of BR‐­MSEP electrode position.

Conclusion:

By high voltage in a used by a clinic, the high‐­frequency pulse stimulation setting, we are more likely to cause the inappropriateness movement by the electromagnetic interference in patients with CIED now, and, from this results, there is the risk of complications serious in certain instances. therefore enough safety measures are necessary for the a enforcement in the CIED patients.

AP19‐­00194

Feasibility and efficacy of left ventricular lead placement guided by subselection inner

, Kazuto Hayasaka, Takeshi Sasaki, Ko Akimoto, Kento Yabe, Chisashi Toya, Masahito Suzuki, Masahiko Goya, Tetsurou Sasano

Disaster Medical Center, Japan

Introduction:

In general, subselection inner catheter (Inner‐­Cath) has been adjunctively used with outer guide catheter (Outer‐­Cath) in failure cases of LV lead placement in a target vein of coronary sinus (CS) tributaries with Outer‐­Cath during cardiac resynchronization therapy (CRT) device implantation. This study aims to investigate the feasibility and efficacy of LV lead placement which is guided by Inner‐­ Cath without Outer‐­Cath as a first‐­line methodology.

Methods:

A total of 53 patients (age 68 ± 13 years, 41 males) who underwent de novo CRT implantation in a single center from January 2017 to May 2019 were included. LV lead placement was initially guided by Inner‐­Cath in 33 patients (Inner‐­Cath group) and Outer‐­Cath in 20 patients (Outer‐­ Cath group). In the Inner‐­Cath group, 7Fr Inner‐­Cath was advanced to CS using a 5Fr EP‐­catheter through 7Fr sheath inserted in a subclavian vein. Meanwhile, 9Fr Outer‐­Cath was used in the Outer‐­Cath group. Procedural outcomes regarding success rate of LV lead placement, additional use of inner or outer catheters and procedure‐­related complications were retrospectively investigated and compared between the 2 groups.

Result:

In most of the study patients, LV lead placement was successfully performed in both groups. (100 % in Inner‐­Cath group vs 90 % in Outer‐­Cath group; P = .138). However, 2 patients of Outer‐­Cath group required to abandon LV lead placement due to the CS perforation or CS dissection that was caused by the repeated CS cannulations with Outer‐­Cath. The procedure time was significantly shorter in Inner‐­ Cath group compared with Outer‐­Cath group (154 vs 181 minutes; P = .023). The additional use of Outer‐­Cath in Inner‐­Cath group was significantly less frequent than that of Inner‐­Cath in Outer‐­Cath group (9.1 % vs 30 %, P = .006). Any significant procedure‐­related complications except 2 patients with CS perforation and CS dissection in Outer‐­Cath group were not observed in both groups.

Conclusion:

LV lead placement guided by Inner‐­Cath alone was feasible in about 90 % of the CRT device implantations without any complications. This methodology for LV lead placement with Inner‐­ Cath may be preferred in CRT candidates with severe LV dysfunction in terms of shorter procedure time, smaller size of guiding sheath and less procedure‐­related complications.

AP19‐­00204

Atrial floating dipole sensing performances in implantable cardioverter defibrillator and cardiac resynchronization therapy device

Giampiero Maglia, Salvatore Pirrotta, Luca Bontempi, Manuel Cerini, Davide Fabricatore, Gianluca Ceravolo, Paola Napoli, Antonio Curnis

A.O. Pugliese Ciaccio, Italy

Introduction:

The DX technology allows atrial sensing in single‐­chamber implantable defibrillators through special RV lead equipped with floating atrial dipole. The DX technology has recently been implemented also in ICDs for cardiac resynchronization therapy (CRT) requiring the implantation of only two leads in patients with no indication to atrial pacing. Several studies have proved the reliability of atrial sensing for the ICD‐­DX device, while little data are available for CRT‐­DX devices for which reliable atrial sensing is essential for optimal CRT delivery. We retrospectively evaluated baseline sensing performances in patients with a CRT‐­DX system as compared with patients with ICD‐­DX systems.

Methods:

Atrial sensing amplitude during sinus rhythm was collected at the time of device implantation. Median values (interquartile range) were then compared between ICD‐­DX and CRT‐­DX groups.

Result:

A total of 134 patients (median age 60 [54‐­67], 79.3% male, left ventricle ejection fraction 32% [30%‐­35%], 28% ischemic etiology) who presented with sinus rhythm at implant were included in the present analysis: 112 (83.6%) received an ICD‐­DX device, 22 (16.4%) a CRT‐­DX device. Device‐­ detected atrial sensing amplitude at implant was 3.5 (1.5‐­5.7) mV in the ICD‐­DX group, and 2.6 (1.5‐­4.1) mV in the CRT‐­DX group (P = .499). Right ventricular sensing amplitude (ICD DX: 12.1 [8.3‐­17.3] mV; CRT‐­ DX: 14.4 [10.9‐­17.0] mV; P = .183) and pacing impedance (ICD DX: 504 [457‐­550] Ohm; CRT‐­DX: 520 [486‐­550] Ohm; P = .265) did not differ as well. First 10‐­day remote monitoring post‐­implant did not report far field oversensing in both groups, and 99% (95‐­100) CRT pacing was achieved in the CRT‐­DX group.

Conclusion:

The DX technology showed similar atrial sensing performances when implemented either in single chamber ICDs or in CRT devices. Optimal CRT delivery was achieved in the CRT‐­DX group, while no far field oversensing was detected perioperatively.

AP19‐­00205

Long‐­term stability of atrial sensing provided by floating atrial dipole in single‐­lead implantable cardioverter defibrillator

Giampiero Maglia, Salvatore Pirrotta, Luca Bontempi, Manuel Cerini, Davide Fabricatore, Gianluca Ceravolo, Paola Napoli, Antonio Curnis

A.O. Pugliese Ciaccio, Italy

Introduction:

The recently introduced single‐­chamber implantable cardioverter defibrillators (ICDs) equipped with a floating atrial dipole (DX system) for single‐­lead atrial sensing have been proved reliable for arrhythmia discrimination and atrial fibrillation monitoring. Data on stability of atrial sensing amplitude during long‐­term follow‐­up have not been reported. Our aim was to retrospectively evaluate the long‐­term stability of atrial sensing amplitude of the single‐­lead ICD provided with a floating atrial dipole.

Methods:

Data were retrieved by a remote monitoring system characterized by daily transmissions. The endpoint of the analysis was the evaluation of P‐­wave sensing stability by comparing mean values of the first 10 days post‐­implant with corresponding values yearly collected for the subsequent 5 years.

Result:

In our cohort, 104 ICD DX recipients (82.7% male, median age 58 interquartile (IQ) interval: 52‐­63) were included, 88 had data at 1‐­year follow up, 60 at 2 years, 41 at 3 years, 29 at 4 years, and 13 at 5 years. Overall atrial sensing amplitude average was 4.7 mV (2.6‐­6.8) for the whole follow up period available. The median values of P‐­wave amplitude measured for each year did not show statistically significant differences until 5‐­year follow up at a random intercept linear mixed model (P = .401). Median values were respectively, 3.6 mV (1.5‐­5.8) at implantation, 4.4 mV (2.3‐­6.8) at 1‐­year, 4.2 mV (1.6‐­6.7) at 2‐­year, 4.3 mV (1.7‐­5.8) at 3‐­year, 4.7 mV (2.1‐­6.9) at 4‐­year and 4 mV (2.25‐­5.9) at 5‐­year.

Conclusion:

The single‐­lead ICD system equipped with floating dipole showed to provide reliable atrial sensing at long term with no significant reductions until 5‐­year follow up.

FIGURE 1 Atrial sensing amplitude (mV) during 5‐­year follow up showed no statistically significant differences at a random intercept linear mixed model (P = .401)

AP19‐­00208

Implantation of leadless pacemaker via left subclavian vein

Kenneth Kita, Rahul Doshi

University of Southern California, Keck, United States

Introduction:

Leadless pacemakers, by standard, are deployed via the femoral vein. There have been instances of device deployment via right internal jugular vein when femoral vein access is unavailable. We present implantation via the left subclavian vein.

Methods:

25 year old male with Down's Syndrome, congenital aortic stenosis, aortic coarctation, atrial septal defect (ASD) and history of a Ross procedure with ASD and coarctation repair. At the age of 5, he received an epicardial pacemaker for complete heart block (CHB). The patient later received a dual chamber transvenous pacemaker in 2009 (age 15), followed by a generator change in 2018 which was complicated by pocket infection. The patient had sinus rhythm with CHB and no underlying escape rhythm. EP consultation at an outside facility recommended extraction of the transvenous system, and implantation of a leadless pacemaker. In the EP lab it was noted that a wire could not be passed up to the heart from the right femoral vein. Venogram in the lab revealed occlusion of the left and right external iliac veins, and the lower half of the inferior vena cava (IVC) could not be visualized. Further delineation with CT angiography revealed chronic occlusion or atresia of the left and right external iliac veins with extensive collateral circulation in the pelvis and inguinal regions, and chronic occlusion of the infrarenal IVC. The patient was subsequently referred to our facility for higher level of care. At our facility, the patient underwent device extraction and leadless pacemaker implant under general anesthesia. First, access was obtained via the right internal jugular vein and two sheaths were placed. Through a 6Fr sheath, a temporary pacing wire was advanced to the right ventricular (RV) apex. Next, a stiff 0.035 guidewire was passed down to the IVC as far as possible via an 8Fr sheath to maintain access for an endovascular occlusion balloon in the event of a superior vena cava (SVC) tear during extraction.

Result:

Attention was next focused on the device pocket. Incision immediately produced purulent drainage. The generator and leads were freed from the pocket. With laser assistance, both atrial and ventricular leads were extracted. Intra‐­procedure transesophageal echocardiogram confirmed absence of pericardial effusion. Left subclavian vein access was maintained with a stiff 0.035 inch guidewire, which was advanced down to the level of IVC occlusion. The 27Fr delivery sheath and dilator was advanced to the lower right atrium. The pacemaker delivery system was introduced through the sheath, and used to cross the tricuspid valve, where the device was positioned and deployed in the mid RV septum. Capture thresholds were consistently below 1.0 mV.

Conclusion:

Leadless pacemaker implantation can be safely and feasibly done via subclavian vein approach from the same location as infected device removal and extraction.

AP19‐­00211

Arrhythmogenic right ventricular cardiomyopathy (ARVC) with right ventricular clot: The best timing for ICD implant

Kim Fong Ng, Ma Soot Keng, Leo Benjamin, Othman Norliza, Quek Chu Zhen, Kim Heng Shee, Lee Chuey Yan

Hospital Sultanah Aminah Johor Bahru, Malaysia

Introduction:

Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a relatively rare inherited cardiac disease characterized by non‐­ischemic ventricular arrhythmias originating from the right ventricle and abnormal ventricular pathology. Macroscopically, there is a scarred appearance with fibrous or fibro‐­fatty replacement of myocardium.

Methods:

A 19 year old university student collapsed while playing football on 16th February 2019 morning. CPR was commenced and automatic external defibrillator was attached. He was direct‐­current cardioverted twice. In Emergency department, he developed ventricular tachycardia and was given another 2 direct‐­current cardioversion. However, he progressed to ventricular fibrillation. CPR was commenced for another 15 minutes. He was intubated for airway protection. The patient was cardioverted due to another episode of supraventricular tachycardia and ventricular tachycardia in CCU. He was given intravenous amiodarone infusion and was transferred to a cardiac referral center on day 3 for further management. This was his first episode of collapse. There was no previous history of medical illness, no family history of sudden death or cardiac disease. Echocardiogram showed good left ventricular function with ejection fraction of 66% and good right ventricular function with TAPSE of 24 mm. There was no regional wall motion abnormality, all chamber size and valves were normal. No clots and no pericardial effusion. Electrocardiography (ECG) showed T wave inversion in V1 to V3 and widening of QRS complexes, 720 milliseconds. Cardiac magnetic resonance (CMR) showed right ventricular clots. The regional right ventricular dyskinesia and akinesia with dilated right ventricle (indexed end diastolic volume of 233) and mildly impaired systolic function fitted in as major CMR criteria for ARVC as per 2010 Task Force criteria.

Result:

The patient was given warfarin for 6 weeks. Repeated CMR 6 weeks later showed resolved right ventricular clot. The patient was finally implanted an implantable cardioverter defibrillator (Ellipse VR St Jude) after 2 months. He was then discharged well the following day. We managed to screen all his family member although all of them were asymptomatic. Echocardiogram of his mother, brother and 2 sisters showed dilated right atrium and right ventricle.

Conclusion:

ARVC with right ventricular thrombus is an uncommon phenomenon which the patient experienced both. Right ventricular thrombi usually represent clots traveling from the legs to the lungs. The diagnosis of ARVC is definitely challenging and it can be easily misdiagnosed. Thus, it is imperative to make a thorough investigation for all possible causes so as not to miss the diagnosis of this rare condition and avoid delay in treatment.

FIGURE 1 ECG showing ventricular fibrillation

FIGURE 2 ECG showing T inversion and widening of QRS complexes at V1 to V3

FIGURE 3 (A‐­F) Cardiac MRI. Akinesia of the right ventricular outflow tract (RVOT) area in diastole (A) and in systole (B) of transaxial images (thin white arrow) .Right ventricular wall enhancement on late gadolinium enhancement (LGE) of free wall (white star) seen in short axis at mid cavity (C) and horizontal long axis(HLA) (F) as well as inferior wall (filled white arrow) of right inflow outflow (RVIO) view (E). Right ventricular thrombus at the apex (curve white arrow) seen in early gadolinium RVOT (D), RVIO view LGE (E) and HLA LGE (f). (A) Transaxial cine diastole (B) Transaxial cine systole (c) Short axis at mid cavity late gadolinium enhancement (LGE) (D) RVOT early gadolinium (E) Right inflow outflow LGE (F) Horizontal long axis LGE

FIGURE 4 (A‐­C): Cardiac MRI. Resolution of thrombus as seen on RVOT early gadolinium (A), RVIO view LGE (B) and HLA LGE (C). There is still right ventricular enhancement of the inferior wall (filled white arrow) in RVIO view LGE (B) and RV free wall (white star) in HLA LGE (C). (A) RVOT early gadolinium (B) Right inflow outflow LGE (C) Horizontal long axis LGE

AP19‐­00213

An unusual indication for subcutaneous implantable cardioverter defibrillator (ICD) following unsuccessful transvenous ICD implantation.

Yuki Sahashi, Nobuhiro Takasugi, Takahide Nawa, Yujiro Kinomura, Hiroyuki Okura

Gifu University Department of cardiology, Japan

Introduction:

Since the approval of subcutaneous implantable cardioverter defibrillator (S‐­ICD) in 2016 in Japan, the number of implantation of S‐­ICD has been increasing. S‐­ICD is suitable for patients with inadequate venous access because of device infection, lead extraction and venous obstruction. We herein report an unusual indication for S‐­ICD following unsuccessful transvenous‐­ICD (TV‐­ICD) implantation. A 73 year‐­old‐­woman with a past history of dilated cardiomyopathy (Left ventricular ejection fraction: LVEF = 20%), chronic heart failure (New York Heart Association; classII), chronic atrial fibrillation (QRS duration:90 milliseconds) and mitral valve replacement was hospitalized due to the ventricular fibrillation. Following the complete recovery of motor and neurological function with intensive care and cardiac rehabilitation, implantation of TV‐­ICD was tried. However, lead delivery into right ventricular apex was failed since it was difficult to place technically because of the abnormally enlarged right atrium. (77*110 mm, Figure) Moreover, sensing and pacing failure was observed at another place of right ventricle such as septum or basal region. Nevertheless, ICD implantation was thought to be still needed since sudden cardiac death because of fatal arrhythmia could be occurred with high probability in the present case. A few weeks later, S‐­ICD implantation was planned and successfully implanted. Although according to the previous reports, an invasive surgical approach of ICD implantations may be a therapeutic option for the patients with limited venous access, mortality rate for the surgical approach remains still relatively high.

Methods:

N/A.

Result:

N/A.

Conclusion:

This case highlighted the possibility that the patients with an unsuccessful implantation due to the enlarged right atrium can be the candidates for S‐­ICD implantation as well as surgical approach.

AP19‐­00215

Predictors of non‐­response to cardiac resynchronization therapy implantation in patients with class I indications

Xi Liu, Yiran Hu, Wei Hua, Min Gu, Shu Zhang

State Key Laboratory of Cardiovascular Disease, Arrhythmia Center, Fuwai Hospital, China

Introduction:

Cardiac resynchronization therapy (CRT) was normally performed in patients with a class I recommendation. However, a small proportion of the strictly selected patients still fail to respond. This study was designed to identify predictors of non‐­response in patients with class I indications for CRT and determine the non‐­response probability of the patients.

Methods:

A total of 296 consecutive patients with a class I recommendation received CRT from January 2009 to January 2017 were retrospectively analyzed. Multivariate logistic regression analysis was performed to identify predictors for non‐­response (defined as cardiac death, heart transplantation, or heart failure hospitalization during 1‐­year follow‐­up).

Result:

Among 296 patients, 30 (10.1%) met non‐­response. Multivariate analysis demonstrated that non‐­response to CRT was associated with a fragmented QRS (odd ratio [OR] = 2.86, 95% confidence interval [CI] 1.14 to 7.12; P = .025) and LVEDD ≥ 77 mm (OR = 3.02, 95% CI 1.17‐­7.82; P = .022) . Patients with both of the predictors had a non‐­response probability of 46.2% (95% CI 19.1‐­73.3).

Conclusion:

In patients with LBBB and wider QRS duration, the proportion of non‐­response to CRT is not low in real world. The presence of the dilated LVEDD or fragmented QRS is a strong predictor of non‐­response to CRT. The probability of non‐­response in patients with these two predictors was 46.2%.

AP19‐­00223

Left ventricular dyssynchrony between right ventricular septal pacing and right ventricular apical pacing: one year follow up

SungSoo Kim

Chosun University Hospital, South Korea

Introduction:

Chronic right ventricular pacing can lead to an increased risk of ventricular dyssynchrony (VD), heart failure and mortality. It is thought that ventricular dyssynchrony is affected by underlying disease, pacing mode, pacing site. Some investigators showed that LV function is better in RV septal (RVS) pacing than in RV apex (RVA) pacing. We investigated the VD in patients implanted with permanent pacemaker (PPM) according to the pacing site after one year.

Methods:

We enrolled 36 patients {11 male (30.6 %), 72.3 ± 10.9 years} with complete AV block who underwent successful pacemaker implantation (ventricular pacing greater than 90%) from 2017 to 2018. They were divided into two groups as pacing site (RV septum vs RV apex). We analyzed baseline characteristics, 12 lead surface electrocardiogram, and echocardiography after one year. The degree of LV dyssynchrony was evaluated by tissue Doppler imaging.

Result:

Baseline characteristics was not different between two groups. At one year follow up, VD was seen in 15 (42.9%) patients. The degree of VD was significantly higher in RVA (65.0% vs 13.3%, P = .005). Paced QRS duration was longer in RVA (172.3 ± 10.8 vs 163.7 ± 7.7, P = .009). However, there was no statistically significant difference in LV ejection fraction (65.0 ± 8.7 vs 62.4 ± 8.9, P = .234) and cardiac death, hospitalization due to heart failure.

Conclusion:

Although RVS pacing has narrower paced QRS complex, lesser ventricular dyssynchrony compared with RVA pacing, they did not show any difference in clinical outcome during one year follow up. A large number of patients and long term follow up are likely to be required.

AP19‐­00225

Successful coronary vein lead implantation by intravascular ultrasound guidance in a patient with life‐­threatening contrast medium anaphylaxis

Shohei Kataoka, Daigo Yagishita, Miwa Kanai, Kyoichiro Yazaki, Satoshi Higuchi, Koichiro Ejima, Morio Shoda, Nobuhisa Hagiwara

Tokyo women's medical university hospital, Japan

Introduction:

A 51 years old male with dilated phase of hypertrophic cardiomyopathy was referred for severe heart failure management. Cardiac resynchronization therapy (CRT) was indicated due to 132 milliseconds of QRS duration, 25% of left ventricular ejection fraction and NYHA class III heart failure symptom. However, the patient had a past history of life‐­threatening contrast medium anaphylaxis with urticarial rash and erosion on skin and oral mucous during contrast‐­enhanced computed tomography. Therefore, the use of contrast agent was considered as contraindication, and then, we planned a coronary vein (CV) lead implantation under the guidance of intravascular ultrasound (IVUS), described as follows.

Methods:

(a) A guiding catheter cannulation into the main CV was performed by intracardiac electrogram guidance with a 6Fr decapolar electrode catheter (Inquiry, Abbott, IL, USA). (b) A 0.014‐­inch guide wire was advanced into the anterior interventricular vein, and an IVUS catheter (EAGLE EYE, Volcano, San Diego, CA, USA) was deployed over the wire. The IVUS imaging revealed an antero‐­lateral CV branch (AL), and the location of the bifurcation was also confirmed on the fluoroscopic image. (c) The guide wire was successfully advanced into the AL branch, and reached to the main CV via a postero‐­lateral branch (PL). Although two CV branches (AL and PL) were confirmed, AL seemed too small for CV lead placement. (d) After the guide wire advancement into the PL, the IVUS revealed approximately 34.5 mm length and 2.0‐­3.8 mm diameter of the PL (Figure). (e) A decapolar electrode catheter was placed using inner catheter into the PL, and acceptable pacing threshold without phrenic nerve stimulation was obtained within the PL. The intracardiac electrogram revealed reasonable electrical activation latency with 106 milliseconds of Q‐­LV interval. (f) Finally, a quadripolar CV lead (4674, AcuityX4 spiral S, Boston, Minneapolis, MN, USA) was successfully placed at the latest activation site.

Result:

Two months after the successful CRT implantation, echocardiography showed a decreased left ventricular end‐­systolic volume greater than 15%, as a definition of mechanical CRT responder.

Conclusion:

A CV lead implantation by IVUS guidance can be a useful solution for patients with contrast medium anaphylaxis.

AP19‐­00232

Left‐­side heart structures and association with all‐­cause mortality in patients with hypertrophic cardiomyopathy following pacemaker implantation: Results from a single center

Nixiao Zhang, Wei Hua, Xiaoping Li, Yiran Hu, Hongxia Niu, Chi Cai, Min Gu, Xuhua Chen, Shu Zhang

Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Acade, China

Introduction:

The association between left atrial diameter (LAD), left ventricular end‐­diastolic diameter (LVEDD), and long‐­term risk of all‐­cause mortality in adults with hypertrophic cardiomyopathy (HCM) following pacemaker implantation has not been well examined.

Methods:

A total of 103 adult patients with HCM admitted to our Arrhythmia Center for symptomatic bradycardia and received pacemaker implantation from November 2002 to June 2013 were enrolled. During follow‐­up, 9 were excluded for generator upgrading of an implantable cardiac defibrillator (ICD). We retrospectively evaluated the clinical characteristics in 94 patients (57.0 ± 15.9 years, mean follow‐­ up 7.3 ± 3.4 years).

Result:

The mean LAD was 41.7 ± 7.8 mm and the mean LVEDD was 45.7 ± 6.6 mm. Overall, 25 died during follow‐­up, of which 68% were cardiovascular death. Based on the receiver operating characteristic curve, the cut‐­off value of LAD = 43.5 mm was identified to predict all‐­cause mortality, with sensitivity and specificity of 0.722 and 0.732, respectively. The cut‐­off value of LVEDD = 42.5 mm was identified to predict all‐­cause mortality, with sensitivity and specificity of 0.944 and 0.482, respectively. In the Kaplan‐­Meier survival, LAD ≥ 43.5 mm and LVEDD ≥ 42.5 mm were both associated with all‐­cause mortality (log‐­rank test P < .05). Cox regression analysis indicated that LAD ≥ 43.5 mm (HR 3.254; 95% CI = 1.043‐­10.158, P = .042) and LAD as a continuous variable (HR 1.072; 95% CI = 1.009‐­1.139, P = .025) were significantly independent predictors of all‐­cause mortality, while LVEDD ≥ 42.5 mm was not significantly associated with all‐­cause mortality in the multivariate model but in the univariate model.

Conclusion:

In HCM patients with pacemaker implantation, LAD was an independent predictor for all‐­ cause mortality, especially with a cut‐­off value of 43.5 mm.

AP19‐­00233

The clinical characteristics, and preliminary application of wearable cardioverter‐­ defibrillator: from Chinese single‐­center experience

Nixiao Zhang, Yiran Hu, Wei Hua, Xiaohan Fan, Shu Zhang

Cardiac Arrhythmia Center, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Acade, China

Introduction:

The clinical characteristics, and preliminary application of wearable cardioverter‐­ defibrillator in China have not been well explored.

Methods:

A total of 15 consecutive patients received WCD from June 2018 to March 2019 were analyzed. Clinical features, WCD compliance, feedbacks and treatment effects were collected from all patients.

Result:

The median age of WCD patients was at 50 (38‐­63) years with 80% male. There were 40% patients with coronary artery disease, 66.7% with sustained ventricular tachycardia/ventricular fibrillation. The major prescription indications were the high risk of sudden cardiac death (SCD) during pre‐­cardiac transplantation (40%), following the acute myocardial infarction with left ventricular ejection fraction ≤ 35%(34%). The median wear time was 31 (18‐­80) days, and the maximum time was 123 days while the minimum was 12 days. Only 5 patients continuously wear WCD over 1 month during a three‐­month follow‐­up. None of the patients continuously wear during the follow‐­up. Two major feedbacks were insomnia and device alarming without causes. Only one patient was recorded ventricular fibrillation for 13 times and successfully cardioverted by WCD.

Conclusion:

A single‐­center experience from China WCD observational study initially demonstrates the clinical characteristics and preliminary application in patients with WCD, which further contributes to improving SCD prevention and enhancing the public awareness of WCD.

AP19‐­00241

Comparison between His‐­bundle pacing guided by Ensite NavX system and conventional fluoroscopy

Yiran Hu, Ligang Ding, Min Gu, Hongxia Niu, Wei Hua, Shu Zhang

Fuwai Hospital, CAMS&PUMC, China

Introduction:

Conventional fluoroscopy guidance, permanent His‐­bundle pacing (HBP) usually involves high fluoroscopy exposure. This study aims to analyze the learning curve for the Ensite NavX system, and compare its pacing parameters and fluoroscopy doses (FD) with that of conventional fluoroscopy guiding HBP.

Methods:

A total of 30 patients receiving HBP from June 2018 to January 2019 were prospectively enrolled into this study (15 patients guided by conventional fluoroscopy and 15 patients by NavX system). Procedure time, FD, and pacing parameters were recorded at implant and 3‐­month follow‐­up.

Result:

Fourteen patients (93.3%) underwent successful HBP using Ensite NavX system. Procedure time basically stabilized after 4 implants. The total FD was 1.4 ± 0.5 mGy in NavX group and 16.1 ± 2.2 mGy in conventional group (P < .001). The His lead FD was 0.4 ± 0.3 mGy in NavX group and 12.5 ± 2.2 mGy in conventional group (P < .001). There was no significant difference in pacing parameters at implant and follow‐­up between the two groups.

Conclusion:

Guided by Ensite NavX system, HBP is simple and efficient with a significant reduction in fluoroscopy exposure.

AP19‐­00251

Need for lead replacement during long term follow up of pacemaker patients in a single operator large volume center in India

Ajay Naik, Aarya Naik

Care Institute of Medical Sciences (CIMS Hospital), India

Introduction:

Pacemaker implantation is established therapy for patients suffering from bradycardia. During ensuing follow up (FU), some leads may degenerate or malfunction; necessitating lead replacement when the device reaches Elective Replacement Indicator (ERI) or earlier. Some devices may be upgraded, needing additional lead deployment.

Methods:

Permanent Pacemaker Implantation (PPI) procedures performed from 2001 to 2019 by a single operator in a large volume center in Western India were analyzed. Patients had been followed up meticulously with excellent retention rate for replacements.

Result:

Permanent Pacemaker Implantation (PPI) was performed in 863 Pts from 2001 to 2019 (Figure 1). Single chamber PPI had been performed in 355 of 863 Pts (41.13 %) and remaining 508 Pts (58.86 %) underwent Dual Chamber PPI. Over the 18‐­year FU period (mean 84 months), device replacement was performed in 173 Pts (20.04%) on reaching ERI. 10 leads needed to be replaced in these 173 patients (5.78% of replacements) for malfunction / degeneration/ suboptimal parameters or due to physical growth in pediatric patients. (Figure 2). Atrial lead was replaced in 7 Pts and Ventricular lead in 3 Pts. Atrial lead was added in 6 Pts (3.46%) for upgradation to dual chamber pacemaker system. Overall, lead‐­related procedure was needed in 16 of 173 replacement procedures (9.24%).

Conclusion:

During Pacemaker replacement for ERI, approximately 1/10th of Patients needed simultaneous lead related procedure. This should be an essential discussion during counselling of patients at initial implant and follow up.

FIGURE 1 Number of pacemaker implantations and replacements

FIGURE 2 Pacemaker replacements and lead related procedures

AP19‐­00252

MRI compatible pacemakers in a single operator large volume center in India: Premium technology adaptation in a low‐­medium level economy

Ajay Naik, Aarya Naik

Care Institute of Medical Sciences CIMS Hospital, India

Introduction:

Permanent Pacemaker Implantation (PPI) is established therapy for Patients (Pts) suffering from bradycardia. Magnetic Resonance Imaging (MRI) compatibility is an important technological advancement in pacemaker therapy, however it is a non‐­essential attribute of therapy. There is an additional premium in terms of cost for these devices.

Methods:

MRI conditional pacemakers were introduced in 2009 in India, where 80% of device implantation procedures are self‐­paid by Pts. This is in the background of India being a Low‐­medium level economy as per World Bank. The proportion of MRI conditional pacemaker implants over past 10 years was studied.

Result:

Permanent Pacemaker Implantation (PPI) was performed in 544 Pts from 2009 to 2019. Single chamber PPI was performed in 161 and Dual chamber PPI in 383 Pts. Pacemaker replacements were performed in an additional 161 patients over this period of 10 years. Of the 383 Dual Chamber PPIs, 180 were MRI conditional devices (47 %); 5 of the 161 Single Chamber PPIs were MRI conditional (3.1 %). Thus, 185 of 544 Pts (34 %) underwent MRI conditional PPI (Figure 1). The number of MRI conditional implants exceeded the non‐­MRI implants in 2016 (7 years after the first introduction of MRI devices in 2009); thereafter they continued to be proportionately higher. Continued increasing trend resulted in only MRI conditional pacemakers being implanted in 2019. Of the 161 Pts undergoing Pacemaker replacements, 20 received an MRI conditional device taking advantage of presence of MRI conditional chronic leads.

Conclusion:

MRI conditional pacemakers represent a non‐­essential premium technology in bradycardia therapy. There has been gradual, steady change with almost complete adaptation to the new technology over the past decade.

FIGURE 1 Non‐­MRI vs MRI conditional pacemaker implantations

AP19‐­00253

Bail‐­out internal jugular vein approach in permanent pacemaker implantation

Aman Makhija, Kavita Tyagi, Arun Mohanty, Rajaram Mantri

Sir Ganga Ram Hospital, India

Introduction:

Permanent transvenous cardiac pacing is usually accomplished through the upper limb subclavian veins via extra thoracic puncture. Subclavian crush is a potential problem with intra‐­thoracic percutaneous subclavian vein access. In the presence of subclavian occlusion, several other vascular access options exist which include the internal jugular veins.

Methods:

69 years male with chronic kidney disease with symptomatic sick sinus syndrome was implanted DDDR pacemaker. An intra‐­thoracic left subclavian puncture was done in view of chronic occlusion of extra‐­thoracic left subclavian vein. One month post procedure, patient developed subclavian crush syndrome with rise of pacing threshold of atrial and ventricular lead (5.0@0.4 and 4.5@0.4 milliseconds respectively). Reimplantation of fresh leads through repeat intra‐­thoracic left subclavian puncture was avoided. Contralateral access was not considered in view of right AV fistula. Attempts to open subclavian occlusion through antegrade and retrograde routes were unsuccessful. As a bailout procedure, percutaneous left internal jugular vein punctures were made and screw in leads were implanted in right atrial appendage and RV low septum locations. The lead were secured by tying the suture sleeve to the sternocleidomastoid muscle. A set of haemostat forceps was used to create a tunnel subcutaneously using blunt dissection from jugular puncture site towards the superior aspect of the clavicle. The forceps were directed under the clavicle hugging close to the posterior and inferior surface of the clavicle to exit into the infraclavicular pocket while dividing the muscle layers. A guide wire followed by a sheath was first passed through this tract. The proximal end of the pacing leads were secured with a silk suture and were then pulled through the tissue tunnel with the sheath to protect the lead one after the other. The proximal end of the leads were thus tunneled beneath the clavicle into left pre‐­pectoral pocket and attached to the pulse generator. There were no vascular or other complications.

Result:

At follow‐­up electrical parameters remained stable.

Conclusion:

Internal jugular vein approach is safe, feasible and may be considered in patients where subclavian access is not available.

AP19‐­00258

Left ventricular dimension predicts risk of electrical storm and mortality in patients with ischemic heart disease and implantable cardioverter defibrillator

Zhengqin Zhai, Keping Chen, Wei Xu, Wei Hua, Yangang Su, Xin Liu, Min Tang, Shuang Zhao, Zeyi Li, Shu Zhang

Fuwai Hospital, Peking Union Medical College, China

Introduction:

Patients with ischemic heart disease could benefit markedly from implantable cardioverter defibrillator (ICD) and electrical storm (ES) has been demonstrated to increase the risk of mortality. Left ventricular (LV) dimension may be associated with risk of electrical storm and may act as long‐­term mortality predictor in these patients.

Methods:

We retrospectively studied the clinical and remote monitoring data of 295 ICD recipients with ischemic heart disease. Multivariate logistic regression was used to analyze the relationship between LV end‐­diastolic dimension (LVEDD) and ES. To evaluate diagnostic performance of LV dimension, we calculated areas under the curve (AUC) of LV dimension as predictor of ES. Kaplan‐­Meier analysis and Multivariate Cox regression were used to find out whether LV dilation could predict the increased mortality risk of patients in the long term.

Result:

During a median follow‐­up of 50 (52‐­71) months, 14.8% of patients experienced ES and a total of 94 patients died of all causes. Increased LVEDD was the only independent predictor of ES, with relative ratio of 2.86, 95% confidence interval (CI) of 1.54‐­5.32 (P = .001). The receiver operating characteristic curve analysis (AUC 0.653, 95% CI 0.58‐­0.72, P < .001) showed a best diagnostic performance for LVEDD of 60 mm to predict the occurrence of ES (sensitivity 0.74, specificity 0.55). In the multivariate Cox regression model, ES (adjusted hazard ratio (aHR) 2.49, 95% CI 1.56‐­3.97, P < .001) and increased LVEDD (aHR 1.04, 95% CI 1.01‐­1.06, P = .002) were associated with high risk of all‐­cause mortality in patients. Additionally, LV dilation (LVEDD ≥ 60 mm) in the presence of ES substantially increased the risk of all‐­cause mortality and cardiovascular mortality compared with patients without ES and LVEDD < 60 mm (aHR 7.23, 95% CI 3.16‐­16.54, P < .001; aHR 16.00, 95% CI 3.54‐­72.30, P < .001). Of note, no positive or negative interactions existed between LV dilation and ES in increasing the mortality of patients with ICD and ischemic heart disease.

Conclusion:

LV dilation (LVEDD ≥ 60 mm) performs well in predicting the occurrence of ES. Both LV dilation and ES act as independent predictors of increased risk of mortality in patients with ICD and ischemic heart disease and could significantly amplify the deleterious effects of each other as distinct disease entities.

AP19‐­00261

Long‐­term clinical outcomes of abandoned cardiac implantable electronic device lead

Euijae Lee, Eue‐Keun Choi, So‐Ryoung Lee, Myung‐Jin Cha, Seil Oh, Yun‐Shik Choi

Seoul National University Hospital, South Korea

Introduction:

As implantation of cardiac implantable electronic devices (CIED) increased, lead malfunction and device system upgrade are emerging issues. However, there is a paucity of information about the long‐­term clinical outcomes of abandoned leads (AL). We aimed to compare the long‐­term adverse outcomes according to the presence of AL in patients with CIED.

Methods:

From a single center CIED registry over 34 years, 130 patients who had AL were identified. We have matched patients with non‐­AL by age, sex, device type, and index date of CIED implantation (2:1, n = 260). We have compared the composite outcomes of CIED‐­related infection (CRI) and thromboembolism (TE) between two groups.

Result:

A total of 2,962 CIED procedures were performed in 2,240 patients between 1984 and 2018. The number of AL was 153 (57 atrial and 96 ventricle leads), and the mean time from abandonment was 8.4 ± 7.3 years in patients with AL (mean age 52.9 ± 15.5 years, male 45.4%, pacemaker 93.8%, and implantable cardioverter defibrillator 6.2%). Common causes of AL were lead malfunction (n = 82, 63.1%), device upgrade or mode switch (n = 24, 18.5%), and CRI (n = 13, 10.0%). During a mean follow‐­ up of 13.4 ± 9.0 years, the primary outcome occurred in 21 (5.4%) patients (14 CRIs and 7 TEs). Cumulative incidence rates were not different between patients with and without AL (0.54 per 100 patients‐­year (PY) vs 0.30 per 100 PY, log‐­rank P = .21 for the primary outcome; 0.36 per 100 PY vs 0.20 per 100 PY, log‐­rank P = .24 for CRI; 0.17 per 100 PY vs 0.10 per 100 PY, log‐­rank P = .65 for TE). In Cox regression analysis, the AL group did not show an increased risk of adverse clinical outcomes (hazard ratio [HR] = 1.14, 95% confidence interval [CI] = 0.45‐­2.87, P = .79 for composite outcome; HR = 1.18, 95% CI = 0.39‐­3.62, P = .77 for CRI; HR = 0.98, 95% CI = 0.19‐­5.13, P = .9 for TE). We have divided patients with AL according to the number of AL (109 patients with single AL and 21 patients with multiple ALs). Patients with multiple ALs had more atrial ALs compared to those with single AL (76.2% vs 33.9%, P < .001). Multiple ALs group showed higher CRI rates compared to the group without AL (P < .001) and single AL group (P = .001). Cox regression analysis indicated that patients with multiple ALs had a 3.77‐­fold greater risk for CRI (HR = 3.77, 95% CI = 1.02‐­13.76, P = .04) compared to patients without AL. However, there was no significant difference in the risk of TE among the three groups.

Conclusion:

Patients with multiple ALs showed an increased risk of CRI, whereas those with single AL have comparable outcomes as those with non‐­AL. It would be appropriate not to abandon multiple leads in patients with CIED.

FIGURE 1‐A Cumulative incidence of primary outcome according to the presence of abandoned lead. B Cumulative incidence of primary outcome according to the numbers of abandoned lead

AP19‐­00270

Migratory symptoms due to Twiddler's syndrome in a patient with a biventricular defibrillator

Corey Smith, Andrew Hopkins

St George Hospital, Australia

Introduction:

Twiddler's syndrome is an uncommon complication of implanted cardiac devices. It is a serious complication with possibility of loss of pacing, failure of defibrillation or inappropriate shocks. Twiddler's syndrome is very rarely seen in cardiac re‐­synchronization therapy/defibrillator (CRT‐­D) devices possibly owing to their increased size and difficulty rotating within the pocket.

Methods:

N/A.

Result:

Case Summary: A 44 year old man with a history of non‐­ischaemic dilated cardiomyopathy and ventricular tachycardia detected on Holter monitor presented 2 months after CRT‐­D implantation with onset of muscular twitching in the right flank. Automated device interrogation was performed (unable to test left ventricular (LV) capture with acceptable atrial and right ventricular parameters) and chest x‐­ray (Figure A) showed LV lead dislodgement into the superior vena cava. Despite clinical suspicion of ACID malfunction the LV lead dislodgement was not recognised in the emergency department and as the atrial and right ventricular defibrillator leads appeared to be in a satisfactory position the patient was discharged with instruction to make a pacemaker clinic follow‐­up. He attended clinic 3 months later reporting that the muscular twitching symptom had moved and was now occurring in the left chest. Clinically there was left diaphragmatic pacing. Pacemaker interrogation revealed inability to capture from the LV lead and an increase in impedance. Atrial and right ventricular lead parameters were stable from implant. Repeat chest x‐­ray (Figure B) showed the LV lead had been retracted nearly fully out of the subclavian vein and there had been a change in position of the atrial lead and generator. The patient denied conscious manipulation of the device. Urgent lead revision was arranged and after 6 months of follow‐­up there was no recurrence and lead position remained satisfactory on repeat chest x‐­ray.

Conclusion:

We present an uncommon case of twiddler's syndrome of a CRT‐­D device and show the natural history with migratory symptoms and documentation of progressive lead retraction over several months. Twiddler's syndrome should be considered in the differential if new onset of muscle stimulation or deterioration in lead parameters are detected. As seen in our case the increasing complexity and variety of implanted cardiac devices may make it difficult for non‐­specialist medical practitioners to recognise a device complication or malfunction.

AP19‐­00274

The role of subclavian venoplasty in patients with prior implant failure

Cyrus Hadadi, Nebu Alexander, John Costello, Zayd Eldadah, Seth Worley

MedStar Washington Hospital Center, United States

Introduction:

Subclavian venoplasty (SV) is important in patients with prior implant failure. We describe our experience with SV in patients referred to a tertiary academic center after prior implant failure.

Methods:

We reviewed the role of SV in 96 patients referred for prior implant failure between June 2017 & November 2018; 21 were referred primarily because of subclavian occlusion (SO) & 75 for failed left ventricular (LV) lead placement because of difficult coronary venous anatomy.

Result:

In 19 of 21 with SO a wire was advanced and venoplasty performed. In 2 a wire could not be advanced, in both cases there were no leads to follow. In 14 of 96 (15%) referred primarily because of difficult CS venous anatomy, SV in addition to assorted interventional tools & techniques was essential to permit LV lead placement. There were no complications related to SV.

Conclusion:

Subclavian obstruction commonly results in primary referral for implant failure. In the majority of the cases (19/21) a wire can be advanced & SV performed. Failure to advance a wire occurred in 2/5 patients with no leads to follow. SV is commonly required as an essential secondary procedure in patients referred primarily for prior LV lead implant failure.

AP19‐­00275

Interventional approach to left ventricular lead implantation

Cyrus Hadadi, Nebu Alexander, John Costello, Zayd Eldadah, Seth Worley

MedStar Washington Hospital Center, United States

Introduction:

Anatomic variability of the coronary venous system frequently hinders left ventricular lead placement using traditional tools & techniques. Interventional tools & techniques (IT&T) have been developed to improve the success cardiac resynchronization therapy. We describe the success & the IT&T employed in patients with previous implant failure using traditional techniques.

Methods:

We reviewed the data on 96 patients with a previously unsuccessful attempt at LV lead placement from June 2017 through November 2018.

Result:

90 of 95 were implanted successfully. The following interventional techniques were judged primary: (a) Vein selector enhanced/sub‐­selector (20); (b) Snare – ortho/antidromic (18); (c) Support wire technique (13); (d) Anchor balloon (3); (e) Coronary branch venoplasty (3); (f) Subclavian venoplasty (19). In 84 cases, two ITT were employed (e.g. subclavian venoplasty & vein selector). Implant failure resulted from: (a) high thresholds in all targets (3). (b) CS atresia & unroofed CS with occluded vein of Marshall (1).

Conclusion:

Use of interventional techniques including the vein selector, snaring, coronary venoplasty, & the anchor balloon makes LV lead implantation successful in the vast majority of prior implant failures.

AP19‐­00276

A new road to CRT: Patent vein of Marshall for left ventricular lead implantation

Cyrus Hadadi, Seth Worley, Torkel Steen, Matthew Sellers, Athanasios Thomaides, Susan O'Donoghue, David Strouse, Santosh Padala, Babar Candemir, Mathew McKillop, Michael Kaufmann, Khalil Kanjwal, Devi Nair, Alexander Kushnir

MedStar Washington Hospital Center, United States

Introduction:

Coronary sinus anomalies, including coronary sinus ostial atresia, atypical right atrial drainage and unroofed coronary sinus, complicate implantation of a left ventricular pacemaker lead for cardiac resynchronization therapy. In many of the above CS anomalies, coronary venous return will flow retrograde through a patent vein of Marshall to the innominate vein. We report a series of cases from multiple international centers of patients with coronary sinus anomalies where a PVOM was utilized for left ventricular (LV) lead placement.

Methods:

We reviewed the data on 20 patients where a patent vein of Marshall was identified & used to attempt LV lead placement in order to better understand: (a) Clinical circumstances that lead to the discovery of the PVOM. (b) Imaging techniques used to identify the PVOM. (c) CS anomalies were associated with a PVOM. (c) Physical characteristics of the PVOM. (d) How the PVOM was used to facilitate attempted LV lead placement. (e) Potential complications associated with using a PVOM for LV lead placement.

Result:

Clinical Characteristics: 44% had at least one previously unsuccessful attempt at LV lead placement due to inability to find or cannulate the CS. 22% had been referred for epicardial LV leads. Imaging Techniques: The PVOM was identified by catheter manipulation & contrast injection in 72% and identified via levophase CS venography in 28%. In 2 cases prior dedicated cardiac CT did not reveal the PVOM, however in 1 case cardiac CT did demonstrate the PVOM pre‐­procedure. CS Anomalies & Characteristics: 33% of PVOM were associated with an unroofed CS. The average PVOM measured 5.3 mm in diameter. LV Lead Implantation: LV lead implantation was successful in 89% of cases, with implant directly down the PVOM in 80% of cases. In 1 case subclavian venoplasty was necessary prior to identification of the PVOM, and in 1 case CS venoplasty and snaring the circumference of the PVOM was necessary in order to advance the LV lead into the CS. Complications: In 1 case the patient experienced a stroke during implantation secondary to an unroofed CS.

Conclusion:

Coronary sinus anomalies are rare congenital and iatrogenic anatomic variants that complicate implantation of a left ventricular pacemaker lead for cardiac resynchronization therapy. Searching for, finding and utilizing a patent vein of Marshall can achieve successful lead implantation.

AP19‐­00280

Left ventricular endocardial pacing improves CRT outcomes in heart failure patients with intermediate QRS duration: A propensity score matched analysis

Jaimie Manlucu, Bart Gerritse, Zhongping Yang, Anthony Tang, Raymond Yee

London Health Sciences Centre / Western University, Canada

Introduction:

Cardiac resynchronization therapy (CRT) has been shown to improve symptoms, reduce mortality and heart failure (HF) hospitalization in patients with wide QRS widths. However, its benefit in patients with intermediate QRS duration (120‐­150 milliseconds) is less predictable. With direct access to the rapidly conducting His‐­Purkinje system, left ventricular (LV) endocardial CRT pacing may improve outcomes by providing a more physiologic means of stimulating the heart.

Methods:

A patient‐­level meta‐­analysis was done to compare data from the alternate site CRT (ALSYNC) study with LV endocardial pacing (n = 118) with data from two conventional CRT studies (PROSPECT (n = 426) and REVERSE (n = 419)) with respect to LV End Systolic Volume Index (LVESVi) reduction at 6 months post implant. Multiple imputation and propensity score weighting were used to account for missing data and differences in baseline characteristics. Analysis used a linear model for the logarithm of LVESVi at 6 months with the baseline value as a covariate. ALSYNC patients with prior CRT were excluded (n = 28).

Result:

The LVESVi reduction in both the ALSYNC and conventional CRT cohorts were better than the applicable target of 15% for patients with QRS duration ≥ 150 milliseconds (P = .05), but much greater in ALSYNC patients when QRS duration was between 120 and 150 milliseconds (P = .038).

Conclusion:

This propensity score matched analysis showed that CRT with LV endocardial pacing resulted in improved LV reverse remodelling in intermediate QRS patients compared to conventional CRT.

Observed LVESVi Reduction by QRS Duration

LVESVi reduction (%)	QRS 120‐­150 milliseconds	QRS ≥ 150 milliseconds
Control	−8.0 ± 27.3 (n = 226)	−20.2 ± 28.3 (n = 425)
ALSYNC*	−25.7 ± 17.8 (n = 14)	−17.5 ± 34.4 (n = 48)
P	0.038	0.05

AP19‐­00281

An extended spacing CRT lead improves delivery of “Optimal MPP” programming

Craig Delaughter, Kevin Palmer

Baylor Heart and Vascular Hospital, United States

Introduction:

Quadripolar CRT leads make multi‐­point (MPP) CRT pacing possible. Subgroup analysis of the Multipoint Pacing US IDE Study revealed a significant improvement in CRT response rates when MPP electrode spacing was ≥30 mm and timing was 5 milliseconds (“Optimal MPP”). We show that these parameters are more likely to be met with use of an extended spacing CRT lead.

Methods:

A total of 28 patients were provided quadripolar CRT by a single implanter as part of the US FDA mandated Multipoint Pacing Post Approval Study. An extended spacing CRT lead (Abbott Medical 1458QL, 60 mm maximum electrode spacing) was attempted in all cases. Follow up was per MPP PAS protocol.

Result:

23 of 28 (82%) patients successfully received the extended spacing (1458QL) lead. 5 of 28 (18%) received a non‐­extended spacing CRT lead (1458Q), typically due to coronary sinus branch vessel limitations. 9 of 23 (39%) 1458QL patients were programmed with “Optimal MPP”. 1 of 5 (20%) 1458Q patient was programmed with “Optimal MPP”. 1458QL utilization in the overall MPP PAS was 138 of 948 (14.6%) patients. “Optimal MPP” programming in the overall MPP PAS was 70 of 948 (7.4%) patients. Of the 14 1458QL patients who did not receive “Optimal MPP” programming in this report, 2 were lost to follow up, 1 developed loss of capture of the 2 most proximal electrodes, 3 developed phrenic nerve stimulation, 3 had ≥30 mm spacing but did not meet 5 milliseconds timing criteria, and 5 were reprogrammed by other cardiology providers for unclear reasons.

Conclusion:

An extended spacing CRT lead can be delivered in nearly all patients (82%). Such spacing provides more options for “Optimal MPP” programming as outlined in the subanalysis of the MPP US IDE Study (39% success in this report). Reprogramming by other cardiology providers, perhaps due to a lack of familiarity with MPP CRT, was the most frequent cause of non‐­”Optimal MPP” programming.

AP19‐­00292

The economy of time and labor in cardiac remote monitoring by standard operating procedure

Ayumi Wakita

Urasoe General Hospital, Japan

Introduction:

Alerts‐­driven clinical management is a promising strategy for patient management with cardiac implantable electrical devices (CIEDs). However, tremendous numbers of alerts have increased the daily work of medical staffs. The additional supporting strategy had better be used for high volume centers.

Methods:

Standard operating procedure (SOP) was generated to perform a prompt and adequate response against alerts and to reduce tasks of medical staffs as follows. First, the information from the remote monitoring system is handled by clinical engineers. According to the SOP, the clinical engineers decide whether the alert should send to the physician or not. Currently, we are using the SOP only for atrial fibrillation (AF) and non‐­sustained ventricular tachycardia (NSVT). In the case of an alert of AF, the clinical engineers only send the alert to the physicians if the AF has lasted for 6 or more minutes without anticoagulation therapy. When repeated alerts for AF with anticoagulation therapy from the same patient are received, we change its SOP to the second SOP. In repeated AF cases, the alert criteria for AF are changed to burden >25%. In the case of a NSVT alert, we send the alert to the physicians if ventricular tachycardia has lasted for 15 or more beats. In addition, any false recognition by remote monitoring system or short duration and high rate ventricular tachycardia (10‐­14 beats, over 150 bpm events) is treated as an alert that should be sent.

Result:

All remote monitoring alerts were collecting from Medtronic or BIOTRONIK company's CIEDs, excluding leadless pacemakers and implantable cardiac monitors. AF events (n = 117) were received from 191 patients during the last six months. Within the AF events, the 88 events (51.5% of total AF events) were ruled out by SOP from consulting the physicians. NSVT events (n = 123 events) were also received during the same periods. Fifty‐­two events (42% of total NSVT events) were excluded by SOP from further consulting. There has been no major adverse event under SOP‐­conducted clinical management. SOP‐­conducted triage of alerts from remote monitoring system of the cardiac device could reduce many unnecessary submissions of alerts to the physicians. All SOP‐­conducted triage of the alerts could be operated by clinical engineers. Before the use of SOP, a triage of alerts from remote monitoring system had tended to make a variation in an evaluation of alerts among medical engineers due to lack of grounds for assessing of alerts. In terms of standardization of handling alerts, SOP contributed to a homogenization of the technological gap between medical engineers.

Conclusion:

SOP combined use of remote monitoring system of cardiac devices has enabled us to a prompt response for important alerts and reduce the task of the physicians without any problem.

AP19‐­00294

Adding His bundle pacing to the biventricular pacing case with persistent bradycardic atrial fibrillation

Naohiko Sahara, Shimizu Takayuki, Keijiro Nakamura, Hitoshi Anzai, Masato Nakamura

Saiseikai‐­tobu hospital, Japan

Introduction:

HIS bundle pacing (HBP) has been reported as an alternative to biventricular pacing (BiV). Here we report a CRT‐­ indication case treated simultaneously with biventricular pacing and HBP.

Methods:

–

Result:

A 70‐­year‐­old man was diagnosed with hypertrophic cardiomyopathy. Two years ago, VVI pacemaker with right ventricular apical pacing (RVAP) was placed for bradycardic atrial fibrillation, but heart failure was exacerbated, and it increased to NYHA1 → 3 and decreased to EF55% → 35%. We considered that the dyssynchrony by RVAP contributed more to the development of cardiac dysfunction than the progression of cardiomyopathy and judged it to be an indication for CRT. In order to evaluate the effectiveness of BiV and/or HBP, invasive hemodynamic monitoring was performed as a preoperative examination. We examined LV dP/dt max and QRS duration for each of RVAP, left ventricular pacing (LVP), HBP and their combinations as shown in the Figure 1. LV dP/dt max tended to increase and QRS duration tended to short with HBP alone or with two‐­point and three‐­point pacing with HBP. Based on this result, we actually upgraded. Since left subclavian vein occlusion was founded, the RV lead that had been placed from the left side was removed, and then the device implantation was performed with the right approach. After placing the LV lead in the lateral branch, the SelectSecureTM3830 Lead was placed at the HIS bundle potential recording site using Fixed Shape C315 Catheters and connected to the atrial lead port of the generator to complete the implantation. The QRS duration of RVAP is 180 milliseconds, and the QRS duration of the two‐­point pacing of RVAP and LVP is 130 milliseconds, while the QRS duration of the two‐­point pacing of HBP and LVP (LV + 50 milliseconds) is 100 milliseconds. Postoperatively, symptoms of heart failure and BNP levels improved.

Conclusion:

Adding His bundle pacing to the biventricular pacing case with persistent bradycardic atrial fibrillation was effective in shortening the QRS width. It is also a successful case of HIS lead placement with the right approach, which is considered to be difficult.

AP19‐­00303

Atrial lead location plays an important role to avoid unnecessary ventricular pacing not only during atrial pacing but also during atrial sensing

Chikashi Suga, Yoshitaka Sugawara, Takashi Yamada, Toshiko Nakai

Suga Clinic, Japan

Introduction:

It is important to avoid unnecessary ventricular pacing (VP) to prevent adverse cardiac events in patients undergoing pacemaker implantation. However, right atrial (RA) pacing sometimes causes prolongation of PQ interval leading to increase of VP frequency. The purpose of this study was to determine if there was any favorable atrial lead location to avoid VP.

Methods:

This study included 12 patients who had sinus rhythm and spontaneous atrio‐­ventricular conduction, and undergoing pacemaker implantation or electrophysiological study (8 males, mean age 52.8 ± 22.1 years). Ventricular lead was placed in right ventricular (RV) apex or septum, and RA lead was placed in RA appendage (RAA), high RA septum (HAS) and low RA septum (LAS) in series in each patient. The following parameters were obtained from ECG and compared according to 3 atrial lead locations: P width, interval from atrial pacing (AP) spike to QRS, interval from AP spike to onset of P wave, and the shortest AV delay which enables avoidance of VP (Non‐­VP AVD) during AP, interval from onset of P wave to local A wave, and Non‐­VP AVD during atrial sensing (AS).

Result:

During AP, interval from AP to QRS (180.8 ± 29.9 vs 164 ± 29.6 vs 143.8 ± 36.2[milliseconds], P < .05) and Non‐­VP AVD (217.5 ± 35.9 vs 195 ± 31.1 vs 175 ± 49.3[milliseconds], P < .05) were shortest during LAS pacing while P width and interval from AP to onset of P wave were not different (P = NS). During AS, LAS lead location resulted in the longest interval from onset of P wave to local A wave (‐­0.8 ± 11.1 vs 7.5 ± 8.7 vs 30.5 ± 11.4 [milliseconds], P < .05) and the shortest Non‐­VP AVD (180 ± 35.6 vs 190 ± 36.5 vs 147.5 ± 38.6 [milliseconds], P < .05).

Conclusion:

LAS lead location resulted in shortest Non‐­VP AVD primarily due to shortening of PQ interval during AP, and due to prolongation of the interval from onset of P wave to atrial sensing during AS. LAS atrial lead positioning seems to be most favorable in terms of avoidance of unnecessary ventricular pacing under the presence of spontaneous atrio‐­ventricular conduction.

AP19‐­00306

Is CT imaging a risk to ICD patients?

Yusaku Nishikawa, Akio Yamazaki, Kou Takahama, Yuma Tumagari, Takehiro Gotoh, Masayuki Tomita, Tatsuhiro Hakumae, Takashi Sasou, Masako Yamada

Mie University Hospital, Japan

Introduction:

It has been said that a computed tomography (CT) scan of the Implantable Cardioverter Defibrillator (ICD) in patients might cause inappropriate tachycardia detection by over sensing and irradiated X‐­rays the body implantation site. Therefore there were instructions from Pharmaceuticals and Medical Devices Agency (PMDA) to turn off the tachycardia detection function during testing. As a result we are present at all chest CT scans of ICD patients turn off the detection function during a scan. However, the chance of miss diagnosing even if keeping also the tachycardia detection function turned on is very slim.

Methods:

Five ICD model were used from five manufacturing companies sold in Japan. The CT scanner Aquilion ONE (CANON medical systems) was used. The ICD was connected to a false heart potential generator, and attached stuck to chest of a human body simulation model. The detection setting of the tachycardia was set at the maximum sensitivity. A scan was carried out in the range of 16 cm from the center of ICD. The tube voltage is 80, 100, 120, 135 kV, the tube current is 50, 150, 250, 350, 450, 550 mA, and the rotation time is 0.35, 0.4, 0.5, 0.75, 1.0, 1.5 seconds. CT imaging was performed five times at each setting to observe the result.

Result:

In all scans, there was no miss diagnosing. There was also no record of the tachycardia detection by noise corruption.

Conclusion:

When X‐­rays are irradiated in a Complementary Metal Oxide Semiconductor (CMOS), the noise by the X‐­rays of ICD occurs. The possibility that treatment is carried out is extremely slim. This is because X‐­rays irradiation to the ICD body is over early than it leads to treatment by the CT scan. On the one hand the risk to turn off a tachycardia detection function is present when arrhythmia occurred during a CT scan. For example, a judgment that the patients whom spontaneous termination is got from by the long detection establishment discontinue testing and shift to treatment is difficult. Also, we may defibrillate it if ventricular tachycardia occurs during a CT scan even if anti tachycardia pacing (ATP) is effective. Because width of a mechanism and the setting of the detection varies according to a model, the investigating with other models is necessary, but it is thought that it does not have to necessarily turn off a tachycardia detection function.

AP19‐­00307

Cardiac resynchronization therapy in patients with persistent left superior vena cava

Suraya Hani Kamsani, Rohith Stanislaus, Mohd Faiz Faizul Fauzi, Amir Firdaus Ali Shaiffudin, Surinder Kaur Atma Singh, Azlan Hussin

Institut Jantung Negara, Malaysia

Introduction:

Persistent left superior vena cava (PLSVC) is one of the most common congenital abnormality found incidentally during cardiac device implantations. Hereby we report two cases of cardiac resynchronization therapy (CRT) device implantations in patients with PLSVC. The first case was a 48‐­year‐­old gentleman who had aortic valve replacement 4 years prior to presenting with complete heart block (CHB). His echocardiogram showed dilated left ventricle (LV) with ejection fraction (EF) of 36%. The second patient was a 57‐­year‐­old lady who had CHB with episodes of Torsades de Pointes. LVEF was 35% and her coronary angiogram showed severe ostial left main stem (LMS) disease, calcified left anterior descending (LAD) with severe ostial disease.

Methods:

For the first patient, we implanted a CRT‐­P via standard left deltopectoral approach. During the implantation, after placing an active fixation right ventricular (RV) at the RV apex, we faced difficulties to engage the coronary sinus (CS) via left axillary vein puncture. Venogram was done to visualize the coronary sinus ostium, and this revealed coronary sinus atresia with PLSVC. As the CS drains into the PLSVC, access to the lateral branches of the CS was only possible through this persistent connection. We improvised our approach using peripheral interventional technique and managed to gain access to the lateral wall via the posterior vein. An active fixation lead was used to ensure stability of the LV lead in that particular position. Capture threshold post implantation was stable at 0.6V at 0.5 milliseconds. Similarly, for the second patient, she had coronary sinus atresia with PLSVC. We cannulated the left SVC using hydrophilic guidewire via sub‐­selection catheter, and passed a 4 Fr hydrophilic coated catheter from left SVC to CS. This was then used as support, while another guidewire was inserted then exchanged with coronary sinus selection catheter. Selective coronary sinus tributaries venography was done and lateral vein was selectively intubated with an inner sub‐­selection catheter. An over‐­the‐­wire lead was successfully deployed through the intubated inner sub‐­selection catheter with a capture threshold of 1.2 V at 0.5 milliseconds. Lastly, an active‐­fixation atrial lead was positioned at the right atrial appendage. A CRT‐­D device was connected and implantation was successfully completed.

Result:

Chest radiography post implantation for both patients showed stable leads position and no pneumothorax. At 1 month follow up, the LV capture threshold and other parameters remained stable.

Conclusion:

The transvenous placement of LV pacing lead via PLSVC can be technically challenging. Use of guidewire support, sub‐­selection catheter and active fixation leads contributed to the success of LV lead implantation in these two cases.

AP19‐­00308

Comparative acute lead‐­related complications of catheter delivery‐­system and stylet delivery system in pacemaker patients:Single center experience

Takashi Hagiwara

Saitama Sekishinkai Hospital, Japan

Introduction:

In pacemaker implantation, the stylet delivery system (Conventional group) was mainstream, but with the recent appearance of catheter delivery system (Model C 315, Medtronic Inc., Minneapolis, MN, USA: Catheter Delivered group) The choice of has become possible. In this study, we compared the two systems from the viewpoint of lead related complications in the acute phase. (Single‐­ center retrospective study)

Methods:

The total number of used leads in 114 cases of pacemakers implanted from April 2018 to March 2019, retrospectively comparing the two systems from the perspective of lead related complications (perforation and dislodgement) in the acute phase.

Result:

Of the 211 total leads used, 97 leads were Catheter Delivered and 114 leads were Conventional. (RA:Catheter Delivered group 44 leads, Conventional group 53 leads, RV:Catheter Delivered group 53 leads, Conventional group 61 leads) Lead‐­related complications occurred in 9 cases in total (7 cases for dislodgement, 2 cases for perforation). Among lead‐­related complications, Catheter Delivered group was dislodgement in 2 cases (2.06%), while that in Conventional group was 7 cases (6.14%), 5 cases of dislodgement and 2 cases of perforation. (P = .18) On the atrial side, dislodgement occurred in 1 case (2.27%) out of 44 leads in Catheter Delivered group. Dislodgement occurred in 5 cases out of 53 (9.43%) in the conventional group. (P = .22) On the ventricular side, dislodgement occurred in one (1.89%) of the 53 leads Catheter Delivered groups. Perforation occurred in 2 out of 61 leads (3.28%) In the conventional group. (P = 1.00) As the elderly people group, 80 years old or older was divided into the elderly people group and the non‐­elderly people group. Among the 54 elderly patients, Catheter Delivered had 0 cases of complications. Complications occurred in 5 of 43 cases in the conventional group (atria: dislodgement 3/ventricular : perforation 2), and the complication rate was significantly lower in the Catheter Delivered group. (P = .014) In the non‐­elderly group, there were 2 internal complications of 43 leads in the Catheter Delivered group (atria: dislodgement 1 / ventricular: dislodgement 1), compared with 2 of 71 leads in the conventional group. (Dislodgement 2) (P = .631) Next, it divided into sex and verified. In the women's group, there were 1 internal complication of 52 leads in the Catheter Delivered group (atrium: 0 / ventricular: dislodgement 1), whereas in the conventional group, 4 out of 59 leads occurred complications. (Atria: dislodgement 2 / ventricle: Perforation 2). (P = .368) In the male group, the complication was 1 in 45 of the Catheter Delivered group (atrium: dislodgement 1 / ventricular: 0), whereas in the conventional group, the complication occurred in 3 out of 55. (Atria: dislodgement 3 / ventricle: 0). (P = .625)

Conclusion:

In pacemaker cases, we compared the catheter‐­delivered and stylet delivery systems with acute lead‐­related complications. In elderly people, catheter delivery systems resulted in significantly fewer acute lead‐­related complications.

AP19‐­00309

Anatomical characteristics of permanent His‐­Bundle pacing in patients with atrioventricular block using the unique technique

Daisuke Yoshimoto, Yuichiro Sakamoto, Ryo Yamaguchi, Takahiko Suzuki

Toyohashi Heart Center, Japan

Introduction:

His‐­bundle pacing (HBP) is known as a physiological pacing, and it has been reported that HBP could achieve lower heart failure hospitalization and mortality rate than right ventricular (RV) pacing with long‐­term follow‐­up. However, it is sometimes challenging for particularly inexperienced physicians to search a success site of permanent HBP in patients with atrioventricular block (AVB) within a limited time. We investigated the anatomical characteristics of the success sites of permanent HBP in patients with AVB and reported on‐­going prospective data of complete anatomical approach for HBP.

Methods:

When we performed His‐­bundle mapping using an active‐­fixation pacing lead (3830 SelectSecure; Medtronic, Inc) through a preshaped sheath (C315 HIS delivery sheath; Medtronic, Inc), we inserted a retractable active‐­fixation lead which was implanted for right atrium later into coronary sinus (CS) by shaping stylet beforehand, that is named “the inserting the atrial lead into CS (iCS) technique”. Successful HBP points which were defined as HBP threshold <2V at 1 milliseconds were investigated retrospectively with a focus on the CS ostium visualized by iCS technique in the 20 degree right anterior oblique. We fixed the CS ostium as the vertex of the angle and measured the angle between the successful HBP point and the horizontal axis as “theta (θ) of HBP”.

Result:

Twenty patients with AVB (complete AVB: 13, advanced AVB: 7) who achieved successful HBP using iCS technique were enrolled. Median θ of HBP was 53.5 during a diastole (interquartile range: 51.25‐­58.75) and 50 during a systole (interquartile range: 42.25‐­53.5). There were only 2 outliers defined as the value multiplying the interquartile range by 1.5. In on‐­going prospective study using θ of HBP during a diastole that was more convergent, all patients, even in 5 patients, achieved HBP by θ of HBP guided complete anatomical approach without a conventional approach using the unipolar electrogram of the pacing lead displayed on electrophysiological laboratory system.

Conclusion:

The anatomical distribution of successful HBP points with a focus on CS ostium using iCS technique tended to converge and might be useful to predict the success sites of permanent HBP in patients with AVB.

AP19‐­00313

Impact of closed loop stimulation system on the physiological heart rate in patients with pacemakers in daily life

Kei Noguchi, Daisuke Yoshimoto, Sumika Yoshihiro, Arashi Okano, Keisuke Irokawa, Ryo Yamaguchi, Yuichiro Sakamoto

Toyohashi Heart Center, Japan

Introduction:

Chronotropic incompetence (CI) is one of serious issues for patients with cardiac implant devices and rate responsive pacemakers have been widely used. CI is commonly defined and diagnosed by the heart rate (HR) response to exercise such as peak exercise HR and HR reserve which is the difference between maximal predicted HR and resting HR. In their daily life, however, there is few conditions in which they have peak exercise HR and repeat exercise tests are not popular, so it is difficult to assess how the pacemakers optimize pacing rate of stimulation pulses. Closed Loop Stimulation (CLS) system developed by BIOTRONIK have the potential of the automatic optimization as physiological responses following monitoring changes of the intracardiac impedance compared to the conventional accelerometer sensor. The aim of this study is to evaluate the rate response function in sick sinus syndrome (SSS) patients with rate responsive pacemakers by comparing with non‐­SSS patients with pacemaker implantation as the control group in their daily life.

Methods:

We investigated the HR histograms of the patients with pacemakers for atrioventricular block as control group, and analyzed the differences of daily HR variation between SSS patients with CLS‐­pacemakers (CLS group) and accelerometer sensor responsive pacemakers made by Medtronic (Med‐­R group) compared to control group retrospectively. The lower rate and upper rate setting were 60 and 130 in all patients, respectively. The patients with any tachycardia episodes were excluded from this study.

Result:

One hundred and six in control group, 35 in CLS group and 52 in Med‐­R group were enrolled. Of control group, 28 patients had the low percentage of atrial sensing (%As < 70%) were excluded, and 6 and 4 patients had the low percentage of atrial pacing (%Ap < 70%) were also excluded of CLS group and Med‐­R group, respectively. Finally, we analyzed 29 in CLS group and 48 in Med‐­R group compared with 78 in control group. There were no significant differences in average age (75.3 ± 8.3 vs 79.0 ± 9.0 vs 78.0 ± 6.5), male ratio (44.3% vs 41.0% vs 55.6%) and the average duration of physical activity (4.0 ± 1.9 hr/day vs 3.2 ± 1.4 hr/day vs 4.3 ± 1.8 hr/day) among control, CLS and Med‐­R group, respectively. Although average HR of both CLS and Med‐­R group did not reach that of control group, Med‐­R group had much lower average HR (control:74.9 ± 3.6 min^‐1, CLS: 72.0 ± 3.1 min^‐1, Med‐­R: 64.9 ± 1.2 min^‐1). In addition, the difference in the average HR for the control group was significantly different between 2 groups (control‐­CLS:2.9 min^‐1 vs control‐­Med‐­R:10.0 min^‐1 , P < .001). Interestingly, the variance of the average HR of Med‐­R group (σ2 = 2.99) tended to converge, while that of CLS group (σ2 = 16.37) were likely to same as control group (σ2 = 22.51).

Conclusion:

CLS system had the possibility of more physiological HR response in each patient.

AP19‐­00314

Absence of shock therapy related to improper sensing of noise on the defibrillation test during the subcutaneous implantable cardioverter‐­defibrillator implantation

Shota Tamura, Masanori Matsuo, Hisashi Katayama, Tomotaka Yoshiyama, Hiroaki Tatsumi, Atsushi Doi, Yasuhiro Izumiya, Minoru Yoshiyama

Department of Cardiovascular Medicine, Osaka City University Graduate School of Medicine, Japan

Introduction:

The subcutaneous implantable cardioverter–defibrillator (S‐­ICD) represents an efficient alternative to a transvenous device in patients who do not require pacing. The intraoperative defibrillation test (DFT) is recommended at implant of an S‐­ICD to confirm appropriate sensing and successful 65‐­ J termination of induced ventricular fibrillation (VF). However, a few worrisome cases of noise oversensing inhibiting the therapies were reported. Our case is the first report on recording the noise in two different vectors during the DFT.

Methods:

N/A.

Result:

We report the case of a 50‐­year‐­old men with a history of cardiopulmonary arrest due to VF who underwent a S‐­ICD implantation for secondary prevention of sudden cardiac death. He did not have a family history of sudden death. The 12‐­lead electrocardiogram after return of spontaneous circulation showed J wave (1 mm, notch type) in II and aVF leads. The thoracic echocardiogram indicated good ventricular function and no valve disease. The coronary angiogram did not include significant stenosis. From these results, our diagnosis was VF due to J wave syndrome, so that we decided to implant the S‐­ ICD (EMBLEM, Boston Scientific, Marlborough, MA). A surface electrocardiogram screening test passed in all vectors [primary (proximal electrode ring to can), secondary (distal electrode ring to can), or alternate (distal to proximal electrode) vector]. Immediately after implantation of the S‐­ICD, there was no sensing failure and noise in all vectors. To perform DFT, we induced VF using a 50‐­Hz burst via the programmer. Although VF was induced, shock was not appropriately delivered because of a sustained diagnosis of noise (repeated noise markers) with visualization of fine noise on the EGM superimposed over the fast ventricular events, then an external rescue shock was needed. We changed the sensing vector into secondary from primary vector and induced VF. Then, the S‐­ICD could deliver an appropriate shock 17 seconds after the induction of VF and successfully terminated VF at 65J without noise marker. During the 2nd DFT, one back‐­up pacing was delivered after the shock, then sensing vector automatically switched from secondary to alternate vector. Noise marker was also detected in alternate vector with visualization of fine noise on the EGM superimposed over the sinus rhythm.

Conclusion:

We reported a case which is absence of shock therapy related to improper sensing of noise on the DFT during the S‐­ICD implantation.

AP19‐­00315

Relationship of atrial tachyarrhythmias and optivol fluid index in patients with pacemaker and preserved ejection fraction

Min‐Tsun Liao, Ting‐Tse Lin, Yen‐Bin Liu

National Taiwan University Hospital, Taiwan

Introduction:

Atrial fibrillation (AF) is the most common arrhythmia and is responsible for significant morbidity and mortality in patients with heart failure (HF) with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF). There is a reciprocal relationship between HF and AF in which HF predisposes to AF and AF worsens HF. Much is known about the role of AF in HFrEF but studies of AF in HFpEF are more limited. Modern pacemakers provide an index of intrathoracic fluid status OptiVol fluid index (OVFI) by measuring transpulmonary electric impedance. This study was to determine whether elevated intrathoracic fluid congestion correlated with increased atrial tachyarrhythmia (AT) events.

Methods:

This study was a retrospective analysis of data from patients with Medtronic Advisa pacemaker (OptiVol build‐­in) and LVEF ≥50% between 2012 and 2014 in our single‐­center hospital. Daily fluid index measurements and values of time in device‐­detected AT/AF episodes were used to identify patients with OVFI threshold crossing with or without AT/AF. Different threshold of OVFI was also be evaluated.

Result:

Findings in 151 patients with 212 follow‐­up visits (mean, 1.4 visits per patient) were evaluated. Device‐­detected AT/AF prevalence was 47%. AT/AF frequency (percent of patients visits with at least 1 episode of AT/AF more than 4 hours since previous device interrogation) was greater in OVFI ≥ 20 vs OVFI < 20 (P = .035). Finally, in terms of temporal sequence, the threshold crossing of OVFI ≥ 20 preceded AT/AF episodes more than 4 hours in 53% of incidences, followed AT/AF episodes more than 4 hours in 23%, and was simultaneous or indeterminate in the remainder.

Conclusion:

These findings not only support the view that worsening pulmonary congestion is associated with increased AT frequency in patients with preserved ejection fraction but also suggest that pulmonary congestion may be responsible for triggering AT events.

AP19‐­00328

Event rates with confirm RxTM SharpSenseTM Technology using a Real‐­World remote monitoring database

Christopher Piorkowski, Allison Connolly, Ignacio Reyes, Avi Fischer, Yelena Nabutovsky, Naushad Shaik, Roland Tilz, John Ip

Abbott, United States

Introduction:

Insertable cardiac monitors (ICM) are effective in detecting arrhythmias. The new Confirm RxTM ICM with SharpSenseTM Technology uses an advanced algorithm to improve accuracy of bradycardia (brady) and pause detection. This study aims to characterize the impact of SharpSenseTM on ICM‐­detected event rates in a large real‐­world cohort.

Methods:

Patients implanted with the Confirm RxTM ICM before June 2019 and who communicated at least one scheduled remote transmission in the Merlin.net™ remote monitoring system made up the study cohort. Event rates in the first 31 days post implant were compared in patients implanted with Confirm Rx with SharpSenseTM and those without. Propensity score matching was used to minimize differences in patient characteristics between groups. Probability of having any events (>0) and of having a high number of events (>10/day) were compared with logistic regression and event rates with Poisson regression. Multivariate models were used to further adjust for differences between groups.

Result:

Of the 23 781 patients who met inclusion criteria (62 ± 17 years, 50% female, 78% US), 653 had devices with SharpSenseTM and 23 128 did not. After matching, 581 had devices with SharpSenseTM and 2324 did not. Devices with SharpSenseTM had significantly lower brady (81 vs 14 events, P < .001) and pause (152 vs 14 events, P < .001) events compared to without. In addition, significantly fewer devices with SharpSenseTM had any brady (Odds Ratio (OR) = 0.35) or pause (OR = 0.39) events compared to without (P < .001) and a significantly lower incidence of detecting a high number of brady (OR = 0.22) and pause (HR = 0.10) events (P < .001). In patients with detected events, significantly fewer events occurred with SharpSense TM (brady OR = 0.49, pause OR = 0.15, P < .001).

Conclusion:

In this patient cohort, SharpSense TM was associated with an 83% lower rate of brady events and 91% lower rate of pause events in the first 31 days post implant. This technology improves the data management of ICM‐­detected events by reducing false positive events and decreasing the overall event count.

AP19‐­00333

Comparison between leadless pacemaker and single‐­chamber conventional pacemaker

Akihiro Sunaga, Hitoshi Minamiguchi, Kentaro Ozu, Tomoaki Nakano, Isamu Mizote, Hiroya Mizuno, Shungo Hikoso, Yasushi Sakata

Osaka University, Japan

Introduction:

In Japan, leadless pacemaker (LPM) was available from September 2017. However, appropriate patient selection, efficacy and safety are unknown in Japanese patients. The purpose of this study was to clarify which patients suitable for LPM and, efficacy and safety of LPM.

Methods:

Among consecutive 271 pacemaker implantations from September 2017 to May 2019 in our hospital, we compared 29 patients implanted with LPM with 6 patients with implanted with single‐­ chamber conventional pacemaker (S‐­CPM).

Result:

In S‐­CPM group, 5 patients had atrial fibrillation with bradycardia and 1 patient had sick sinus syndrome. In LPM group, 11 patients had atrial fibrillation with bradycardia, 4 patients had atrioventricular block and 14 patients had sick sinus syndrome. There was no significant difference between two groups in age, sex, white blood cell, hemoglobin, C‐­reactive protein and hospitalization period. Twelve patients (41%) with LPM had prior device infection or infection status and no patient (0%) in S‐­CPM had. Eleven patients (59%) with LPM had prior open‐­heart surgery and no patient (0%) in S‐­CPM had. Procedure time was shorter in patients with LPM than those with S‐­CPM (58 ± 14 vs 96 ± 30, P < .001). Sensing threshold was smaller in patients with LPM than those with S‐­CPM (8.4 ± 4.2 vs 13.1 ± 3.1 mV, P = .014). There was no significant difference between 2 groups in pacing threshold (0.7 ± 0.4 vs 0.6 ± 0.1 mV, P = .056) and impedance (737 ± 171 vs 660 ± 95 mV, P = .296). However, 3 months after discharge, there was no significant difference between two groups in sensing threshold (12.9 ± 3.8 vs 13.5 ± 1.4 mV, P = .747) as well as pacing threshold (0.7 ± 0.5 vs 0.8 ± 0.2 mV, P = .701) and impedance (558 ± 100 vs 637 ± 64 mV, P = .105). The sensing threshold in patients with LPM significantly increased after discharge from implantation (P < .001). During median [interquartile range] follow‐­up period of 284 [182, 445] days in patients with LPM and 483 [202, 495] days in those with S‐­CPM, there was no complication in both groups.

Conclusion:

Even in chronic phase, the LPM is effective and safe for chronic as well as S‐­CPM.

AP19‐­00335

Measurement of sternum‐­heart space in patients with and without median sternotomy

Wanlan Chen, Yongjun Gong, Limin Xia, Yu Zhang, Xianhao Wu, Zheng Lu, Huichao Pan, Yanan Pang, Yi Zhou, Rui Xu, Hongyang Lu, Jian Cao, Wei Zhou, Jun Yang, Zhaohui Qiu

Department of Cardiology, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shangh, China

Introduction:

The Extravascular Implantable Cardioverter Defibrillator (EV ICD) as an innovational approach provides alternatives to commercially available ICDs in certain clinical situations. Previous clinical investigations have demonstrated the feasibility of applying an investigational lead under the sternum with a minimally invasive procedure to deliver lifesaving defibrillation and anti‐­tachycardia pacing therapy. Clinical information for the substernal space in patients with median sternotomy is needed to reveal the structure of the substernal space and guide the delivery of the lead.

Methods:

CT images from patients with prior sternotomy (n = 10, S‐­group) and without prior sternotomy (n = 10, NS‐­group) were collected to measure the distance between the midline of sternum and the epicardial surface of the heart. Measurements were segmented into four regions: Region 1 between the xiphisternal junction (XJ) and xiphoid tip; Regions 2 to 4 along the midline of sternum, superior to the XJ, with distance from XJ of 20 mm, 50 mm and 60 mm, respectively (Figure 1A). In S‐­group, the measurements could be replaced with those between a sternal wire and the epicardial surface of the heart when the sternal wire was between the sternum and the heart, which was a result of the sternotomy procedure. Averaged distances were calculated and one‐­tailed t‐­test was utilized to compare the distances of four regions between the two groups.

Result:

High quality CT images were collected from 20 subjects (70% male, aged 69.3 ± 11.5 years) with slice thickness ≤ 1 mm and in‐­plane resolution ≤ 0.8 mm. Results (Figure 1B) showed significant difference of the averaged distances between sternum/sternal wire and the epicardial surface of the heart in Region 1 (S‐­group: 4.15 ± 2.95 mm, NS‐­group: 8.09 ± 3.58 mm, P = .02). A trend of difference in the distances were observed in Region 2 (S‐­group: 5.87 ± 4.28 mm, NS‐­group: 8.81 ± 7.14 mm, P = .15), Region 3 (S‐­group: 10.3 ± 8.00 mm, NS‐­group: 15.34 ± 8.42 mm, P = .09) and Region 4 (S‐­group: 13.61 ± 8.80 mm, NS‐­group: 15.72 ± 5.90 mm, P = .37).

Conclusion:

Initial CT‐­image analysis in 20 patients shows a smaller space for post‐­sternotomy patients as expected, but there appears to be a narrow but viable space for lead position even in that specific patient group.

FIGURE 1 (A) Three‐­dimensional reconstruction of CT images from a patient with prior median sternotomy. Distances between the midline of sternum and the heart notch on various axial views are measured and grouped into four regions to calculate the average. (B) Results of measurements in Sternotomy group (S‐­group) and Non‐­sternotomy group (NS‐­group) show difference in Region 1 and a trend of difference in Regions 2‐­4

AP19‐­00348

Safety and efficacy of percutaneous lead extraction of cardiac implantable electric devices in the elderly

Ayako Okada, Morio Shoda

Shinshu university school of medicine, Japan

Introduction:

Background With the incidence of cardiac implantable electric device (CIED) infection increasing, lead extraction (LE) has become an important treatment. Elderly patients are at particular risk of infection, but may hesitate to consent to LE out of unfounded concerns that it is a dangerous procedure. The aim of this study was to clarify the safety and effectiveness of LE in elderly patients.

Methods:

Methods We retrospectively analyzed the characteristics, device type, indications, procedures, and clinical results of LE in a non‐­elderly group (NEG; 14‐­79 years of age, n = 39) and elderly group (EG; >80 years of age, n = 25) who underwent percutaneous LE between April 2014 and December 2018 at our hospital.

Result:

Results Average age was 70 years in NEG and 85 years in EG. LE indication in the NEG was infection in 27 patients (69%) and non‐­infection in 21 (21%), while that in the EG was infection in all 25 patients (100%). Blood stream infection was detected in 7 NEG patients and 3 EG patients, with methicillin‐­resistant staphylococcus epidermidis being the most common. All LE procedures were performed under general anesthesia in an operating room with cardiovascular surgeon back‐­up. Excimer laser sheath (n = 78 leads), laser with mechanical sheath (n = 44 leads), mechanical sheath (n = 1 lead), and manual traction (n = 1 lead) techniques were used to extract a total of 128 leads (82 in the NEG and 46 in the EG) after an average implantation time of 5.0 (2.0, 12.0) years in the NEG and 8.5 (3.0, 12.8) years in the EG, which were not significantly different (P = .24). The complete procedural success rate was similar between the NEG and EG (98.8% vs 100%). Only 1 procedure‐­related complication was observed in the cohort (cardiac tamponade in a NEG patient).

Conclusion:

Conclusion Percutaneous LE was both safe and successful for elderly patients as well as in the younger population.

AP19‐­00352

Successful implantation of pacing lead through isolated persistent left superior vena cava using fixed‐­curve lead delivery catheter for His bundle pacing: A case report

Akira Kimata, Hiro Yamasaki, Satoshi Shimoo, Masayuki Hattori, Chihiro Ota, Noboru Ichihara, Yuki Komatsu, Miyako Igarashi, Yukio Sekiguchi, Akihiko Nogami, Kazutaka Aonuma, Masaki Ieda

University of Tsukuba, Japan

Introduction:

Persistent left superior vena cava (PLSVC) is a common congenital malformation, but PLSVC with absence of the right superior vena cava, known as isolated PLSVC, is extremely rare. We experienced the pacemaker implantation in patient with isolated PLSVC.

Methods:

N/A.

Result:

A 71‐­year‐­old man was admitted to our hospital with complete atrioventricular block. Before pacemaker implantation, his venography from right and left arm showed isolated PLSVC. After puncture of the left subclavian vein, a fixed‐­curve lead delivery catheter for His bundle pacing (Model C315His, Medtronic, Minneapolis, MN, Figure A) was introduced into right atrium through PLSVC. Since the tip of the catheter turned toward the tricuspid orifice relatively easily, the ventricular pacing lead (Model 3830, Medtronic) was able to advance to the septal side of the middle right ventricle (Figure B). The atrial pacing lead (Model 5054, Medtronic) was placed at the right atrial lateral wall using manually shaped stylet. After implantation (Figure C), lead parameters were acceptable, and he remained free from bradycardia. Pacing lead implantation through PLSVC using conventional has been difficult, because it is necessary to use specialized shaped stylet. On the contrary, the method using the fixed‐­curve lead delivery catheter do not need special techniques and can be effective.

Conclusion:

The method we described can be a new therapeutic approach with high feasibility in patients with such isolated PLSVC.

AP19‐­00359

The influence and safety of oral amiodarone discontinuation on appropriate and inappropriate shock after implantation of implantable cardioverter defibrillator

Masato Hachisuka, Hiroshi Hayashi, Toshiki Arai, Kakeru Ishihara, Rei Mimuro, Yujin Maru, Yuhi Fujimoto, Eiichiro Oka, Kanako Hagiwara, Hiroshige Murata, Teppei Yamamoto, Akinori Sairaku, Kenji Yodogawa, Yu‐ki Iwasaki, Wataru Shimizu

Nippon Medical School, Japan

Introduction:

Amiodarone is often prescribed in patients with implantable cardioverter defibrillator (ICD) to prevent life‐­threatening ventricular tachyarrhythmia. Although discontinuation and reduction of amiodarone is desired because of life‐­threatening side effect such as interstitial pneumonia and liver dysfunction, the influence and safety of AMD discontinuation on incidence of appropriate and inappropriate ICD shock has not been fully elucidated. The present study aimed to evaluate the clinical outcomes and safety of oral amiodarone discontinuation on appropriate and inappropriate therapy in patients who underwent ICD or cardiac resynchronization therapy defibrillator (CRTD) implantation.

Methods:

One‐­hundred fourteen consecutive patients (96 men, age 65 ± 12 years) who underwent ICD (n = 77) or CRTD (n = 37) implantation from 2011 to 2017 were enrolled in the study. The clinical parameters and outcomes were compared between the patients who discontinued or reduced amiodarone and who did not.

Result:

Among the 114 consecutive patients, 56 (49%) patients were under amiodarone therapy at the time of implantation. These 56 patients had lower left ventricular ejection fraction (LVEF) (28 ± 12% vs 35 ± 15% P = .01) and had higher prevalence of chronic kidney disease (30% vs 13% P = .03) compared to patients without amiodarone. During 36 ± 25 months of follow‐­up, amiodarone was discontinued in 9 (7%) patients and a significant reduction of amiodarone was observed in 24 (21%) patients (196 ± 61 mg/day vs 94 ± 27 mg/day P < .01) (AMD‐­withdrawal group; n = 33). The remaining 24 patients continued 156 ± 64 mg/day of amiodarone (AMD‐­continue group). Compared the AMD‐­withdrawal group and AMD‐­continue group, there was no difference in patient characteristics including age, gender, LVEF, number of patients with AF and primary prevention between the two groups. The incidence of appropriate shock (30% vs 30% Log‐­rank P = .56) and inappropriate shock (13% vs 18% Log‐­rank P = .96) were similar between the two groups. The cause of inappropriate ICD shock was due to false interpretation of tachycardic atrial fibrillation (62%) and atrial tachycardia (37%).

Conclusion:

The discontinuation and reduction of amiodarone is safe and did not increase the incidence of both appropriate and inappropriate therapy in patients after ICD/CRTD implantation.

AP19‐­00360

Suitability of leadless pacemaker for complete atrioventricular block after transcatheter aortic valve replacement

Ryo Tateishi, Akira Mizukami, Tetsuya Kobayashi, Hironobu Sumiyoshi, Takuya Kawakami, Yoshihiro Hanyu, Yuki Shimizu, Jiro Hiroki, Hirofumi Arai, Kenji Yoshioka, Syunsuke Kuroda, Shu Yamashita, Daisuke Ueshima, Iwatsuka Ryota, Makoto Suzuki, Akihiko Matsumura

Yokohama Minami Kyosai Hospital, Japan

Introduction:

Complete atrioventricular block (CAVB) is a major complication of transcatheter aortic valve replacement (TAVR). However, patients who undergo TAVR are sometimes frail and have difficulty transvenous pacemaker placement immediately after TAVR. Moreover, because some reports indicate CAVB after TAVR is transient unlike conventional CAVB, leadless pacemakers may be a suitable option. Therefore, we analyzed the ventricular pacing rate and safety about leadless pacemaker implantation in CAVB patients after TAVR.

Methods:

We retrospectively enrolled 27 consecutive CAVB patients (5 after TAVR, 22 without TAVR) who were treated with leadless pacemaker MicraTM at our institution. Four patients were excluded due to a lack of follow‐­up data, leading to 4 patients in the group of CAVB after TAVR, and 19 patients in the group without TAVR.

Result:

In total, 23 patients (54.1% male, mean age 82.8 ± 9.8 years old) were included in analysis. After median of 74 (IQR 65‐­93) days after implantation, the ventricular pacing rate was assessed. CAVB patients after TAVR had significantly lower ventricular pacing rate compared to patients without TAVR (12.8% [8.8‐­25.4] vs 96.6% [58.4‐­100.0], P = .044). With chronological assessment, the ventricular pacing rates of all CAVB patients after TAVR were shown to gradually decrease. During the follow‐­up period, 4 patients in the group of CAVB after TAVR have no complications associated with leadless pacemaker implantation.

Conclusion:

Our study demonstrates that the ventricular pacing rate of CAVB patients after TAVR was smaller than that of usual CAVB patients. In consideration of the gradual decrease in ventricular rate and invasiveness of procedures, leadless pacemakers may be suitable for complete atrioventricular block after transcatheter aortic valve replacement.

AP19‐­00379

Effect of cardiac resynchronization therapy on improvement of mitral regurgitation: Insight into etiologies and dominant factor for recovery of regurgitation

Hiroya Okamoto, Yasuya Inden, Toshifumi Nakagomi, Koichi Furui, Shuro Riku, Kazumasa Suga, Keita Mamiya, Toshiro Tomomatsu, Aya Fujii, Satoshi Yanagisawa, Rei Shibata, Toyoaki Murohara

Department of Cardiology, Nagoya University Graduate School of Medicine, Japan

Introduction:

Cardiac resynchronization therapy (CRT) improves functional mitral regurgitation (MR); however, little is known about which factor can affect the improvement of MR. We aimed to investigate the effect of CRT on the MR according to various pathologies, and to evaluate dominant factor that could influence the improvement of MR after CRT implantation.

Methods:

This study included 182 patients who underwent CRT implantation in Nagoya University Hospital between 2006 and 2016 with a fully echocardiography data at both baseline and 6‐­month after implantation. MR severity was classified into 5 grades (0; none to 4; severe). Responders were defined as a relative reduction of left ventricular end‐­systolic volume (LVESV) ≥ 15% at 6‐­month follow‐­up on the echocardiography.

Result:

One hundred and seventeen patients (64%) were classified as responders. The MR grade was significantly reduced from 1.85 ± 1.08 to 1.31 ± 0.88 (P < .001) in the responder group. However, the MR grade increased in the non‐­responder group from 1.58 ± 0.99 to 1.66 ± 1.13 (P = .415). Both the ischemic cardiomyopathy (ICM) and non‐­ICM groups exhibited a significant improvement of MR. In the total population, relative reduction of LVESV (r = 0.43, P < .01) and LVEDV (r = 0.35, P < .01) were strongly correlated with the improvement of MR. This significant relationship was strongly found in the non‐­ICM group. By contrast, recovery of dyssynchrony was not correlated with the improvement of MR.

Conclusion:

The CRT responders showed the significant MR improvement. The MR improvement was mostly associated with the reduction of LVESV and LVEDV, which was highly observed in the non‐­ ICM group.

AP19‐­00381

Stroke and thrombosed vertebral artery associated with retained epicardial pacing wire

Yeon‐Jung Kim, Sung‐Ho Jung, Sun U. Kwon

Asan medical center, South Korea

Introduction:

Temporary epicardial pacing wires have been widely used in cardiac surgery to manage post‐­operative bradyarrhythmias. These wires are routinely removed from patients before discharge. However, they are occasionally retained due to difficulties in removal. Rare complications may occur from retained wires. We describe a case of retained temporary epicardial pacing wires that migrated into the right subclavian artery and caused stroke.

Methods:

A 63‐­year‐­old man was admitted for sudden vertigo with ataxia in left limbs. Brain magnetic resonance imaging revealed acute cerebral infarction in the left superior cerebellar artery territory and right vertebral artery occlusion. Nine years ago, he underwent open heart surgery to remove cardiac myxoma in the left atrium with maze operation to control atrial fibrillation. The epicardial pacing wire was placed during the surgery and it was retained due to difficulties in removal after the surgery.

Result:

Computed tomography revealed metallic density linear structure along the right atrial appendage, ascending aorta, and right subclavian artery (Panel A). On duplex sonography, right vertebral artery was seen to be occluded by mobile thrombus around a foreign, wire‐­like material (Panel B and C). After one month of oral anticoagulation, thrombus in the right vertebral artery disappeared in follow‐­up computed tomography and the wire was removed surgically (panel D).

Conclusion:

Migration of retained epicardial pacing wires after cardiac surgery is a rare complication with variety of clinical features. Although the exact mechanism is unknown, it may be related with constant periodic movement of the heart and diaphragm. Temporary epicardial pacing wires should be removed whenever possible. If they are retained after cardiac surgery, a careful follow‐­up is needed.

AP19‐­00385

Microdislodgement of right ventricular passive fixation lead for complete atrioventricular block after the repair of ventricular septal perforation

Shin Kashimura, Shuhei Yamashita, Keisuke Suzurikawa, Koutarou Uchida, Ryouta Kitajima, Shunsuke Kataoka, Daisuke Shinmura, Koutarou Fukumoto, Takahiro Koura, Kouji Negishi, Shun Shibuya, Keiichirou Kasama, Yasuko Uranaka

Yokohama Municipal Citizen's Hospital, Japan

Introduction:

Complete atrioventricular block (CAVB) is a severe complication of ventricular septal perforation due to myocardial infarction. The report of the instability of endocardial ventricular passive fixation lead onto damaged myocardium is rare.

Methods:

N/A.

Result:

76 year‐­old man was admitted for ST‐­elevated myocardial infarction due to proximal left anterior descending artery occlusion complicated with ventricular septal perforation. After the percutaneous catheter intervention, the urgent operation was performed. Ruptured ventricular septum which size was 15 mm was repaired using polyethylene and bovine pericardial patch. 4 days after the operation, CAVB was developed and passive fixation lead was placed at the base of right ventricle (RV). Using active fixation lead and placing the ventricular lead to RV septum was avoided due to damaged and repaired myocardium. The lead could not be delivered to the RV apex because the patch was arched out into RV. The next day, the pacing threshold was 0.5V/0.4 milliseconds. 9 days later, CAVB recurred and the pacing threshold increased to 4.5V/0.4 milliseconds without clear evidence of the dislocation of the lead by chest X‐­ray. Emergent resetting of the ventricular lead to more caudal direction was performed.

Conclusion:

Placing the passive fixation lead onto damaged and repaired myocardium required attention. Microdislodgement could occur even 1 week after the operation.

AP19‐­00386

Peak deflection index as a predictor of a free‐­wall implantation of leadless pacemakers

Takatsugu Kajiyama

Chiba University Graduate School of Medicine, Japan

Introduction:

Leadless pacemaker eliminates any malfunctions related to intravenous leads. However, some cases exhibit pericardial effusion, presumably related to device implantation to right ventricular free‐­wall. The present study was carried out to find ECG features during ventricular pacing by Micra, which enabled to distinguish free‐­wall implantation from septal implantation without imaging modalities.

Methods:

Consecutive 24 patients who received implantation of Micra in our facility were enrolled. Location of device in the right ventricle was evaluated using echocardiography or computed tomography in order to determine whether the device was implanted on the septum or the freewall. The difference of 12‐­lead ECG during ventricular pacing from Micra were analyzed between the septum group and the free wall group.

Result:

According to the imaging investigation, the body of the Micra was clearly identifiable in 17 patients. The location of the device was classified into septal in 12 patients and free‐­wall in 5. In lead V1 (0.620 ± 0.048 vs 0.472 ± 0.114, P = .015) and V2 (0.521 ± 0.034 vs 0.426 ± 0.075, P = .017), the peak deflection index (PDI) was significantly larger in the FW group than Sep group, whereas there was no difference in the QRS duration, transitional zone, and QRS notching.

Conclusion:

The PDI in V1 and V2 could be useful to predict the implantation of a Micra device on the free‐­wall and may potentially stratify the risk of a postprocedural pericardial effusion.

AP19‐­00402

Update to cloud migration of remote monitoring data self extract system

Keisuke Irokawa, Daisuke Yoshimoto, Sumika Yoshihiro, Arashi Okano, Kei Noguchi, Ryo Yamaguchi, Yuichiro Sakamoto

Toyohashi Heart Center, Japan

Introduction:

The popularity of hospitals in Japan use Remote monitoring system (RMS) of cardiac implantable electronic devices (CIEDs) as a standard management method. However, the management and analysis of RM data have some disadvantages such as increasing the work burden of paramedical staffs and transmission mistakes by human error. Therefore, some RM‐­data‐­Self Extract System (RM‐­ SES) have developed to manage many CIEDs efficiently but are not widespreaded yet. We developed a RM‐­SES independently in 2016, and got some benefits such as improvement of RM data processing, accuracy of the data and reduction of the work burden of paramedical staffs. This system used to work at a single center using local area network, and recently has been centralized and output the data from our institution to each of the three group institutions. In addition, our RM‐­SES was upgraded to cloud migration, so this cloud system is available in more institutions. We reported the methods and benefits of this cloudized RM‐­SES.

Methods:

We moved the RM‐­SES server from our institution to the cloud. At the same time, RM data output destinations of 4 RM web site (CareLink, LATITUDE. Merlin.net, Home monitoring) were also changed from our institution's server to that on the cloud. At first, the server on the cloud acquires RM data, and then it performs data extraction, data unification and data processing. Finally, the processed data is output to the server of each facility connected by the VPN for safety. The formats of output data are CSV and PDF. We automatically capture the CSV data, and that is visualized using each institution's database format such as the FileMaker etc.

Result:

We succeeded in turning the existing system into a cloud, which enable us to make centralizing a server and simplify system management in each institution with characterizations of low cost and easy management. The output data format are CSV and PDF, that is considered to be excellent in frequent use, therefore it is able to cope with any institutions even if hospital systems are variable. Although our RM‐­SES has been working in limited institutions yet, we have already prepared introduced it to somewhere. It is expected to be a breakthrough point for the spread of RM‐­SES.

Conclusion:

We upgraded the previous RM‐­SES to the cloud system. We believe this system will widespread through all Japan and all over the world because this system may be offered by inexpensive, versatile and useable specialization.

AP19‐­00403

Improvement of atrial contraction assessed by tissue Doppler imaging in a patient with “pseudo” atrial standstill after implantation of atrial pacemaker

Tsukasa Oshima, Katsuhito Fujiu, Eriko Hasumi, Jumpei Ishiwata, Toshiya Kojima, Masao Daimon, Issei Komuro

Tokyo University Hospital, Japan

Introduction:

Atrial standstill (AS) is characterized by the absence of atrial electrical and mechanical activity. Most patients with AS are implanted with a VVI pacemaker due to difficulty in identification of a suitable implantation site for the atrial pacing lead owing to electrical silence, regardless of the atrioventricular conduction status. However, ventricular lead‐­induced tricuspid regurgitation (TR) is reportedly associated with a poor prognosis in patients who already have greater than mild TR before pacemaker implantation. Here, we present the case of a 75‐­year‐­old female with “pseudo” AS, severe TR, and heart failure.

Methods:

We performed electrophysiological study for searching the suitable site for atrial pacing, because ventricular lead may exacerbate TR and right heart failure.

Result:

We successfully implanted a single‐­chamber atrial pacing (AAI) mode pacemaker and achieved precise atrial pacing to compensate for interatrial synchrony, resulting in left atrial contraction recovery, improved left ventricular function and atrial volume reduction. Furthermore, we could prove amelioration of effective left atrial contraction after implantation of AAI pacemaker in patients with AS using the pulsed‐­wave Tissue Doppler imaging.

Conclusion:

The pulsed‐­wave Tissue Doppler imaging and electrophysiological study are effective for diagnosis of AS even in patients diagnosed of it using ECG and help achieve physiological atrial pacing without aggravation of tricuspid regurgitation.

AP19‐­00408

“RESC” method is feasible as an alternative treatment for patients with infection of cardiac implantable electronic device

Feng‐Ching Liao

MacKay Memorial Hospital, Taiwan

Introduction:

Current guidelines recommend that all infected cardiac implantable electronic devices (CIED) should be removed, however, keep used CIED remained with simple debridement is not uncommon with regards to financial or anatomical concerns. In this observational study, we report the outcomes of our modified procedure for the real‐­world dilemma.

Methods:

Our surgical method “RESC” is as follows: R (removal): all non‐­essential foreign materials, including old sutures and leads, were removed. E (excision): all non‐­viable tissue, chronically inflamed tissue, granulation tissue, and scar tissue were completely excised. S (sterilization): the remaining generator was completely sterilized. C (Creation): we created a new pocket at sub‐­muscular layer for reimplantation. By electronic medical records, 30 patients were divided into three groups: RESC (n = 9) in group A, simple debridement (n = 16) in group B, and guideline‐­recommended replacement (n = 9) in group C.

Result:

The baseline characteristics were similar among the groups. In view of infection‐­free within one year, group A was better than group B (100% vs %, P = .001) and was comparable to group C (100% vs 100%, P = na).

Conclusion:

RESC method was feasible and beneficial for selective patients who had difficulty in CIED infection.

TABLE 1 Baseline characteristics of the patients

	Group A (n = 9), n(%)	Group B (n = 16), n (%)	(A) vs (B) P	Group C (n = 5), n (%)	(A) vs (C) P
Age (yr), mean (SD)	67.1 (10.0)	74.1 (10.8)	0.123	71.6 (8.0)	0.258
Male	6 (66.7)	12 (75.0)	0.673	5 (100.0)
BMI, mean (SD)	26.4 (6.8)	25.9 (5.0)	0.837	21.9 (3.4)	0.197
Device type			1.000		0.505
PPM	7 (77.8)	13 (81.3)		5 (100.0)
ICD/CRT‐­P/CRT‐­D	2 (22.2)	3 (18.7)		0 (0.0)
Implantation			0.630		1.000
New	6 (66.7)	13 (81.3)		4 (80.0)
Replacement	3 (33.3)	3 (18.7)		1 (20.0)
LVEF, mean (SD)	58.5 (10.7)	54.3 (13.0)	0.422	62.0 (7.8)	0.536
Cardiac disease	5 (55.6)	9 (56.3)	1.000	2 (40.0)	1.000
Hypertension	7 (77.8)	14 (87.5)	0.602	5 (100.0)	0.505
DM	3 (33.3)	4 (25.0)	0.673	1 (20.0)	1.000
Dyslipidemia	5 (55.6)	9 (56.3)	1.000	2 (40.0)	1.000
CKD (eGFR < 60 mL/min/1.73 m2)	5 (55.6)	7 (43.8)	0.688	1 (20.0)	0.301
Malignancy	0 (0.0)	3 (18.8)	0.280	1 (20.0)	0.357
Prosthetic or biological valve	4 (44.4)	7 (43.8)	1.000	3 (60.0)	1.000
Chronic anticoagulation	3 (33.3)	3 (33.3)	0.673	3 (60.0)	0.580
Chronic antiplatelet therapy	6 (66.7)	10 (62.5)	1.000	3 (60.0)	1.000
CWV drain	8 (88.9)	11 (68.8)	0.364	5 (100.0)	1.000
Treatment	<0.001	0.012
Removal (R)	9 (100.0)	0 (0.0)	<0.001	5 (100.0)	0.580
Excision (E)	9 (100.0)	16 (100.0)	5 (100.0)	0.580
Sterilization (S)	9 (100.0)	0 (0.0)	<0.001	0 (0.0)	<0.001
Creation (C)	9 (100.0)	5 (31.3)	0.001	0 (0.0)	<0.001

Abbreviation: SD, standard deviation.

TABLE 2 Outcomes of procedure combination, reinfection, and mortality

	Group A (n = 9),	Group B (n = 16),	(A) vs (B) P	Group C (n = 5),	(A) vs (C) P
	n(%)	n (%)		n (%)
Reinfection	0 (0.0)	11 (68.8)	0.001	0 (0.0)	na
LOS (days), mean (SD)	9.9 (2.7)	5.1 (5.4)	0.022	7.8 (4.3)	0.284
Mortality	2 (22.2)	2 (12.5)	0.602	1 (20.0)	1.000

Abbreviation: SD, standard deviation.

AP19‐­00409

Successful implantation of leadless pacemaker in patient with anterior mediastinal tumor

Hiroaki Watanabe, Tomoyuki Kabutoya, Takafumi Okuyama, Ayako Yokota, Takahiro Komori, Tomonori Watanabe, Yasushi Imai, Kazuomi Kario

Jichi Medical University Hospital, Japan

Introduction:

The leadless pacemaker is delivered into the right ventricle of the heart directly through the femoral vein by using a transcatheter delivery system. Leadless pacemaker have many advantages for some patients with complex vascular complications such as superior vena cava (SVC) occlusion.

Methods:

A 96‐­year‐­old woman with small body habitus (weight: 35 kg, height: 141 cm, body mass index [BMI]: 17.4, body surface area [BSA]: 1.17 m²) was referred to our hospital presented with frequent syncope. She had no history of cardiovascular disease, and also had no frailty and dementia. But she had a benign large anterior mediastinal tumor. An electrocardiogram (ECG) showed normal sinus rhythm, on the other hand, Holter ECG recorded transient complete atrioventricular block (CAVB) for maximum 10 seconds. The left ventricular ejection fraction (LVEF) on echocardiography was 55% without any structural heart disease. The cause of syncope was considered due to CAVB, we decided to implant a permanent pacemaker. Before the procedure, computed tomography (CT) scan demonstrated a huge anterior mediastinal tumor with a maximum diameter of 11 cm that seems to squeeze superior vena cava. The traditional transvenous lead system approaches were unavailable because of SVC occlusion, so we selected to implant a leadless pacemaker.

Result:

The procedure was performed under conscious sedation, and the starting rhythm was sinus rhythm. The temporary pacemaker was inserted into the right ventricle via the left femoral vein. The leadless pacemaker was implanted on the right ventricular septum via the right femoral vein. There were no associated complications with the leadless pacemaker implantation. The leadless pacemaker is a useful option in patient with complex vascular complications. Previous studies found that low BMI and high age may be one of the risk factors associated with complication. We could performed implantation of leadless pacemaker safely.

Conclusion:

We experienced the case of successful implantation of leadless pacemaker in patient with anterior mediastinal tumor.

AP19‐­00414

Predicting factor of septal implantation of a leadless pacemaker by left and right anterior oblique view

Hirofumi Arai, Akira Mizukami, Jiro Hiroki, Shu Yamashita, Akihiko Matsumura

Kameda Medical Center, Japan

Introduction:

Leadless pacemaker implantation has a risk of cardiac perforation. Midseptal implantation was optimal method to reduce the complication. We usually checked left anterior oblique (LAO) view and right anterior oblique (RAO) view to confirm septal position. It was reported that left lateral (LL) view was useful for confirmation of septal position but we can't always check LL view during procedure due to mechanical problem, patient's physical constitution, and so on. We hypothesized that LAO/RAO device length ratio and LAO device spinal angle related to septal implantation defined by LL view. We examined these values for predicting factor of septal implantation confirmed by LL view.

Methods:

We retrospectively analyzed 42 consecutive patients who underwent leadless pacemaker implantation from September 2017 to September 2018. We implanted leadless pacemaker by LAO and RAO view and confirmed septal direction. We checked LL chest radiography after the procedure. We defined septal implantation as straight to dorsal direction by LL view. We measured LAO/RAO device length ratio and LAO device spinal angle and evaluated correlation of these factors and septal implantation confirmed by LL chest radiography.

Result:

We excluded the cases with missing data leading to 38 patients (60.5% male, mean age 81.6 ± 10.4 years old) for analysis. Septal implantation confirmed by LL chest radiography was achieved in 6 patients (15.8%). The LAO/RAO device length ratio was significantly higher in these patients (0.87 ± 0.09 vs 0.60 ± 0.15, P < .001). But there was no correlation between septal implantation and LAO device spinal angle (50.4 ± 21.8 vs 33.4 ± 23.6, P = .11). We measured LL view device angle (straight as 0, dorsal direction as +, abdominal direction as −) and evaluated the correlation between the LAO/RAO device length ratio and the LL view device angle. There was strong correlation (r = 0.87, 95%CI 0.76‐­0.93, P < .001).

Conclusion:

LAO/RAO device length ratio may be a predicting factor of septal implantation confirmed by LL view.

AP19‐­00416

A case report of Left bundle branch area pacing (LBBAP) optimized cardiac resynchronization therapy(CRT)

Xiaofei Li, Wentao Ma, Hui Li, Hao Wang, Zhe Zheng, Shu Zhang, Yan Yao, Xiaohan Fan

State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular D, China

Introduction:

This report demonstrates a case on left bundle branch area pacing (LBBAP)‐­optimized cardiac resynchronization therapy (CRT) in a heart failure patient with atrial fibrillation and atypical complete left bundle branch block (LBBB).

Methods:

A 54‐­year old male had symptoms of shortness of breath for 3 years. Four months ago, he was diagnosed as severe aortic valve stenosis with heart failure, and trans‐­thoracic echocardiography showed enlarged left ventricular end‐­diastolic diameter (LVEDD) of 70 mm and reduced left ventricular ejection fraction (LVEF) less than 40%. Because the baseline ECG showed atrial fibrillation and complete LBBB with a QRS duration of 186 milliseconds (Figure 1), the ventricular dyssynchronization caused by LBBB might contribute to the impaired LV function. During the procedure of aortic valve replacement, an epicardial lead was implanted on lateral wall of left ventricle in case of the requirement of implant of cardiac resynchronization therapy (CRT). After 4 months of optimal medical therapy, no significant improvement was observed in cardiac function, with further reduced LVEF of 29% and enlarged LVEDD of 75 mm. The patient was indicated for implantation of CRT. During the procedure, LBBAP was attempted by using trans‐­septal protocol after placement of defibrillation lead. Although LBBAP did not completely correct LBBB, a relatively narrow paced QRS was achieved. The LBBAP lead was plugged into the atrial port since the patient had chronic atrial fibrillation, and the AV delay was set as 30 milliseconds. Two‐­dimensional mechanical dispersion (defined as time to peak strain delay, PSD) was analyzed on three different pacing modes (LBBAP optimized BiV, LBBAP only, and BiV) for evaluating LV synchrony. ECG and echocardiography were evaluated 6‐­month follow‐­up.

Result:

Post‐­procedure ECG and echocardiography evaluation had shown that LBBAP‐­optimized BiV pacing was presented with the narrowest QRSd (QRSd: 124 milliseconds vs 150 milliseconds vs 158 milliseconds for LBBAP‐­optimized BiV, LBBAP only, and BiV mode, respectively, Figure 2D,E,F) and the most improved LV synchrony (PSD: 50 milliseconds vs 63 milliseconds vs 101 milliseconds for LBBAP‐­optimized BiV, LBBAP only, and BiV mode, respectively, Figure 2A,B,C). At 6 months’ follow‐­up, the narrowed QRSd persisted stable (QRSd 125 milliseconds) and improved LV synchrony still remained (PSD 49 milliseconds). LVEF increased from baseline 29% to 40%, and LVEDD decreased from 75 mm to 62 mm. The serum B‐­type natriuretic peptide decreased from 2688.0 pg/ml to 431.8 pg/ml and cardiothoracic ratio reduced from baseline 0.59 to 0.51 (Figure 3), and the NYHA classification was improved from class III to class I. The patient had not suffered heart failure episodes after CRT implantation and the pacing threshold of LBBAP remained to be 0.5V/0.4 milliseconds.

Conclusion:

LBBAP‐­optimized BiV pacing may result in improved electrical and mechanical resynchronization for heart failure patients with atrial fibrillation and atypical LBBB.

AP19‐­00418

Combined computed tomography with dynamic perfusion and mechanics with predicted activation pattern can successfully guide implantation of a wireless endocardial pacing system

Baldeep Singh Sidhu, Justin Gould, Bradley Porter, Benjamin Sieniewicz, Steven Niederer, Christopher Aldo Rinaldi

Guys and St Thomas NHS Foundation Trust, United Kingdom

Introduction:

The WiSE‐­CRT system delivers wireless endocardial pacing to achieve cardiac resynchronisation therapy. It consists of a subcutaneous transmitter, battery and endocardial electrode. The transmitter detects right ventricular pacing from the co‐­implant and delivers ultrasound energy to the electrode causing left ventricular (LV) pacing and cardiac resynchronisation. Ideally, the electrode should be placed in an area of late contracting or activating areas whilst avoiding myocardial scar. Furthermore, the transmitter must be placed in close proximity to the electrode but since this is implanted before the electrode, identifying the optimal location pre‐­procedurally is important. Currently, the optimal location for both the transmitter and electrode is unknown. We hypothesised that pre‐­procedural imaging to estimate scar and measure mechanics combined with modelling and simulation to predict activations times would be able to predict the optimal location for both the electrode and transmitter.

Methods:

Patients eligible for the WiSE‐­CRT system were recruited. They underwent a cardiac CT with stress perfusion to identify areas of perfusion heterogeneity and a retrospective gated CT to measure latest mechanical activation and patient specific modelling to predict electrical activation. These were analysed on a dedicated platform to identify the target segments for electrode deployment. We modelled the power coverage for the transmitter and identified the optimal location for this. The pre‐­procedural target segments for electrode deployment were merged and overlaid onto live fluoroscopy to help guide the implant procedure. A pressure wire in the LV cavity was used to measure the acute haemodynamic response (AHR) with biventricular endocardial pacing in different myocardial segments. Segments with an improvement of ≥10% in dP/dt(max) were considered a favourable location for the LV electrode based on our previous AHR studies.

Result:

Five consecutive patients were studied with a mean age of 70.3 ± 6.9 years; NYHA Functional class 2.8 ± 0.4; QRS duration 166.6 ± 34.5 milliseconds; LVEF 28.4 ± 6.2%. Two patients had ischaemic cardiomyopathy and three non‐­ischaemic cardiomyopathy. The transmitter was modelled pre‐­ procedurally and placed in the recommended site in all cases. Overall, the AHR of pacing within 24 different LV myocardial segments was tested; a significantly greater number of target segments had an AHR ≥ 10% vs non‐­target segments (87.5 vs 18.75%, P = .002). Furthermore, all segments with a perfusion defect on stress CT had an AHR less than 10%. Therefore, the electrode was deployed within the target segment in all cases.

Conclusion:

We successfully used cardiac computed tomography and simulation to guide the optimal placement for the WiSE‐­CRT transmitter and electrode.

AP19‐­00419

One year follow up on multi‐­center evaluation of MultiPoint Pacing in Chinese heart failure patients

Wei Hua, Min Gu, Yangang Su, Xiaolin Xue, Lin Cai, Fan Liu, Wei Xu, Jingfeng Wang, Xuebin Li, Baopeng Tang, Jing Xu, Farong Shen, Shu Zhang

Abbott, United States

Introduction:

The benefits of MultiPointTM Pacing (MPP) has been previously demonstrated to improve Cardiac Resynchronization Therapy (CRT) in heart failure (HF) patients, however clinical evidence from the Chinese population is lacking. Here we present data from a large Chinese HF patient cohort with MPP CRT over one year follow up.

Methods:

A multi‐­center prospective study evaluated patients who received implants of the Quadra Assura MP™ CRT‐­D system (Abbott, USA). QRS duration, LV ejection fraction (LVEF), LV end systolic volume (LVESV), 6 minute walk test (6MWT), and Minnesota Living with Heart Failure Score (MLHFS) were collected at both baseline and 12 month follow up. Response to CRT was defined as an absolute increase of >5% in LVEF on 12 month visit compared to the baseline.

Result:

A total of 93 patients were enrolled from 11 hospitals in China. The CRT‐­D system was successfully implanted in 91 attempted implants (98%). Among the 58 patients who completed the 12 month follow up by June 2019, 46 (79%) patients had the MPP function turned on over the one year follow up and were used for the present analysis. The average QRS duration was reduced by 22% (171 ± 19 to 134 ± 20 milliseconds), LVEF was improved by 18% (25 ± 8 to 43 ± 12), and LVESV was reduced by 40% (169 ± 78 to 101 ± 72 ml) compared with baseline (Figure 1). The average 6MWT increased from 304 ± 126 to 624 ± 570 m and MLHFS improved from 47 ± 20 to 23 ± 24. (P < .01 for all results) The CRT response rate was 77% among the patients with MPP turned on over the 12 months.

Conclusion:

From a large Chinese HF population receiving MPP CRT, we found MPP is safe and effective for treating heart failure with significant improvements in clinical outcome and quality of life over one year follow up.

AP19‐­00420

The WiSE‐­CRT system results in reverse left ventricular remodelling and improved symptoms in patients who are deemed non‐­responders to conventional epicardial cardiac resynchronisation therapy

Baldeep Sidhu, Justin Gould, Bradley Porter, Timothy Betts, Simon James, Andrew Turley, Christian Butter, Martin Seifert, Pasquale Vergara, Lucas Boersma, Sam Riahi, Petr Neuzil, Mauro Biffi, Igor Diemberger, Martin Arnold, David Keane, Pascal Defaye, Jean‐Claude Deharo, Richard Schilling, Andrew Chow, Christopher Aldo Rinaldi

Guys and St Thomas NHS Foundation Trust, United Kingdom

Introduction:

The management of heart failure patients who are CRT non‐­responders (remain symptomatic and have no evidence of reverse left ventricular (LV) remodelling following epicardial CRT) remains limited. Studies have shown that endocardial LV pacing is potentially superior to epicardial LV pacing since it allows faster electrical activation, is more physiological and provides a greater selection of pacing sites enabling the operator to select the optimal site without any myocardial scar. The WiSE‐­CRT system was developed to provide endocardial LV pacing and may be particularly useful in CRT non‐­responders to improve patient outcomes.

Methods:

All CRT non‐­responders who successfully had the WiSE‐­CRT system implanted were analysed. Patients were considered CRT responders if they had evidence of left ventricular remodelling at 6 months or had an improvement in their clinical composite score (CCS); alive, no heart failure hospitalisations, improvement in NYHA functional class or improvement in patient global assessment.

Result:

Overall 17 patients were analysed, baseline demographics include: age of 68.2 ± 7.9 years, 94.1% male, 41.1% ischaemic aetiology, NYHA functional class 2.8 ± 0.4, QRS duration 169.1 ± 23.8 milliseconds and LVEF 25.6 ± 8.0%. There were no acute complications and only 1 patient developed a pocket haematoma during the follow‐­up period. Overall, 58.8% of patients had an improvement in their CCS, 53.3% had an improvement in end‐­systolic volume (ESV) of ≥ 15% and 64.7% had an absolute increase in LVEF of ≥ 5% or improvement in ESV of ≥15%.

Conclusion:

The management of CRT non‐­responders remains difficult with limited treatment options. Our analysis has shown that in this high‐­risk patient group, the WiSE‐­CRT system results in a considerable improvement in the clinical composite score and leads to reverse left ventricular remodelling. These encouraging results suggest an important role for the WiSE‐­CRT system in the management of CRT non‐­responders.

AP19‐­00423

Patients implanted with a WiSE‐­CRT system have a trend towards superior reverse left ventricular remodelling compared with those receiving conventional epicardial cardiac resychronisation therapy upgrades

Baldeep Sidhu, Justin Gould, Bradley Porter, Timothy Betts, Simon James, Andrew Turley, Christian Butter, Martin Seifert, Pasquale Vergara, Lucas Boersma, Sam Riahi, Petr Neuzil, Mauro Biffi, Igor Diemberger, Martin Arnold, David Keane, Pascal Defaye, Jean‐Claude Deharo, Richard Schilling, Anthony Chow, Christopher Aldo Rinaldi

Guys and St Thomas NHS Foundation Trust, United Kingdom

Introduction:

Heart failure (HF) patients undergoing CRT upgrades are more symptomatic and have lower rates of reverse LV remodelling compared with de novo implants. WiSE‐­CRT delivers endocardial LV pacing and has many advantages over epicardial CRT which can be particularly useful in this upgrade population. Currently, WiSE‐­CRT is reserved for patients considered high risk for epicardial CRT such as venous occlusion, risk of pocket infection and multiple co‐­morbidities placing patients at an increased risk.

Methods:

Consecutive patients undergoing epicardial CRT upgrades at Guy's and St Thomas’ between 2014‐­2018 were compared with patients undergoing high‐­risk CRT upgrades with a WiSE‐­CRT.

Result:

95 patients were included; 58 epicardial and 37 endocardial CRT. Baseline demographics for epicardial vs endocardial CRT upgrades include: 71.2 ± 12.2 vs 67.9 ± 11.4 years (P = .098), 77.6 ± 0.4 vs 83.8 ± 0.4% (P = .023) male, 39.7 ± 0.5 vs 37.8 ± 0.5% (P = .859) ischaemic, QRS 176.3 ± 27.5 vs 182.4 ± 29.0 milliseconds (P = .315) and LVEF 30.2 ± 8.2 vs 29.7 ± 7.9% (P = .796). At 6 month follow‐­up, epicardial CRT upgrades had an 81% improvement in clinical composite score (alive, no HF hospitalisations, improvement in NYHA or global assessment) and 78% had improvement following WiSE‐­CRT (P = .784). There was a trend towards a non‐­significant improvement in LV remodelling following WiSE‐­CRT compared with epicardial CRT; 73.5 ± 0.4 vs 66.0 ± 0.5% (P = .367) of patients had an absolute change in LVEF ≥ 5% and 69.0 ± 0.5 vs 52.8 ± 0.5% (P = .185) of patients had improvement in LVESV ≥ 15%.

Conclusion:

Patients undergoing high‐­risk CRT upgrades with a WiSE‐­CRT system have comparable outcomes with those patients undergoing epicardial CRT upgrades. There is a tendency towards improved LV remodelling following WiSE‐­CRT, however further studies are required to determine if this reaches significance in a larger patient cohort.

AP19‐­00435

Hybrid human and machine learning adjudication approach for evaluating arrhythmia discriminator algorithm performance

Christopher Piorkowski, Fady Dawoud; Fujian, Qu; Kyungmoo Ryu

Abbott, United States

Introduction:

Implantable cardiac monitors (ICMs) are being increasingly used to diagnose cardiac arrhythmias including ventricular asystole (pause) and bradycardia (brady), leading to a vast increase in the number of episodes triggered and transmitted to remote monitoring clinics. Reviewing large amount of ICM episodes can be challenging and time consuming for clinics. Machine learning algorithms have the potential to quickly adjudicate large amounts of data. The objective of this analysis is to assess the accuracy of a hybrid human and machine learning approach for adjudicating ICM episodes, and the feasibility of using this approach to evaluate recent detection algorithm enhancements in Confirm Rx™ ICM.

Methods:

Pause and brady episodes triggered and transmitted to Merlin.net™ patient care network were extracted and used to train a random‐­forest gradient‐­boosting machine learning (ML) model. The ML model incorporated 15 relevant features derived from stored electrocardiograms such as R‐­wave amplitude and R‐­R intervals. Model convergence used 3‐­fold cross validation minimizing exponential loss. The human verification data subset was selected according to consistent criteria based on ML and ICM algorithm outcomes. The accuracy of the ML model alone and the hybrid approach combining the model‐­based result with human verification was evaluated using an independent fully adjudicated dataset.

Result:

The training dataset contained 34 383 pause and 14 938 brady episodes from 9578 devices. ML model with 150 learners and learning rate of 0.15 achieved combined 99.1% sensitivity and 97.2% specificity in training. The validation dataset contained 2408 pause and 1502 brady episodes randomly sampled from 115 devices. The trained ML model alone achieved sensitivity of 100% and 97.6% with specificity of 96.3% and 91.6% in pause and brady episodes, respectively. Using the hybrid adjudication approach on the same data subset, sensitivity was 100% and 100% while specificity increased to 100% and 99.4%, respectively. Based on the outcomes of the ML model and ICM detection algorithms, the hybrid approach identified 359 (14.9%) pause and 311 (20.7%) brady episodes for human verification, thereby allowing 5.8 times reduction in human effort in comparison to manually adjudicating the entire validation dataset.

Conclusion:

The hybrid adjudication approach leveraging machine learning techniques and human verification is highly accurate and significantly reduces human adjudication burden. It allows accurate performance evaluation of ICM detection algorithm enhancements.

AP19‐­00439

Following elimination of T‐­wave oversensing, myopotential noise emerges as a major cause of inappropriate shock in S‐­ICD

Kenta Tsutsui, Yoshifumi Ikeda, Ritsushi Kato, Hitoshi Mori, Saki Hasegawa, Sou Asano, Mai Tahara, Sayaka Tanaka, Shir Iwanaga, Toshihiro Muramatsu, Shintaro Nakano, Kazuo Matsumoto

Saitama Medical University International Medical Center, Japan

Introduction:

Inappropriate shock (IAS) is a major complication of subcutaneous implantable cardioverter‐­defibrillator (S‐­ICD) that dreadfully impacts an affected patient's quality and longevity of life, and reportedly occurs at an egregious rate of 5‐­15% every year. T‐­wave oversensing (TWO), a common cause of IAS, is expected to decrease thanks to anti‐­TWO measures such as preoperative surface electrocardiogram screening and the 9 Hz in‐­device electrogram filter (SmartPass^®).

Methods:

To determine if an incidence of TWO‐­induced IAS is suppressed, and if it is indeed the case, to determine remaining causes of IAS, we conducted a single‐­center registry study that tracks the postoperative course of 54 consecutive patients who received S‐­ICD from 2016 to 2019.

Result:

During the follow‐­up period of 638 ± 355 days, IAS occurred in 11% of the study population (6/54) which appears comparable to previously reported incidence. Remarkably, the TWO‐­induced shocks were eliminated (0/6). Instead, myopotential oversensing emerged as the most common cause of IAS events (4/6) while atrial fibrillation ranked the second (2/6). The in‐­device electrogram of the four myopotential‐­induced IAS patients retrieved during the post‐­shock interrogation revealed that (1) provocation maneuver mimicking a triggering activity (e.g. abdominal clench, push‐­ups, raising the left upper extremities, lifting a heavy item) reproduced myopotential noise disguised as R‐­waves, which should trigger an IAS if uninterrupted, in multiple vectors; (2) in‐­device R‐­wave amplitude of the myopotential‐­induced IAS group did not differ from those of shock‐­free patients (Alternative, 1.1 ± 0.4 mV vs 1.8 ± 0.9 mV, Secondary, 2.3 ± 1.4 mV vs 2.5 ± 1.2 mV, Primary, 2.1 ± 0.8 mV vs 3.0 ± 1.5 mV); and (3) there was no temporal changes in R‐­wave amplitude from the implantation (Alternative, 1.2 ± 0.5 mV vs 1.1 ± 0.6 mV, Secondary, 1.7 ± 0.6 mV vs 1.8 ± 0.7 mV, Primary, 1.7 ± 1.1 mV vs 1.9 ± 1.2 mV), indicating that the R‐­wave amplitude trend consistently over time. These findings suggest that it is neither constantly low nor acutely dropped R‐­wave amplitude but a relatively high noise level that drives IAS. All the patients who suffered from a myopotential‐­induced IAS were male. Right‐­sided S‐­ICD lead implantation (which was chosen providing the preoperative screening on the left sternal border failed but that on the right sternal border was satisfactory) was associated with a markedly higher risk of the myopotential‐­induced inappropriate shock when compared with the left‐­sided implantation (50% vs 2%, P = .003).

Conclusion:

The present study highlights the fact that IAS continues to occur due to myopotential noise oversensing despite TWO elimination. Further study should address the underlying mechanism of a myopotential‐­induced inappropriate shock and generalizability of this observation.

AP19‐­00442

Changing QRS duration and morphology with a A‐­paced rhythm and A‐­sense rhythm in post Cardiac Resynchronization Therapy (CRT) patients

Ameya Udyavar, Saurabh Deshpande

Jag Jivan Ram Western Railway Hospital, Mumbai Central, Mumbai, India., India

Introduction:

Meticulous interpretation of the post‐­procedure ECGs of patients with cardiac resynchronization‐­defibrillator therapy (CRT‐­D) device is paramount during follow up to ensure optimal synchronization of both the chambers. We present the ECGs of a patient who was implanted with a CRT‐­ D device and was noted to have different morphologies of the biventricular paced QRS depending on where it was an atrial‐­sense (A‐­sense) or atrial‐­paced (A‐­paced) rhythm. This interpretation is of importance to ensure A‐­sense rhythm and optimal atrioventricular (AV) delay for maximum benefit of CRT therapy.

Methods:

A 61‐­year‐­old male, diabetic and hypertensive, presented with heart failure. He had a past history of myocardial infarction with LVEF of 30%. He had LBBB at baseline and was implanted with a CRT‐­D device. During follow‐­up after 6 months, his QRS morphology and duration was noted to change depending on whether it was A‐­sense or A‐­paced rhythm. The first ECG shows an A‐­paced rhythm with QRS duration (QRSD) of 200 ms, R wave in V1, deep S wave in V5, V6 and RS pattern in lead II. While during A sense rhythm the QRSD reduced to 140 ms, RS pattern in V1 and QS (W) pattern in lead II. This narrowing of the QRS and a better BiV paced morphology during A‐­sensed rhythm will ensure better clinical outcome. There may be multiple reasons for narrowing of the QRS and change in morphology. 1. The A‐­paced rhythm will cause a delayed left atrial contraction causing decrease LV filling. 2. The morphology of the QRS suggests that A‐­sense causes a better fusion of the QRS. This fusion might be due to an earlier intrinsic right bundle activation along with the LV paced activation. It is important to note the percentage of A‐­paced beats so that beta‐­blockers may need to be adjusted accordingly to ensure A‐­sense beats.

Result:

N/A

Conclusion:

In a case of CRT, correct interpretation of the ECG is of paramount importance to ensure A‐­sense rhythm with a better fused QRS. So, it is prudent to allow the intrinsic atrial beats for the beneficial effects of CRT.

AP19‐­00444

Usefulness of Micra leadless pacemaker for persistent atrial fibrillation patients with atrioventricular conduction failure after transcatheter aortic valve replacement

Marika Yamada, Tomoo Harada, Akira Kasagawa, Makoto Takano, Kenichi Sasaki, Yoshihiro Akashi

Division of Cardiology, Department of Internal Medicine, St. Marianna University School of Medicine, Japan

Introduction:

The aim of this study was to compare cardiac function of a group with implanted conventional single chamber lead pacemaker and a group with implanted Micra leadless pacemaker in persistent atrial fibrillation (AF) patients with atrioventricular conduction failure after transcatheter aortic valve replacement (TAVR).

Methods:

We retrospectively evaluated the clinical features among 37 consecutive patients who had pacemaker implantation for atrioventricular conduction failure after TAVR from January 2016 through November 2018. Of the 37 cases, there were 10 cases of persistent AF with atrioventricular conduction failure after TAVR, 5 cases were implanted with conventional single chamber lead pacemakers, and the other 5 cases were undergoing Micra leadless pacemaker implantation. We compared cardiac function before and six months after each pacemaker implantation in these two groups.

Result:

As shown by Table 1, there was no significant difference about before and after the measurement of left ventricular ejection fraction (EF) and right ventricular systolic pressure (RVSP) by echocardiogram between two groups.

Conclusion:

Although follow‐­up in a short period of time, Micra leadless pacemaker may have no difference in their effects on cardiac function compared with conventional single chamber lead pacemakers in patients with persistent AF with atrioventricular conduction failure after TAVR. For elderly patients with persistent AF requiring a pacemaker with atrioventricular conduction failure after TAVR, the Micra leadless pacemaker may be useful.

TABLE 1 Clinical features between conventional pacemaker group and Micra leadless pacemaker group

	Conventional pacemaker (n = 5)	Micra leadless pacemaker (n = 5)	P value
Age, yrs	86 ± 4	85 ± 5	.680
Female	4 (80%)	5 (100%)	.292
Height (cm)	148.6 ± 14.0	152.6 ± 7.1	.583
Body weight (kg)	49.4 ± 12.8	60.5 ± 15.4	.251
Body mass index (kg/m2)	22.1 ± 2.7	25.9 ± 6.8	.271
Creatinine clearance (ml/min)
Pre	35.0 ± 4.0	37.8 ± 13.1	.080
Post	52.0 ± 18.5	50.3 ± 21.7	.303
Left ventricular ejection fraction (%)
Pre	65.8 ± 6.7	69.8 ± 5.8	.341
Post	66.0 ± 8.9	64.6 ± 4.2	.757
Right ventricular systolic pressure (mmHg)
Pre	33.8 ± 5.0	34.6 ± 5.0	.788
Post	28.0 ± 6.5	34.8 ± 5.5	.110

Pre: before pacemaker implantation, post: six months after each pacemaker implantation.

AP19‐­00447

A case in which remote monitoring was useful for analysis of unexpected ventricular pacing observed above the upper rate

Taishi Hirahara, Yoshimasa Tsurumaki, Norifumi Kubo, Hideo Fujita, Shin‐ichi Momomura

JCHO Saitama Medical Center, Japan

Introduction:

We reported a case in which remote monitoring was useful for analysis of unexpected ventricular pacing observed above the upper rate after pacemaker implantation for transient complete atrioventricular block.

Methods:

None.

Result:

The case was an 82‐­year‐­old woman. She was diagnosed obstructive hypertrophic cardiomyopathy (HOCM) with severe left ventricular outflow tract pressure gradient, non‐­sustained ventricular tachycardia and paroxysmal atrial fibrillation. She was taking cibenzoline, atenolol and amiodarone. She visited our hospital for syncope in 2016 and transient C‐­AVB was observed after admission. It was possible that syncope was caused by the side effect of anti arrhythmic drugs. But we decided to perform pacemaker implantation, because the medication for HOCM was necessary and she did not want ICD implantation. She was performed dual chamber pacemaker implantation. (Boston Scientific, ACCOLDADE MRI L331) Atrial lead fixed at right atrial appendage and ventricular lead fixed at right ventricular apex. After implantation, she had been followed at an outpatient clinic. Device's setting was DDD mode. Atrial tachycardia appeared in 2017. We recommended her to have catheter ablation, but she rejected and electrical cardioversion was performed. On July 2018, she visited our hospital because of palpitation. On the ECG, atrial tachycardia appeared. The ECG showed atrial tachycardia at a rate of 140 and ventricular pacing was showed transiently above the upper pacing rate. A ventricular pacing spike was observed 280 ms after previous QRS. We checked the device to rule out ventricular undersensing. As a result, mode switch was in operation because of atrial tachycardia. Atrial pacing threshold could not be measured, but atrial wave amplitude was 1.9 mV, ventricle amplitude and pacing threshold did not change either. Therefore, the cause of ventricular pacing above the upper rate was unknown. In this case, remote monitoring had performed and ventricular high rate episodes were captured in the remote monitoring record. Because of atrial tachycardia with 1 to 1 ventricular conduction, ventricular sensing was recognized as a ventricular premature beat. The mode switch was in operation and device mode had changed to DDI. In addition, device counter changed form A‐­A counter to V‐­V counter. Because of atrial tachycardia interval and DDI mode, atrial pacing was performed just on the ventricular sensing and ventricular sensing was just in the atrial blanking period and ventricular sensing was ignored. And after paced AV delay interval, ventricular pacing was performed.

Conclusion:

We reported a case which the cause of unknown ventricular pacing above the upper rate has been confirmed by referring to remote monitoring records.

AP19‐­00450

The role of cardiac rehabilitation in patients undergoing pacemaker implantation: a preliminary data from single center randomized controlled trial

Jinhee Ahn, Byeong Ju Lee, Bu Kyung Kim, Ji Yeon Kim

Pusan National University Hospital, South Korea

Introduction:

Previous studies demonstrated that exercise‐­based cardiac rehabilitation (CR) improves clinical outcomes in patients with heart failure. Patients undergoing pacemaker (PM) implantation because of significant bradycardia often have limited exercise capacity, however the role of CR in these populations is not known.

Methods:

This study is a single‐­center, randomized clinical trial and still recruiting eligible patients since April in 2018. A total of 16 patients with 6‐­minute walking distance less than 85% of predicted value on the next day of PM implantation were enrolled and randomly assigned to CR group (n = 5, 31.2%) or non‐­CR group (n = 11, 68.8%). The CR group trained a total of 10 times of individualized exercise‐­based CR for 1 month. SF‐­36, 6‐­minute walking test (6MWT), muscle power, and cardiopulmonary exercise test (CPET) at baseline and 1 month follow‐­up period were compared inter‐­ and intra‐­groups.

Result:

Patients in CR group were older and had higher ventricular pacing burden, but there were no differences in PM indication, SF‐­36 score, 6MWT, muscle power, or CPET parameters on baseline between groups. After a mean follow‐­up period of 39.6 days, both groups showed significantly improved 6 MW distance but the difference was similar. In CPET, VO2 max was improved in CR group (13.0 to 15.9 mL/(kg x minute), P = .034), but not in non‐­CR group. In addition, only CR group showed improved quality of life (mental health score 14.3 to 21.0, P = .009), unlike the non‐­CR group. Lead dislodgement or change in PM parameter was not shown in any patient.

Conclusion:

Exercise‐­based CR seemed to improved quality of life in some part and exercise capacity in patients with PM implantation.

AP19‐­00451

A case of left ventricular endocardial pacing in cardiac resynchronization therapy with interventricular septum puncture

Su Hao

APHRS, China

Introduction:

This report demonstrates the feasibility of left ventricular endocardial pacing in CRT with interventricular septum puncture. A patient with dilated cardiomyopathy and typical left bundle branch block (LBBB) was admitted for implanting cardiac resynchronization therapy (CRT). However, the absence of the orifice was found through retrograde coronary venography imaging in surgery. Meanwhile the patient and his family members refused implantation of left ventricular epicardial electrode through thoracotomy.

Methods:

Interventricular septum puncture.

FIGURE 1 Survival without hospitalization for HF

Result:

A novel CRT with interventricular septum puncture for left ventricular endocardial pacing was carried out. The surgery was smoothly accomplished and the effect of CRT is great.

Conclusion:

This report demonstrates the feasibility of left ventricular endocardial pacing in CRT with interventricular septum puncture.

Keywords: cardiac resynchronization therapy, endocardial pacing, interventricular septum puncture

AP19‐­00452

Clinical research of left ventricular endocardial pacing in cardiac resynchronization therapy

Chen Dong

APHRS, China

Introduction:

The purpose of this research was to evaluate the efficacy, safety of cardiac resynchronization therapy (CRT) with interatrial septum or interventricular septum puncture implanted into the left ventricular endocardial electrode.

Methods:

A retrospective analysis of 6 heart failure patients with coronary venous malformation or CRT nonresponse diagnosed at the First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China from 2014‐­08 to 2018‐­10, with left ventricular endocardial electrodes implanted through interatrial septum or interventricular septum puncture. Among them, 4 patients underwent interatrial septum puncture and 2 patients interventricular septum puncture. The QRS duration was got before and after operation, and left ventricular ejection fraction (LVEF), left ventricular end‐­diastolic diameter (LVEDD), left ventricular end‐­systolic diameter (LVESD), left atrial anterior and posterior diameter (LAD) and NYHA class were measured, and the parameters of left ventricular electrode (threshold, impedance) were also measured after 3, 6, 12 and 24 months.

Result:

6 patients underwent successful implantation of left ventricular endocardial electrodes through interatrial septum or interventricular septum puncture. There were no serious complications during operation. The QRS duration was significantly narrower than before. LVEF was significantly increased and LVEDD was significantly reduced within 24 months. However, LVESD and LAD were unchanged, and the parameters of left ventricular electrodes (threshold, impedance) were relatively stable. Meanwhile no obvious abnormal events were found such as diaphragmatic stimulation, thromboembolism, hemorrhage and ventricular arrhythmia, and the patient's heart function was significantly improved. None was deaths.

Conclusion:

The left ventricular endocardial electrode was successfully inserted through the interatrial septum or interventricular septum puncture, and certain clinical efficacy was obtained.

Keywords: Left ventricular endocardial pacing; Cardiac resynchronization therapy (CRT); Interatrial septum puncture; Interventricular septum puncture; Heart failure

AP19‐­00457

Long‐­term prognosis of advanced heart failure patients with very severe left ventricular systolic dysfunction after cardiac resynchronization therapy

Kyung Min Min, Tae Ho Youn, Min Jung Bak, David Hong, Sang Yoon Lee, Seong Soo Lee, Young Jun Park, Kyoung Min Park, Young Keun On, June Soo Kim, Seung Jung Park

Samsung Medical Center, South Korea

Introduction:

Many clinical trials of cardiac resynchronization therapy (CRT) for heart failure (HF) adopted left ventricular ejection fraction (LVEF) as a part of inclusion criteria and upper cut‐­off point was around 30% to 40%. However, few patients with significantly reduced LVEF (<20%) were enrolled in the studies.

Methods:

Long‐­term outcomes of CRT for advanced HF patients with very severe LV systolic dysfunction (vs‐­LVSD group, LVEF < 20%, n = 33) were retrospectively compared to those with moderate to severe LVSD (ms‐­LVSD group, 20% ≤ LVEF < 40%, n = 136). The primary outcome was hospitalization for HF. The secondary outcome was a composite of hospitalization for HF, cardiac death, heart transplantation, implantation of LV assist device or stroke. Echocardiographic response and super‐­ response were defined by relative reduction in LV end systolic volume (LVESV) ≥15% and ≥30%, respectively.

Result:

The vs‐­LVSD group had a significantly lower baseline LVEF than the ms‐­LVSD group (16.4 ± 2.6% vs 27.4 ± 4.8%, P < .001). However, the rate of hospitalization for HF in the vs‐­LVSD group (10/33, 30.3%) was not significantly different from that in the ms‐­LVSD group (39/136, 28.7%) over the follow‐­up duration of 33.7 ± 27.3 months (hazard ratio [HR], 0.83; 95% confidence interval [CI], 0.42 to 1.6; P = .58, Figure 1). The secondary composite outcome was noted in 13 (39.4%) patients in the vs‐­LVSD group and in 40 (29.4%) patients in the ms‐­LVSD group (HR, 1.09; 95% CI, 0.57 to 2.09; P = .80, Figure 2). Proportion of responders or super‐­responders was not significantly different between the vs‐­ LVSD and ms‐­LVSD groups (Responders, P = .18; Super‐­responders, P = .12, Table 2).

Conclusion:

In terms of long‐­term clinical and echocardiographic outcomes, the efficacy of CRT for advanced HF patients with very severe LV systolic dysfunction was well‐­maintained just as for those with less severe dysfunction.

FIGURE 1 Survival without hospitalization for HF

FIGURE 2 Survival without hospitalization for HF, cardiac death, heart transplantation, implantation of LV assist device or stroke

FIGURE 3 Comparison of response to CRT by baseline LVEF

TABLE 1 Baseline Characteristics

Characteristics	vs‐­LVSD (n=33)	ms‐­LVSD (n=136)	P‐­value	n
Sex (male) ‐­ no. (%)	24 (72.7)	84 (61.8)	.21	169
Age ‐­ yrs	62.1 ± 10.4	65.9 ± 12.7	.08	169
Baseline EF ‐­ %	16.4 ± 2.6	27.4 ± 4.8	<.001	169
LVESV ‐­ ml	235.7 ± 57.4	166.4 ± 53.5	<.001	150
QRS duration – msec	170.1 ± 28.9	165.5 ± 27.0	.39	167
LAVI ‐­ ml/m2	66.7 ± 27.5	60.1 ± 27.3	.24	153

AP19‐­00462

Usefulness and safety of emergent magnetic resonance imaging in patients with cardiac implantable electronic devices

Kosuke Asahara, Hiroshi Tasaka, Mitsuru Yoshino, Masatomo Ozaki, Reo Hata, Atsushi Sakata

Kurashiki Central Hospital, Japan

Introduction:

The use of magnetic resonance imaging (MRI) in patients with MRI‐­conditional cardiac implantable electronic devices (MRI‐­CIEDs) has been rapidly increasing in many fields. In clinical practice, the usefulness and safety of emergent MRI in patients with MRI‐­CIEDs is still unknown.

Methods:

Between November 2012 and April 2019, 329 patients with MRI‐­CIEDs underwent MRI. Of them, we retrospectively analyzed 44 patients who had undergone emergent MRI (mean age, 81 ± 8 years; men, 73%), including one patient with an implantable cardioverter defibrillator and one patient with a cardiac resynchronization therapy defibrillator. Pacing parameters including lead impedance, signal amplitude, and pacing threshold of atrial and ventricular leads measured before and after MRI were compared.

Result:

Patient characteristics, MRI region, MRI time, indication for pacemaker placement and type of device are shown in Table 1. Brain MRI for suspected acute stroke was performed on 29 patients, 18 (62%) of whom received a definite diagnosis. Between before and after MRI, no significant differences were observed in ventricular lead impedance (480 ± 90 vs 478 ± 87 Ω, P = .42), signal amplitude (atrial lead: 2.9 ± 1.8 vs 2.7 ± 1.5 mV, P = .91; ventricular lead: 10.1 ± 4.0 vs 9.8 ± 4.7 mV, P = .33) and pacing threshold (atrial lead: 0.5 ± 0.2 vs 0.6 ± 0.2 mV, P = .21; ventricular lead: 0.9 ± 0.3 vs 0.9 ± 0.2 mV, P = .57). Only atrial lead impedance significantly decreased between before and after MRI (517 ± 89 vs 499 ± 86 Ω, P < .01). No adverse events occurred during MRI.

Conclusion:

This study's relatively high diagnostic rate of acute stroke, with no adverse events.

TABLE 1 Study details

Variable	n
Patients	44
Total number of MRI times	46
Age, years	81 ± 8
Sex
Male	32
Female	12
MRI Region
Head	39
Abdomen	3
Spine	3
Chest	1
MRI time, min (mean and standard deviation)	22 ± 7.1
Indication for pacemaker placement
Atrioventricular block	22
Sick sinus syndrome	18
Atrial fibrillation bradycardia	2
Old myocardial infarction with ventricular tachycardia	2
Device
Pacemaker	42
Implantable cardioverter defibrillator	1
Cardiac resynchronization therapy defibrillator	1

AP19‐­00464

First in Asia case report and literature review on subcutaneous implantable cardiac defibrillator (S‐­ICD) related infection with extraction and reimplantation

Man‐wah, Amy Chu, KK Chan, KL Chui, HL Chan, CK Lau, KH Yau, WL Kwong, TK Lai, TY Chan, CH Chan

Queen Elizabeth Hospital, Hong Kong

Introduction:

More patients were receiving SICDs instead of conventional trans‐­venous ICDs for prevention of sudden cardiac death. Below is the first case report in Asia and literature review about S‐­ICD‐­related infection and its management approach.

Methods:

A 34‐­year‐­old man with history of recurrent syncope for 10 years was admitted to our unit in 2014 for Brugada syndrome presented with another episode of syncope precipitated by flu. His electrocardiogram showed transient type 2 Brugada pattern. Flecainide challenge test and electrophysiological study were positive. Further investigations including transoesophageal echocardiogram, event recorder and coronary angiogram were all normal. SICD was implanted for prevention of sudden cardiac death via 3 incision technique. His postoperative followup course was uneventful. There was no ventricular arrhythmia detected and no shock therapy was required. The patient developed cellulitis over xiphoid region after a scratch injury 4 years after S‐­ICD implant. There was SICD pocket site abscess formation through the subcutaneous tunnel from xiphoid region despite prompt antibiotic therapy. His wound swab grew methicillin sensitive staphylococcus aureus. There was no positive blood culture. In view of the rapid progression of symptoms and abscess formation despite antibiotic therapy, early explanation of S‐­ICD. He was treated with 3 weeks of antibiotic therapy. SICD was reimplanted with subcutaneous approach at a deeper subcutaneous plane. Intraoperative defibrillation threshold test (DFT) was successful and postoperative follow up was uneventful.

Result:

Previous studies showed S‐­ICD implantation related infection was 1.7‐­4.1%, while the rates of Trans‐­venous ICD (TV‐­ICD) infection was 0.6‐­1.7%. However, there was no head‐­to‐­head comparison. For superficial infection after S‐­ICD, conservative management without removal of device may be considered. However, S‐­ICD infection could progress to systemic infection. For deep seated S‐­ICD infection, device removal should be considered early. A recent published retrospective cohort study of 123 patients reported 5 patients (4.7%) had S‐­ICD infection at 2 year follow up. 4 patients had reimplantation by subcutaneous approach as the initial approach. 3 of them had uneventful follow up course 1 year after reimplantation. 1 of them required repositioning of pulse generator to sub‐­serratus anterior muscle at 34 days. This retrospective cohort showed that continuation of S‐­ICD therapy with subcutaneous approach was possible after early surgical intervention when compared to early study in which 4 out of 7 infected S‐­ICD cases were switched to TV‐­ICD.

Conclusion:

S‐­ICD infection could progress to systemic infection. Early identification and treatment is important. Continuation of S‐­ICD therapy with subcutaneous approach is possible after early intervention.

AP19‐­00474

Coronary sinus cannulation during cardiac resynchronization therapy with a hydrophilic guidewire, amplatz coronary catheter, or multi‐­electrode catheter

Minsoo Kim, Jun Kim, Ungjeong Do, Min Soo Cho, Gi‐Byoung Nam, Kee‐Joon Choi, You‐Ho Kim

Asan Medical Center, South Korea

Introduction:

Localization of the coronary sinus (CS) ostium and establishment of a stable platform in the coronary sinus are essential for successful cardiac resynchronization therapy (CRT). Angiographic (contrast‐­guided) or electrophysiological (electrogram‐­guided) approaches have been used for CS cannulation. The success rate of CS cannulation using a hydrophilic guidewire is unknown.

Methods:

We evaluated 102 consecutive patients who underwent cardiac resynchronization therapy between September 2013 and June 2019. We analyzed the success and complication rates of CS cannulation using a nitinol hydrophilic guidewire, Amplatz coronary catheter, or multi‐­electrode catheter.

Result:

The electrophysiologic approach was successful in cannulating the CS in 10 of the 102 patients. Cannulation using a hydrophilic guidewire initially was successful in 65 (70.7%) of 92 patients. CS cannulation was successful using a multi‐­electrode catheter in 7 and an Amplatz coronary catheter in 16 of 27 patients. Of the remaining 4 patients, 3 had successful CS cannulation using a multi‐­electrode catheter. CS cannulation was unsuccessful in 1 patient. Coronary sinus dissection occurred in 2 of 21 cases with and 1 of 81 cases without using a multi‐­electrode catheter. LV lead implantation was successful in 3 cases with CS dissection.

Conclusion:

CS cannulation using a hydrophilic guidewire was effective and safe. Selective use of an Amplatz coronary catheter or multi‐­electrode catheter can further improve the success rate.

AP19‐­00475

Cardiac resynchronization therapy in patients with aortic valve disease

Minsoo Kim, Jun Kim, Ungjeong Do, Min Soo Cho, Gi‐Byoung Nam, Kee‐Joon Choi, You‐Ho Kim

Asan Medical Center, South Korea

Introduction:

The efficacy of cardiac resynchronization therapy (CRT) is unknown in patients with aortic valve disease. We aimed to evaluate outcomes of CRT in patients with aortic valve disease.

Methods:

We analyzed 14 consecutive patients with aortic valve disease who underwent CRT from 2004 to 2019. Clinical and electrocardiographic data were reviewed. Procedural and echocardiographic outcomes were analyzed.

Result:

In the 14 patients (age, 69.6 ± 9.1 years; men, 10), the aortic diseases were as follows: surgical aortic valve replacement (n = 9), transcatheter aortic valve implantation (n = 2), moderate aortic regurgitation (n = 2), and low‐­gradient severe aortic stenosis (n = 1). Coronary artery disease was present in 3 patients. Other prior cardiac procedures included mitral valve replacement (n = 4), coronary artery bypass graft (n = 2), tricuspid valvuloplasty (n = 1), and maze operation (n = 1). Left bundle‐­branch block was present in 12 patients; intraventricular conduction disturbance, in 1 patient; and paced rhythm in 1 patient. Atrial arrhythmia was present in 6 patients. A CRT pacemaker was implanted in 6 patients. AV junction ablation was performed in 1 patient. Atrial lead revision was performed in 1 patient. QRS duration decreased from 176.4 ± 27.5 ms to 158.6 ± 25.8 ms (P = .003) after CRT. Left ventricular end‐­ systolic volume decreased from 174.0 ± 91.5 ml to 134.8 ± 68.1 ml (n = 13) acutely after CRT (P = .073). Left ventricular ejection fraction increased from 25.9% ± 6.8% to 33.2% ± 5.8% (n = 13) acutely after CRT (P = .003) and further increased to 41.2% ± 15.4% (n = 11) at last follow‐­up.

Conclusion:

Cardiac resynchronization therapy was effective for reverse remodeling and improving the left ventricle in the patients with aortic valve disease in this study.

AP19‐­00476

Atrioventricular junction ablation with cardiac resynchronization therapy

Minsoo Kim, Jun Kim, Ungjeong Do, Min Soo Cho, Gi‐Byoung Nam, Kee‐Joon Choi, You‐Ho Kim

Asan Medical Center, South Korea

Introduction:

Atrioventricular junction (AVJ) ablation improves the outcomes of cardiac resynchronization therapy (CRT) in patients with atrial fibrillation (AF). We report our initial results of AVJ ablation in patients with CRT.

Methods:

Eight consecutive patients who underwent AVJ ablation between May 2017 and June 2019 were included. Clinical, electrocardiographic, and echocardiographic data were reviewed and analyzed.

Result:

The mean age was 69.2 years, and 4 patients had non‐­ischemic cardiomyopathy. Left bundle branch block was present in 6 cases. Two patients who were unsuitable for AF ablation (high‐­risk) underwent AVJ ablation. Seven patients had persistent AF, and 1 had a paroxysmal AF/organized atrial flutter. AVJ ablation (using an external irrigation catheter) was successful using a right‐­sided approach in 7 patients and a left‐­sided approach in 1. Left ventricular (LV) lead dislodgement occurred in 1 case. Immediate decreases in the left atrial size (from 53.4 ± 6.5 mm to 43.7 ± 19.5 mm, P = .27) and left ventricular end‐­systolic volume (from 136.6 ± 40.2 mL to 104.7 ± 38.8 mL, P = .13), with improvement in LV ejection fraction (from 27.8% ± 4.8% to 36.4% ± 8.4%, P = .01), were observed. Of 3 patients with > 6 months of echocardiographic follow‐­up data, LV ejection fraction improved to 50.7% ± 2.1% (P = .02). The AV conduction resumed in the first case 24 months after AVJ ablation.

Conclusion:

AVJ ablation is highly effective for reverse remodeling of the left ventricle and improving ventricular function in patients with AF and severe LV dysfunction.

AP19‐­00481

Utilization of guideline‐­directed device therapies in heart failure patients: a real‐­world analysis using electronic health record data

Alan Cheng, Dan Schaber, Christopher Manrodt, Gregg C. Fonarow, Anne B. Curtis

Medtronic, plc, United States

Introduction:

Guideline‐­directed device therapy improves outcomes for eligible patients with heart failure with reduced ejection fraction (HFrEF). Utilization rates of device therapies in HFrEF following the 2012 ACCF/AHA/HRS Focused Update for Device‐­based Therapies of Cardiac Rhythm Abnormalities have not been well studied. We sought to analyze utilization of guideline‐­directed device therapy in newly indicated HFrEF patients from 2012‐­2016 using aggregated Electronic Health Record (EHR) data.

Methods:

Computable phenotyping algorithms for ICD indications were developed as part of the GLIDE HF (GuideLine Indications Detected in EHR for HF) program and used diagnoses, procedures, measures, prescriptions, and the output of Natural Language Processed (NLP) provider notes. Algorithms were assessed using the Optum^® EHR de‐­identified data of 1.54 million US patients with a diagnosis of HF, cardiomyopathy, or prior infarct. HFrEF patients with > 1 year of prior records with a new Class 1 or Class 2a indication for an ICD or CRT‐­D from 2012‐­2016 were included in the newly‐­indicated analysis.

Result:

From 2012‐­2016, records showed 91,667 HFrEF patients were newly indicated for an ICD or CRT‐­D. Guideline‐­recommended devices were used in 3619 of 11,756 (30.8%) CRT‐­D indicated patients and in 6,196 of 78,477 (9.47%) ICD‐­indicated patients. Among 75,757 patients meeting a Class I ICD indication, 5,986 (7.9%) were implanted with ICDs, whereas among 2,464 patients meeting a Class I CRT‐­D indication, 1264 (51.3%) were implanted with a CRT‐­D. While implantable device therapy utilization was low in indicated patients, 91,357 (99.7%) had records of imaging of the left ventricle, 72,289 patients (80.1%) had records of changes to HF medication with follow‐­up imaging, and 46,637 (50.9%) had prior coronary interventions or diagnostic catheterizations prior to the date of indication.

Conclusion:

In this contemporary cohort of HF patients, a substantial proportion of potentially eligible patients did not receive ICD or CRT‐­D therapy, especially when compared with other cardiovascular interventions and treatments in these patients. Further research is warranted into the factors associated with the use of devices in patients with current Class I guideline indications.

AP19‐­00483

Electrophysiologist visits among a real‐­world cohort of guideline‐­indicated patients: implications for ICD use

Alan Cheng, Dan Schaber, Gregg C. Fonarow, Anne B. Curtis, Christopher Manrodt

Medtronic, plc, United States

Introduction:

The value of ICD therapy for the prevention of sudden cardiac death is well established. In the US, most ICDs are implanted by electrophysiologists (EPs). Patterns of referral nationally in ICD‐­ indicated patients are not well studied. We sought to examine EP referral and implant patterns in a 2016 prevalence pool of ICD‐­indicated patients using electronic health records (EHR).

Methods:

Records from 1.54 million US patients from the Optum^® EHR de‐­identified dataset with a diagnosis of HF, cardiomyopathy, or prior infarct from 2007 to 2016 were evaluated for Class 1 or Class 2a indications for an ICD, using algorithms developed as part of the GLIDE HF (GuideLine Indications Detected in EHR for HF) program. Patients were included if they had records that met criteria for an ICD recommendation, were < 79 years, were alive in 2016, and did not have neurologic exclusions. Office visits, consults, and diagnostic imaging encounters were identified for the group of providers identified as EPs. Patients were divided into two groups, based on whether they were determined to have seen an EP through an office visit, consult, or diagnostic imaging encounter.

Result:

Among the 226,978 patients who had records of a Class 1 or 2a indication for an ICD, 122,678 (54.1%) had not seen an EP. In patients who had no record of being seen by an EP, 12,374 (10.1%) had a new device implant, compared to 46,304 of 104,300 (44.4%) who had seen an EP. Among ICD‐­ indicated patients with no EP visit or consult, 67.1% had 2 or more encounters with a cardiologist. In the subgroup of patients with an indication for secondary prevention, 25,279 of 44,530 (56.8%) were seen by an EP and were more likely to have a device implanted (63.8% for EP, 21.2% for no EP). In patients with primary prevention indications, 66,418 of 154,497 (43.0%) were seen by an EP and were more likely to be treated with an ICD (36.1% for EP, 8.5% for no EP).

Conclusion:

Less than half of patients with records of an ICD indication were referred to an EP in this retrospective analysis. Patients who had survived sudden cardiac arrest were more likely to be seen by an EP. Patients with an EP visit were more likely to receive guideline‐­indicated defibrillators.

AP19‐­00484

Incessant ventricular tachycardia following permanent his bundle pacing

Ulhas M Pandurangi, S Aishwarya, K Kotti, Jaya Pradhap, B Radhika, Muthu Seenivasan, Aparna Balaji, C Nagendran, Dinesh Seenivasalu, Mahima P. Manoj, G Nithin, G Sailendri, S Benjamin, Ravi Kumar, S Nirmala, Dasari Himaja, S Sandini, K Swathi

The Madras Medical Mission, India

Introduction:

Permanent His Bundle Pacing (PHBP) is emerging as the most physiological way of cardiac pacing. The issues related with acute performance of the pacing lead are being recognized. Occurrence of sustained ventricular tachycardia presumably due to myocardial and conduction tissue injury caused by active fixation lead at the His bundle has not been reported so far.

Methods:

A 65‐­ year‐­ old female, rheumatic heart disease, mitral valve replacement (22 mm OmnicarbonTM mechanical mitral prosthesis, 17 years back) normally functioning prosthetic valve, moderate aortic regurgitation and severe LV dysfunction (EF 30%, LVID(d) 65 mm) underwent PHBP for syncope due to sick sinus disease with wide QRS ventricular escape rhythm (Figure 1). The bradycardia was considered not due to any reversible causes. At a site (Figure 2) where the His bundle lead (Medtronic SelectSecureTM 3830) recorded His bundle potential (Figure 3), unipolar pacing (2.0V @1 ms threshold) resulted in non‐­selective HBP with QRS duration of only 20 ms more than the native QRS (Figure 4). Post screwing (3 turns) bipolar HBP resulted in non‐­selective, preferential left bundle pacing (1.5V @1 ms threshold) with further QRS widening (Figure 5A). To achieve better paced QRS morphology it was decided to pace at a different site. Immediately after the lead was unscrewed, patient developed sustained monomorphic tachycardia of the morphology similar to the paced morphology (Figure 5B). The tachycardia was hemodynamically unstable. Three attempts of external electrical cardioversion (100J‐­250J) failed. Adenosine (12 mg IV) terminated the tachycardia for few seconds. Atrial and ventricular overdrive pacing including from the site of HBP (Figure 6) could not terminate tachycardia. The diagnosis of ventricular tachycardia was established by these maneuvers. A single radiofrequency ablation lesion (40W, 50°C, 7F TherapyTM ablation catheter) at the site where the lead was screwed‐­in (Figures 7 and 8) terminated the tachycardia in 5 seconds (Figure 9). The ablation was continued for total 60 seconds. The tachycardia could not be induced by programmed atrial and ventricular stimulation even on isoprenaline. The lead was finally screwed‐­in distal to the ablation site with satisfactory parameters (Figure 10).

Result:

During the 1st month follow‐­up patient remained asymptomatic. The injury caused by the HBP lead was still evident on the ECG (Figure 11)‐­ qRBBB and PR interval 240 ms. A 24‐­hour Holter monitoring showed episodes of appropriate atrial and ventricular pacing and no sustained ventricular arrhythmias.

Conclusion:

A sustained ventricular tachycardia responsive to adenosine but not to overdrive atrial or ventricular pacing can occur after unscrewing active fixation from the HBP site. The RFA at the fixation site cures the tachycardia.

AP19‐­00485

Real‐­world assessment of disparities in the use of guideline‐­directed defibrillator therapy

Alan Cheng, Dan Schaber, Christopher Manrodt, Gregg C. Fonarow, Anne B. Curtis

Medtronic, plc, United States

Introduction:

Inconsistency in the use of implantable defibrillators among eligible patients has been previously reported. Use of algorithms to identify indicated patients from electronic health records (EHR) may help researchers identify differences in care in a real‐­world setting. We sought to examine treatment with ICDs or CRT‐­Ds among newly indicated patients across race and sex groups.

Methods:

US patients < 79 years of age with new indications for an ICD or CRT‐­D from 2012 to 2016 were identified from Optum^® EHR de‐­identified data using GLIDE HF (GuideLine Indications Detected in EHR for HF) program algorithms. Patients implanted with a device were identified from procedure reports. Implant rates were compared according to race and sex.

Result:

Among 78,377 male patients newly indicated for an ICD/CRT‐­D, devices were implanted in 12,834 (16.7%), whereas 5,873 of 46,268 indicated female patients were implanted (12.7%; P < .001). Devices were implanted in 15.6% of white patients, 14.3% of Hispanic patients, 13.3% of black patients, and 11.2% of Asian patients. White men received a device more often than men of other races (17.1% vs 12.1%‐­15.2% for other races; Table). Device use in Asian women was lower (9.5%) than other female race groups (range 12.5%‐­12.8%). White men were significantly more likely to receive a device (P < .001), while Asian women were significantly less likely to receive a device (P = .041).

Conclusion:

In this large real‐­world analysis of device‐­indicated patients, disparities in ICD/CRT‐­D use were observed across both race and sex. Device use was highest among white men, highlighting the need for further investigation into the causes of these differences in care.

TABLE: Gender and Racial Differences in Defibrillator Utilization

Race	Gender	Indicated	Treated	%	P‐­value
Asian	Female	515	49	9.51	.041
Asian	Male	923	112	12.13	.381
Black	Female	9723	1246	12.81	.808
Black	Male	11995	1639	13.66	.081
Caucasian	Female	32693	4190	12.82	.998
Caucasian	Male	59562	10200	17.13	<.001
Hispanic	Female	1800	225	12.5	.731
Hispanic	Male	3260	496	15.21	.106
Other	Female	1537	163	10.61	.024
Other	Male	2637	387	14.68	.096

AP19‐­00486

Lead anchoring and mechanical stability of a substernal extravascular ICD lead

Linnea Lentz, Melissa Christie, Maggie Pistella, Tom Lulic, Noah Barka, Varun Bhatia

Medtronic, United States

Introduction:

The extravascular defibrillator (EV ICD) system may offer patients critical sudden cardiac death protection while remaining outside the heart and preserving the native vasculature. The EV ICD system uses a novel design and implant procedure to keep lead electrodes in place under the sternum. To understand factors that affect lead stability in the substernal space, pre‐­clinical data were acquired using acute and chronic animal studies, human cadaver evaluation, and bench testing.

Methods:

Multi‐­species chronic studies have been conducted in ovine (n = 4), porcine (n = 9), and canines (n = 4) with two different veterinary implanters. Animals were implanted with an EV ICD lead, anchoring technique for each animal was recorded, and imaging data were collected over 12 weeks. Chronic lead slip was measured using CT scans by tracking electrode and anchor sleeve position over time. In addition, human cadavers were implanted with the EV ICD system to measure holding force of the anchor sleeve. The effects of suture technique, suture tie down force, and number of sutures on lead holding force at the anchor sleeve were assessed. Acute animal studies were performed to compare suture tie down forces between veterinarians using the same anchoring method, same suturing technique and same number of sutures.

Result:

In the chronic animal studies, 9 different suture techniques were recorded, and lead motion was quantified as ranging from 0 mm to 31 mm (Figure 1A). Large variation in lead motion was also observed within suturing techniques that were used more than 3 times through the animal studies. Bench test, cadaver studies, and acute animal test data showed an effect of type of knot, number of sutures, and tie down force, on the holding force of the anchor sleeve (Figure 1B). Tie‐­down forces measured in the lab ranged from 1 pound (0.45 kg) to 3 pounds (1.36 kg) between veterinarians.

Conclusion:

Before standardizing suture technique for the EV ICD lead, variable amount of lead motion was observed in the chronically implanted animals. Significant variability in suturing technique, including tie‐­down force and number of sutures used, was seen between veterinary implanters, suggesting that suturing techniques affect the lead holding force of the anchor sleeve. This was confirmed in the cadaver studies and the bench testing, where the suturing techniques, specifically tie down forces were controlled. Different suture technique resulted in different holding forces. Furthermore, standardizing the type and number of sutures and controlling the tie down force resulted in consistent holding forces (Figure 1B). These studies suggest that there is a need to use robust suturing technique to assure appropriate mechanical stability of the EV ICD system for its unique use conditions.

AP19‐­00490

The effect of His‐­Purkinje system pacing in patients with chronic heart failure

Yao Wang

The First Affiliated Hospital of Nanjing Medical University, China

Introduction:

Background: His‐­Purkinje system pacing mainly refers to His bundle pacing (HBP) and left branch bundle pacing (LBBP). His‐­Purkinje system pacing is characterized by activating ventricle via the intrinsic conduction system, thus carrying out the ventricular synchronous contraction, improving cardiac function and reversing ventricular remodeling. Objectives: We aimed to analyze the effect of His‐­ Purkinje system pacing in chronic heart failure patients, and compare the efficacy and parameters between HBP and LBBP.

Methods:

The chronic heart failure patients (LVEF < 50%) who needed pacemaker therapy from September 2014 to December 2018 in the First Affiliated Hospital of Nanjing Medical University were included. They received HBP or LBBP. The data of two‐­dimensional echocardiography and electrocardiogram in the process of preoperative and postoperative follow‐­up were obtained, including left ventricular ejection fraction (LVEF), left ventricular end‐­diastolic dimension (LVDd), left ventricular end‐­systolic dimension (LVDs), and QRS duration (QRSd). The parameters of the pacemaker during and after the operation were recorded, including threshold and impedance. Preoperative and postoperative parameters of all patients were compared to analyze the effect of His‐­Purkinje system pacing on chronic heart failure. The parameters between HBP group and LBBP group were also compared.

Result:

According to the 6‐­month follow‐­up results after device implantation, some parameters changed significantly: LVDd decreased from 65.72 ± 9.76 mm to 59.76 ± 10.88 mm (P < .0001), LVDs decreased from 55.08 ± 11.21 mm to 46.44 ± 12.73 mm (P < .0001), NYHA decreased from 3.00 ± 0.71 to 2.09 ± 0.67 (P < .001), QRSd decreased from 150.20 ± 34.14 ms to 118.50 ± 20.18 ms (P < .0001), and LVEF increased from 33.96 ± 10.58% to 45.46 ± 13.36% (P < .0001). In HBP group, some parameters changed significantly after 6‐­month follow‐­up: LVDd decreased from 65.75 ± 10.11 mm to 61.08 ± 12.27 mm (P = .02), LVDs decreased from 55.00 ± 11.32 mm to 48.00 ± 13.99 mm (P < .01), NYHA decreased from 3.17 ± 0.72 to 2.20 ± 0.63 (P = .02), QRSd decreased from 138.70 ± 25.99 ms to 115.30 ± 24.12 ms (P < .01), and LVEF increased from 34.28 ± 9.90% to 44.06 ± 13.78% (P < .01). In LBBP group, these parameters changed significantly after 6‐­month follow‐­up: LVDd decreased from 65.69 ± 9.83 mm to 58.54 ± 9.78 mm (P < .001), LVDs decreased from 55.15 ± 11.57 mm to 45.00 ± 11.83 mm (P < .0001), NYHA decreased from 2.85 ± 0.69 to 2.00 ± 0.71 (P < .01), QRSd decreased from 160.80 ± 38.18 ms to 121.5 ± 16.15 ms (P < .001), and LVEF increased from 33.65 ± 11.56% to 46.75 ± 13.39% (P < .001). The lead threshold of HBP and LBBP was 1.28 ± 0.64 V and 0.53 ± 0.083 V (P < .01) before discharge, and was 1.53 ± 0.71 V and 0.61 ± 0.14 V (P < .01) during the 6‐­month follow‐­ up. The mean of absolute value of change of lead threshold was 0.54 ± 0.48 V in HBP group and 0.16 ± 0.14 V in LBBP group (P = .04).

Conclusion:

His‐­Purkinje system pacing could reverse left ventricular remodeling, and improve cardiac electrical synchrony in chronic heart failure patients. Both HBP and LBBP could improve cardiac function in chronic heart failure, and LBBP had an edge of lower and more stable lead threshold.

Keywords: Heart failure; His‐­Purkinje system; cardiac resynchronization therapy (CRT); His bundle pacing (HBP); Left bundle branch pacing (LBBP)

AP19‐­00491

Upgrading to His‐­Purkinje system pacing in heart failure patients after chronic right ventricular pacing

Zhiyong Qian

The First Affiliated Hospital of Nanjing Medical University, China

Introduction:

Background: Chronic right ventricular pacing (RVP) is associated with an increased incidence of heart failure and mortality. His‐­Purkinje system (HPS) pacing, including His bundle (HB) and left bundle branch (LBB) pacing could produce favorable electrical and mechanical activation, leading to recovery of cardiac function in heart failure patients. Objectives: We aimed to report the effects of upgrading to HPS pacing in heart failure patients after chronic RVP in our center.

Methods:

Totally 23 patients with an average ventricular pacing percentage of 66.7% were included. According to left ventricular ejection fraction (LVEF) at upgrading ≥ or < 50%, patients were divided into Group 1 (n = 11, mean LVEF 60.2 ± 4.8%) and Group 2 (n = 12, mean LVEF 36.8 ± 8.5%). HB pacing was performed using the pacing lead (model 3830, Medtronic Inc.) delivered through a C315 HIS sheath (Medtronic Inc.) and fixed at HB area. LBB pacing was achieved by penetrating the interventricular septum into the LV sub‐­endocardium with the same pacing lead. All patients underwent clinical and echocardiographic evaluation before replacement and at 6‐­month follow‐­up.

Result:

After upgrading to HPS pacing, paced QRS duration was significantly shortened from 176.6 ± 43.1 ms to 122.8 ± 28.2 ms (P < .001). For patients in Group 1, serum brain natriuretic peptide (BNP) levels significantly decreased and cardiac status of NYHA classification improved from 2.6 ± 0.6 to 1.5 ± 0.5 (P < .001). For patients in Group 2, NYHA classification decreased from 2.7 ± 0.5 to 1.9 ± 0.7 (P = .003) and LVEF increased from 36.8 ± 8.5% to 43.5 ± 9.3% (P = .02). Similar outcome was found in patients with HB and LBB pacing.

Conclusion:

Upgrading to HPS pacing was feasible and effective with improved cardiac function in heart failure patients with both reduced and preserved LVEF after chronic RVP.

Key words: His bundle pacing, left bundle branch pacing, heart failure, pacing‐­induced cardiomyopathy

AP19‐­00492

Efficacy and safety of leadless pacemaker implantation in patients with transcatheter aortic valve implantation

Tomoyuki Tani, Seiji Yamazaki, Go Takenouchi, Yuki Katagiri, Hiroki Bouta, Yasunobu Gohira, Yuichiro Hosoi, Ken Kuroda, Yuri Otomaru, Kazumasa Yamasaki

Sapporo Higashi Tokushukai hospital, Japan

Introduction:

Both transcatheter aortic valve implantation (TAVI) and leadless pacemaker implantation are less invasive and effective for elderly patients with high risk frailty. However, it is not rare that the implant procedure is so hard in TAVI patient because severe aortic valve stenosis patients also have aortic arteriosclerosis which occurs cardiac rotation, tricuspid valve narrowing and tortuous aortic change. We evaluated the efficacy and safety of leadless pacemaker implantation in severe aortic valve stenosis patients who underwent TAVI.

Methods:

Total 49 patients received leadless pacemaker implantation between July 2017 and June 2019 in our hospital. Multi slice CT was performed in all patients on the several days later to detect the location of pacemaker. We compared patients’ characteristics and pacemaker data retrospectively.

Result:

The demographic characteristics shows an age of 86.2 ± 6.4 years old, 16 males (32.7%), BMI 21.5 ± 3.3, 22 antiplatelet therapy (44.9%) and 42 patients (85.7%) were over 80 years old. There were 29 patients with TAVI (TAVI group) and 20 patients without TAVI (non‐­TAVI group). There were no significant differences in pacing threshold at the implantation in both groups. The variation of pacemaker data was also no significant differences until discharge. CT shows all of the leadless pacemakers located in RV septum or anterior interventricular attachment. There were 3 major complications. One patient developed pericardial effusion that required drainage and one patient had intraabdominal hemorrhage due to iliac vein injury that was successfully stopped by compression externally in TAVI group. There was also one cardiac tamponade case which was recovered by pericardiocentesis.

Conclusion:

Leadless pacemaker implantation seemed to be safe and usefulness in elderly patients who underwent TAVI.

AP19‐­00493

Permanent left bundle branch pacing in patients with persistent left superior vena cava

Zhiyong Qian, Yao Wang, Jiangang Zou

The First Affiliated Hospital of Nanjing Medical University, China

Introduction:

Background: Persistent left superior vena cava (PLSVC) is an uncommon congenital abnormality of coronary sinus venous which always makes device implantation difficult, especially in cardiac resynchronization therapy (CRT) candidates who needed the placement of left ventricular (LV) lead. Objectives: We aimed to report four cases of PLSVC undergoing successful permanent left bundle branch (LBB) pacing.

Methods:

Two patients with heart failure and complete LBB block, and another two patients with atrioventricular block and normal cardiac function were included. Prior to implantation, echocardiography did not show any clues of PLSVC in one patient, so the lead placement was performed from the left‐­side approach. For the other three patients without a connecting innominate vein, the implantation was from the right‐­side axillary vein. LBB pacing was achieved by penetrating the interventricular septum into the LV sub‐­endocardium with the pacing lead (model 3830, Medtronic Inc.). Reconfiguration of the sheath (C315 HIS, Medtronic Inc.) was needed in one patient from the left‐­side approach.

Result:

All patients showed Qr morphology in paced ECG with narrow QRS durations (123.8 ± 4.8 ms) and short LV activation time (77.5 ± 9.6 ms). LBB potential was recorded in 3 patients. Pacing threshold and sensing amplitude were 0.6 ± 0.1V/0.5 ms and 10.9 ± 3.2 mV respectively at implantation and remained stable during follow‐­up. Two patients with heart failure had increased LV ejection fraction and improved cardiac function status at 3‐­month follow‐­up.

Conclusion:

Permanent LBB pacing is feasible and effective in patients with PLSVC. LBB pacing could be a first‐­line choice in CRT candidates since LV lead placement in these patients is challenging.

Keywords: left bundle branch pacing, persistent left superior vena cava, heart failure

AP19‐­00494

Chronic retrievability with a leadless pacemaker: a worldwide Nanostim^™ experience

Reinoud Knops, Petr Neuzil, Derek Exner, Niek Beurskens, Jordan Nevo, Paul Friedman, Daniel Cantillon, Vivek Reddy

Amsterdam UMC, location AMC, Netherlands

Introduction:

After 1,423 Nanostim^™ leadless pacemakers (LPs) were implanted during worldwide clinical trials, enrollments were halted in October 2016 due to premature battery malfunctions and remained paused in November 2017 due to a docking button detachment vulnerability. A common therapeutic option has been to retrieve the LPs which have provided valuable clinical experience to inform system revision strategies as patients continue ongoing follow‐­up.

Methods:

Patients implanted with a right ventricular active‐­fixation Nanostim LP were enrolled in multicenter clinical trials in the United States, Canada, Europe, Japan, and Australia. Data was collected by investigative sites during each retrieval attempt. Serious Adverse Device Effects (SADEs) were documented per the International Standard Organization definition and adjudicated by a clinical events committee comprised of independent physicians.

Result:

As of May 30th 2019, a total of 87% (146/168) of retrieval attempts for chronic Nanostim LPs have been successful. Among the 168 retrieval attempts, 37 (22%) were associated with a reported battery malfunction. The mean time from implant to attempted retrieval was 2.3 ± 1.4 years (range 0 days to 6.1 years). The mean time from implant to successful retrieval was also 2.3 ± 1.4 years (range 0 days to 6.1 years). Retrieval success rate remained at least 79% regardless of implant duration (See Figure). There were 22 unsuccessful retrieval attempts, primarily due to inaccessibility of the proximal portion of the LP. Among the 168 retrieval attempts, 5 Serious Adverse Device Effects (SADEs) were related to the device and/or procedure. These events are comprised of one cardiac tamponade, one AV fistula, one access site bleeding event, one complication related to valve damage, and one docking button detachment.

Conclusion:

A high retrieval success rate over a large volume of retrieval procedures, accompanied by low procedural complication rates, demonstrates that chronic retrieval of the Nanostim LP can be safely performed through 6 years post‐­implant. Regardless of implant duration, retrieval success rates were high.

AP19‐­00495

Acute performance of the micra transcatheter pacemaker in Chinese patients

Shu Zhang, Keping Chen, Liqun Wu, Xingbin Liu, Yangang Su, Yujie Zhou, Jiangang Zou, Xiaofeng Hou, Jianan Wang, Meixiang Xiang, Chengjun Guo, Xuejun Ren, Shufeng Liu, Fenglin Zhu, Ming Zhang, Kejiang Cao

State Key Laboratory of Cardiovascular Disease, Arrhythmia Center, Fuwai Hospital, National Center f, China

Introduction:

Previous results from the global Micra clinical trials demonstrated a high implant success rate and excellent safety and efficacy. However, performance in the Chinese population has not previously been reported. We report acute performance results from the China Micra Transcatheter Pacing Study.

Methods:

The purpose of the prospective, multi‐­site, single arm China Micra Transcatheter Pacing Study is to confirm the safety and efficacy of the Micra Transcatheter Pacing System for human use in Chinese patients. Patient baseline characteristics, procedural information, and acute safety and electrical performance through 1 month were summarized.

Result:

Micra was successfully implanted in 81 (98.8%) of 82 patients recruited from 7 participating centers in China. Patients were on average 68.6 ± 11.8 years of age, with an average BMI of 23.7 ± 3.8 kg/m², 50.6% were female, and patients had multiple co‐­morbidities, including chronic lung disease (24.7%) and diabetes (25.9%) (see Table). The most commonly reported primary indication for pacing was bradyarrhythmia with atrial fibrillation (44.4%) followed by sinus node dysfunction (40.7%). Devices were mostly implanted in the RV septum/mid‐­septum (92.6%), with a median number of 2 deployments for successful implants. Through 30 days post‐­implant there were 2 major complications reported (2.4%); 1 arteriovenous fistula event and 1 pyrexia event. There were no perforation/effusion events reported and no deaths reported through 30 days. Mean pacing capture thresholds at implant were 0.52 ± 0.29 V @ 0.24 ms and remained stable through 1 month (0.50 ± 0.57 V).

Conclusion:

Performance of the Micra Transcatheter Pacemaker in the Chinese population demonstrates a high 98.8% implant success rate and low rate of major complications through 30 days post‐­implant, reinforcing the positive results observed in the global trials.

TABLE: Patient characteristics

Patient characteristics	Successfully implanted patients (N=81)
Age (years)	68.6 ± 11.8
BMI	23.7 ± 3.8
Gender (% female)	41 (50.6%)
Atrial arrhythmia	54 (66.7%)
Congestive heart failure	1 (1.2%)
Chronic lung disease	20 (24.7%)
Coronary artery disease	27 (33.3%)
Hypertension	52 (64.2%)
Diabetes	21 (25.9%)
Pacing Indication
Bradyarrhythmia with AF	36 (44.4%)
Sinus node dysfunction	33 (40.7%)
AV block	12 (14.8%)

AP19‐­00502

Reduced CIED infections with an antibacterial envelope: microbiologic analysis of the WRAP‐­IT study

M. Rizwan Sohail, Ralph Corey, Bruce Wilkoff, Jeanne Poole, Suneet Mittal, Charles Kennergren, Arnold Greenspon, Alan Cheng, Jeff Lande, Daniel Lexcen, Khaldoun Tarakji

Cleveland Clinic, United States

Introduction:

Cardiovascular implantable electronic device (CIED) infections are associated with significant morbidity, mortality, and cost. There is limited evidence on antibiotic prophylactic strategies to prevent CIED infection. Recently, the TYRX Envelope, which elutes a combination of rifampin and minocycline for a minimum of 7 days, was shown to significantly reduce major CIED infections in the WRAP‐­IT trial. We sought to characterize the pathogens among patients who experienced an infection in the current era.

Methods:

All patients undergoing CIED replacement, upgrade, revision, or de novo cardiac resynchronization therapy (CRT‐­D) received standard of care antibiotic prophylaxis and were randomized 1:1 to receive TYRX or not. The primary endpoint was major CIED infection within 12 months of the procedure. Major infection was defined as an infection resulting in (1) system extraction or revision, (2) long‐­term suppressive antibiotic therapy, or (3) death. Data were analyzed using the Cox proportional hazards regression model.

Result:

A total of 6,983 patients were randomized worldwide with 3,495 randomized to receive an envelope and 3,488 randomized to the control. At 12 months, 25 major infections (0.7%) were observed in the envelope group and 42 major infections (1.2%) in the control group, resulting in a 40% reduction of major infections (HR: 0.60, 95% CI: 0.36‐­0.98, P = .04). Of 63 infections assayed, causative pathogens were identified in 36 infections whereas cultures were negative in 27 cases. Staphylococcus species (n = 22) were the predominate pathogens and a 53% reduction was observed with the use of TYRX (Figure). Moreover, there was only 1 CIED pocket infection with Staphylococcus species in the envelope group compared to 14 pocket infections in the control group. A comparison of timing of infection in the envelope group showed the presentation of 11 endocarditis/bacteremia infections at 103 ± 84 days compared to 14 pocket infections presenting at 70 ± 78 days from the procedure.

Conclusion:

In this large randomized trial, the use of the TYRX Envelope containing rifampin and minocycline resulted in a significant reduction of major CIED infections and was effective against staphylococcal species, which are the predominant cause of pocket infections.

AP19‐­00504

Defibrillation performance with the substernal extravascular implantable cardioverter defibrillator: first‐­in‐­human chronic experience

Haris Haqqani, David O'Donnell, Emily Kotschet, Jeffrey Alison, Iain Melton, Russell Denman, Tina Lin, Bridget Portway, Amy Thompson, Linne Lentz, Robert Sawchuk, Lou Sherfesee, Samuel Liang, Paul DeGroot, Ian Crozier

Medtronic plc, United States

Introduction:

The Extravascular Implantable Cardioverter Defibrillator (EV ICD) is a novel defibrillator that offers both pacing and defibrillation using a 40J device the size of a Transvenous ICD (TV ICD) with a lead positioned in the substernal space. Previous studies have demonstrated the feasibility of a lead placed in the substernal space (anterior mediastinum) to achieve defibrillation. The EV ICD Pilot study is the first chronic human experience of the safety and efficacy of an implanted EV ICD system. This analysis examines defibrillation performance.

Methods:

The EV ICD Pilot Study is a prospective trial conducted in four centers in Australia and New Zealand. A custom defibrillation lead was inserted into the substernal space under fluoroscopic guidance. The device was placed in a left lateral pocket. Defibrillation efficacy was characterized by inducing and converting ventricular fibrillation (VF) episodes. Success was defined as termination of VF with either (1) a single 20J shock or (2) on two consecutive episodes with a 30J shock. Testing at 15J was conducted if conversion was successful at 20J. Chronic defibrillation testing was performed at physician discretion.

Result:

A total of 26 subjects were enrolled and 21 underwent the EV ICD implant procedure. The implanted cohort was 85% male with an average age of 55 years and median left ventricular ejection fraction of 33%. Of the 21 subjects, 19 had complete defibrillation testing and 17 (89.5%) met defibrillation success criteria with 15 successful at 20J and 11 also successful at 15J. 2 of 2 subjects tested at 10J also had success. Mean shock impedance at implant was 67 ± 10 Ω (n = 19). Of the two subjects who did not complete testing, one subject was due to difficulty inducing VF and in one subject the lead could not be advanced to the desired location. Five instances of chronic defibrillation testing were performed electively. One subject did not have successful testing at 30J and underwent system explant. In these 5 patients, implant and chronic shock impedance was 63 ± 9 Ω vs 78 ± 18 Ω. To date, two spontaneous episodes of monomorphic VT in one subject were successfully terminated with programmed 40J shocks.

Conclusion:

Successful defibrillation using energies similar to current TV ICDs can be achieved in a system with a substernal lead. Limited data to date shows variable chronic defibrillation performance. Results support continued clinical evaluation in a large‐­scale pivotal study to further understand factors influencing defibrillation thresholds in the EV ICD system.

AP19‐­00506

Improved survival associated with Attain^™ Performa^™ quadripolar exclusive LV pacing polarities

Nathan Grenz, Jodi Koehler, Robert Stadler

Medtronic, United States

Introduction:

Quadripolar (Quad) left ventricular (LV) leads provide more pacing options to improve CRT response, maximize device longevity and avoid phrenic nerve stimulation. Medtronic Attain Performa leads are equipped with 16 programmable pacing polarities. Four of these (LV1 to RV Coil, LV2 to RV Coil, LV1 to LV2 and LV2 to LV1) are traditional polarities available with bipolar leads. However, there is limited data demonstrating improvement in patient outcomes with Quad exclusive LV pacing polarities.

Methods:

Data from the Optum^© Electronic Health Record (EHR) de‐­identified database were linked with the Medtronic CareLink^™ Network and de novo Quad CRT‐­D device implants between 2013 and 2017 were identified. Patients were followed for up to 24 months. LV pacing polarity was compared for the primary outcome of all‐­cause mortality. Differences in mortality were adjusted for age, gender, diabetes, hypertension, myocardial infarction and coronary artery disease.

Result:

Data from 4780 patients with Quad leads was available for analysis. Age was 68 ± 11 years at implant, 29% of patients were female and the follow‐­up duration was 12 ± 8 months. A traditional LV pacing polarity was programmed in 49% of patients. The most commonly programmed traditional LV pacing polarity was LV1 to LV2 in 24% of patients, while the most commonly programmed Quad exclusive polarity was short bipolar LV2 to LV3 in 15% of patients. At 24 months, mortality was significantly higher in the traditional LV group (11.7% vs 8%, P < .001). A Quad exclusive LV pacing polarity was associated with a lower rate of death after multivariable adjustment (HR: 0.71, CI: 0.54 to 0.93, P = .012).

Conclusion:

Quad exclusive LV pacing polarities were associated with improved survival in this observational read‐­world experience. This difference may reflect more targeted pacing site selection with Quad exclusive polarities. Newer leads such as the active fixation Attain Stability Quad lead which allows placement at an increased range of implant sites may further improve survival after CRT.

AP19‐­00507

PVC burden accuracy of a PVC detector designed for continuous long‐­term monitoring using an Insertable Cardiac Monitor

Gautham Rajagopal, Jerry Reiland, Jodi Koehler, Shantanu Sarkar

Medtronic Plc, United States

Introduction:

High premature ventricular contraction (PVC) burden may increase the risk of arrhythmia, PVC‐­induced cardiomyopathy and heart failure. Presently, 24‐­hour Holter monitoring is the most commonly used method to determine PVC burden. However, this may be insufficient to assess the exact PVC burden due to the day‐­to‐­day variability in the PVC burden. An insertable cardiac monitor (ICM) device capable of monitoring PVC burden over a longer period can be a useful tool for evaluating temporal dynamics of PVC burden leading to appropriate and timely clinical interventions in patients with high PVC burden. This study is aimed at evaluating the PVC burden accuracy of a PVC detection algorithm that was developed for continuous long‐­term monitoring of PVC burden in an ICM.

Methods:

The PVC algorithm uses long‐­short‐­long RR interval sequence and similarity and differences in R‐­wave morphology for three consecutive beats to detect the occurrence of single PVC events. Various threshold combinations were used for long‐­short‐­long RR interval sequence and degree of difference and similarity of R‐­wave morphology to enable the detection of various types of PVCs including interpolated PVCs. The algorithm was designed to obtain a very high specificity and clinically reasonable sensitivity for reporting PVC burden. The algorithm was developed using ECG strips stored in an ICM from real world patients. The validation was performed using episodes stored by an ICM in patients with unexplained syncope and Holter data, which uplinked ICM ECG over a 2‐­hour period. All ECG strips were manually annotated for PVCs and true PVC burden and detected PVC burden are compared using the Pearson's correlation coefficient. Sensitivity and specificity performance of the PVC detector will also be reported.

Result:

The stored episode validation data set consisted of 787 patient activated episodes from 134 patients, providing over 460,000 beats for analysis with 8386 PVCs (1.8%) in 91 patients. The Holter validation data set consisted of 2‐­hour snippets of 24‐­hour Holter files from 20 patients providing over 170,000 beats of which 2247 PVC beats (1.3%) in 16 patients. On the stored episode (Holter) validation data set, the algorithm detected PVC beats with a gross sensitivity of 75.2% (74.4%) and specificity of 99.6% (99.6%). The correlation between the detected PVC burden vs the true PVC burden for the two data sets is shown in Figure. The Pearson's correlation coefficient was 0.97 and 0.89 (P‐­value < .001 for both) in the stored episode and Holter data sets respectively.

Conclusion:

The PVC detection algorithm designed for continuous long‐­term monitoring of PVC burden in an ICM had high specificity with only 0.4% of the normal events being incorrectly identified as PVCs, while detecting around 3 out of 4 PVCs which ensures high correlation of detected PVC burden with true PVC burden.

AP19‐­00511

Reverse electrical remodeling of the native conduction system after cardiac resynchronization therapy

Hee‐Jin Kwon, Seung‐Jung Park, Seong Soo Lee, Young Jun Park, Kyoung‐Min Park, Young Keun On, June Soo Kim

Samsung medical center, South Korea

Introduction:

Cardiac resynchronization therapy (CRT) induces structural reverse remodeling of left ventricle (LV). However, limited data exists on electrical remodeling of native conduction system and its clinical significance, especially, changes in PR interval. Additionally, maintenance of a relatively short PR interval (<220 ms) is critical for the application of automated optimization algorithm of some CRT devices.

Methods:

Surface 12‐­lead ECG and echocardiographic data (baseline and the last follow‐­up) were assessed in 97 consecutive CRT recipients (65 ± 7 years old; male, 60%) with sinus rhythm and a long‐­ term follow‐­up (>1 year). Relative decrease in LV end systolic volume was measured to define CRT‐­ responder (≥15%) and super‐­responder (≥30%).

Result:

Over a mean follow‐­up duration of 37.3 ± 20.8 months, LV ejection fraction significantly increased (24 ± 6% to 39 ± 15%, P < .001) and 70% of patients were responders. Intrinsic QRS duration (measured during CRT‐­Off) decreased among responders, but increased among non‐­responders with a significant difference by responder status (−11 ± 41 ms vs +10 ± 11 ms, P < .001). However, intrinsic PR interval (measured during CRT‐­Off) did not show significant change from baseline value even in responders (213 ms to 214 ms, P = NS) or super‐­responders (190 ms to 189 ms, P = NS). There was only a slight increase in its value among non‐­responders (203 ± 34 ms to 217 ± 44 ms, P = NS). Of 24 patients with baseline PR > 220 ms, 6 (25%) showed follow‐­up intrinsic PR ≤ 220 ms.

Conclusion:

LV volume and QRS duration reduced markedly with CRT response. However, there was no significant change in PR interval irrespective of CRT responsiveness, even in super‐­responders. CRT may be associated only with intraventricular, but not with atrioventricular conduction system remodeling.

AP19‐­00518

The safety and benefits of left bundle branch pacing in patients with atrioventricular block

Lan Su, Tianchen Xv, Weijian Huang

The First Affiliated Hospital and Key Lab of Cardiovascular Disease of Wenzhou, Wenzhou Medical Uni, China

Introduction:

The application of His bundle pacing (HBP) on patients with atrioventricular (AV) block should be of concern. Left bundle branch pacing (LBB pacing), pacing beyond the site of block will be considered for infra‐­nodal block. The study is to access the clinical benefits and safety of LBB pacing in patients with AV block, especially for infra‐­nodal block.

Methods:

183 patients diagnosed with AVB were included. The Select Secure lead (model 3830; Medtronic) was used. Characteristics of LBB capture are summarized as following: 1) The paced QRS morphology of RBBB pattern with unipolar pacing; 2) LBB potential could be recorded; 3) Selective and non‐­Selective LBBP; 4) Stimulus to peak left ventricular activation time (LVAT); 5) Pacing threshold and Echocardiographic measurements were assessed during 1 year follow‐­up.

Result:

All patients were success achieved LBB area pacing. The detailed baseline characteristic and follow‐­up were shown in the Table 1. Thresholds of intra and infra‐­nodal patients remained stable during 1 year follow‐­up. Echocardiographic measurements showed that LBB pacing remained the cardiac function. There was one case who occurred dislodgment and revised LBBP lead after 1 month post‐­ implantation.

Conclusion:

LBB pacing had ideal pacing parameters and preserve cardiac function and may be an excellent alternative for AVB patients.

AP19‐­00519

Changes in QRS duration after cardiac resynchronization therapy in patients with non‐­left bundle branch block

Sein Khine, Jemelee Hernandez, Tan Nee Hooi, Tan Boon Yew, Ho Kah Leng, Chong Thuan Tee Daniel, Teo Wee Siong, Lim Tien Siang Eric, Lim Chun Yih Paul, Chua Chi Ming Kelvin, Ching Chi Keong

National Heart Centre Singapore, Singapore

Introduction:

Response to cardiac resynchronization therapy (CRT) in patients with non‐­left bundle branch block is variable when compared to patients with left bundle branch block (LBBB). We aim to describe the degree of QRS narrowing in patients with non‐­LBBB who underwent CRT.

Methods:

Patients with non‐­LBBB who underwent CRT from January 2017 to December 2018 at National Heart Centre Singapore were reviewed. Patients with non‐­LBBB either de novo CRT implantation or device upgrade were included. In patients with de novo implantation, those with preserved AV conduction were included. Electrophysiology parameters and procedure details were reported. QRS duration of each patient was assessed before (pre‐­QRS) and immediately after CRT (post‐­ QRS). Changes in QRS duration between de novo implantation and device upgrade patients were compared.

Result:

27 patients with non‐­LBBB who received CRT were studied. Male was 89%. De novo implantation was done in 48%. The mean age was 66 ± 11 years. Mean LVEF was 27% ± 6%. Atrial fibrillation was seen in 37%. Mean PR interval in patients with sinus rhythm was 192 ms ± 82 ms. Mean pre‐­QRS duration were 153 ms ± 26 ms in de novo group and 168 ms ± 22 ms in device upgrade group. Quadripolar left ventricular (LV) leads was used in 96% and implanted at posterolateral (9), mid lateral (8), anterolateral (7) and other branches (3) of coronary sinus (CS). Intermittent phrenic nerve stimulation was seen in 18% with high output from distal electrodes. Only one patient (3%) had minor CS dissection. Mean LV lead threshold was 1.1V ± 0.6V@0.5 ms, right ventricular lead threshold was 0.7V ± 0.36V@0.5 ms and right atrial lead threshold was 0.8V ± 0.4V@0.5 ms. Simultaneous biventricular (BiV) pacing mode was programmed in 55%. Mean post‐­QRS duration was 121 ms ± 26 ms in de novo group (P = .03) and 134 ms ± 24 ms in device upgrade group (P = .001).

Conclusion:

CRT implantation narrows the QRS in patients with either device upgrade or de novo implantation in our study. Additional data is required to apply QRS narrowing as a marker of effectiveness to CRT in this subgroups of patients.

AP19‐­00527

Impact of echocardiography‐­guided left ventricular lead placement on cardiac resynchronization therapy: an acute electro‐­ and echo‐­cardiac comparative study

Naoto Nishina, Masahiro Esato, Takayuki Tsuyuki

Ijinkai Takeda General Hospital, Japan

Introduction:

Cardiac resynchronization therapy (CRT) improves mortality and morbidity in patients with drug refractory heart failure (HF) with wide QRS complex and diminished left ventricular (LV) function, but the clinical outcome is variable with approximately 30% of non‐­responder cases. Echocardiography‐­guided (EG) left ventricular (LV) lead placement at the site of latest mechanical activation improves outcome in patients. The purpose of this study was to examine the acute effect of electro‐­ and echo‐­cardiac function indexes between the CRT patients with and without EG LV lead placement

Methods:

Of the thirty‐­one patients who underwent CRT implantation during the period from March 2012 to June 2018, the electro (QRS width)‐­, and echo‐­cardiac parameters (left ventricular ejection fraction (EF), left ventricular diastolic and systolic dimension (Dd and Ds)) were measured in both pre‐­ and postoperative status. These parameters were comparatively examined between the 20 patients, who received the speckle tracking echo assessment in order to determine the optimal the LV lead placement site (EG LV group), and the residual 11 patients, with conventional LV lead placement (Non‐­EG LV group).

Result:

Preoperative electro‐­, echo‐­cardiac parameters and patient characteristics were comparable between the groups. All of the post‐­operative electro‐­, and echo‐­cardiac parameters were significantly improved in the EG LV group (pre‐­ vs postoperative: QRS width, 159.1 milliseconds vs 142.1 milliseconds; P < .05, LVEF, 27.1% vs 37.0%; P < .05, Dd, 63.0 mm vs 55.3 mm; P < .05, Ds 55.1 mm vs 46.2 mm; P < .05), whereas no significant differences, except the Ds, were observed in the non‐­EG LV group (QRS width, 148.5 milliseconds vs 134.3 milliseconds; P = .20, LVEF, 32.7% vs 37.7%; P = .07, Dd, 61.2 mm vs 59.6 mm; P = .14, Ds 51.7 mm vs 48.9 mm; P < .05). Furthermore, the degree of echo‐­cardiac parameters (as ΔLVEF, ΔDd, and ΔDs) were also significantly, or tend to be improved in the EG LV group compared with non‐­EG LV group (ΔLVEF, 10.0% vs 5.0%; P = .06, ΔDd, 7.7 mm vs 1.5 mm; P < .05, and ΔDs, Ds 8.8 mm vs 2.8 mm; P < .05) (Figure).

Conclusion:

CRT patients with EG LV placement yielded consistent improvements in acute electro‐­, and echocardiac parameters compared with those without. This strategy for CRT may affect the long‐­ term clinical outcomes.

AP19‐­00531

P‐­wave visibility in ECGs of the Biotronik BioMonitor III implantable loop recorder

Sam Lovibond, Justin Mariani, Paul Gould, Rukshen Weerasooriya, Rajeev Pathak, Tina Lin, Ian Matthews, Kushwin Rajamani, Dennis Lau

Alfred Hospital, Australia

Introduction:

Implantable loop recorders (ILRs) are standard of care in the investigation of some patients with presyncope, syncope or cryptogenic stroke. Through electrocardiogram (ECG) generation, ILRs provide detailed rhythm analysis to enable diagnosis of specific arrhythmias. Basic rhythm analysis can occur with an ECG that shows only QRS complexes. However, the addition of reliable P‐­waves to the ECG enables better rhythm evaluation, especially during arrhythmia. The BioMonitor III (Biotronik, Berlin, Germany) is the new, smaller version of its predecessor the BioMonitor 2. It seeks to have all the diagnostic capabilities of the previous version with improved patient comfort through miniaturization as well as improved quality of the stored ECG. The BIO|CONCEPT.BIOMONITOR III (BC.BM III) trial is currently underway within Australia. Through analysis of ECGs collected during the BC.BM III study, we aim to assess the quality of the BioMonitor III ECG and whether visible p‐­waves support the arrhythmia recognition.

Methods:

Patients in the BC.BM III trial who underwent successful ILR implant were eligible. Patient consent was provided by the BC.BM III investigators and additional ethical clearance for the substudy was gained. Deidentified ECGs were collated from the BC.BM III database following remote monitoring download. ECGs with device‐­detected arrhythmias (Atrial Fibrillation, High Ventricular Rate, Sudden Rate Drop, Asystole or Bradycardia) were included in the study. Specific ECGs were then marked for selective review; with the 1st, 2nd, 3rd, 10th, 20th, 30th etc. ECG identified for each device‐­detected arrhythmia, for each patient. ECGs were then reviewed by a Cardiologist (the reviewer) for: predominant rhythm, evident p‐­waves (yes/no), the presence of atrial fibrillation (yes/no) and whether the presence of p‐­waves was deemed very helpful in rhythm diagnosis (yes/no). ECGs in the non‐­AF group were then compared (p‐­waves vs no p‐­waves). ECGs with p‐­waves were then assessed for whether the presence of the p‐­waves considerably aided arrhythmia diagnosis.

Result:

1739 ECGs with device‐­detected arrhythmias from 44 patients were included in the study. 298 ECGs were then designated for selective review. 52 (17.4%) of reviewed ECGs demonstrated AF and 246 (82.6%) demonstrated non‐­AF. Of the 246 ECGs not in AF, 180 (73.2%) had visible p‐­waves. Of the 66 ECGs without p‐­waves in the non‐­AF group, 37 (15%) were unclear or uninterpretable due to artifact and/or noise, 22 (8.9%) were regular narrow complex rhythms and 7 (2.9%) were narrow complex tachycardias. Of the 180 ECGs with p‐­waves, the presence of p‐­waves was deemed very helpful in correct rhythm diagnosis in 62 (34.4%).

Conclusion:

This study suggests the BioMonitor III produces ECGs with reliably visible p‐­waves during device‐­detected arrhythmia. In a relevant number of cases, the visibility of P‐­waves contributes to reliable rhythm identification.

AP19‐­00534

Failure of cardiac resynchronization therapy in a patient with abnormal location of coronary sinus ostium

Ji Yeoun Seo

Ajou University, South Korea

Introduction:

Cardiac resynchronization therapy (CRT) has become an effective treatment of advanced heart failure with New York Heart Association (NYHA) Class II‐­IV symptoms, sinus rhythm, left ventricular ejection fraction (LVEF) below 35% and left bundle branch block (LBBB, QRS duration ≥ 150 milliseconds) despite optimal medical treatment. In CRT procedure, LV lead implantation via the coronary sinus (CS) has been limited by individual patients’ unique anatomic variations and an abnormal location of CS can make CRT implantation technically challenging. Herein, we report one case of CRT implanting failure due to abnormal CS location.

Methods:

Case presentation A 64‐­years old man with non‐­ischemic dilated cardiomyopathy, severe LV systolic dysfunction (LVEF: 15%), LBBB with QRS duration 182 msec and NYHA class II symptoms was referred to our hospital. Despite we followed him up for 8 months with optimal medication, there was no interval change in LV systolic function and electrocardiogram (ECG) finding. And ventricular tachycardia event was confirmed in follow‐­up ECG and a 24‐­hours holter monitoring. Therefore, we decided to implant CRT‐­defibrillator (CRT‐­D) for him.

Result:

He gave informed consent and overnight fast. Under conscious sedation, we punctured left subclavian vein. After delivering right ventricle (RV) lead (Intica 7 VR‐­T, Biotronik), it was very difficult to cannulate the LV lead into CS. We tried CS cannulation using long intravascular sheath (Biotronik) but CS was not seen when the contrast was administered at usual location of CS cannulation. After trying to cannulation several times, we eventually failed to identify the CS ostium. To confirm the location of CS ostium, we performed coronary angiography. During washout phase, we found the CS ostium in the right atrium (RA) posterolateral area with acute angle running (Figure 1). We stopped to trying to deliver the LV lead into CS and implanted single chamber implantable cardioverter defibrillator (ICD, Plexa ProMRI S 65, Biotronik). ICD insertion was successful.

Conclusion:

Coronary sinus anatomy is important factor of CRT implantation.

FIGURE 1 Location of coronary sinus (CS) ostium of patient. (A) is left anterior oblique (LAO) 55° view, (B) is right anterior oblique (RAO) 30° view

AP19‐­00536

Performance of MICRA pacemaker at 12 months follow‐­up

Nee Hooi Tan, Khine Sein, Hernandez Jemelee, Paul Chun Yih Lim, Kelvin Chi Ming Chua, Eric Tien Siang Lim, Kah Leng Ho, Boon Yew Tan, Daniel Thuan Tee Chong, Wee Siong Teo, Chi Keong Ching

NATIONAL HEART CENTRE SINGAPORE, Singapore

Introduction:

Leadless trans‐­catheter pacemaker systems have been developed to overcome the need for a pacemaker pocket and transvenous lead.

Methods:

Describe the procedure details & electrical parameters during implantation and up to 12 months follow‐­up.

Result:

16 patients were recruited from August 2016 to September 2018. Mean age of patients was 66.9 ± 8.7 years old (8 male). Indications for pacemaker were sick sinus syndrome (56.3 %, n = 9) & complete AV block (43.7%, n = 7). 87.5% (n = 14) were patients on haemodialysis via upper limbs arteriovenous fistula (AVF) & lack of venous access for traditional transvenous permanent pacemaker implantation. 6.3% (n = 1) were patient on long term steroids & immunosuppressant therapy with the concern about wound healing. Mean duration of implantation procedure was 63.25 ± 41.8 minutes, while mean fluoroscopy time was 11.86 ± 5.02 minutes. 15 patients underwent the procedure under local anaesthesia with conscious sedation and 1 patient who had subcutaneous ICD & MICRA leadless pacemaker implanted during the procedure was done under general anaesthesia. The pacemaker was deployed successfully on 1.5 ± 0.9 attempts (ranging from 1 to 4 attempts). The device was implanted at RV apical‐­septum in 15 patients & RV low‐­septum in 1 patient. Mean values of the R wave were 9.0 ± 5.5 mV, impedance were 669 ± 177 ohms & pacing threshold were 0.76 ± 0.54 V at pulse width of 0.28 ± 0.09 milliseconds during implantation. The femoral puncture sites of all patients were closed with a Figure of 8 stitch suturing method. 1 patient developed hematoma at the groin puncture site post‐­procedure was managed conservatively. At 12 months, 9 patients passed away due to underlying other medical illness & not device related. 1 of the patient passed away 2 months after MICRA implantation due to MRSA sepsis from haemodialysis catheter related bacteremia.

Conclusion:

Implantation of leadless pacemakers is feasible & safe. The pacemaker & electrical parameters were stable at 12 months follow‐­up. Longer‐­term follow up is clearly required but the early experience appears positive.

Electrical parameters evaluated during follow up
	3 months	6 months	12 months
Number of patients evaluated (n)	n = 9	n = 9	n = 7
Mean R wave	15.2 ± 3.5 mV	16.1 ± 3.5 mV	17.9 ± 2.0 mV
Mean Impedance	589 ± 94 ohms	569 ± 90 ohms	559 ± 74 ohms
Mean pacing threshold	0.52 ± 0.17 V at 0.24 milliseconds	0.50 ± 0.08 V at 0.24 milliseconds	0.52 ± 0.13 V at 0.24 milliseconds

AP19‐­00537

Strategies to reduce complications in complex device procedures such as ICD and CRTD implantation: a decade long contemporary single‐­centre experience

Dean Boddington, Yi‐Wen Becky Liao, Charles Yao‐Cheng Ho

Bay of Plenty District Health Board‐­ Tauranga Hospital, New Zealand

Introduction:

A new implantable cardiac defibrillator(ICD) and cardiac resynchronization therapy(CRT) service was commenced at Tauranga Hospital in 2009 by two relatively inexperienced operators. Significant attention was placed in implementing strategies to prevent complications involving all aspects of the service. Two specific procedural strategies employed include routine use of cephalic vein access and positioning of right ventricular(RV) lead in a septal position as default position. A device database was established to record demographics, procedural characteristics and complications. We reviewed results of all ICD and CRTD procedures at our centre over 10‐­years.

Methods:

Data for consecutive patients undergoing ICD and CRTD implantation or replacement at Tauranga Hospital from 2009‐­2018 were collected for characteristics and outcomes from electronic records and device database. Two authors collected the data to ensure accuracy. Short‐­term followup was available for all patients, and long term for 96.3% of patients as they remained in the region.

Result:

A total of 307 procedures were audited, 72% were elective procedures. Mean age was 63+/‐­12 years, 80% were male. Ethnic distribution was predominantly New Zealand European 60% and Maori 28%. New ICDs were implanted in 184 (60%) and CRTDs in 53 (17%).Generator device replacements were performed in 70 (23%)patients. Four device manufacturers were used including Medtronic 36%, Biotronik 25%, St Jude 18% and Boston Scientific 21%. Figure 1 shows the breakdown of venous access strategies and figure 2 illustrates RV lead positioning. Median procedural time for new ICD implants was 60 (49‐­70) minutes and CRTDs 139 (106‐­169)minutes. There were 15 (4.9%) operative complications in total displayed in Figure 3. Requirement for lead repositioning occurred in 5 (1.6%) with 3 out of 4 repositioned RV leads positioned at RV apex initially. Haematomas requiring drainage, cessation of anticoagulant or hospitalisation occurred in 5 (1.6%). Resiting battery unit was needed in 2 (0.6%) patients. Infection requiring device and lead removal, lead fracture at unit replacement and phrenic nerve stimulation forcing abandonment of left ventricular pacing occurred in 1 (0.3%) each. There were no pneumothorax, stroke, cardiac perforation, tamponade or death. ICD therapy occurred in 106 (34.5%), with first therapy at median of 0.8 years post implantation, 25.5% were inappropriate. Mean device longevity until replacement was 6.6 ± 1.7 years.

Conclusion:

The total procedural complication rate is low at 4.9% despite being the first 10‐­year experience of complex device implantation for two inexperienced operators. In particular there were no serious complications such as pneumothorax, cardiac perforation, tamponade or death. We attribute this low complication rate to our implementation of strategies aimed at reducing these events.

AP19‐­00561

Evaluation of ICD therapies in patients receiving ICD for primary and secondary prevention in a tertiary care centre in India

A Shaheer Ahmed, Nitish Naik, Rakesh Yadav, Gautam Sharma, Ambuj Roy

All India Institute of Medical Sciences, India

Introduction:

Real world data pertaining to Implantable cardioverter defibrillator therapies for primary and secondary prevention in Indian patients is not available. Contemporary data published since the landmark ICD trials have shown lower rates of ICD therapies. The objective of the study was to look into the distribution of ICD therapies, time to first ICD therapy and predictors of appropriate ICD therapies in primary and secondary prevention indications

Methods:

It was a prospective observational study. All patients who underwent ICD/CRT‐­D implantation in the year 2017 were included in the study. Device interrogation and clinical follow up was done every 3‐­6 months. Device therapies were evaluated by trained electrophysiologist

Result:

Complete follow up was available in 93 out of 111 patients. Mean age of patients was 54+/‐­ 14 years.78% of patients were males. 40% of patients had dilated cardiomyopathy and 38% had coronary artery disease. 52 patients had ICD and 41 CRT‐­D implantation. They were followed up for a mean of 349 days. 21% in secondary prevention and 7% in primary prevention group received appropriate ICD therapies. One patient received inappropriate shock for atrial fibrillation in primary prevention group. Overall 113 ICD shocks and 69 ATPs were delivered in 14 patients. 27 episodes of VT in 5 patients were self‐­terminated, out of which 4 patients did not receive any ICD therapy during follow up. There was no difference in rate of therapies between patients who received ICD for documented VT/VF and patients with syncope due to presumed ventricular arrhythmias (22 vs 20%).96%, 71% and 73% were on beta blocker, Angiotensin blocker, Mineralocorticoid receptor blockers. 2 patients suffered non‐­arrhythmic death during follow up and did not receive ICD therapy during follow up. Secondary prevention and Heart rate>70/min predicted ICD therapy in univariate, but not in multivariate analysis.

Conclusion:

Rate of ICD therapies were significantly higher in the secondary prevention group. Time to first ICD therapy shorter in secondary prevention group. Patients who received ICD for syncope had no difference in ICD therapies and lesser shock burden compared to document VT/VF. Rate of ICD therapies in Indian patients are comparable with international registry data.

TABLE 1 Baseline characteristics of study population

	Overall (n = 93) (%)	Primary (n = 42) (%)	Secondary (n = 51) (%)	P value
Age (Mean ± SD)	54.0 ± 14.4	55.8 ± 15.1	52.7 ± 13.8	.307
Male Gender	72 (77.4)	30 (70.7)	42 (82.7)	.171
EF
>40%	23 (24.7)	2 (4.9)	21 (40.4)	.0001
30‐­39%	15 (16.1)	6 (14.6)	9 (17.3)
<30%	55 (59.1)	33 (80.5)	22 (42.3)
Diagnosis
CAD	35 (37.6)	14 (31.7)	21 (42.3)	.004
DCM	37 (39.8)	25 (60.7)	12 (23.1)
HCM	8 (8.6)	3 (7.3)	5 (9.6)
Sarcoidosis	3 (3.2)	0 (0)	3 (5.8)
ARVC	6 (6.5)	0 (0)	6 (11.5)
Idiopathic	2 (2.2)	0 (0)	2 (3.9)
Others	2 (2.2)	0 (0)	2 (3.9)
Heart Failure admissions	18 (19.4)	12 (29.3)	6 (11.5)	.032
eGFR (ml/min)
Normal or mild	80 (86)	33 (80.5)	47 (90.4)	.217
Moderate	11 (11.8)	6 (14.6)	5 (9.6)
Severe	2 (2.2)	2 (4.9)	0 (0)
Device type
ICD	52 (55.91)	11 (26.8)	41 (78.9)	.0001
CRT D	41 (44.1)	30 (73.2)	11 (21.2)
NYHA class
I	15 (16.1)	1 (2.4)	14 (26.9)	.002
II	60 (64.5)	28 (68.2)	32 (61.5)
III	17 (18.3)	11 (26.8)	6 (11.5)
IV	1 (1.1)	1 (2.4)	0 (0)
QRS duration (msec)	131.3 ± 32.7	138.3 ± 29.2	126.9 ± 34.7	.096
QRS axis
Normal	45 (48.4)	19 (46.3)	26 (50)	.158
LAD	44 (47.3)	22 (53.7)	22 (42.3)
RAD	4 (4.3)	0 (0)	4 (7.69)
QTc duration	467.9 ± 42.1	471.3 ± 33.5	465.3 ± 48	.500
Morphology
LBBB	44 (47.3)	29 (70.7)	15 (28.9)	.0001
RBBB	8 (8.6)	0 (0)	8 (8.6)
Fragmented QRS	4 (4.3)	0 (0)	4 (7.7)	.09
Index event
VT/VF	33 (35.5)	0 (0)	33 (64.7)
SCD	3 (3.2)	0 (0)	3 (5.9)
Syncope	15 (16.1)	0 (0)	15 (29.4)
Holter*
NSVT	16 (47.1)	4 (30.7)	12 (57.1)	.126

*Holter done in 34 patients prior to device implantation

TABLE 2 Summary of ICD therapies

	Overall (n = 93)	Primary (42)	Secondary (51)	P value
No. of patients with ICD therapies	14 (15.1%)	3 (7.1%)	11 (21.6%)	.048
Number of ICD shocks	113	5	108
Number of ATP	69	2	67
Time to first therapy (days)#	124 (8‐­345)	219 (210‐­249)	86 (8‐­345)	.145
Inappropriate shock	1 (1.08)	1 (2.4)	0 (0)	.452
Shock VT (No. of patients)	7 (7.5)	2 (4.8)	5 (9.8)	.306
Shock VF (No. of patients)	7 (7.5)	2 (4.8)	5 (9.8)	.306
Failed Shocks	3	0	3
Failed ATP	27	2	27
NSVT	30 (32.6)	9 (21.4)	21 (42)	.036
No. of NSVT episodes	423	54	369	.031
Self‐­ terminated/Monitored VT/VF episodes	27	4	23	.243

# Represented in median and range

TABLE 3 Summary of ICD therapies among secondary prevention

Overall (n = 52)	VT/VF (36)	Syncope (15)	P value
No. of patients with ICD therapies	10	7	3	.988
Number of ICD shocks	108	89	19	.463
Number of ATP	67	50	17	.397
Time to first therapy (IQR)	85.5 (45‐­158)	82 (45‐­158)	89 (57‐­278)	.781
Inappropriate shock	0	0	0
No. of patients Shock VT	5 (9.8)	4 (10.8)	1 (7.1)	.579
No. of patients Shock VF	5 (9.8)	3 (8.1)	2 (14.3)	.421
No. of patients ATP	9 (18)	6 (16.7)	3 (21.4)	.490
Failed Shock	3	3	0	.539
Failed ATP	27	12	15	.461
NSVT	21	5 (35.7)	16 (44.4)	.574
No. of NSVT episodes	369	319	50	.655
Self‐­ terminated/Monitored VT/VF episodes	23	23	0	.198

TABLE 4 Comparison of baseline characteristics between patients who received and didn’t receive therapy

	Therapy (14) %	No therapy (79) %	P value
Age	54.71 ± 15.3	53.9 ± 14.3	.849
Male Gender	11 (78.6)	61 (77.2)	.609
EF
>40%	6 (42.9)	17 (21.5)	.276
>30%	2 (14.3)	13 (16.5)
<30%	6 (42.9)	49 (62)
Diagnosis
CAD	4 (28.6)	31 (39.2)	.028
DCM	5 (35.7)	32 (40.5)
HCM	0 (0)	8 (10.1)
Sarcoidosis	0 (0)	3 (3.8)
ARVC	4 (28.6)	2 (2.5)
Idiopathic	1 (7.14)	1 (1.27)
Others	0 (0)	2 (2.5)
Heart Failure admissions	4 (28.6)	14 (17.7)	.270
eGFR (ml/min)
Normal or mild	14 (100)	66 (83.5)	.426
Moderate	0 (0)	11 (13.9)
Severe	0 (0)	2 (2.5)
Device type
ICD	10 (71.4)	42 (53.2)	.165
CRT D	4 (28.6)	37 (46.8)
NYHA
I	4 (28.6)	11 (13.9)	.483
II	8 (57.1)	52 (65.8)
III	2 (14.3)	15 (19)
IV	0 (0)	1 (1.3)
QRS duration (msec)	118.6 ± 33.7	134.3 ± 32.2	.097
QRS axis
Normal	9 (64.3)	36 (45.6)	.512
LAD	5 (35.7)	39 (49.4)
RAD	0 (0)	4 (5.1)
QTc duration (msec)	461.8 ± 34	469.1 ± 43.5	.553
Morphology
LBBB	4 (28.6)	40 (50.6)	.108
RBBB	2 (14.3)	6 (7.6)
Fragmented QRS	0 (0)	4 (5.1)	.515
Index event
VT/VF	9 (64.3)	27 (34.18)	.033
SCD	0 (0)	3 (3.8)	.609
Syncope	3 (21.4)	12 (15.2)	.401
Holter (34 patients)
NSVT	2 (28.6)	14 (51.9)	.252

TABLE 5 Distribution of medical therapy in relation to ICD therapy

	Therapy	No therapy	P value
Beta Blocker	14 (100)	75 (94.9)	.515
ACEI	6 (42.9)	36 (45.6)	.544
ARB	1 (7.1)	12 (15.2)	.378
ARNI	1 (7.1)	1 (1.3)	.280
RAAS blockade	8 (57.1)	49 (62)	.730
MRB	8 (57.1)	49 (62)	.730
Diuretics	8 (57.1)	58 (73.4)	.216
Amiodarone	5 (35.7)	20 (25.3)	.419
Digoxin	0 (0)	1 (1.3)	.849
Ivabradine
Beta blocker (% of maximum dose)
<50	9 (64.3)	54 (68.4)	.410
50‐99	5 (35.7)	16 (20.3)
>100	0 (0)	4 (5.1)
RAAS Blockade (% of maximum dose)
<50	5 (35.7)	28 (35.4)	.232
50‐99	2 (14.3)	19 (24.1)
>100	1 (7.14)	0 (0)
MRB (% of maximum dose)
<50	0 (0)	1 (1.3)	.946
50‐99	5 (35.7)	25 (31.7)
100	3 (21.4)	21 (26.6)

TABLE 6 Follow up data of study population

Overall (n = 93)	Primary (42)	Secondary (51)	P value
Duration of follow up	349.1 ± 126.7	372 ± 99.8	330.2 ± 126.7	.08
Mortality	2 (2.2)	2 (4.7)	0 (0)	.201

TABLE 7 Predictors of ICD therapy

Therapy	Unadjusted		Adjusted
	OR (95% CI)	P value	OR (95% CI)	P value
Secondary prevention	3.39 (0.88‐­13.11)	0.076	2.77 (0.65‐­11.7)	.165
CAD	0.61 (0.17‐­2.14)	0.451
HF admissions	1.85 (0.50‐­6.78)	0.349
LVEF <30%	0.45 (0.14‐­1.45)	0.185	0.58 (0.16‐­2.07)	.409
Left axis deviation	0.56 (0.17‐­1.85)	0.350
NYHA III/IV	0.65 (0.13‐­3.2)	0.605
HR <70/min	0.43 (0.13‐­1.38)	0.158	0.41 (0.12‐­1.35)	.144
Beta blocker dose >50%	1.63 (0.49‐­5.46)	0.422
MRB dose >50%	0.95 (0.30‐­3.01)	0.940
Angiotensin Blockade dose >50%	0.86 (0.21‐­3.41)	0.832

TABLE 8 Distribution of medication in the study population

	Overall (n = 93)	Primary (42)	Secondary (51)	P value
Beta Blocker	89 (95.7)	40 (95.2)	49 (96.1)	.615
ACEI	42 (45.2)	21 (50)	21 (41.2)	.395
ARB	13 (14)	7 (16.7)	6 (11.8)	.497
ARNI	2 (2.2)	1 (2.4)	1 (2)	.702
RAAS blockade	57 (61.3)	29 (69.1)	28 (54.9)	.163
MRB	57 (61.3)	30 (71.4)	27 (52.9)	.069
Diuretics	66 (71)	38 (90.5)	28 (54.9)	.0001
Amiodarone	25 (26.9)	3 (7.1)	22 (43.1)	.0001
Digoxin	1 (1.1)	1 (2.4)	0 (0)	.452
Ivabradine	7 (7.5)	7 (16.7)	0 (0)	.003
Beta blocker (% of maximum dose)
<50	63 (67.7)	28 (66.7)	35 (68.6)	.279
50‐99	21 (22.6)	11 (26.2)	10 (19.6)
>100	4 (4.3)	0 (0)	4 (7.8)
RAAS inhibition
(% of maximum dose)
<50	33 (35.5)	20 (47.6)	13 (25.5)	.064
50‐99	21 (22.6)	7 (16.7)	14 (27.5)
>100	1 (1.1)	1 (2.4)	0 (0)
MRB (% of maximum dose)
<50	1 (1.1)	1 (2.4)	0 (0)	.159
50‐99	30 (32.3)	17 (40.5)	13 (25.5)
100	24 (25.8)	11 (26.2)	13 (25.5)

TABLE 9 Distribution of medical therapy in reduced LV function

Overall (n = 70)	Primary (39)	Secondary (31)	P value
Beta Blocker	66 (94.3)	37 (94.8)	29 (93.6)	.813
ACEI	37 (52.9)	21 (53.9)	16 (51.6)	.853
ARB	11 (15.7)	7 (18)	4 (12.9)	.407
ARNI	2 (2.9)	1 (2.6)	1 (3.2)	.693
RAAS blockade	50 (71.4)	29 (74.4)	21 (67.7)	.543
MRB	51 (72.9)	30 (76.9)	21 (67.7)	.391
Diuretics	61 (87.1)	37 (94.9)	24 (77.4)	.035
Amiodarone	17 (24.3)	3 (7.7)	14 (45.2)	.0001
Digoxin	1 (1.4)	1 (2.6)	0 (0)	.557
Ivabradine	7 (10)	7 (8)	0 (0)	.013
Beta blocker (% of maximum dose)
<50	47 (67.1)	27 (69.2)	20 (64.5)	.323
50‐­99	15 (21.4)	9 (23.1)	6 (19.4)
>100	3 (4.3)	0 (0)	3 (9.7)
RAAS inhibition (% of maximum dose)
<50	29 (30)	20 (51.3)	9 (29)	.100
50‐­99	19 (27.1)	7 (18)	12 (38.7)
>100	1 (1.4)	1 (2.6)	0 (0)
MRB (% of maximum dose)
<50	1 (1.4)	1 (2.3)	0 (0)	.453
50‐­99	26 (37.1)	17 (43.6)	9 (29)
100	23 (32.9)	11 (28.2)	12 (38.7)

Distribution of ICD therapies

AP19‐­00572

Implant procedure results from the First‐­in‐­Human chronic experience of the substernal extravascular implantable cardioverter defibrillator

David O'Donnell, Haris Haqqani, Emily Kotschet, David Shaw, Anil Prabhu, Nicholas Roubos, Jeffrey Alison, Iain Melton, Russell Denman, Tina Lin, Aubrey Almeida, Bridget Portway, Amy Thompson, Linnea Lentz, Robert Sawchuk, Lou Sherfesee, Samuel Liang, Ian Crozier

GenesisCare, Australia

Introduction:

The Extravascular Implantable Cardioverter Defibrillator (EV ICD) is a novel system designed to place an ICD lead outside of the vasculature and in the substernal space (anterior mediastinum). Previously reported proof‐­of‐­concept studies demonstrated the acute safety and feasibility of defibrillation using a lead placed in the substernal space. The EV ICD Pilot Study was designed to characterize the safety and efficacy of chronic system implants. This analysis will focus on the EV ICD system implant procedure and training methods used for this first‐­in‐­human study.

Methods:

The EV ICD Pilot Study is a prospective, non‐­randomized study conducted in four centers in Australia and New Zealand. Patients with Class I or IIa indications for ICD were enrolled. Cardiologists and Cardiac Surgeons completed a hands‐­on tunneling training program. For the first 5 implant procedures, surgeons partnered on substernal access through the diaphragmatic attachments and provided emergency support throughout the study. Under fluoroscopic guidance, cardiologists delivered the lead into the substernal tissue using a tunneling tool and sheath. The lead pin was tunneled subcutaneously to the device pocket on the left lateral chest wall for device connection. Fluoroscopy and procedure times were recorded. Implants were assessed using radiographic images and CT scans (Figure), and electrical performance (sensing and pacing) in various postures and exercises. Adverse events were adjudicated by a Clinical Events Committee for relatedness to the system or procedure.

Result:

Twenty‐­six subjects were enrolled and 21 underwent the EV ICD implant procedure. The median (IQR) fluoroscopy time and time from first incision to final lead placement were 4.2 (3.4,7.7) minutes and 25 (21,35) minutes, respectively. 86% of subjects had the EV pocket posterior of left mid‐­ axillary line. In 67% of procedures tunneling was described as Easy/Extremely Easy. The lead was repositioned during the initial procedure in eight subjects; retunneling was performed in 3 procedures. 17 subjects were discharged with the system. Lead placement was inadequate in a single case. There were no intraprocedural complications with five other system or procedure related adverse events all considered minor and/or resolved without sequelae.

Conclusion:

The EV ICD implant procedure and training methods demonstrate no intraprocedural complications with a limited number of minor adverse events related to the system or procedure. This first‐­in‐­human chronic study supports the procedure and training methods implemented in prior studies and will inform the strategy for a large‐­scale pivotal study.

AP19‐­00589

ECHO analysis of ventricular pacing entirely through the coronary sinus for patients with prior tricuspid valve disease

Hussain Basrawala, Abhishek Shah, Chin Lee, Rahul Doshi

LAC + USC, United States

Introduction:

Transvenous right ventricular pacing poses a unique challenge in patients with surgical tricuspid intervention. Epicardial pacing has been used but lead failure rates are higher compared to transvenous pacing. The purpose of this study was to evaluate the changes in interventricular and intraventricular activation in patients with tricuspid valvular (TV) disease and/or surgery who underwent permanent coronary sinus (CS) lead implantation as the sole ventricular lead.

Methods:

This study examined 10 patients with surgical TV or significant native TV dysfunction who underwent permanent pacemaker implantation with a left ventricular CS lead as the only ventricular pacing lead (to avoid crossing the TV). We assessed changes in interventricular and intraventricular activation. Interventricular activation was defined as time from the onset of the pacing spike (or QRS) to the peak flow through the outflow tracts as measured by pulsed wave doppler. Additional interventricular activation was defined as time from the onset of the pacing spike (or QRS) to the peak velocity of lateral wall activation as defined by the S’ with tissue doppler imaging (TDI). Intraventricular activation was defined as time from the onset of the pacing spike (or QRS) to the peak velocity of septal and lateral activation as defined by the S’ with TDI. All comparisons were made with intrinsic conduction prior to CS lead implant and with CS lead pacing post CS lead implantation.

Result:

We examined 10 patients who had ECHOs prior to surgical intervention and ECHOs after CS lead placement to assess any change in ventricular activation timing. There was no statistically significant change in activation after CS pacing compared to prior CS pacing. The activation of the RV lateral wall as measured by the S’ on TDI showed a trend towards significance. Prior to implant it was 164 milliseconds and after CS implant it was 195 milliseconds (P = .06).

Conclusion:

We examined 10 patients who had ECHOs prior to surgical intervention and ECHOs after CS lead placement to assess any change in ventricular activation timing. There was no statistically significant change in activation after CS pacing compared to prior CS pacing. The activation of the RV lateral wall as measured by the S’ on TDI showed a trend towards significance. Prior to implant it was 164 milliseconds and after CS implant it was 195 milliseconds (P = .06).

AP19‐­00591

ECHO analysis of ventricular pacing entirely through the coronary sinus for patients with prior tricuspid valve disease

Hussain Basrawala, Abhishek Shah, Chin Lee, Rahul Doshi

LAC + USC, United States

Introduction:

Transvenous right ventricular pacing poses a unique challenge in patients with surgical tricuspid intervention. Epicardial pacing has been used but lead failure rates are higher compared to transvenous pacing. The purpose of this study was to evaluate the changes in interventricular and intraventricular activation in patients with tricuspid valvular (TV) disease and/or surgery who underwent permanent coronary sinus (CS) lead implantation as the sole ventricular lead.

Methods:

This study examined 10 patients with surgical TV or significant native TV dysfunction who underwent permanent pacemaker implantation with a left ventricular CS lead as the only ventricular pacing lead (to avoid crossing the TV). We assessed changes in interventricular and intraventricular activation. Interventricular activation was defined as time from the onset of the pacing spike (or QRS) to the peak flow through the outflow tracts as measured by pulsed wave doppler. Additional interventricular activation was defined as time from the onset of the pacing spike (or QRS) to the peak velocity of lateral wall activation as defined by the S’ with tissue doppler imaging (TDI). Intraventricular activation was defined as time from the onset of the pacing spike (or QRS) to the peak velocity of septal and lateral activation as defined by the S’ with TDI. All comparisons were made with intrinsic conduction prior to CS lead implant and with CS lead pacing post CS lead implantation.

Result:

We examined 10 patients who had ECHOs prior to surgical intervention and ECHOs after CS lead placement to assess any change in ventricular activation timing. There was no statistically significant change in activation after CS pacing compared to prior CS pacing. The activation of the RV lateral wall as measured by the S’ on TDI showed a trend towards significance. Prior to implant it was 164 milliseconds and after CS implant it was 195 milliseconds (P = .06).

Conclusion:

Sole CS pacing appears to have no significant effect on ventricular activation sequence. However, there was a trend towards delayed activation of the lateral RV with CS lead pacing.

AP19‐­00608

Incidence and clinical predictors of implantation‐­related complications of transvenous cardiac implantable electronic devices in a tertiary hospital in the Philippines

Lemuell Karla Sanchez

St. Lukes Medical Center Quezon City, Philippines

Introduction:

As the use of cardiac implantable electronic devices (CIEDs) which include pacemakers (PM), implantable cardioverter‐­defibrillators (ICD) and cardiac resynchronization therapy (CRT) is expanding exponentially worldwide, implantation‐­related complications are also increasing. Although the epidemiology of these complications has been described in developed regions, data is lacking in developing countries wherein inherent demographic and procedural factors may alter trends in outcome. We aim to assess the incidence and risks associated with CIEDs by a local database.

Methods:

We analyzed the clinical data of 253 adult patients who underwent de novo implantation, replacement, and upgrade procedures of CIEDs in a single institution between May 2013 and May 2018. Analysis of the different clinical and procedure‐­related factors for complications were done using logistic regression. Statistical analysis was done using STATA version 12.

Result:

Of the 253 subjects, 13 patients (5.1%) had complications which included pocket hematoma (n = 1), pocket erosion/infection (n = 3), lead dislodgement (n = 10), and bacteremia (n = 1). Predictors of overall complication included the use of dual‐­chamber ICDs (odds ratio [OR]=26.8, 95% CI: 1.39‐­516.90; P = .02), presence of moderate to severe tricuspid regurgitation (OR = 4.57; 95% CI: 1.85‐­24.56; P = .04), and chronic kidney disease (OR = 9.01; 95% CI: 1.05‐­77.60; P = .04). Predictors of lead dislodgement included obesity (OR = 8.71; 95% CI: 1.01‐­74.99; P = .04), moderate to severe tricuspid regurgitation (OR = 11.92; 95% CI: 1.52‐­93.53; P = .01), and low molecular weight heparin use (OR = 7.38; 95% CI: 1.05‐­52.05; P = .04).

Conclusion:

Despite the relatively lower patient‐­ and procedure‐­volume, our local experience is comparable to the global data in terms of overall complication rates. Both patient‐­ and procedure‐­related predictors identified patients with a particularly high risk of complications. The clinical utility of these findings includes the provision of measures for quality improvement and informed consent.

AP19‐­00648

Characteristics and feasibility of left bundle branch pacing via a novel intraseptal technique in patients with left bundle branch block

Weijian Huang, Shengjie Wu, Lan Su, Xueying Chen, Bingni Cai, Jiangang Zou, Rongfang Lan, Guosheng Fu, Guangyun Mao, Pugazhendhi Vijayaraman, Kenneth A Ellenbogen, Zachary I Whinnett, Roderick Tung

Department of Cardiology, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Chin, China

Introduction:

His bundle pacing can correct left bundle branch block (LBBB) but may be limited by suboptimal lead delivery and high thresholds. To assess the feasibility of left bundle branch pacing achieved by capture the left conduction system via a novel intraseptal technique (iLCS) to deliver cardiac resynchronization therapy (CRT).

Methods:

Patients with LBBB from multicenters indicated for CRT or pacing therapy were included. iLCSP was performed by fixing 3830 lead into the left ventricular septal sub‐­endocardium targeting the region of the proximal left conduction system. Pacing characteristics, success rate, threshold and R‐­wave amplitude were assessed.

Result:

A total of 94 patients with the native QRS duration of 167.2 ± 17.2 milliseconds were included. In 92 patients, iLCSP was achieved and demonstrated RBBB pattern with the paced QRS duration of 116.4 ± 12.6 milliseconds (Figure 1B, middle panel). Fusion of iLCSP and native conduction via the RBB eliminated RBBB and resulted in an average QRS duration of 103.2 ± 10.1 milliseconds (Figure 1C). In a subgroup that underwent a two‐­lead implantation technique (n = 21), a Purkinje pre‐­potential was recorded during His corrective pacing from the intraseptal lead (Figure 1B, right panel). Output dependent selective and non‐­selective iLCSP were demonstrated in 52% patients, with the same stimulus to peak left ventricular activation time of 82 milliseconds (Figure 1B, left and middle panel). Lead parameters remained stable at 1‐­year (threshold 0.61 ± 0.17V/0.5 milliseconds, R wave 13 ± 5.8 mV, Figure 1D, E). During follow‐­up, only one patient had an increase in LBB capture threshold to 2.5V/0.5 milliseconds and there were no other complications such as dislodgment, infections, embolism or stroke associated with the implantation.

Conclusion:

Permanent iLCSP is feasible and safe in patients with LBBB.

AP19‐­00651

Baseline serum high density lipoprotein cholesterol level predicts long‐­term clinical outcomes in patients with heart failure receiving cardiac resynchronization therapy

Shangyu Liu, Zhimin Liu, Shengwen Yang, Wei Hua, Yan Yao

Fuwai Hospital, CAMS&PUMC, China

Introduction:

Cardiac resynchronization therapy (CRT) is the current standard of care for patients with refractory heart failure and ventricular dyssynchrony. However, approximately 30% of patients may not benefit from CRT, despite meeting criteria for implantation.

Methods:

A total of 512 patients with CRT between January 2010 and December 2015 were retrospectively enrolled and categorized into 2 groups based on serum HDL‐­C level (HDL‐­C ≥1.0 mmol/L、<1.0 mmol/L ). After the follow‐­up, re‐­hospitalization due to worsening heart failure (HF) or all‐­cause mortality (including heart transplantation) was analyzed using Kaplan‐­Meier curves and log‐­ rank test. Serum HDL‐­C level was evaluated in Cox proportional‐­hazards regression models as an independent prognostic factor.

Result:

There were 267(52.1%)patients with lower HDL‐­C which had lower cholesterol, proportion prescribed with spironolactone, had higher body mass index, higher proportion of hypertension, diabetes, high‐­sensitivity C reactive protein, and had lower serum Cholesterol. During a median follow‐­up period of 36.1 ± 26.0 months, 95 (19.3%) patients died, 7 (1.4%) underwent heart transplantation and 137 (27.8%) had at least one HF readmission. Log‐­rank test analyses demonstrated that lower HDL‐­C was associated with a significantly higher HF re‐­hospitalization (χ2 = 4.876, P =  0.027) and all‐­cause mortality (χ2 = 4.267, P =  0.039). Cox analysis showed that lower HDL‐­C was the independent risk factor for HF re‐­hospitalization (hazard ratio [HR] = 0.301, 95% confidence interval [CI]: 0.150‐­0.604, P =  0.001) and all‐­cause mortality (HR = 0.193, 95%[CI]:0.080‐­0.470, P =  0.006).

Conclusion:

In CRT patients, baseline serum HDL‐­C level was associated with clinical condition. HDL‐­C level was the independent risk factor for HF re‐­hospitalization and all‐­cause mortality.

FIGURE 1 A diagram to describe the flow of participants through the study

FIGURE 2 Plot of Kaplan Meier estimates of survival free of all‐­cause death and heart failure hospitalization according to level of HDL‐­C

AP19‐­00666

Implantation experience of defibrillators and cardiac resynchronization therapy: The National Institute of Cardiovascular Diseases (NICVD), Device Registry 2017‐­18

Mueed Abdul

National Institute of Cardiovascular Diseases Karachi, Pakistan

Introduction:

The incidence of heart failure and sudden cardiac death is increasing at an alarming rate all around the globe and same is the case of Pakistan. The leading cause is ischemic heart disease but non‐­ ischemic cardiomyopathies are also playing its part. It has increased the rate of heart failure, arrhythmia, and sudden cardiac death, morbidity and mortality have also been increased resulting in frequent emergency department visits. Sudden cardiac death (SCD) is an important cause of death in adult and young patients. Over the past years, the rate of implantable cardiac defibrillator (ICD) implantation is increased dramatically all over the world. With advances in technology and improved training, techniques of implantation are improving, resulting in better outcomes in term of device‐­related infections, ICD therapy, lead problems, and generator issues, during and after implantation. The National Institute of Cardiovascular Diseases (NICVD) cardiac resynchronization therapy (CRT) and ICD registry provides a real‐­time picture of the need for ICDs and CRT devices in clinical practice across Pakistan. NICVD, Karachi is the largest cardiac institute of Pakistan, which provides all cardiac services under one roof. And it receives patients from all over the country. Therefore it is the recommended center to see the incidence of high energy devices in the Pakistani population.

Methods:

This is a single center registry of NICVD, Karachi includes patients from May 2017 to June 2018, admitted through emergency or outpatient department and were diagnosed as a case of heart failure, survival of sudden cardiac death or cardiomyopathies. All cases are included on the base of ACC/AHA guidelines of device‐­based therapy. All procedures were performed by experienced operators together with fellows in training under close supervision. Patients’ characteristics, diagnoses, procedural details, and indication for placement of ICD were taken from history and hospital records. Complications related to implantation and adverse events occurring during follow‐­up were also extracted from hospital emergency or outpatient department.

Result:

A total of 930 patients were included in this registry. Out of this biventricular pacing devices, CRTD were 216 (28.0%) and CRT P were 54 (5.8%). Single ICD were 422 (45.0%) and dual ICD were 238 (25.0%). Majority of patients were of ischemic cardiomyopathy that comes up to 726 (78.06%) and non‐­ischemic cardiomyopathy were 204 (21.93 %). Primary prevention, 704 (75.698%), were more than secondary prevention, 226 (24.30%). This also showed that male received more devices than female (730 (78.49%) vs 140 (1505%)) patients. Diabetic were 499 (48.27%) and hypertensive were 475 (51.07%) among all patients. Hypertrophic cardiomyopathy (HCM) was in 16 (1.72%) and arrhythmogenic right ventricular dysplasia (ARVD) was in 10 (1.075%) also included are those who have high‐­risk feature or secondary prevention.

Conclusion:

This report gives an overview of the clinical practice and device implantation. Heart failure patients are increased over the period of time, and the common cause according to this report is ischemic cardiomyopathy. Biventricular pacing therapy is also increased and CRT D were used more than CRT P. Gender difference was noted for device therapy as male received more high energy devices. High energy devices were used more for primary prevention.

TABLE 1 Demographic profile, indications and implanted devices

Characteristics	Total
Total	930
Demographic Profile
Male	790 (84.94%)
Hypertension	475 (51.1%)
Diabetes	499 (48.27%)
Hypertrophic cardiomyopathy (HCM)	16 (1.7%)
Arrhythmogenic right ventricular dysplasia (ARVD)	10 (1.1%)
Indications
Primary	704 (75.698%)
Secondary	226 (24.30%)
Ischemic cardio myopathy (IHD)	726 (78.1%)
Non‐­ischemic cardiomyopathy (NIHD)	204 (21.9%)
Devises
Cardiac resynchronization therapy (CRT) devices	216 (23.2%)
Cardiac resynchronization therapy (CRT) pacemaker	54 (5.8%)
Single implantable cardioverter defibrillator (SICD)	422 (45.4%)
Dual implantable cardioverter defibrillator (DICD)	238 (25.6%)

AP19‐­00669

The World‐­Wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP‐­IT): Long‐­Term Follow‐­Up

Suneet Mittal, Bruce Wilkoff, Charles Kennergren, Jeanne Poole, Ralph Corey, Frank Bracke, Antonio Curnis, Kamel Addo, Joaquin Martinez‐Arraras, Ziad Issa, Calum Redpath, Jean Moubarak, Surinder Kaur Khelae, Lucas VA Boersma, Panagiotis Korantzopoulos, Jo Krueger, Jeff Lande, Gina Morss, Khladoun Tarakji

Valley Health System, United States

Introduction:

Cardiac implantable electronic device (CIED) infections are associated with substantial morbidity and mortality. A fully‐­absorbable multifilament mesh envelope (TYRX) was developed, which elutes minocycline and rifampin. In the largest global randomized trial of CIEDs to date, the WRAP‐­IT study, the primary objective was achieved with TYRX demonstrating a 40% reduction in major CIED infections, 61% reduction in pocket infections, and with no increased risk of complications through 12 months follow‐­up. We now sought to assess the longer‐­term effects of the envelope on infection reduction and on safety in these patients.

Methods:

WRAP‐­IT was a worldwide multi‐­center trial in patients undergoing CIED replacement, upgrade, revision, or de novo CRT‐­D implant. All patients received standard‐­of‐­care infection prevention strategies and were then randomized 1:1 to receive the envelope or not. The primary endpoint was major CIED infection within 12 months of the procedure. The secondary endpoint was to confirm that the envelope does not increase CIED procedure‐­ or system‐­related complication rates through 12‐­months post‐­procedure. We further characterized the envelope effect on infection and complications through the entire follow‐­up period. Data were analyzed with an as‐­treated approach using a Cox proportional hazards regression model and the observed hazard ratio for the effect of the envelope on the rate of CIED procedure‐­ or system‐­related complications was compared to a non‐­inferiority margin of 1.33.

Result:

A total of 6903 patients (mean age: 70.0 ± 12.5 years, 28% female) underwent CIED generator replacement or revision, upgrade, or de novo CRT‐­D implant in 181 centers, in 25 countries, by 776 physicians. Device types included CRT‐­D (49%), CRT‐­P (4%), ICD (26%), and IPG (20%). At the initial procedure, 3396 patients received an envelope and 3507 did not receive an envelope. Mean follow‐­up duration was 20.9 ± 8.3 months. The effect of the envelope was sustained through 36 months of follow‐­ up with a significant reduction in all CIED infections (HR: 0.70, CI: 0.5‐­0.98, P = .036) and without increased risk of procedure‐­ or system‐­related complications (non‐­inferiority test, P < .001) (Figure). Implant site pain was less common in the envelope group (0.1% vs 0.4%, P = .0298). There were no significant group differences in the incidence of pocket erosion, lead damage, or pocket hematoma (all P > .05). There were no reports of allergic reactions to the components of the envelope (mesh, polymer, or antibiotics).

Conclusion:

In addition to standard‐­of‐­care infection prophylaxis, the TYRX envelope significantly reduced CIED infection by 40% through 12 months follow‐­up, and the beneficial effects of the envelope are sustained beyond the first year post‐­procedure. The envelope does not increase risk of complication and was associated with a reduced risk of implant site pain.

AP19‐­00675

Practical use of effective left‐­ventricular pacing algorithm in patients with cardiac resynchronization therapy

Shohei Tanaka, Hiroshi Tasaka, Atsushi Sakata, Reo Hata, Masatomo Ozaki, Mitsuru Yoshino, Kazushige Kadota

Kurashiki Central Hospital, Japan

Introduction:

Cardiac resynchronization therapy (CRT) is required to ensure delivery of a high percentage of ventricular pacing and capture of a significant portion of left ventricular (LV) myocardium. Recently, effective CRT with an automatic electrogram (EGM)‐­based algorithm enabled us to quantify the percentage of effective LV pacing by detection of QS/QS‐­r morphology on the unipolar LV EGM. The purpose of this study was to evaluate the correlation between the percentage of LV pacing recorded by 24‐­hour Holter monitoring (%Holter pacing) and that of effective LV capture by effective CRT (%e‐­CRT pacing).

Methods:

We retrospectively analyzed 19 patients, including 3 patients with atrial fibrillation, who had undergone implantation of a cardiac resynchronization therapy defibrillator (Claria; Medtronic, USA) between February 2018 and January 2019. The %Holter pacing was calculated by visually assessing QRS morphology. The %e‐­CRT pacing was extracted from each device during hospitalization. Data collection was performed within 5 days after device implantation. The %Holter pacing and %e‐­CRT pacing in each patient were plotted and compared.

Result:

A scatterplot of %e‐­CRT pacing vs. %Holter pacing in the 19 patients is shown in the Figure. A total of 17 patients (89.5%) showed a %e‐­CRT pacing higher than 90%. The average of %e‐­CRT pacing was not significantly different form that of %Holter pacing (96.3 ± 2.4 vs. 97.0 ± 3.3%; p = 0.15, paired t test) with correlation coefficient r 0.82. The remaining 2 patients had a relatively low %e‐­CRT pacing (46.4% and 51.9%, respectively); the former had pseudofusion beats due to atrial fibrillation tachycardia, and the latter variable conduction delay in the His‐­Purkinje system.

Conclusion:

The effective CRT algorithm revealed delivery of a high percentage of effective LV pacing, which had a good correlation with the percentage of LV pacing recorded by 24‐­hour Holter monitoring.

AP19‐­00678

A case of LBB pacing correcting CLBBB with heart failure by DDD pacemaker

Rongzeng Du

Affiliated Hospital of Jiangsu University, PR China, China

Introduction:

Male,85 years old, be hospitalized because of shortness of breath and palpitation for 3 days. ECG showed I°‐­AVB,complete left bundle branch block (CLBBB)(170ms) and Monitoring ECG showed Intermittent III°‐­AVB. UCG showed EF 38%,LVEDD 56mm, LA 51mm, IVS 15mm. Blood BNP showed 1710pg/ml.

Methods:

The patient refused CRT or CRTD therapy, so we used DDD pacemaker and screwed lead 3830 into left bundle branch (LBB) area from right ventricular septal side.

Result:

The pacing ECG showed right bundle branch block (RBBB, 125ms) and CLBBB disappeared. The pacing parameters were R‐­wave amplitude 13.1 mv, threshold 1.1v/0.4ms and impedence 860Ω at the tip of lead 3830. After 3 months, UCG showed EF 47%,LVEDD 54mm, LA 48mm and the patient was free of symptoms. The pacing parameters were stable: R‐­wave amplitude 8‐­11.2 mv, threshold 0.5v/0.4ms and impedence 332Ω at tip of lead 3830. The pacing ECG was the same as before.

Conclusion:

LBB pacing could correct CLBBB wtith heart failure by DDD pacemaker if the patient refused CRT or CRTD therapy.

AP19‐­00680

A super‐­responder to CRT concealed by silicosis for eight years

Qinhui Sheng

Peking University first hospital, China

Introduction:

An ECG from a 79‐­year‐­old man was sent to me when he got a chest tightness during his admission in respiratory ward of our branch hospital. It was a tachycardia with wide QRS, and the sinus rhythm after cardio version by amiodarone also showed wide QRS complex because of CLBBB (Figures 1 and 2). He had been a frequent patient admitting to the department of respiratory medicine at least once a year for 8 years. Eight years ago, he began to suffer dyspnea, and was diagnosed as silicosis since he had been a drifting worker for 3 years when he was around 20 years old. His Symptoms of dyspnea aggravated and exercise tolerance reduced rapidly. Now, the old man can only walk 50m (1 block) on level ground or climb 1 floor up. He didn't have any histories of hypertension or diabetes, and neither alcohol addiction nor smoking habit. Physical examination found moist rales with little dry rales over both lungs, cardiac dilated to the left, and systolic murmurs audible at apex, but we couldn't find any signs of pulmonary hypertension. So what on earth were the main causes for his symptoms of breathless. Then the patient was transferred to our department to get further management in May 9th, 2018.

Methods:

ECG on admission still showed CLBBB with a prominent wide QRS duration 186ms. Echocardiogram showed obvious left ventricle dilation and severe systolic dysfunction with LVEDD 6.8cm and LVEF 24%. When we reviewed all of his hospital records during the past 8 years, we got some clues listed below: 1, the first ECG recorded in 2010 when he was admitted to pulmonary department was CLBBB and the QRS duration was 133ms, the QRS duration became wider gradually through the 8 years and now it was 186ms. 2, he had 5 echocardiograms during the 5 past years, showed his LVEDD from 5.8cm to 6.8cm and LVEF from 40% to 24% now, while the right ventricle size was normal through all these years. 3, the chest X rays and CT pulmonary scans examined almost every year showed no obvious change signs although there were some small nodules in the upper lung areas without any progressions. These findings confirmed us that he suffered a chronic heart failure even more than his silicosis since his cardiac abnormalities aggravated while the pulmonary disease was stable. There was another episode we got from his records. Two years ago when he had the chest tightness at first time, he was suspicious of AMI because of a mild elevation of TnI and received a coronary angiography. No obvious stenosis were found and no stents planted. But he was prescribed with optional medicine therapy, including ACEI, ℬ‐­blocker, and aldosterone antagonist because of the reduction of LVEF, but still his symptoms deteriorated. We did a CTA scan again to completely exclude possible IHD. Hence the ultimate diagnosis for this patient was revised to dilated cardiomyopathy and silicosis.

Result:

According to the guidelines, he had a strong indication for CRT, and we know patients with LBBB, wider QRS, and non‐­ischemic can get magnitude of benefit from CRT. It's very hopeful that he could be a good responder to CRT. So a CRTD (Viva Quad XT CRT‐­D DTBA2QQ, Medtronic) was implanted successfully in May 16th. All of the parameters were excellent, adaptive CRT was programmed ON, and the pacing ECG showed a beautiful narrow QRS within 120ms (Figure 2), patient’ symptoms relieved significantly shortly after implantation. Seven months later, the patient complained of abdominal beating. Unfortunately phrenic nerve stimulation happed. Instant ECG showed normal capture of ventricle, due to adaptive CRT, total VP actually LV pacing was pretty good at a rate of 98%, thresholds and other parameters were pretty well as before. Then chest x‐­ray revealed it. It seemed that LV lead went deeper than before. When compared to the last one at 3days post‐­implanting, we found it was not the lead moving, but the cardiac size decreased sharply, much more clear compared to pre‐­ implantation (Figure 3). And echocardiogram showed us a nearly normal heart with LVEDD 5.0cm and LVEF 60%. Since the threshold was good, we decreased the output and the stimulation alleviated. Five months later, when the patient returned for his 1year follow‐­up, we are surprised to see a totally normal heart, LVEDD 4.5cm and LVEF 67%. He is indeed a super responder to CRT.

Conclusion:

This story sounds really wonderful, but I share this case not because of its amazing results. Think about his suffering for 8 years before, this is key point I want to share: what is the most important aspect for this patient's successful therapy? Although a good technology CRT is vital, as well as the new functional adaptive CRT gives him more benefits, the process the patient getting his correct diagnosis is far more important. This case illustrated that we should pay more attention to our patients, analyze all the data carefully and comprehensively, before we make a final diagnosis and decision.

AP19‐­00700

A rare case of dislocation of ventricular electrode

Pengkang He

Peking University First Hospital, China

Introduction:

A 70 year's old woman received dual chamber pacemaker due to sick sinus syndrome. She was routinely examined every year and pacemaker worked normally. The pacemaker was malfunction in 2018's routine examination. The ventricular electrode parameters of both pacing threshold and sense were abnormal. The chest x‐­ray demonstrated the right ventricular lead was dislodgment. The ventricular lead moved into pulmonary artery.

Methods:

We were not certain about the relationship between the lead and both pulmonary and aorta artery walls. We decided to remove the ventricular lead by a snare system in our hybrid catheter room in case we need open chest surgery to repair pulmonary wall. Detailed angiography of aorta was performed during the operation in order to clarify if any damage was implicit upon the aorta wall. The ventricular lead was removed by the snare without any difficult and a new ventricular lead was been replaced.

Result:

A CTPA was performed after ventricular lead removal and showed embolism in right pulmonary artery. This complication might imply that slight damage upon the artery wall have been caused during the removal procedure. The patient then received rivaroxaban 10mg twice a day for 3 months.

Conclusion:

A very rare scenario of ventricular dislocation and the reason was not very clear.

AP19‐­00708

Outcome of his bundle pacing in patients with atrioventricular and interventricular dyssynchrony

Jemelee Hernandez, Sein Khine Nee, Hooi Tan Chi, Keong Ching

National Heart Centre Singapore, Philippines

Introduction:

His bundle pacing (HBP) aims to provide a physiologic pattern of ventricular activation to reduce atrioventricular dyssynchrony and the clinical complications of increased right ventricular pacing burden. It is also an attractive rescue strategy to decrease interventricular dyssynchrony in patients not eligible for cardiac resynchronization therapy. However, barriers to its wider use include operator's learning curve, prolonged procedure and fluoroscopy time, rapid battery depletion and early lead revision. The objective of this study is to determine the acute clinical and procedural outcomes of His bundle pacing in patients with atrioventricular and interventricular dyssynchrony.

Methods:

This is a descriptive study on patients who underwent His bundle pacing from August 2018‐­April 2019. Clinical factors including indication, ECG, left ventricular function, and procedural data including device check were obtained from review of records.

Result:

Eight (8) patients were included in the study with a mean age of 71 + 13 years and 75% were male. The indications for His bundle pacing include (1) permanent atrial fibrillation (AF) with tachycardia‐­bradycardia syndrome (n=5); (2) sinus node dysfunction (n=2) with the His lead inserted at the right ventricular port; and (3) permanent AF in rapid ventricular response with nonischemic cardiomyopathy with subsequent AV node ablation for which the His lead was placed at the left ventricular port. The mean ejection fraction prior to the procedure is 56 + 14% and the mean QRS duration prior to implant was 104 + 13 ms with only one patient having right bundle branch block. The mean procedure time was 116 + 39 minutes.

Conclusion:

His bundle pacing is a safe and feasible alternative technique to minimize right ventricular pacing and maintain a physiologic narrow QRS with selective and nonselective capture in patients with atrioventricular and interventricular dyssynchrony.

TABLE 1 ECG and device parameters at 24 h and 3 mo post‐implantation

24 h (mean ± SD) (n = 8)	3 mo followup (mean ± SD) (n = 6)
R wave sensing (mV)	3.9 ± 1.5	4.1 ± 0.98
Threshold (V at 1 ms)
Selective capture	1.95 ± 1.71	3.05 ± 2.3
Non‐selective capture	1.3 ± 0.86	1.88 ± 1.87
QRS duration (ms)	115 ± 15	108 ± 10

AP19‐­00717

Factors associated with the quality of life of patients with implantable cardioverter defibrillator in South Korea

Gieun Yim, Sanghee Kim, Yeonsoo Jang, Boyoung Joung

Severance Hospital, South Korea

Introduction:

While increasing the number of patients with Implantable Cardioverter Defibrillator (ICD) has been reported in South Korea, little is known about Quality of Life (QOL) and factors associated with the QOL for ICD recipients in Korea. The purpose of this study was to 1) evaluate the factors associated with ICD concerns and QOL, 2) compare ICD concerns and QOL according to the duration of ICD implantation and the purpose of prevention.

Methods:

Descriptive survey design was applied with 109 ICD recipients who visited a university‐­ affiliated hospital in Seoul, Korea. For measurement, questionnaires for ICD concerns, perceived control, social support, patient acceptance, and QOL were used.

Result:

ICD related concerns were significantly higher in patients with one or more comorbidities (p=0.006) or in those who had experienced shock (p=0.026). QOL was significantly lower in patients with low income, low education level, NYHA class ≥2, and patients who lived alone, were unemployed, and had comorbidities. The significant predicting factors associated with lower QOL were low feeling of control (p=.003), low acceptance of device (p=.005), low economic status (p=.021), and having co‐­ morbidities (p=.030). These factors accounted 43.3% of the variance in QOL. Compared with patients within 2 year after the ICD implantation, the feeling of control was significantly improved in those 4 years after implantation (p=.004). Compared with secondary prevention patients, primary prevention patients had higher ICD concerns and lower QOL. Secondary patients had significantly higher perceived control (p=.022) and perceived social support (p=.008).

Conclusion:

Higher ICD related concerns and lower QOL was reported in patients within 2 years after implantation and who had ICD for primary prevention. These findings suggest that appropriate screening is needed to detect vulnerable patients with ICD and additional personalized interventions to improve QOL to these populations should be developed and provided.

FIGURE 1. Significant differences of quality of life related to demographic and clinical factors

TABLE 2 Factors associated with Quality of Life (N=109)

Variables	β	S.E	t	P	95% C.I. for β
(Constant)	1.608	0.307	5.246	<.001**	0.999–2.216
Education
High School	0.043	0.110	0.387	.700	−0.177–0.262
≥College	0.099	0.112	0.878	.382	−0.124–0.322
Monthly Income
200≤ – <400	0.217	0.109	1.990	.049*	0.000–0.434
≥400	0.298	0.127	2.343	.021*	0.045–0.550
Live together	0.043	0.128	0.335	.738	−0.210–0.296
Employment	−0.069	0.111	−0.621	.536	−0.288–0.151
NYHA class	0.035	0.083	0.417	.677	−0.130–0.199
Co‐­morbidity	0.172	0.078	2.207	.030*	0.017–0.326
Concerns	−0.003	0.005	−0.698	.487	−0.012–0.006
Control	0.026	0.008	3.074	.003**	0.009–0.043
Social support	0.080	0.065	1.235	.220	−0.048–0.208
Acceptance	0.008	0.003	2.876	.005**	0.002–0.013
	Adjusted R2 =.433, F=7.880, P = <.001**

β: the regression coefficient, S.E.: standard error of the regression coefficient, C.I.: confidential interval, NYHA: New York Heart Association

Reference Group: Education_≤Middle school, Income_<200, Live together_No, Employment_No, NYHA class_II, Co‐­morbidity_Yes

*: P < .05, **P<.01.

AP19‐­00738

Visualization of tricuspid valve annulus for implantation of his bundle pacing in patients with symptomatic bradycardia

Gu Min, Yiran Hu, Wei Hua, Hongxia Niu, Xuhua Chen, Minsi Cai, Nixiao Zhang, Hui Li, Xiaohong Zhou, Shu Zhang

Fuwai Hospital, CAMS&PUMC, China

Introduction:

His bundle pacing (HBP) is a physiological pacing therapy, but the implantation of His bundle pacing remains a challenge. This study explored the feasibility of using visualization of tricuspid valve annulus (TVA) to locate the site for His bundle pacing.

Methods:

During the pacing lead placement of His bundle pacing in patients with symptomatic bradycardia and indicated for pacing therapy, the TVA and tricuspid septal leaflet were revealed by contrast injection in the right ventricle under the fluoroscopic RAO view and the target site for HBP was identified near the intersection of the tricuspid septal leaflet and the right ventricular border. Based on the revealed anatomic imaging marker, the pacing lead was purposely implanted for permanent HBP at either atrial or ventricular side (Figure A, B, C).

Result:

At the initial exploratory phase, the visualization of TVA was used for placing the pacing lead helix at the atrial side of HBP in one patient and at the ventricular side of HBP in another patient. When the pacing lead helix in the atrial side, the HBP was characterized with selective HBP with the capture threshold of 1.2V@1.0 ms and R‐­wave amplitude of 1.6 mV. The ventricular‐­side HBP was characterized with selective HBP at a low capture threshold (0.5V@1.0 ms) and non‐­selective HBP with an increased pacing output (1.1V@1.0 ms), R‐­wave amplitude of 4.9 mV. Echocardiograph at 3‐­month follow‐­up showed no changes in tricuspid valve function.

Conclusion:

Location of the TVA revealed by right ventriculography can be used as a landmark to identify the site of His bundle where the pacing lead helix could be purposely placed, making implantation outcome predictable.

AP19‐­00739

The usefulness and limitation of impedance cardiography for cardiac resynchronization therapy devices optimization

Kojiro Ogawa, Miyako Igarashi, Tomoaki Hasegawa, Akihiko Nogami, Kazutaka Aonuma, Masaki Ieda

Hitachi General Hospital, Japan

Introduction:

Identifying the optimal atrioventricular (AV) or interventricular (VV) delay is beneficial to patients using cardiac resynchronization therapy (CRT) devices. Ultrasound echocardiography (UCG) has been the most commonly used method; however, it requires high technical knowledge. Impedance cardiography (ICG) can calculate stroke volume by measuring changes in transthoracic electric impedance. This study sought to assess the clinical utility of ICG in comparison with UCG for the optimization of CRT devices.

Methods:

The patients who underwent CRT device implantation were retrospectively analyzed. Cases of upgrading to a CRT device were included. A week after implantation, optimization of AV delay (AVD) was performed in every patient with ICG (AVD‐­ICG) and UCG (AVD‐­UCG). VV delay (VVD) was then determined according to the optimal AVD using these two methods.

Result:

Forty‐­two patients were finally enrolled. Average AVD‐­ICG was significantly shorter than AVD‐­UCG (128 ± 49 vs. 146 ± 41 ms, p = 0.018). The difference between AVD‐­ICG and AVD‐­UCG were 20 ms or less in nineteen patients (45%) including five patients (12%) who had the same optimized AVD with two methods. The remaining twenty‐­three patients had the difference over 20 ms, here defined as AVD‐­ICG/AVD‐­UCG mismatch. Among these patients, AVD‐­ICG was shorter in sixteen (38%) and longer in seven (17%) when compared to AVD‐­UCG (Figure A). Simple regression analysis revealed a mild positive correlation between AVD‐­ICG and AVD‐­UCG (r = 0.48, p = 0.001, Figure B). In multivariate analysis, the presence of moderate or severe mitral regurgitation (MR) postoperatively was an independent predictor of AVD‐­ICG/AVD‐­UCG mismatch (odds ratio=10.71; 95% confidence interval=1.72 to 66.72; p = 0.018). On the other hand, the results of optimization of VV delay were similar using both ICG and UCG (0 [0 to 20] vs. 20 [0 to 20] ms, p = 0.153). VVD‐­ICG and VVD‐­UCG were exactly the same in 19 (45%) patients.

Conclusion:

ICG is a non‐­invasive monitoring tool to optimize the settings of CRT devices which could substitute UCG. In VVD optimization, ICG could substitute UCG as the results were similar between the two methods. However, there was a significant difference in AVD optimization results between ICG and UCG, especially in patients with MR after CRT.

AP19‐­00741

Overweight as a protective factor against mortality in non‐­ischemic cardiomyopathy patients with implantable cardioverter defibrillator

Bin Zhou, Shuang Zhao, Min Tang, Shu Zhang

State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Di, China

Introduction:

Previous studies had shown the impact of body mass index (BMI) on clinical outcomes of ischemic cardiomyopathy (ICM) patients with implantable cardioverter defibrillator (ICD). But little is known about the impact of BMI on clinical outcomes of non‐­ischemic cardiomyopathy (NICM) patients with ICD.

Methods:

This study retrospectively analyzed the data from the Study of Home Monitoring System Safety and Efficacy in Cardiac Implantable Electronic Device–implanted patients (SUMMIT) registry in China. 480 NICM patients with ICD having BMI data were enrolled. Patients were divided into four groups according to the native recommended BMI classification: underweight (BMI <18.5kg/m²), normal range (BMI, 18.5–24kg/m²), overweight (BMI, 24–28kg/m²), obese (≥28kg/m²). Those classified as underweight or obese made up 9.3% (underweight, 4.3%; obese, 5%) of the study population and were excluded from the analysis, leaving a total of 435 patients. The primary endpoint was all‐­cause mortality. The secondary endpoint was appropriate ICD therapy for VT/VF and appropriate ICD shock for VT/VF.

Result:

Of 435 patients, 261 (60%) had normal BMI, 174 (40%) were overweight. Over a median follow‐­ up time of 57.7months, 63 patients (14.5%) died, 158 patients (36.3%) experienced appropriate ICD therapy for VT /VF, 102 patients (23.4%) were treated with appropriate ICD shock. In the Kaplan‐­Meier analyses, overweight had an decreased risk of mortality compared with normal range (log‐­rank test: P = 0.024, χ² = 5.028). Based on multivariate Cox regression modeling, overweight still had a decreased risk of mortality compared with normal range (HR = 0.512, 95% CI 0.292‐­0.898, p = 0.019). However, the risk of appropriate ICD therapy or shock for VT/VF was similar between overweight and normal range patients (HR = 0.918, 95% CI 0.734‐­1.409, p = 0.918; HR = 1.081, 95% CI 0.721‐­1.621, p=0.706 respectively).

Conclusion:

Compared with normal range, overweight is a protective factor against mortality, but has no impact on ventricular arrhythmias in NICM patients with ICD.

AP19‐­00743

Impact of contrast media use during cardiac resynchronization therapy implantation for renal dysfunction

Emi Nakano, Keigo Hattori, Akihiro Nakada, Takaharu Shirahama, Hirotaka Komatsu, Nadenari Hozawa, Masahiro Yamauchi

IMS Tokyo Katsushika General Hospital, Japan

Introduction:

Renal dysfunction is often associated with chronic heart failure. It is well known that cardiac resynchronization therapy (CRT) improves renal function in long term outcome. However, the use of contrast agents during CRT implantation may worsen renal failure and also can cause contrast‐­ induced nephropathy (CIN).

Methods:

We analyzed 39 patients who underwent CRT implantation (mean age 69.7±14.2 years; 29 male; mean EF 27.6±9.1%; all patients in NYHA≧III). Normal saline started 12h before procedure with an infusion rate of 1ml/Kg of body weight per hour and be continued for 24h. CRT was implanted using standard technique and 20‐­40ml contrast was used to enhance the coronary sinus. Renal function was compared before and a day after CRT.

Result:

Twenty‐­nine patients had stage3 CKD or greater: Stage3a was 12 (30.7%), stage3b was 10 (25.6%) and stage4 was 7 (17.9%). Acute CRT responders (defined by increase in LVEF≧5% within a week after operation) were 43.5%. When analyzed based on the stage of CKD, there was significant improvement of renal function in stage3 CKD regardless of acute CRT responder. eGFR showed a trend towards ameliorated even in stage4 CKD (Table 1). Furthermore, there was no CIN.

Conclusion:

There was no worsening renal function with the use of <40ml contrast during CRT implantation in patients with advanced renal dysfunction.

TABLE 1 Mean GFR before and after CRT implantation

CKD stage	Baseline pre CRT eGFR (ml/min/1.73m2)	Post CRT eGFR	P value
3a (N=12)	52.6 ± 4.6	58.4 ± 8.3	0.001
3b (N=10)	37.6 ± 5.1	44.8 ± 8.2	0.001
4 (N=7)	22.4 ± 4.4	28.0 ± 7.7	0.08

AP19‐­00746

More efficacy and safety of bipolar catheter ablation than unipolar ablation in ventricular myocardium

Fengxiang Zhang, Baohan Fan, Qiushi Chen, Weiwu Zhu, Pipin Kojodjojo

Section of Pacing and Electrophysiology, Division of Cardiology, the First Affiliated Hospital of Na, China

Introduction:

Bipolar ablation has been used successfully for catheter ablation of arrhythmias refractory to conventional unipolar ablation. However, there is no commercially available equipment for bipolar ablation and limited data exists about the optimal configuration.

Methods:

Isolated ventricular septum (VS) and left ventricular free walls (FW) from freshly harvested adult porcine hearts were suspended in a Hartmann's solution bath warmed to 37°C. A customized radiofrequency energy generator was developed to perform bipolar ablation. Lesions were created by sequential unipolar (UNI) and bipolar (BI) ablation using contact‐­forcing sensing catheters (fixed at 20g) in multiple combinations. (power varied from 20W to 40W; 4mm irrigated versus 8mm tipped catheters as the return electrode; active electrode on epicardium versus endocardial surfaces) Maximum power delivered, impedance, tissue and catheter tip temperatures, lesion dimensions, transmurality and the occurrences of steam pops were recorded.

Result:

275 lesions from 9 pig hearts (mean weight of 506 ± 111 g) were analysed. On the FW, BI resulted in narrower and smaller lesions compared to UNI (p<0.01) but a higher proportion of BI lesions were transmural. UNI created more steam pops (30W ‐­ 86.2% vs 46.2%, p<0.01). Lesion volume was larger when the active catheter during BI was placed on the epicardial surface (429.2 ± 148.9 vs 334.5 ± 156.3 mm³, p = 0.04). Increasing power from 20W to 40W resulted in stepwise increases in lesion volume, lesion depth and transmurality, at the expense of more steam pops. Similar findings were replicated on the IVS. The 8mm tip ground electrode resulted in larger lesion volume compared to 4mm irrigated tip (365 ± 143.9 vs 300.1 ± 111.0 mm³, p=0.04). Temperatures up to 80°C were recorded on the ground electrode during BI.

Conclusion:

BI increases the ability to target deep myocardial targets, with a lower risk of steam pops.

AP19‐­00750

Recurrent episodes of Tordes de Pointes in patient with high degree AV block

Hazleena Mohamed Hasnan, Ramachandran Sathappan, Yew Fung Kwan, Suhashni Gnaneswaran, Nor hanim Mohd Amin

Hospital Raja Permaisuri Bainun, IPOH, Perak, Malaysia

Introduction:

A 69 years old gentleman was presented with multiple episodes of loss of consciousness at home. Electrocardiogram during admission showed high degree AV block with heart rate 50 beat per minute. Echocardiography revealed ejection fraction of 48% with anteroseptal wall hypokinesia. Coronary angiogram was done and noted two vessels disease. Both vessels, left anterior descending and obtuse marginal 1 arteries were stented and transvenous temporary pacemaker was inserted and set to pace at 60 beat per minute. Unfortunately, this patient developed multiple episodes of unconsciousness and seizure in the ward. During each episode, cardiac monitor showed Tordes de Pointes which required direct current cardioversion to be reverted into sinus rhythm. In view of recurrent Tordes de Pointes despite of correction of electrolytes abnormality, all ECG of this patient were re‐­examined. We found out, during high degree AV block, the QTc interval was prolonged at 674 msec. When we paced at 60 beat per minute, the QTc interval reduced to 560 beat per minute and when paced at 75, the QTc interval decreased to 492 msec. Besides that, we noted during high degree AV block, there were variation in QRS cycle length and morphology. Dual chamber implantable cardioverter defibrillator was inserted and set to pace at 75 beat per minute. After that, no more episode of Tordes de Pointes.

Methods:

N/A

Result:

N/A

Conclusion:

QTc interval will be prolonged during slowing of heart rate. It is the magnitude of QTc prolongation rather than bradycardia per se that determines the risk of Tordes de Pointes. In addition to that, in our case, the variation in QRS morphology increases the likelihood to develop Tordes de Pointes.

AP19‐­00763

A large cerebral infarction in patient with atrial standstill: a lethal complication of a rare case

Tangkar Rahmadhani

Binawaluya Cardiac Center, Indonesia

Introduction:

Atrial standstill is a rare case but can lead to a serious condition such as tromboembolic event.

Methods:

A 66 year‐­old female patient referred to our hospital with confusion, dizziness and motoric aphasia for almost 3 weeks. She was diagnosed as an ischemic stroke and hospitalized in other hospital. She had diabetic and history of percutaneus coronary intervention (PCI) in 2017 and 2019. Her electrocardiographic showed junctional rhythm 41 beats per minute with occasional premature ventricular complexes. Echocardiography revealed no atrial contraction, normal left ventricular function, trivial aortic, tricuspid regurgitation and no thrombus seen. Non‐­contrast CT Brain showed a large cerebral infarction with transformation of hemorrhagic on the left frontoparietal lobe. Permanent pacemaker implantation was performed and showed no electrical activity in all area of the right atrium. The patient then successfully implanted a single chamber ventricle permanent pacemaker. One month later she came in outpatient clinic with a good improvement.

Result:

Atrial standstill is a rare, progressive disease that can potentially lead to a lethal tromboembolic event. Early awareness of this condition can provide good outcome.

Conclusion:

Atrial standstill is a rare, progressive disease that can potentially lead to a lethal tromboembolic event. Early awareness of this condition can provide good outcome.

Keywords: atrial standstill, stroke, permanent pacemaker

AP19‐­00772

Prophylactic radio‐­frequency ablation (RFA) before an implantable cardioverter defibrillator (ICD): a retrospective cohort analysis

DeepChandh Raja, Jayapradhap Velu, Aishwarya Srinivasan, Radhika Bharanikumar, Ulhas Pandurangi

The Canberra Hospitals and Australian National University, Australia

Introduction:

We have limited data on concurrent catheter ablation in patients undergoing an ICD.

Methods:

Retrospectively, we compared the number of patients receiving appropriate ICD therapies‐­ shock/ ATPs/ both after an ICD in patients who received an additional RFA (substrate homogenization) before the procedure (Group A, n=43) and the group which did not (Group B, n=64).

Result:

Baseline demographic variables were comparable. Group A had patients predominantly of ischemic cardiomyopathy (high‐­risk substrate for SCD, 77% vs 55%, p=0.03) and patients for secondary prevention (98% vs 58%, p<0.001). Either group received comparable number of anti‐­arrhythmic drugs after the ICD implant. Though the patients who received ICD shocks, ATPs or either of them were lesser in Group A, the numbers could not reach statistical significance (24%, 19%, 30% vs 27%, 20%, 28%, p=0.8). Similarily, the mean number of ICD shocks were considerably lower in Group A (0.37±0.8 vs 1.2±3, p=0.055). An additional analysis of patients comprising only secondary prevention (42 vs 27) revealed statistically significant and lesser number of ICD therapies in group A (40% vs 74%, p=0.006) with a relative risk reduction of 46% and absolute risk reduction of 34%. The number needed to treat to prevent shocks in this subset was 2.9. A regression analysis in the whole cohort revealed that ARVC was the only predictor of a patient receiving an ICD shock.

Conclusion:

Our data reveals significantly lesser number of ICD therapies (shocks or ATPs) post‐­ implant in patients for secondary prevention, who also received a concurrent prophylactic RFA. The implications of this finding are numerous and must encourage multi‐­center RCTs in large numbers to address the research question.

AP19‐­00773

Increased cardiac perforation risk with a screwed ventricular cardiac implantable electronic device lead

Yeong‐Min Lim, Jae‐Sun Uhm, Moon‐Hyoung Lee

Anyang SAM medical center, South Korea

Introduction:

Clinicians increasingly are more faced with the challenging choice of lead extraction, they used to more screwed lead when implanting cardiac implantable electronic device (CIED) leads. The relationship between the characteristics of CIED leads in terms of fixation types and cardiac perforations remain controversial.

Methods:

Cardiac computed tomographic (CT) images of 472 CIED leads with 276 consecutive patients (age: 67.7±15.0 years, 49.6% male) were reviewed by one radiologist and two cardiologists. We compared radiologic and clinical cardiac perforation rate in various situations. We defined radiologic perforation on reformatted CT images when the lead tip traversed past the outer myocardial layer. We defined clinical perforation if, in addition to radiologic perforation, there were accompanying hemopericardium or need for pericardiocentesis.

Result:

220 patients had permanent pacemaker and 56 patients had ICD or CRT. Radiologic cardiac perforation was shown in 6.6% of total leads. Radiologic cardiac perforation of screw ventricular leads was significantly more frequent than tined ventricular leads (12.8% and 3.8%, respectively, p=0.006). There are no significant differences in cardiac perforation between atrial and ventricular leads (5.0% and 7.9%, respectively, p=0.386), between screw and tined atrial leads (6.4% and 3.3%, respectively, p=0.351), between pacing and defibrillator ventricular leads (7.0% and 11.3%, respectively, p=0.390), between MR‐­conditional and MR‐­unsafe ventricular leads (9.5% and 6.3%, respectively, p=0.768). There was no radiologic cardiac perforation in the case of septal ventricular leads. Also, 4 clinical perforations (0.08%) were documented and three in four had the history of anticoagulation.

Conclusion:

Radiologic cardiac perforation by CIED leads is not rare. For reducing cardiac perforation by a screwed ventricular CIED lead, septal pacing strategy may help the physicians in case of high‐­ risk patients.

AP19‐­00774

Right ventricular pacing causes RV dysfunction ‐­ a 2D/3D Echocardiographic study

Kunal Sinkar, Neeta Bachani, Raghav Bansal, Ankit Mahajan, Chetan Rathi, Robin Pinto, Yash Lokhandwala

Holy Family Hospital, India

Introduction:

Right Ventricular (RV) apical pacing, though generally well‐­tolerated, may have detrimental cardiac effects, and the pacemaker (PM) lead can cause tricuspid valve regurgitation (TR). The effect of PM on Left ventricular (LV) contractility and synchrony are well demonstrated, but little is known about its influence on RV function. The complex geometry of the RV makes its evaluation more difficult than the LV. Traditionally the RV has been largely considered a conduit ventricle and thus has been the neglected ventricle. However, in recent times the effect of RV function affecting prognosis in heart failure patients has rejuvenated interest in RV dysfunction. Assessment of TR and evaluation of RV function after pacemaker implantation was study objective.

Methods:

The study was performed in 40 patients who required permanent PM for AV block in structurally normal heart. The baseline right sided echocardiographic parameters including 3D RVEF (Ejection fraction) following RV pacing, within 24 hours and at follow up of 6 months.

Result:

The age was 70+11 years. Immediately post PM implantation (within 24 hours), there was no change in the grade of TR. However, during follow up at 6 months, 9 subjects (22.5%) developed TR, though this was mild in 1 patient and trivial in 8 subjects. The pulmonary arterial systolic pressure (PASP) didn't change immediately post‐­PM (within 24 hours). However, at follow up after 6 months, the mean PASP increased 25.13 + 0.791 mm Hg vs 31.38 + 11.821 mm Hg, p = (0.002). This was likely related to left ventricular diastolic dysfunction which was unmasked or increased by right ventricular pacing. The RVEF was found to be significantly depressed both soon after PM insertion and at follow up (Table).

Conclusion:

TR develops in a significant proportion of patients who undergo RV pacing, and its severity increases with time. There is mild RV dysfunction post‐­PM, which increases over the course of six months. RV ventricle dysfunction was not related to presence of TR and without significant dilatation of right side of heart. Absence of TR should not be taken as sole evidence of absence of RV dysfunction.

TABLE ‐ Right ventricular pacing causes RV dysfunction ‐­ a 2D/3D Echocardiographic study

Parameter group	Parameter	Baseline	Post‐­Pacemaker implantation	p value	At 6‐­months follow‐­up	p value
RV DIMENSION
A. RVOT PROXIMAL	Right ventricular outflow tract (RVOT) PROXIMAL – mm	22.8±3.3	23.2±3.3	0.3347	24.2±3.3	0.0260
B. RVOT DISTAL	Right ventricular outflow tract (RVOT) DISTAL‐­ mm	20.5±3.1	20.7±2.7	0.5148	20.7±2.5	0.5442
C. RV LENGTH	Right ventricle (RV) LENGTH ‐­ mm	59.9±6.8	59.4±6.3	0.3062	59.7±6.6	0.8783
D. RV BASAL DIAMETER	Right ventricle (RV) BASAL DIAMETER‐­ mm	29.2±4.9	29.1±4.7	0.8164	29.2±4.2	1
E. RV MID DIAMETER	Right ventricle (RV) MID DIAMETER‐­ mm	26.0±5.2	26.2±4.4	0.7045	25.4±3.8	0.4198
RA DIMENSIONS
A. RA MAJOR	Right atrial (RA) MAJOR‐­mm	37.2±6.3	36.8±5.7	0.3837	37.4±6.5	0.7826
B. RA MINOR	Right atrial(RA) MINOR‐­mm	30.9±6.7	31.0±5.9	0.8780	30.5±6.5	0.6001
TR SEVERITY
A. TR grade	Tricuspid regurgitation (TR) GRADE (COLOUR FLOW) (Normal; Trivial; Mild )	39:1	39:1	NS	30:8:1	0.0104
B. PASP	Pulmonary arterial systolic pressure(PASP) ‐­mm Hg	25.13 + 0.791	25.13 + 0.791	1.000	31.38 + 11.821	0.002
RV function
A. FAC	Fractional area change(FAC) ‐­ %	42.5±3.8	42.0±4.1	0.0164	39.4±5.8	0.0002
B. TAPSE	Tricuspid annular plane systolic excursion (TAPSE) ‐­mm	18.6±3.9	17.7±3.2	0.0462	15.5±4.5	0.0001
C. RIMP	Right index of myocardial performance (RIMP)Tissue doppler (TD)	0.64±0.1	0.63±0.1	0.2334	0.61±0.1	0.0443
D. VELOCITY	Systolic (S ‘) VELOCITY ‐­ cm/sec	13.7±2.4	13.1±2.1	0.0301	10.7±2.4	<0.0001
E. E/E ‘	Right ventricle (RV) (E/E’)	9.7±2.0	8.4±2.2	0.0001	7.8±2.2	<0.0001
F. RVEF (3D)	Right ventricular (RV) Ejection fraction(EF) ‐­ %	47.5±5.9	46.3±5.4	0.0026	44.7±7.9	0.0078

AP19‐­00775

The BIO|CONCEPT.BIOMONITOR III study: sensing performance and home monitoring transmission success of a new miniaturized implantable cardiac monitor

Justin Mariani, Sam Lovibond, Paul Gould, Rusken Weerasooriya, Rajeev Pathak, Tina Lin, Ian Matthews, Kushwin Rajamani, Dennis Lau

Alfred Hospital, Australia

Introduction:

Implantable Cardiac Monitors (ICMs) are widely used for the long‐­term detection and monitoring of cardiac arrhythmias. The BIOMONITOR III device (BM III, Biotronik, Germany) is a novel miniaturized ICM. BM III uses the established BIOTRONIK Home Monitoring system to transmit daily messages that contain arrhythmia detection statistics, subcutaneous ECG episodes and data on device sensing performance. In BM III, fractal coating of electrode tips and improved signal filtering were introduced to improve visibility of P‐­waves signals as an important diagnostic criterion.

Methods:

In this prospective, non‐­randomized trial (CT‐­ID: NCT03850327), we investigated the sensing performance of the BM III device in 47 patients at 10 Australian sites. Patients were enrolled with ICM‐­indications of syncope/pre‐­syncope, cryptogenic stroke and AF monitoring. During a 1‐­month observation period, Home Monitoring data were evaluated for R‐­wave amplitude, noise burden and overall home monitoring transmission success. Noise burden is the fraction of daily time during which sensing is restricted by noise, e.g. electrical interference or muscle potentials. Transmission success is the percentage of days with a message between first and last message. Additionally, 15 investigators assessed ECG recordings for visibility of P‐­waves, which is reported as fraction of expected P‐­waves which were unequivocally identified by the physician.

Result:

44 patients transmitted data. The overall transmission success was 96.7%. Averaged R‐­waves from 44 patients were 0.69 ± 0.38 mV. Reported separately for each week after insertion, amplitude values showed no recognizable trend. The daily variability of the R‐­wave was 0.044 ± 0.028 mV (standard deviation of R‐­waves of each patient). After one week, noise burden stabilized near 1%, with 0.9 ± 1.7% in week 2 and 1.1 ± 1.9% in week 4 after insertion. Periodic subcutaneous ECGs from the Home Monitoring Service Centre were evaluated by 15 investigators. Evaluation of 83 sECGs from 28 patients yielded a mean P‐­wave visibility of 91.3 ± 22.1%, with a median value of 100%. Low P‐­ wave visibility was a rare exception, so that a major fraction of assessments (83%) showed a P‐­wave visibility of >90%

Conclusion:

Analysis from Home Monitoring data from this clinical investigation showed that the novel BM III provided the established high level of transmission success during the 1‐­month observation period. The mean R‐­wave amplitude of 0.69 mV corresponds to the long sensing vector which is derived from the predecessor device, BioMonitor 2. Low noise burden and excellent P‐­wave visibility of BM III represent improvements in sensing performance which might increase the diagnostic value of BM III.

AP19‐­00786

Device algorithm interaction resulting in loss of biventricular pacing in CRT

Suchit Majumdar

Apollo Gleneagles Hospital, Kolkata, India

Introduction:

46 yrs. gentleman with recurrent heart failure due to dilated cardiomyopathy was implanted CRTP (Abbott). LV lead was placed epicardial due to inability to deliver coronary sinus venous lead endocardially. On routine follow up noted to have multiple counts of AMS (Automatic mode switch) resulting in temporary loss of biventricular pacing. Apart from this the lead parameters are normal.

Methods:

Not Applicable.

Result:

On evaluation of the AMS, we found an interesting phenomenon that the AMS episodes were not triggered by any atrial arrhythmia. Rather there was prior automatic shortening of programmed sensed AV delay (SAV) from 100ms to 20ms. Normally, there was far field R wave (FFRW) sensing in the atrial channel which fell into PVAB (post ventricular atrial blanking period). The FFRW sensing mostly depends on sensing of R waves from RV by lead in RA. With SAV shortening, the FFRW did not advance and fell outside the PVAB but into PVARP and was counted as an atrial event but not tracked. This erroneous counting of atrial events resulted in reaching the AMS set sate of 180 atrial events per minute and triggered the AMS The AMS resulted in changing into DDI mode and AS VS pacing. Here the sudden decrease of sensed AV delay was due to periodic checking of lead threshold by LV cap confirm algorithm by the device which in turn triggered the AMS episodes. There is decrease of sensed AV delay in LV cap confirm to ensure that intrinsically conduction QRS doesn't interfere with threshold testing. The cause of nonadvancement of FFRW is the late activation of RV from LV in presence of LBBB and need for transseptal conduction. LV cap confirm is an algorithm to automatically measure LV threshold and adjust pacing amplitude according to it. Far field R wave (FFRW) oversensing depends on the relative amplitudes of atrial EGM and FFRW, the timing and gap between them and the variability of oversensing FFRW. FFRW can be managed by increasing atrial sensitivity in patients with AEGM:FFRW ratio >2:1. In St Jude devices, the decay delay can be reduced, and initial sensitivity threshold can be increased to avoid FFRW. If all these are not successful, the PVAB (post ventricular atrial blanking) period can be increased. In this case, the AEGM: FFRW ratio was >4:1. Hence the atrial sensitivity was increased which resulted in no more AMS episodes after that.

Conclusion:

Device algorithms for automatic threshold testing in CRT can occasionally lead to erroneous triggering of safety algorithms like AMS and can result in loss of biventricular pacing. Device manufacturers should take care that triggering of AMS should not occur if the device itself is running some tests. Also, there should be labelling of the threshold tests in the EGM from the device so that the physician can easily make out the cause of such phenomenon.

AP19‐­00789

A midterm assessment of LV function using 3‐­D speckle tracking echo and pacing parameters in selective his bundle pacing vs RV apical pacing patients

Sai Krishna Yerramareddy, VS Prakash

M S Ramaiah Medical College, India

Introduction:

Recent studies have demonstrated that right ventricular apical (RVA) pacing has a deleterious impact on left ventricular function, His bundle pacing (HBP) is a physiological alternative to RVP. This study sought to evaluate the mid‐­term effects of HBP VS RVP by 3D speckle echo by GLS and compare the lead parameters at 6 months post‐­implantation.

Methods:

Selective HBP candidates (n = 36) were compared to RV apical pacing candidates (n = 38) who met class I or class IIa indications for pacemaker implantation as given by the American College of Cardiology Foundation/American Heart Association and the Heart Rhythm Society updated guidelines. The state in which the QRS duration was as narrow as the intrinsic duration during relatively low output but was wider during high output was considered to be SHBP. All patients underwent 3D speckle echo (Global longitudinal strain) at the time of implantations and 6 months post procedure. Pacing parameters such as pacing threshold, lead impedance, and sensing amplitude were tested after lead fixation and after 6 months post procedure.

Result:

GLS in the RV pacing was −17.18 with SD of 2.06 at the time of the procedure, 6 months post procedure there was a significant reduction in the GLS (−16.33 with SD of 1.96) with P value <0.001. There was no difference in the LV ejection fraction between the two groups. Stimulation thresholds were 1.12 ± 0.47 in the HBP at the time of implantation, the thresholds at 6 months post procedure significantly increased to 1.56 ± 1.30. In comparison, RVP stimulation thresholds were 1.06±0.74 at the time of implantation and decreased to 0.96±0.29 6 months post procedure. The lead impedance of the HIS lead was 774.56 with SD of 179.75 at the time of implantation and the impedance decreased to 589.89 with SD of 114.80 at 6 months follow up, The RV lead had an impedance of 750.95 with SD of 136.96, the impedance decreased to 609.20 with SD of 145.17. No significant differences were detected between the two groups during the 6‐­month observation. The R‐­wave amplitudes were relatively lower in the SHBP group at baseline (5.8 ± 2.3 vs 10.2 ± 4.8 mV) and were stable 6‐­month follow‐­up visits No differences were noted in ventricular pacing (%) during follow‐­up. The QRS duration was significantly narrower in the HBP group compared to the RV pacing group.

Conclusion:

In conclusion, the RVP group had a significant reduction in GLS 6 months post procedure, The HBP group had stable GLS, a significantly narrower QRS duration, with increased stimulation thresholds, and the R wave amplitude was significantly lower in the HBP group compared to the RV pacing group.

AP19‐­00791

Acute and mid‐­term outcomes of subcutaneous implantable cardioverter defibrillator therapy in patients at risk of ventricular tachyarrhythmia: a single‐­center experience in Japan

Kenichi Iijima, Daisuke Izumi, Yasuhiro Ikami, Yuki Hasegawa, Sou Otuki, Nobue Yagihara, Akinori Sato, Masaomi Chinushi, Tohru Minamino

Niigata University Graduate School of Medical and Dental Sciences, Japan

Introduction:

Subcutaneous implantable cardioverter defibrillator (S‐­ICD; EMBLEM S‐­ICD, Boston Scientific, USA) was launched in February 2016 in Japan. S‐­ICD is characterized by no need for transvenous leads that can cause serious complications during implantation and long‐­term use of defibrillators. S‐­ICD has been expected to make patient care with defibrillators safer. However, our clinical experience with S‐­ICD is even less than that with conventional transvenous ICD (TV‐­ICD).

Methods:

To investigate efficacy and safety of S‐­ICD, we retrospectively compared outcomes of two patient groups who underwent the implantation of defibrillators (S‐­ICD group, n=49, and TV‐­ICD group, n=69). TV‐­ICD group, set as a historical control, consisted of patients who received TV‐­ICD before the launch of S‐­ICD (from 2012 to 2106) and who had neither history of monomorphic ventricular tachycardia nor need for pacing for bradycardia. We investigated outcomes of the patient groups such as initial success rate of implantations, procedure time, types and incidence of acute and mid‐­term complications, and incidence of appropriate or inappropriate shock delivery.

Result:

All S‐­ICD recipients passed the screening of surface electrocardiogram simulating sensing vectors of S‐­ICD in at least one vector. Defibrillators were successfully implanted in all patients of both groups. Procedure time was shorter in S‐­ICD group (95.4 ± 22 min. vs. 123 ± 36 min., p<0.01). There was no complication associated with implantation in the S‐­ICD group. In TV‐­ICD group, some acute complications occurred and most of them were associated with intravenous leads (lead dislodgement in 3 (4%), right ventricular perforation by the lead in 2 (3%), device infection in 1 (1%), and hematoma in the generator pocket in 1 (1%)). In the mid‐­term follow up, neither syncope nor sudden death due to improper detection or therapy of arrhythmia was observed in both groups. In the follow up of S‐­ICD patients for 690 days on average, appropriate shocks for ventricular tachyarrhythmias occurred in 4 patients (8%). Inappropriate shocks occurred in 3 (6%) due to supraventricular tachycardia or noise sensing. In 3 (6%) patients in S‐­ICD group, late‐­onset sensing malfunction (lowering of QRS wave amplitude or noise sensing) was observed on average 13 months after implantation and inappropriate shock was triggered by the noise in 1 patient.

Conclusion:

S‐­ICD can be implanted with less risk and invasion compared with TV‐­ICD. All the ventricular tachyarrhythmia events were properly treated with S‐­ICD. In some patients with S‐­ICD, late‐­ onset sensing malfunction developed in their mid‐­term follow up. Thus, paying continuous attention to the status of sensing may be more important in the patient care with S‐­ICD. Long‐­term efficacy and safety outcomes of S‐­ICD need to be further investigated.

AP19‐­00812

Ventricular‐­side His bundle pacing using a mapping system

Minsi Cai, Yi‐ran Hu, Wei Hua, Shu Zhang

Fuwai Hospital, China

Introduction:

Permanent His‐­bundle pacing (HBP) has emerged as a promising approach to delivering physiological pacing, maintaining long‐­term ventricular synchrony. According to anatomic site of HB, the pacing site can be divided into two sides, the atrial‐­side and ventricular‐­side HBP (v‐­HBP). At present, there is no approach reported for purposely guiding v‐­HBP in the course of implantation

Methods:

(1) The construction of 3‐­dimentional (3D) right atrium (RA) geometry and tagging of the ventricular HB potential: three orthogonal pairs of electrode patches were placed on patients’ skins, in order to create the required three‐­dimensional electrical navigation field. Surface patches were used as reference. Under local anesthesia, right femoral vein was punctured and a short 6F sheath was advanced into the vein. Using a quadripolar mapping catheter (Model 410443, St. Jude Medical, Inc., St. Paul, MN, USA) connected by NavX system, the three‐­dimension electroanatomic map of the superior vena cava (SVC), inferior vena cava (IVC), RA appendage (RAA), tricuspid valve annulus (TVA) and right ventricular were created (Figure 1A/B). Then, the ventricular HB potential was mapped and tagged using the following criteria: mapping at the TVA toward the HB region, only His (H)‐­ventricular (V) potential but without atrial (A) potential was recorded by intra‐­cardiac electrogram (EGM) of Ensite NavX system (Figure 1C). (2) Implantation of HB lead guided by NavX system: under local anesthesia, the left subclavian vein was punctured and a short 8F sheath (Model HLS‐­1008M, Medtronic, Inc.) was advanced over a guidewire to retain access. The C315 His sheath (Medtronic, Minneapolis, MN, USA) was advanced into the RA via the guidewire. Then, the Select Secure pacing lead (Model 3830‐­69cm, Medtronic, Minneapolis, MN, USA) was advanced to the tip of the sheath. The tip and the ring of the HB lead were required to be beyond the terminal part of the sheath a little (otherwise the shape of lead was deformed due to the proximal electrode within the sheath) in order to provide bipolar connections for HB potential recording (bipolar fashion). The lead was guided by NavX system to the tagged HB, and was screwed in the region of HB using 4–5 clockwise rotations when EGM showed H‐­V potential without A potential.

Result:

The final pacing parameters in this location were as follows: HB capture threshold was 0.7V at 1.0ms; local myocardial capture threshold was 2.8V at 1.0ms, R‐­wave amplitude was 5.8mV (Figure 2). Finally, contrast medium was injected through His sheath to show the v‐­HBP site under fluoroscopy (Figure 3A).

Conclusion:

The achieved v‐­HBP not only had the advantage of a lower and more stable HBP capture threshold, and a higher ventricular sensing amplitude, but also extremely‐­low fluoroscopy exposure. Nevertheless, long‐­term follow‐­up and more further researches are needed to be implemented.

AP19‐­00826

Venoplasty as an alternative or adjunct for high risk patients referred for transvenous lead extraction

Leigh Cummins, Andrew Mamo, Virag Kushwaha, Sean Gomes

Prince of Wales Hospital, Australia

Introduction:

Venous obstruction is a relatively uncommon, but potentially serious complication of cardiovascular implantable electronic device (CIED) implantation. Obstruction may present with symptoms or complications from ‘upstream’ venous congestion. Obstruction may also limit the ability to replace non‐­functional leads or perform device upgrades. Traditionally, patients with obstruction requiring intervention have had lead extraction or open surgery as the only options for intervention. More recently, venoplasty has emerged as an alternative option for the treatment of CIED related venous obstruction. We present data from a consecutive case series of patients managed at our institution for CIED associated venous obstruction, which were managed with venoplasty as an adjunct or alternative to transvenous lead extraction.

Methods:

We conducted a combined retrospective and prospective examination of cases managed at our institution over a three‐­year period for venous obstructive complications of CIEDs, and reviewed cases which were managed with venoplasty procedures. All patients were initially referred for transvenous lead extraction. We collected baseline demographic and clinical/device data, obstructive complication data, details of the extraction procedure, and procedural outcome data. We also detail our institution's typical approach to venoplasty, and highlight the emerging role this procedure has in the management of complex CIED patients.

Result:

Over the review period we performed five venoplasty procedures for venous obstructive complications of CIEDs. 80% of cases were female. The median age was 61 years [range: 37‐­75 years]. 80% were performed in order to allow exchange, upgrade or introduction of further CIED leads, which had been otherwise impossible because of venous obstruction. The remaining case was performed (in combination with lead extraction) to alleviate symptomatic SVC obstruction. 80% of cases had two device leads in situ prior to venoplasty; the remaining case had three leads in situ. All cases were successful in overcoming venous obstruction, resulting in passage of new leads in the cases for which this was indicated. All cases had significant improvement in luminal calibre on venogram at the completion of the procedure. The case involving SVC obstruction demonstrated significant symptomatic improvement, and resolution of clinical signs of obstruction at the time of follow‐­up. There were no peri‐­ procedural complications.

Conclusion:

Review of these cases demonstrates that venoplasty can be performed safely and effectively in select patients who have venous obstruction complicating CIED implantation. Venoplasty has the potential to relieve symptoms from venous occlusions, as well as to potentiate introduction of new device leads (for example, in the setting of upgrading to a biventricular or defibrillator system, or in the setting of existing lead failure).

AP19‐­00831

Pocket infection does not always occur soon after device operation

Hiroshi Furusho, Keisuke Usuda, Satoshi Niwa, Toyonobu Tsuda, Takeshi Kato, Kenji Sakata, Soichiro Usui, Kenshi Hayashi, Masayuki Takamura

Kanazawa University Hospital, Japan

Introduction:

Even infection is localized at the device‐­pocket, all device extraction is recommended as class I indication. It is well known that pocket infection occur more often after device exchange than after new implantation. However, the duration between the device operation and the infection event and also the background‐­factor affecting the duration are not well‐­known.

Methods:

We retrospectively studied 48 patients who underwent transvenous lead extraction in our hospital after 2011. Among them, 26 cases (18 males) who suffered pocket‐­only infections (group PI) were included, and also, 14 non‐­infected cases (group N) were studied as control.

Result:

Mean age of group PI was 70±14 years (62±11 in group N, p=0.08), and their body‐­mass index was 21±4 (24±2.9 in group N, p=0.03). Their underlying arrhythmia were 3 sick‐­sinus syndrome, 9 atrio‐­ ventricular block, 3 bradycardic atrial fibrillation, and 6 ventricular‐­tachycardia / ‐­fibrillation. Nineteen pacemakers and 7 Implantable cardioverter defibrillator (ICD)s had been implanted. Ten suffered hypertension, 6 diabetes mellitus, 6 coronary artery diseases and 1 renal failure on hemodialysis. Causative agents included 8 CNS, 3 Streptococcus epidermidis, 3 MSSA, 1 MRSA, and 3 Corynebacterium. At the pocket site, device or leads were prolapsed from the skin in 9 cases, and discharge of pus was seen in 13 cases on admission. Mean duration from last device implantation or exchange operation was shorter in group P (1.7±1.9 years vs 4.3±2.6 years in group N, p=0.003), among the 26 patients in group, the duration was less than 3 mouths in 4 cases, 3 mouths to 1 year in 9 cases, and more than 1 year in 13 (50%) cases.

Conclusion:

Pocket‐­only infection cases were rather old, skinny, and having some infection risks. The triggering infection for extraction in these cases does not always occur close to their previous operation. Therefore, continuous care on pocket‐­site may be important for such high‐­risk patients.

AP19‐­00855

Introducing an externalized permanent active fixation pacing as a safest approach in patients requiring prolonged temporary pacing

Haseeb Raza

National Institute of Cardiovascular Diseases, Pakistan

Introduction:

Temporary‐­permanent (T‐­P) pacemakers can serve as safest, short‐­term, easily implanted and stable temporary pacing option in various acute clinical conditions. Managing patients with systemic infections and concurrent need for acute pacing due to new‐­onset of hemodynamic relevant bradycardia such as at high grade AV‐­block is very difficult. Immediate permanent pacemaker implantation is deferred in patients with severe sepsis or other related medical conditions. So prolonged temporary pacing is needed as a bridging therapy. The complication rate of temporary pacing including dislodgement of pacing leads is significantly rising which can lead to further morbidity and mortality of the patient. To minimize this complication, an active fixation permanent pacing approach was introduced.

Methods:

52 year old female patient, presented in the emergency department with complaints of dizziness. Examination showed lower rate of radial pulse with BP 150/70 mmHg .Chest was clear to auscultation and there was no neurological deficit .ECG showed complete heart block so TPM passed (via right subclavian vein) in the emergency department to save the patient. Labs were collected which showed increased TLC, referring to underlying infection. Antibiotic cover was started. As the infection may take more than a week to resolve, it was planned to proceed for external PPM (Temporary PPM) because the patient became TPM dependent meanwhile and we could not afford to lose the patient if the TPM gets dislodged during the infection resolution time. So using Right internal jugular vein approach, single chamber VVIR generator was fixed to the right side of neck with the RV lead actively fixed to the RV apex. After the resolution of infection, Dual chamber PPM was implanted on the left side via left subclavian vein approach and external PPM was removed.

Result:

Patient was discharged and asked to visit Pacemaker clinic after 3 days. She was asymptomatic and doing well.

Conclusion:

The purpose of presenting this is that patients presenting with severe sepsis or other indications who defer permanent pacemaker implantation requiring prolonged temporary cardiac pacing can be benefitted by implantation with active‐­fixation permanent pacing. It is a safe, effective, and convenient method. Subclavian approach is more comfortable than internal jugular access. Externalized permanent active‐­fixation pacemaker lead connected to a permanent pacemaker generator for temporary pacing may also be beneficial because of improved lead stability, and greater patient mobility and comfort. This technique is cost effective, improves the quality of life and minimizes the risks and complications associated with the immobilization of the patients.

Keywords: Temporary pacing; Complete Heart Block;Temporary‐­permanent active fixation; dislodgement; severe sepsis; externalized pacemaker

AP19‐­00856

Significance of basic modalities in diagnosis and management of inadvertent placement of temporary pacemaker leads

Haseeb Raza

National Institute of Cardiovascular Diseases, Pakistan

Introduction:

Temporary cardiac pacing, can be a lifesaving process, involves electrical cardiac stimulation to treat bradyarrhythmia or tachyarrhythmia until it resolves or until long term therapy can be initiated. (1) Inadvertent malposition of pacing leads is a recognized complication of the procedure, which can be fatal particularly if lead placement is in the left ventricular cavity because of the risk of thromboembolic events. Malposition leads can be either due to unrecognized congenital heart defects including atrial or ventricular septal defects, Patent foramen ovale or due to iatrogenic perforation of interventricular septum but sometimes it may be due to faulty insertion via trans‐­arterial instead of trans‐­ venous access.

Methods:

47 year old female had history of syncopal episode one day ago while she was working in her house as well as previous history of pre syncopal episodes which lasted for 2‐­3 minutes. She had no history of diabetes, hypertension, and stroke/transient ischemic attacks. Her attendants took her to nearby hospital where her electrocardiogram showed complete heart block. On examination, blood pressure was 100/70 mmHg, pulse rate was 46 bpm, cardiovascular and respiratory examination was unremarkable. On duty doctor took the consent for temporary pacemaker placement and placed the temporary pacemaker lead via right femoral approach without fluoroscopic guidance. After hemodynamic stabilization she was referred to our electrophysiology center for further management. She landed in our electrophysiology department, when evaluated, she was hemodynamically stable and her electrocardiogram showed pacing spikes with appropriate capture but with R wave in lead V1. This led to the suspicion of pacing lead malposition resulting in left ventricular pacing via interventricular septum perforation. There were no post procedure chest x‐­ray or electrocardiogram records available. So patient was directly taken to the electrophysiology lab, lied down under the fluoroscopy to visualize the lead and the lead was found to be present in the left ventricle but it did not perforated the interventricular septum, in fact the lead entered the left ventricle through aorta i.e. right femoral artery was punctured by the first doctor which led the way to the left ventricular cavity. The condition was explained to the patient and again consent was taken to pass another temporary pacemaker via the right sub‐­clavian approach followed by removal of the lead present in the left ventricle. This time the electrophysiologist placed the new temporary pacemaker lead to the Right ventricle apex successfully and removed the lead present in the left ventricle.

Result:

Patient had no reversible cause for the complete heart block so Dual chamber Permanent Pacemaker was implanted the next day via left subclavian access. She was discharged next day after the procedure and is active in her daily activities now.

Conclusion:

We have reported these cases to emphasize the importance of post procedural investigations which are easily available even at primary care centers including 12‐­lead electrocardiography and chest X‐­ray. These modalities are very helpful in early detection and management of inadvertent lead placement and may help in avoiding life threatening complications.

Keywords: Inadvertent lead placement, septal perforation, electrocardiogram, chest x‐­ray, fluoroscopy, temporary pacemaker, paced rhythm

AP19‐­00859

Device‐­based discriminators to improve performance of arrhythmia detections in an insertable cardiac monitor

Fujian Qu, Fady Dawoud, Benjamin Coppola, Joanna Urbanski, Neha Malhotra, John Gill, Pritika Toutam, Kyungmoo Ryu, Avi Fischer

Abbott, United States

Introduction:

Insertable cardiac monitors (ICMs) are being increasingly used to diagnose arrhythmias. An enhancement in arrhythmia diagnostic algorithms in Confirm Rx^™ ICM was sought to improve the detection of arrhythmias while maintaining sensitivity. The objective of this study was to develop and validate new discriminators to reduce the incidence of inappropriate detections of bradycardia, pause, and atrial fibrillation (AF) episodes.

Methods:

Stored electrograms (SEGMs) of episodes detected by Confirm Rx ICM were adjudicated and the root cause of inappropriate detections characterized. One set of SEGMs (training set) was used to develop new discriminators. A second set of SEGMs (validation set) was used to validate the new discriminators by applying the discriminators to existing detections of pause/bradycardia/AF episodes. The percentage of reduction in false positives and true positives by the discriminators was determined.

Result:

For the training set, 3,804 bradycardia, 3,164 pause, and 59 AF detections were used from 53, 87, and 14 patients, respectively. The training set revealed that undersensing of low amplitude signals was the primary reason for inappropriate pause/bradycardia detection. Sinus rhythm with irregular R‐­R intervals, frequent ventricular premature contractions, and inaccurate R wave sensing contributed to inappropriate AF detection. The validation set consisted of 1,411 bradycardia, 2,265 pause, and 136 AF detections from 790, 928, and 35 patients, respectively. The new discriminators reduced inappropriate bradycardia, pause, and AF episodes by 99%, 99%, and 61%, respectively, with minimal reduction in sensitivity (100%, 98%, and 99% retained, respectively).

Conclusion:

These results demonstrate that discriminators substantially reduce inappropriate Confirm Rx ICM detection with minimal effect on sensitivity. Implementation of these new algorithms may lead to reduced episode review burden, improved clinic workflow, and improved patient management.

AP19‐­00860

Evaluation of new algorithm enhancements to improve accuracy of arrhythmia detections in an insertable cardiac monitor

Peter Paul Delnoy, Colin Movsowitz, Fujian Qu, Kevin Davis, Kyungmoo Ryu, Avi Fischer, Opesanmi Esan

Abbott, United States

Introduction:

Recent enhancements in Abbott Confirm Rx^™ insertable cardiac monitor (ICM) arrhythmia detection algorithms (SharpSense^™ Technology) aim to improve the positive predictive value for arrhythmia detection while maintaining high sensitivity. In this analysis, we sought to characterize the clinical performance of the newly developed SharpSense^™ Technology.

Methods:

De‐­identified device episodes from a set of Confirm Rx^™ devices with complaints related to false episodes were extracted from Merlin.net patient care network for the evaluation. All episodes were manually adjudicated to determine if the episodes were true or false, then run through SharpSense^™ algorithms.

Result:

A total of 25,359 episodes (from 40 devices/ 3 clinics) were analyzed (pause: 19,107 [75%], bradycardia: 5,591 [22%] and atrial fibrillation (AF): 661 [3%]). Devices were implanted between May 2017 and Jan 2019 for syncope (60.0%), AF‐­related (21.4%), and other including cryptogenic stroke and palpitations (18.6%). Median duration of device follow‐­up was 116 days with an interquartile range of 39 days. SharpSense^™ technology reduced false pauses, bradycardia, and AF episodes by 98.2%, 98.7%, and 49.5%, respectively, with 1.0%, 0.0%, and 0.0% reduction in true episodes, respectively. Overall reduction in false positive episodes was 96.9% while maintaining high relative sensitivity (compared to without SharpSense) of 99.7%.

Conclusion:

This analysis demonstrates that the newly developed SharpSense^™ algorithms significantly reduce false pause, bradycardia, and AF episodes with minimal reduction in true episode detection.

AP19‐­00861

Achievement of arrhythmogenicity after the first appropriate therapy in patients with primary prevention of ICD. – Sub‐­analysis of NIPPON STORM STUDY –

Yasuhito Kotake, Ryobun Yasuoka, Motohide Tanaka, Tomoya Nagano, Masahiro Maruyama, Takashi Noda, Takashi Nitta, Yoshifusa Aizawa, Tohru Ohe, Takashi Kurita

Kindai University, Japan

Introduction:

Arrhythmogenicity in patients with primary prevention of ICD (1ry‐­pts) is thought to still have not been accomplished because several clinical data showed lower incidence of appropriate ICD therapy (app‐­Tx) in 1ry‐­pts compared with secondary ICD patients (2nd‐­pts). We hypothesized that the substrates for VT/VF in 1ry‐­pts have deteriorated to the same extent as 2nd‐­pts after 1st app‐­Tx.

Methods:

To test our hypothesis, we conducted sub‐­analysis of the NIPPON Storm Study, which was a prospective observational study involving 985 patients with structural heart disease (LVEF≦50%) enrolled from 48 Japanese centers. Incidence of 1st app‐­Tx was compared between 1ry‐­pts (n=531) and 2nd‐­pts (n=454). Further, we selected 251 patients (62±14 yo, 82% male) who experienced at least one appropriate ICD therapy, and compared occurrence of 2nd app‐­Tx between 1ry‐­pts (n=116) and 2nd‐­pts (n=135).

Result:

1st app‐­Tx was observed significantly higher in 2nd‐­pts than 1ry‐­pts (log‐­rank p=0.0013, Figure). However, there was no significant difference in subsequent 2nd app‐­Tx between 1ry‐­pts and 2nd‐­pts (log‐­ rank p=0.8141, Figure). In addition, we evaluated incidence of 2nd app‐­Tx according to respective basal structural disease, i.e., ischemic and non‐­ischemic cardiomyopathy, and found no significant differences between1ry‐­pts and 2nd‐­pts among these sub‐­groups (log‐­rank p=0.2613 and p=0.9801 respectively).

Conclusion:

Once an app‐­Tx occurred, arrhythmogenicity may have been accomplished in 1ry‐­pts because there was a comparable incidence of subsequent app‐­Tx to 2nd‐­pts.

AP19‐­00875

Successful development of cardiac resynchronization therapy (CRT) device implantation service in a small centre in APHRS region: decade long contemporary single‐­centre experience

Becky (Yi‐Wen) Liao, Dean Boddington, Charles Yao‐Cheng Ho

Bay of Plenty District Health Board‐­ Tauranga Hospital, New Zealand

Introduction:

Tauranga Hospital, serving a population around 250 000, commenced CRT pacing services in 2009 with two operators who had experience with pacemaker and ICD implantation but no prior experience with CRT devices. An overall strategy of procedural safety was put in place with specific strategy of cephalic vein access for all leads where possible. We reviewed results of CRT‐­P/CRT‐­ D implantation at our centre from inception of service through the following 10 years.

Methods:

Data for consecutive patients undergoing CRT‐­P/D implantation or device replacement at Tauranga Hospital from April 2009 to July 2019 were retrospectively collected for characteristics and outcomes from electronic records and pacing database. Two authors collected data to ensure accuracy.

Result:

Total of 131 procedures studied. Patient mean age was 68±9 years and 80% were male. There were 70 (53%) new CRT‐­Ds implanted and 42 (32%) new CRT‐­Ps. 19 (17%) of procedures were upgrades. All patients had cardiomyopathy of which 60% were non‐­ischaemic. 76% of devices were implanted for cardiomyopathy with LBBB. The rest were for pacing induced cardiomyopathy or patients with cardiomyopathy and heart block. Majority (80%) of patients were in sinus rhythm. First procedure successful implantation was achieved in 100/108 (92%) new CRT procedures but 4 developed phrenic nerve stimulation causing abandonment of LV pacing. 7 (6%) patients had a second procedure performed. Two repeat procedures were performed to reposition LV lead because of phrenic nerve stimulation. Of the 8 patients in whom LV lead could not be positioned during first procedure, 2 had successful LV lead positioning with a second procedure at the same centre; 3 had successful positioning of an LV lead at another centre; and 1 had a His bundle pacing lead implanted at the same centre. Procedural complications included two haematomas (1.5%), one right atrial lead dislodgement (0.9%), one left ventricular lead dislodgement (0.9%) and one small pneumothorax (0.9%) not requiring an intercostal drain. There were no infections, cardiac perforations/tamponade or deaths. Improvements in LV Ejection Fraction (>10%) occurred in 48% of patients at follow‐­up.

Conclusion:

In this audit of CRT‐­P/D procedures performed at Tauranga Hospital, 6% of patients required a second procedure to achieve an acceptable overall 93% successful rate of delivery of long term CRT pacing. A further 3% were referred to another centre and have achieved successful CRT therapy. Apart from the requirement for repeat procedure, the complication rate was very low. We believe the strategy of gaining cephalic vein access for all leads where possible has contributed to success and the low complication rate. The study demonstrates that CRT can be safely and successfully performed in a relatively low volume centre if strategically implemented.

AP19‐­00889

An overview of clinical outcomes in implantable cardioverter defibrillator implantation in thailand: a single‐­center experience

Nattakorn Songsirisuk

KCMH, Thailand

Introduction:

The implantable cardioverter defibrillator (ICD) is an important tool to prevent sudden cardiac death. There was long experience of ICD implantation in Thailand, but the incidence of ICD shocks in Thai patients has never been studied.

Methods:

This study was conducted in a tertiary referral center. The study protocol was approved by the University Institutional Review Board (IRB). Between January 1, 2002 and December 31, 2017, 310 consecutive patients (79% men, mean age 55 ± 18 years) with ICD implantation at King Chulalongkorn Memorial Hospital were evaluated.

Result:

From 310 patients, the ICDs were implanted for primary prevention in 117 (38%) patients and for secondary prevention in 193 (62%) patients, single‐­chamber ICDs were implanted in 234 (75%) patients and dual‐­chamber ICDs were implanted in 76 (25%) patients. Over a median follow‐­up of 30 months, 112 (36%) patients had experienced of ICD therapy which were appropriated therapy in 80 (26%) patients, and 98 (32%) patients had experienced of ICD shock which were appropriate shock in 66 (21%) patients. The incidence of ICD therapy and shock were higher in the secondary prevention patients compared with the primary prevention patients (P=0.01 and P=0.01, respectively). Inappropriate ICD shock occurred in 46 (15%) patients. No difference of incidence of inappropriate ICD shock between single and dual chamber groups (P=0.36). By multivariate analysis, age ≤60 years [HR= 4.01 (95% CI=1.68 to 9.61); P = 0.002], new onset AF [HR= 6.22 (95% CI=3.62 to 11.83); P <0.001], and new onset SVT [HR = 3.53 (95% CI=1.95 to 6.40); P < 0.001] were independent predictors of inappropriate ICD shocks.

Conclusion:

This was the first study from Thailand to report outcomes in an ICD cohort. A quarter of patients in this study received appropriate ICD therapy, suggesting significant benefit of ICD. Although, supraventricular tachyarrhythmia was the main cause of inappropriate ICD shock, the benefit of dual‐­ chamber ICD over single‐­chamber ICD in terms of shock appropriateness was not observed in this study.

TABLE 1 Baseline characteristics of study patients

Variables	Total (n= 310)	Single chamber group (n=234)	Dual chamber group (n=76)
Age (years)	53 ± 18	52± 17	58±18
Male [n (%)]	244 (79%)	185 (79%)	59 (78%)
Female [n (%)]	66 (21%)	49 (21%)	17 (22%)
Implantation indication [n (%)]
‐­primary prevention	117 (38%)	85 (36%)	32 (42%)
‐­secondary prevention	193 (62%)	149 (64%)	44 (58%)
Principle diagnosis [n (%)]
‐­Ischemic cardiomyopathy	103 (33%)	74 (32%)	29 (38%)
‐­Non‐­ischemic cardiomyopathy	84 (27%)	64 (27%)	20 (26%)
‐­Hypertrophic cardiomyopathy	18 (6%)	11 (5%)	7 (9%)
‐­Brugada syndrome	63 (20%)	52 (22%)	11 (15%)
‐­Long QT syndrome	2 (1%)	2 (1%)	0 (0%)
‐­ARVD	8 (3%)	7 (3%)	1 (1%)
‐­Other	20 (6%)	17 (7%)	3 (4%)
Comorbidity [n (%)]
‐­Ischemic heart disease	116 (37%)	82 (35%)	34 (45%)
‐­Post CABG	30 (10%)	21 (9%)	9 (12%)
‐­Post PCI	69 (22%)	46 (20%)	23 (30%)
‐­Post valvular surgery	14 (5%)	11 (5%)	3 (4%)
‐­Hypertension	114 (37%)	81 (35%)	33 (43%)
‐­Diabetes mellitus	56 (18%)	42 (18%)	14 (18%)
‐­Chronic kidney disease	80 (26%)	55 (24%)	25 (33%)
‐­Old CVA	26 (8%)	19 (8%)	7 (9%)
History of heart failure [n (%)]	146 (47%)	104 (44%)	42 (55%)
Rhythm [n (%)]
‐­Sinus	217 (70%)	170 (73%)	47 (62%)
‐­Paroxysmal AF	58 (19%)	34 (14%)	24 (31%)
‐­Persistent/permanent AF	35 (11%)	30 (13%)	5 (7%)
Echocardiography
‐­LVEF (%)	41 ± 20	41 ± 20	40 ± 20
‐­LVEDD (mm)	58 ± 13	58 ± 13	58 ± 15
‐­LA size (mm)	38 ± 10	38 ± 10	39 ± 9
Medication [n (%)]
‐­Amiodarone	60 (19%)	44 (19%)	16 (21%)
‐­Beta‐­blocker	178 (57%)	129 (55%)	49 (64%)
‐­Calcium channel blocker	14 (5%)	8 (3%)	6 (8%)
‐­ACEIs/ARBs	144 (46%)	101 (43%)	43 (57%)
‐­Diuretic	142 (46%)	102 (44%)	40 (53%)
‐­Statin	143 (46%)	99 (42%)	44 (58%)
‐­Antiplatelet	123 (40%)	85 (36%)	38 (50%)
‐­Anticoagulant	71 (23%)	53 (23%)	18 (24%)

ACEIs = Angiotensin‐­converting enzyme inhibitors (ACEIs); AF = atrial fibrillation; ARB = Angiotensin II receptor blockers; ARVD = arrhythmogenic right ventricular dysplasia; CABG = coronary artery bypass grafting; CVA =cerebrovascular accident; LA = Left atrium; LVEDD = left ventricular end‐­diastolic diameter; LVEF = left ventricular ejection fraction; PCI = Percutaneous coronary intervention; SVT = supraventricular tachycardia; VT = ventricular tachycardia.

TABLE 2 Cumulative incidence of ICD therapy

All	Primary prevention	Secondary prevention
ICD therapy
1 year	19%	5%	14%
2 years	23%	5%	18%
3 years	25%	5%	20%
ICD shock
1 year	16%	4%	12%
2 years	21%	5%	16%
3 years	26%	6%	20%
Appropriate ICD shock
1 year	11%	2%	9%
2 years	15%	3%	12%
3 years	18%	3%	15%
Inappropriate ICD shock
1 year	7%	2%	5%
2 years	9%	3%	6%
3 years	11%	3%	8%

AP19‐­00892

The right ventricular outflow tract: the most desirable site for true septal pacing – a single operator experience

Rajasekhar Varada

Yashoda Hospitals, India

Introduction:

Right Ventricular Outflow Tract (RVOT) Septum has been proposed as a preferred site for right ventricular lead placement. However, techniques and methodology of positioning the lead in RVOT septum have not been well validated. Data concerning lead performances and complications for lead repositioning with this technique were deficient. The purpose of study was to demonstrate the ease of positioning a lead in the RVOT septum and to determine immediate and long term effects of Right Ventricular Outflow Tract Septal pacing in terms of pacing parameters and lead stability.

Methods:

This was a Retrospective observational follow‐­up study that included a cohort of 140 cases, who underwent RVOT (Right Ventricular Outflow Tract) Septal pacing, for class I indication for pacemaker implantation performed by a single operator. Lead positioning was achieved by the means of a custom shaped stylet (Image 1) as described by Harry Mond et al and optimal position was confirmed with the use of fluoroscopy in the anteroposterior and lateral projections (Image 2). 1‐­year follow‐­up information on stimulation threshold, R‐­wave sensing, lead impedance, and lead complications were collected. Information was obtained on ventricular lead performance at implant, at 6‐­month and at 12‐­month follow‐­up, Statistical analysis was done using Microsoft Windows 7 software Statistical test applied were ANNOVA test, T test, Jarque–Bera test.

Result:

Lead performance at the RVOT septal position was stable at 1‐­year follow‐­up. Ventricular electrical parameters were acceptable with stable 1‐­year stimulation thresholds, sensing, and impedance for all lead types. One‐­year results demonstrated mean stimulation threshold of 0.68V (±0.23V), mean R wave of 9.03 mV (±3.45 mV), and mean impedance values of 519.14Ω (±67.87Ω). There were no cases of high pacing thresholds or inadequate sensing. There were no known patient deaths related to pacemaker complications.

Conclusion:

This study confirms that RVOT septal pacing can be achieved fairly rapidly and efficiently by use of a stylet that can be shaped in the cath lab and optimal position achieved with satisfactory long term performance. The RVOT septum has emerged as an attractive site, which is technically as easy to reach as the right ventricular apex. Successful implantation within the RVOT is readily achievable, but requires an understanding of RVOT anatomy and specific stylet shaping. The selection of the RVOT septum as the primary pacing site in the majority of patients with bradycardia indications were supported that indicates that long term electrical performance at this site is favorable.

AP19‐­00893

Syncope in dual chamber pacemaker patient due to dis‐­engagement of pin connector: simple thing big impact

Timotius Sumampouw

Perhimpunan Dokter Spesialis Kardiovaskular Indonesia, Indonesia

Introduction:

Syncope in a pacemaker patient is a serious symptom. It is rarely due a pacemaker system malfunction.

Methods:

A 62 years‐­old man presented with a history of syncope after dual chamber permanent pacemaker replacement due to end of life. He was dependent pacemaker because of total AV block. Pacemaker interrogate within normal limit. Holter monitoring was performed and showed pacing rhythm with no episode of tachycardia or bradycardia event, CT Brain also revealed normal brain with minimal sub‐­galeal hemorrhagic due to head trauma. He was then sent home after careful evaluation. However, a few days later this patient came again with another syncope episode. Careful examination of the lead and generator using chest x‐­ray and fluoroscopy showed that the right ventricular (RV) lead pin was not fully engage to the connector head.

Result:

After re‐­engagement of RV lead to the connector head, this patient never complained of syncope again.

Conclusion:

Disengagement of a lead tip from connector header is a rare condition and usually occurs during pacemaker replacement procedure. Careful check and re‐­check during procedure can prevent this event.

AP19‐­00909

Single‐­center experience of leadless pacemaker implantation, including one case which was extracted

Yoshifumi Ikeda, Ritsushi Kato, Kenta Tsutsui, Sayaka Tanaka, Hitoshi Mori, Mai Tahara, Saki Hasegawa, Kazuo Matsumoto

Saitama Medical University, Japan

Introduction:

Leadless pacemaker offer the benefits of cardiac pacing with the potential for a significant decrease in many of the risks associated with conventional pacemaker, including hematoma formation, pneumothorax, lead‐­related complications, and vascular obstruction. However, cardiac tamponade or complete dislodgement as a complication are serious problems. We report a single center experience of 18 cases of leadless pacemaker implantation including one case which was extracted in our hospital.

Methods:

Eighteen cases of leadless pacemaker implantation were performed at our hospital from October 2017 to June 2019. The information of these patients was extracted from our database and the characteristics, outcomes and so on were investigated retrospectively.

Result:

Twelve of 18 cases were AF brady, 3 cases were AVB, and 3 cases were SSS. Also, 4 of these cases whose device was extracted because of a device infection and 4 were dialysis patient with limited blood access. The implantation procedure of all cases was successful, but one of the leadless pacemaker was dislodged incompletely on the next day and was extracted. The device was placed in the right ventricular septum in 14 cases and in the apex in 4 cases. Average value of measured amplitude at implantation 1.6 ± 1.2 mV, impedance 552.3 ± 82.6 ohm and threshold 1.1 ± 0.7 V (0.4 ms). 1.5 ± 1.2 mV, 507.6 ± 82.6 ohm and 0.9 ± 0.6 V at one month and 1.7 ± 1.2 mV, 488.6 ± 114.4 ohm and 1.1 ± 0.9 V at 6 months after implantation. Procedure‐­related complications were 4 cases of hematoma, 1 case dislodgement, and no cardiac tamponade happened at our hospital. The extraction procedure was extremely difficult, requiring four hours.

Conclusion:

Leadless pacemaker is an excellent device, but we need to be well informed about management of complications.

AP19‐­00913

Clinical outcome of His resynchronization versus biventricular pacing in heart failure: real world, single center experience

Tai Chung So

Queen Elizabeth hospital, Hong Kong

Introduction:

In cardiac resynchronization therapy (CRT) using biventricular pacing (BiV), one‐­third of them is non‐­responder. His‐­bundle pacing (HBP) correcting bundle branch block lead to restoration of mechanical and electrical resynchronization. Therefore His bundle pacing in lieu of a left ventricular lead (His‐­CRT) is proposed as an alternative method for cardiac resynchonization. There are case report and studies supporting the use of His‐­bundle pacing as cardiac resynchconization therapy. While the HIS‐­ SYNC trial showed significant reduction in QRS duration and improvement in EF in His‐­CRT group, it failed to show difference in cardiovascular hospitalization and mortality between His‐­CRT and BiV‐­ CRT. Thus the role of His‐­bundle pacing in cardiac resynchronization remains unclear. The objective of this study is to evaluate the clinical outcome in His‐­CRT versus BiV‐­CRT.

Methods:

This is a retrospective review of patient with heart failure receiving device therapy in the period of 8/2018 to 1/2019. The end‐­point follow‐­up is up to 6 months. The primary outcome was major adverse cardiac event (MACE), comprising all‐­cause mortality, ventricular arrhythmia and hospitalization for heart failure. Patient with heart failure, defined as clinical heart failure or LVEF <35%, receiving His‐­CRT or BiV‐­CRT were included, pacing rate less than 90% were excluded to ensure adequate effect of His‐­CRT and BiV‐­CRT. The outcome variable was analyzed by time‐­to‐­first event survival analysis, Cox proportional hazard models was used to estimate hazard ratio and Kaplan‐­ Meier analysis compared by log‐­rank test. Data was analyzed by Microsoft Excel 2010.

Result:

A total number of 10 patients were included with 3 out of 10 receiving His‐­CRT and 7 out of 10 receiving BiV‐­CRT. In His‐­CRT group, 2 out of 3 patient developed heart failure (66%) while in BiV‐­CRT group, 3 out of 7 developed event (42%, 2 heart failure and 1 VT) (Hazard ratio: 0. 702; p = 0.689)

Conclusion:

There is no significant difference between His‐­CRT and BiV‐­CRT in term of clinical outcome. The limit of this study is the number of patient and heterogeneity of background of patient. On the other hand it reflects a real world experience in using His‐­CRT. Therefore further studies is needed to evaluate the possibility and feasibility of His‐­CRT and its role, for example : as alternative of Bi‐­V CRT, bail‐­out of Bi‐­V CRT or complementary of BiV‐­CRT.

AP19‐­00914

Pacemaker‐­induced ventricular fibrillation during radiofrequency catheter ablation for ventricular tachycardia

Michael Chi Yuan Nam, Simon Claridge, Nikki Jones, Richard Bala, Mark Sopher, Girish Babu

Bournemouth Hospital ‐­ UK, United Kingdom

Introduction:

N/A Methods

Methods:

N/A

Result:

N/A

Conclusion:

N/A

AP19‐­00915

Coronary sinus as an alternative ventricular pacemaker lead option for persistent left sided superior vena cava

Michael Chi Yuan Nam, Chris Critoph

Bournemouth Hospital ‐­ UK, United Kingdom

Introduction:

N/A

Methods:

N/A

Result:

N/A

Conclusion:

N/A

AP19‐­00917

Effectiveness and performance of confirm Rx^™ SharpSense^™ technology: a multi‐­center retrospective analysis

Christopher Piorkowski, Harish Manyam, Dhanunjaya Lakkireddy, Eteri Byazrova, Stephen Pavia, Muhammad Afzal, Jinu John, Fujian Qu, Fady Dawoud, Kevin Davis, Kyungmoo Ryu, Avi Fischer, Richard Trohman

Abbott, United States

Introduction:

With the intent of reducing false detections (while maintaining sensitivity), recent enhancements have been introduced to the Abbott Confirm Rx^™ insertable cardiac monitor (ICM) arrhythmia detection algorithms (SharpSense^™ Technology). However, the performance of these algorithm enhancements may vary at individual clinics depending on the implant indications, implant techniques, and device programming preferences, etc. In this analysis, we conducted a multi‐­center retrospective analysis to evaluate the effectiveness and performance variation of SharpSense technology.

Methods:

Pause, bradycardia (brady), and atrial fibrillation (AF) episodes triggered and transmitted to Merlin.net^™ patient care network by the Confirm Rx ICMs without SharpSense were analyzed using the enhanced detection algorithms. The enhanced algorithms reject pause and brady detection if under‐­ sensing of R waves contributed to the trigger and reject AF detection if presence of p‐­wave is found in the signal. Human adjudication combined with supervised machine learning of triggered and transmitted episodes was used as the reference for assessing the performance of these enhanced algorithms.

Result:

A total of 294,416 episodes (512 devices/8 clinics) were analyzed (pause: 143,418 [61%], bradycardia: 70,250 [30%] and AF: 21,088 [9%]). The implant indications were syncope (27%), AF (42%), and other ‐­ cryptogenic stroke, palpitations, etc. (31%). Median device follow‐­up duration was 317 days with an interquartile range of 225 days. For the entire dataset, SharpSense reduced false pauses, brady, and AF episodes by 98.8%, 94.9%, and 45.7%, respectively, with 0.4%, 0.1%, and 1.4% reduction in true episodes, respectively. Overall reduction in false positive episodes was 97.8% with relative sensitivity (compared to without SharpSense) of 99.9%. In clinic‐­averaged, SharpSense reduced false pauses, brady, and AF episodes by 98.4 ± 1.5%, 96.1 ± 4.5%, and 45.4 ± 12.5%, respectively, with 0.5 ± 1.1%, 0.1 ± 0.1%, and 1.1 ± 1.6% reduction in true episodes, respectively.

Conclusion:

The analysis demonstrates that the newly developed SharpSense^™ algorithms significantly reduce false pause, bradycardia, and AF episodes with minimal reduction in true episode detection. The performance of SharpSense is highly consistent across individual clinics.

AP19‐­00922

Device detected subclinical atrial fibrillation and left atrial remodeling

Young Jun Park, Seong Soo Lee, Hee jin Kwon, Kyoung Min Park, Young Keun On, June Soo Kim, Seung Jung Park

Samsung medical center, South Korea

Introduction:

Long term intracardiac monitoring in patients with permanent pacemakers (PPM) and implantable defibrillators detects subclinical atrial fibrillation (SCAF) in 28%‐­68% of these patients within the first 1 to 3 years after implantation. Atrial fibrillation (AF) is known to be associated with left atrial (LA) remodeling. However, the association of SCAF with LA remodeling has not been investigated

Methods:

This study is a single center retrospective study. In patients with bradyarrhythmia, underwent implantation of PPM were enrolled. Patients with preexisting AF, atrial lead malfunction, didn't perform baseline or follow up transthoracic echocardiography (TTE). LA diameter, LA volume index (LAVI), tricuspid regurgitation (TR) grade, mitral regurgitation (MR) grade were evaluated using TTE. We subdivided group of patients depending on SCAF burden: no SCAF, low burden of SCAF, high burden of SCAF. The changes in TTE parameters according to the burden of SCAF were investigated.

Result:

A total of 228 patients were enrolled. 117 (51.3%) were male, and the mean age was 68.2 years. During the median follow up 5.4 years at least one SCAF episodes were detected by in 161 patients (70.6%). Baseline LA diameter and LAVI were 41 (39.1), 42 (39.4), 43 (44.8) mm, (mL/m²) according to the burden of SCAF. Delta LAVI was −2.0, 2.4, 13.9 (mL/m²) according to the burden of SCAF. Progression of TR was 0.1, 0.8, 1.4 according to the burden of SCAF.

Conclusion:

High burden of SCAF was associated with LA remodeling and progression of TR.

AP19‐­00924

Accuracy of arrhythmia detection using confirm Rx implantable cardiac monitor: a prospective multicenter randomized clinical trial

Miki Yokokawa, Brian Jaffe, Randy Ip, Carson Castellani, Mark Castellani, John Ip

Sparrow Hospital, United States

Introduction:

Implantable cardiac monitor (ICM) has been used to detect occult cardiac arrhythmias in a variety of clinical situations. The reliability and accuracy of diagnosing cardiac arrhythmia could impact patient care. Despite good sensitivity reported previously, current detection algorithms lead to an elevated number of false‐­positive results. The objective of this study is to analyze the accuracy of diagnosing cardiac arrhythmias using Confirm Rx SharpSense Technology.

Methods:

In the prospective multicenter randomized study, a total of 48 patients (age: 58 ± 17 years, men: 25 [52%]) with cryptogenic stroke (n = 30) or recurrent unexplained episodes of palpitations (n = 4) or syncope (n = 14) received an Confirm Rx ICM for detection of arrhythmias. Arrhythmic events are defined as pauses of ≥ 3.0 seconds, bradycardia with heart rate of ≤ 40 bpm, tachycardia with heart rate of ≥ 150 bpm, and atrial fibrillation (AF). All of the arrhythmic events were adjudicated by two cardiologists to assess the accuracy.

Result:

A total of 1263 arrhythmic events including 835 AFs, 121 bradycardias, 236 tachycardias and 71 pauses were transmitted over a mean follow‐­up of 4.9 ± 2.9 months. Two‐­hundred twenty of 835 AF events (26%) and 264 of 428 non‐­AF events (42%) were accurately detected by Confirm Rx ICMs (P < .0001). The reason for inaccurate AF detection was frequent ectopic beats (n = 412), P‐­wave oversensing (n = 32), T‐­wave oversensing (n = 72), both P‐­ and T‐­waves oversensing (n = 23), sinus tachycardia with R‐­wave undersensing (n = 26) and sinus arrhythmias (n = 48) and others (n = 2). In the retrospective analysis of the original data set, Confirm Rx SharpSense classified 41 of 63 false positive AF as non‐­AF and drove a 65% reduction in false positive AF detection by properly identifying ectopic beats. Confirm Rx SharpSense rejected all 47 false positive pauses.

Conclusion:

The accuracy of cardiac arrhythmia detection with current algorithms in ICMs remains suboptimal. Arrhythmia detection performance by using the new algorithms, Confirm Rx SharpSense Technology, may improve the accuracy of diagnosing cardiac arrhythmias. More patients and longer follow‐­up are required to confirm these findings.

AP19‐­00942

Long‐­term performance of left bundle branch pacing in patients with left bundle branch block

Weijian Huang, Shengjie Wu, Lan Su, Lei Xu, Songjie Wang

Department of Cardiology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China

Introduction:

Recently, left bundle branch pacing (LBBP) has been demonstrated its feasibility and safety in patients indicated for ventricular pacing and cardiac resynchronization therapy (CRT). However, there is lack of long‐­term clinical benefits assessment. This study sought to assess the long‐­ term clinical benefits of LBBP in left bundle branch block (LBBB) patients.

Methods:

A total of Four LBBB patients who met the criteria of LBBP with a more than 3‐­years follow‐­up were included. The following criteria were applied to confirm left conduction system capture: (a) RBBB paced morphology in V1 lead with terminal R wave with shape dV/dt; (b) Output‐­ dependent morphology changes between septal myocardial and nonselective‐­ LBBP, or selective‐­LBBP and nonselective‐­LBBP; (c) Abrupt shortening of the stimulus to peak left ventricular activation time (LVAT) with increasing output or shortest and constant stimulus to peak LVAT with capture and higher output. (d) Direct recording of Purkinje potentials during escape rhythm or ectopic beats or during His corrective pacing in those with a two‐­lead implantation technique. The implanted characteristics and clinical outcomes were assessed.

Result:

The QRS morphology was changed from intrinsic LBBB pattern with duration of 159.5 ± 17.5 milliseconds to the paced right bundle branch block pattern with duration of 101 ± 3.9 milliseconds. Output dependent selective and nonselective LBBP were achieved in three patients. The stimulus‐­LVAT peak remained constant at threshold and higher output (78 ± 3.9 vs 77.5 ± 4.8 milliseconds, P = .391). The average R‐­ wave amplitude was 7.7 ± 2.1 mV. The mean follow‐­up duration was 38.1 ± 2.6 months. The threshold for LBB capture was 0.56 ± 0.12V/0.5 milliseconds at acute and remained stable of 0.69 ± 0.23 V/0.5 milliseconds at 3 years follow up (P = .182). LVEF increased from baseline of 38.7 ± 6.1% to 64.1 ± 2.2% (P = .016) and LVESV decreased from baseline of 142.7 ± 91.3 mL to 33.7 ± 10 ml in those three patients with baseline LVEF < 50% at 3 years follow up. NYHA function class improved from baseline of 3.3 ± 1 to 1.3 ± 0.5 (P = .016). Cardiothoracic ratio decreased significantly from 0.64 ± 0.01 to 0.57 ± 0.02 (P = .01). No macro lead displacements, infections, embolism, deaths or heart failure hospitalizations were observed during follow‐­up.

Conclusion:

Left bundle branch pacing is a feasible and effective method for achieving electromechanical resynchronization of left bundle branch block with resultant improvements in left ventricular structure and function.

AP19‐­00943

Advantages of remote monitoring for permanent his bundle pacing follow up

Ulhas M Pandurangi, Aparna Balaji, Aishwarya S, Kotti K, Jaya Pradhap, Radhika B, Muthu Seenivasan, Nagendran C, Dinesh Seenivasalu, Mahima P Manoj, Nithin G, Sailendri G, Nirmala S, Dasari Himaja, Sandini S, Swathi K

The Madras Medical Mission, India

Introduction:

His bundle pacing (HBP) has gained a lot of interest in the recent times. However, His bundle lead is more prone to undersensing, oversensing and higher capture thresholds compared to the conventional apical lead. This calls for a standard monitoring protocol to optimize battery and device performance, especially in those patients without a backup ventricular lead. There are published guidelines for in‐­clinic follow up of these patients. The data is scarce regarding follow up through remote monitoring (RM) and the influence of RM on conservation of battery and optimizing device performance.

Methods:

We followed up 18 patients prospectively during the period from June 2018 to February 2019 who underwent a HBP using the Medtronic SelectSecureTM MRI SureScanTM 3830 (4.1Fr) lumen less lead driven by the Medtronic C315 HIS (7Fr) delivery catheter. Out of these, 11 (61%) patients are under RM. As a standard practice, the His output for these patients was set at 5V @ 1 milliseconds and the His sensitivity at 0.90 mV for the first month. These patients were advised to do the first transmission 15 days post implant, the next at 1 month and every 3 months there on.

Result:

Out of 11 patients, 10 patients (91%) did a successful transmission after 15 days, while 9 patients (81%) transmitted after 1 month and 8 patients (73%) transmitted at 3 months. At the 1 month remote follow up, 8 patients (88%) had a His threshold less than 2V @ 1 milliseconds with a mean of 1V ± 0.75V. These patients were called to the clinic and the His output was optimized from 5V @ 1 milliseconds to a value + 1.5V than the measured threshold. However, there was 1 patient (11%) who had a threshold of 4V @ 1 milliseconds and the His output continued to be at 5V @ 1 milliseconds without any in‐­clinic intervention until the next year. Intermittent loss of capture was observed in 1 patient (9%) at the 3rd month transmission and the His output was increased to an appropriate value to ensure consistent capture. There were 2 patients (18%) identified with atrial oversensing by the His lead, one during the transmission done at 15 days post implant and the other at the 1st month transmission. These patients were called to the clinic and the His sensitivity was reduced to prevent oversensing. There was 1 patient (9%) who was identified with intermittent ventricular undersensing at the 15th day transmission and the His sensitivity was increased to ensure appropriate sensing. These patients had an opportunity of early intervention to identify device performance issues and optimize device longevity and none of them ended up having a lead malfunction or poor battery performance. Few data from RM which helped proactive intervention is shown in figure below.

Conclusion:

With the help of RM follow up, early proactive intervention is possible to optimize HBP parameters, thereby providing a standard of care and better quality of life.

AP19‐­00956

Late responder to cardiac resynchronization therapy with long‐­standing persistent atrial fibrillation, heart failure and a reduced ejection fraction

Akira Kimata, Asumi Takei, Hiroyuki Takahara, Masamichi Yasutomi, Ayako Kunimura, Kenzo Fukuhara, Hiroaki Shiraki, Sonoko Hirayama, Toru Ozawa, Hiroyuki Mataki, Nobutaka Inoue

Kobe Rosai Hospital, Japan

Introduction:

In a selected patient population with heart failure (HF) and a reduced ejection fraction (EF), cardiac resynchronization therapy (CRT) is effective and can slow down or reverse further progression of the disease. There is conclusive evidence of the beneficial effect of CRT in patients with sinus rhythm, a typical left bundle branch block (LBBB) morphology, and a QRS duration > 120 milliseconds. However, the benefit in patients with conditions other than these is still controversial. On the other hand, the effectiveness of beta‐­blockers in atrial fibrillation (AF) patients with HF and a reduced EF is unclear.

Methods:

N/A.

Result:

Case: A 70‐­year‐­old male suffered from dilated cardiomyopathy, long‐­standing persistent AF, diabetes, and renal insufficiency for approximately 10 years, and his HF status was NYHA functional class II. He was admitted for orthopnea with a diagnosis of acute worsening chronic HF. On admission, a decreased SpO2 and bilateral lower leg edema were observed, and pleural effusion were revealed by X‐­ ray. An echocardiogram revealed that the left ventricle (LV) and atrium were markedly dilated (LVDd 65 mm, LVDs 59 mm, LAD 62 mm, LVEDV 138 ml, and LVESV 107 ml). The systolic LV function was severely impaired (LVEF 18%). After admission, his condition was improved to a NYHA functional class III with intensive and sufficient medical treatment. His electrocardiogram revealed AF at a rate between 60 and 100 beats/min with left axis deviation and a QRS duration of 120 msec. Non‐­sustained ventricular tachycardia (VT) was documented after admission. An ICD implantation for primary prevention was recommended in terms of his LV function. Considering the benefits of a sufficient dose of beta‐­blockers for VT, we thought that CRT‐­D would be better than an ICD to avoid RV pacing, which was feared to possibly increase. A response within one year was not evident (he was not a “responder” according to its general definition) after the CRT, however, the dilatation of the left ventricle and atrium were gradually decreased for 2 years after the CRT‐­D implantation. The changes in the echocardiogram parameters before the CRT and at two years after the CRT were as follows: (a) LVDd 64 to 55 mm, (b) LVESV 73 to 39 mm, (c) LVEF 35 to 42%, (d) LAD 64 to 58 mm. Further, his HF symptoms also gradually improved to NYHA functional class I over the same period. The BNP level and renal function improved (BNP 656 to 160 pg/mL and Cr 1.55 to 1.22 mg/dL, respectively). Thus, a beneficial effect of the CRT was observed and he has never been hospitalized for over 3 years.

Conclusion:

We reported a case with long‐­standing persistent atrial fibrillation and a QRS duration of 120 msec, which CRT was effective in during the late phase of the postoperative period.

AP19‐­00958

Interim analysis of the ‘DEvice‐­Detected CArdiac Tachyarrhythmic Events and Sleep‐­ disordered Breathing (DEDiCATES)’ study

Hye Bin Gwag, Seung‐Jung Park, Youngjun Park, Seong Soo Lee, Kyoung‐Min Park, Young Keun On, June Soo Kim

Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, South Korea

Introduction:

In the Device‐­Detected CArdiac Tachyarrhythmic events and Sleep‐­disordered breathing (DEDiCATES) study, we aim to determine whether device‐­detected sleep‐­disordered breathing (SDB) events are associated with increased risk of cardiac arrhythmias or other cardiovascular (CV) outcomes. We performed interim analysis of the study to investigate the prevalence of baseline SDB in cardiac implantable electronic device (CIED) patients.

Methods:

The study was designed as a prospective, multicenter, and observational study to include 600 patients: 300 each with low‐­voltage pacing or high‐­voltage defibrillating devices. Eligible patients have dual chamber CIEDs with AP Scan^™ function (Boston Scientific Inc., Marlborough, MA, USA) which reports the average number of sleep disturbance events per hour per night in the form of a Respiratory Disturbance Index (RDI). The daily RDI values were collected to measure the severity and burden of SDB. The baseline severity of SDB was determined according to RDI data recorded during the first 1 week, 1 month, and 3 ± 1 months after CIED implantation; patients with RDI ≥ 30/h for at least one night are classified into the severe SDB group.

Result:

A total of 313 patients who completed the first device interrogation at 3 ± 1 months were included for analysis. The mean age and CHA2DS2VASc score were 69 and 3.1, respectively. Forty‐­nine percent of patients were men, and 35.5% were classified as high risk for SDB by Berlin questionnaire. The rate of severe SDB increased as the monitoring time got longer (83.8% at 1 week, 91.6% at 1 month, and 96.4% at 3 ± 1 months). There was no baseline demographic difference between the severe and non‐­ severe SDB groups, except that baseline body mass index (BMI) was higher in the severe group (24.5% vs 21.5%, P = .01). The mean RDI was 36.3, 34.2, and 33.0 per night during the first 1 week, 1 month, and 3 ± 1 months, respectively. The BMI was significantly higher in patients with supra‐­median mean RDI than those with infra‐­median value as well. In multivariate analysis, male gender and higher BMI were significantly associated with supra‐­median mean RDI.

Conclusion:

The prevalence of severe SDB at baseline was very high (>90%) according to conventional method using a single RDI value, which seems to be inadequate for CV risk stratification considering that most patients were classified into the severe group. In future outcome analysis, we expect to establish a discriminative SDB criteria to detect high‐­risk patients better than the conventional one.

AP19‐­00959

Early experiences with leadless pacemakers: venous closure strategies

Antonia Anna LUKITO, Dicky Armein Hanafy

Pelita Harapan University, Indonesia

Introduction:

Leadless pacemakers had been reported having many advantages over conventional single lead VVI pacemakers, as the risk of lead, pocket and subclavian venous puncture site related complications could be alleviated. Furthermore, leadless pacemakers design translates to fewer medical complications and fewer post‐­implant activity restrictions. However, leadless pacemaker using transcatheter venous puncture and higher size of transcutaneous catheters and sheath may cause another problem. El‐­Chami et al has reported 0.61% of events at the groin puncture site.

Methods:

We compare two elderly patients case with two difference approach of venous closure strategies.

Result:

Case 1, a 85‐­yo female presenting with symptomatic transient high degree AV block, was decided to have a leadless pacemaker. The procedure was uneventful and the vascular closure using figure‐­of‐­eight suture and wound closure sterile pad. The patient was discharged the next day, and came back to outpatient clinic after one week. The wound was dry and healed, but the skin was still open, and mild hematoma was observed. The skin eventually back to normal in one‐­month visit. Case 2, a 73‐­yo male presenting with symptomatic paroxysmal brady‐­arrhythmia and atrial fibrillation, was decided to have a leadless pacemaker. The procedure was uneventful and the vascular closure using two unit suture‐­ mediated closure system, instead of figure‐­of‐­eight suture. The patient was discharged the next day, and came back to outpatient clinic after one week. And the wound and the skin was nicely back to normal, without any hematoma.

Conclusion:

The leadless pacemakers need to be inserted percutaneously using higher caliber sheath (27Fr), mostly via transfemoral. After procedure and the sheath need to withdraw from the femoral vein, it leaves a big hole in the vein. This may lead to higher vascular complications compared to other diagnostic procedures using the 6 to 7 Fr sheath. Predictor of vascular access complications are older age, female gender, diabetes, small body surface area, sheath size, emergency procedure, intensity of anticoagulation and platelet inhibition, and comorbidities. Vascular closure device post transcatheter procedures has been approved by FDA to use for femoral artery and vein closure strategy, yet the cost‐­ efficient aspect need to be considered. Vascular closure strategy need to be applied in personalized way, considering the risk profile of the patients and the cases. In the patients with low risk for vascular access complications, figure‐­of‐­eight suture would be sufficient. In contrary, for the patients with high risk for vascular complications, vascular closure device using suture‐­mediated closure system would be the choice.

AP19‐­00961

Overcoming the limitations of selective his bundle pacing using non selective his bundle pacing‐­ a comparative study

Varsha Rakshitha Prakash, Prakash Vadagenalli Sathyanarayanarao

Ramaiah Medical College ana Hospitals, India

Introduction:

His Bundle pacing, a novel method used in lieu of RV pacing to overcome the limitations of the same, is associated with shortcomings of its own such as i) the need for a higher threshold to capture the His Bundle region ii) a lower R wave amplitude, iii) longer procedure and fluoroscopy time as also iv) a higher incidence of lead dislodgement, to mention a few. This study aims to assess whether Non Selective His Bundle Pacing can overcome the shortcomings of His Bundle Pacing while retaining the benefits of the same.

Methods:

125 Patients requiring pace maker implantation/CRT who underwent Selective/ Non Selective His Bundle pacing were recruited for the study. Various parameters (mentioned below) were compared in the 2 groups The various parameters compared were (a) capture threshold obtained at the time of implantation at 1 millisecond (b) capture threshold obtained 4 weeks after implantation (c) Amplitude of the R wave (mv) (d) Fluoroscopy time in minutes (e) Lead implantation time in minutes (f) percentage of ventricular pacing achieved vii) LV Ejection fraction after 2 years (in patients with an initial normal and a low ejection fraction).

Result:

Enclosed in Table 1.

Conclusion:

(a) Non selective His bundle pacing appears to perform better in terms of short and long term outcomes compared to Selective His Bundle pacing (b) Compared to selective, non selective His bundle pacing is better in terms of i) lower capture threshold, ii)taller R wave amplitude, iii) reduced fluoroscopy exposure iv) shorter time taken for implantation as also v) minimal/nil lead dislodgement (c) Non selective His bundle pacing compares equally well with regard to effect on LV function and could be considered as a good alternative to selective His bundle pacing.

AP19‐­00963

Usefulness of cardiac echocardiography in the diagnosis and treatment of non‐­acute phase lead perforation following pacemaker implantation

Takuo Tsurugi, Shozo Kaneko, Kodai Negishi, Katsuhide Hayashi, Hideharu Okamatsu, Yasuaki Tanaka, Junjiroh Koyama, Ken Okumura

Saiseikaikumamto hospital, Japan

Introduction:

Though cardiac perforation is an uncommon complication of pacemaker (PM) therapy, it could be lethal with cardiac tamponade. Computed tomography (CT) is now becoming a gold standard for diagnosing lead perforation. We examined the usefulness of cardiac echocardiography (UCG) for diagnosis of cardiac perforation due to active fixation lead and determination of the treatment strategy.

Methods:

From July 2004 to June 2019, 2549 PMs were implanted in Saiseikai Kumamoto Hospital and the data were retrospectively studied.

Result:

Pericardial effusion, which was caused by lead perforation, occurred in 9/2549 cases (0.3%). Acute phase perforation within 24 hours of PM implantation occurred in 3 cases and two of them needed open chest surgery for repair of cardiac perforation. Non‐­acute phase perforation occurred in the other 6 cases, and could be treated without surgical procedures. In all of these 6 cases, it was difficult to diagnose lead perforation by chest CT. The detailed examination of UCG, however, showed remarkable findings of lead perforation, including the tenting of the right ventricular free wall at the local site of ventricular lead tip and, and thrombus or fibrin tissue on the surface of ventricular epicardium. Accordingly, in 5/6 cases, we diagnosed as a minor perforation due to the helical penetration of the ventricular lead. After the drainage of pericardial effusion, it was possible to remove and reposition the ventricular lead only with a cardiac surgery backup in these 5 cases. In the other one case, pericardial effusion was improved with correction of Warfarin overdose. All six cases had no recurrence of pericardial effusion.

Conclusion:

In the non‐­acute phase perforation cases, UCG was useful for the diagnosis of cardiac perforation due to the helical ventricular lead. UCG can provide a key finding in selecting the optimal therapy for lead revision.

AP19‐­00969

Transvenous pacemaker implantation in the pediatric population at a tertiary care referral hospital from South India: a decade‐­long experience

Sinam Inaotan Singha, Deepak Padmanabhan, Bharatraj Banavalikar, PV Sanjai, Milan Kumar Ghadei, Muzaffar Ali, Jayaprakash Shenthar

Sri Jaydeva Institute of Cardiovascular Sciences, India

Introduction:

Transvenous pacemaker implantation in pediatric population is uncommon. We describe our acute and long term outcomes of transvenous pacemaker implantation in pediatric population.

Methods:

We reviewed the database of permanent pacemaker implantation records at Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bengaluru, South India and selected patients < 18 years of age who underwent transvenous permanent pacemaker implantation. Data on the age and weight of the patient, the indication for implant, the procedural details, acute procedural success, and outcomes on follow‐­up including clinical symptoms and signs of venous occlusion, lead displacement and lead fracture were extracted.

Result:

Between 2009 and 2018, 81 patients (males:females ‐­ 44:37) with a mean age of 10.39 + 5.33 years (9 months to 18 years) and mean body weight of 28 ± 5.3 kilograms (4.5 to 43 kgs) underwent transvenous permanent pacemaker implantation. 39 patients (48%) were < 10 years of 1 age. The indications for the implant were congenital AV block ‐­ 53 patients (65%), post‐­operative CHB ‐­ 16 patients (20%), sick sinus syndrome ‐­ 7 patients (9%) and other causes ‐­ 5 patients (6%). Venous access was achieved with extrathoracic axillary vein puncture in 42 (52%), cephalic cutdown 38 (47%), and subclavian puncture in 1 (1%). The pulse‐­generator was placed in the infraclavicular subpectoral pocket in 65 (80%) patients and in the prepectoral pocket in 16 (20%) patients. Single‐­chamber pacemakers were implanted in 62 (77%) patients and dual‐­chamber pacemakers in 19 (23%), all using bipolar leads. Age‐­stratified distribution of the type of device implantation is depicted in Figure 1. During a mean follow‐­up of 54 months ± 30.8 months, there were no adverse events including the clinical evidence of venous occlusion, pulse‐­generator erosion, device malfunction, lead dislodgement, raised pacing threshold and death. There was no pulse‐­generator replacement during the follow‐­up period.

Conclusion:

Transvenous permanent pacemaker implantation in pediatric patients is feasible and safe with good acute and long‐­term outcomes.

AP19‐­00974

Trends in pacemaker implantation at a tertiary care referral hospital from South India: a decade in review

Sinam Inaotan Singha, Deepak Padmanabhan, Bharatraj Banavalikar, Sanjai P V, Milan Kumar Ghadei, Muzaffar Ali, Jayaprakash Shenthar

Sri Jaydeva Institute of Cardiovascular Sciences, India

Introduction:

There is very little data on the pattern of pacemaker implantation and the reimbursement from Indian subcontinent. We reviewed the data over the last 10 years to ascertain if there was a change in practice pattern.

Methods:

We reviewed the database of the pacemaker implantation records at Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bengaluru, South India, a tertiary care teaching institute. The data were analyzed for demographics such as the indications, age and sex distribution and payment structure over a 10‐­year period.

Result:

A total of 3277 patients, 1855 males (57%) and 1422 females (43%) with a mean age of 62 + 16.3 years (9 months to 99 years) underwent pacemaker implantation between 2008‐­2018. The yearly trend of sex distribution is depicted in Figure 1A. The indications were acquired AV block (AVB) in 2470 (75%), sick sinus syndrome in 534 (16%), tri‐­ and bifascicular blocks with syncope in 121 (4%), post‐­ operative CHB in 57 (2%), and congenital CHB in 95 (3%). The reimbursement patterns for the implantation is shown in Figure 1b. Univariate analysis revealed a significant increase in the number of implants (194 vs 536), the contribution of government insurance schemes (51% vs 69%; P value < .0001), and the percentage of patients > 60 years of age (49% vs 65%; P value < .0001) and older women > 60 years (43% vs 61%; P value = .0046) has increased significantly from 2008 to 2018 predominantly due to government insurance cover. There is a progressive decrease in out of pocket (OOP) expenditure (41% vs 26%; P value = .0001) and donated devices from 2008 as compared to 2018 (8% vs 0.2%; P value < .0001). However, there was no significant change in the use of private health insurance in the same period (8% vs 5%; P value = .125).

Conclusion:

There is a significant change in the demographics of pacemaker implantation over a 10‐­year period. The change is driven by increasing patient coverage by government insurance schemes. The government insurance has benefitted older patients and especially women.

AP19‐­00977

Electrophysiological parameters and anatomic findings of left bundle branch pacing in an in vivo canine model

Xueying Chen, Yangang Su, Junbo Ge

Zhongshan Hospital of Fudan University, Shanghai Institute of Cardiovascular Diseases, China

Introduction:

Left bundle branch pacing (LBBP), an alternative to His bundle pacing (HBP), could maintain the electrical synchrony of the left ventricle in a low and stable threshold. However, the definitions of LBBP have not been well established.

Methods:

A canine model (n = 3; male; weight 30‐­40 kg) was subjected to receive HBP and LBBP procedure. The characteristics of the electrocardiogram (ECG) and intracardiac electrogram (EGM) and the pacing parameters between HBP and LBBP were collected and compared. The hearts were isolated and stained by Lugol's iodine (5%) to show the relative locations between the leads and the conduction system.

Result:

The means of potential to ventricle (PV) interval in HBP was significantly different to that in LBBP (26.67 ± 3.06 vs 12.67 ± 1.15, P = .002). The pacing parameters including pacing threshold, R wave amplitude and impedance were significantly different in HBP as compared to those in LBBP, respectively (2.30 ± 0.66 vs 0.67 ± 0.15, P = .014; 2.67 ± 0.42 vs 11.33 ± 3.06, P = .008; 423.3 ± 40.4 vs 660.0 ± 45.8, P = .003). The paced morphology of ECG was the same as the intrinsic in HBP while it was a RBBB pattern in LBBP. The anatomic findings showed that the HBP lead was located at the right septum across the tricuspid and the LBBP lead was placed deeply and vertically with the ring of the lead inside the septum. The means of the lead depth were significantly different between HBP lead and LBBP lead (1.83 ± 0.29 mm vs 12.33 ± 1.53 mm, P < .0001). While from the left septum, the LBB and Purkinje network were stained dark brown and the tip of the LBBP lead's helix could be seen around the left bundle branch (LBB).

Conclusion:

In this small size in vivo canine model study, HBP and LBBP could be performed feasibly and their characteristics could be summarized as: (a) with His and LBB potentials; (b) a RBBB paced morphology in LBBP; and (c) pacing parameters significantly different between HBP and LBBP. Moreover, the precise anatomic findings were direct evidences of the depth and the location of the leads around the conduction system.

TABLE 1 The characteristics between HBP and LBBP

Characteristics	HBP (n = 3)	LBBP (n = 3)	P value
Potential to ventricle interval (milliseconds)	26.67 ± 3.06	12.67 ± 1.15	.002
Pacing threshold (V/0.5 milliseconds)	2.30 ± 0.66	0.67 ± 0.15	.014
R wave amplitude (mV)	2.67 ± 0.42	11.33 ± 3.06	.008
Impedance (Ω)	423.3 ± 40.4	660.0 ± 45.8	.003
QRS duration (milliseconds)	72.67 ± 3.51	80.33 ± 5.69	.118
Sti‐­LVAT (milliseconds)	52.33 ± 3.51	39.67 ± 1.53	.005
Lead depth in the septum (mm)	1.83 ± 0.29	12.33 ± 1.53	<.0001
Septum thickness around the lead (mm)	7.57 ± 0.40	11.17 ± 2.47	.067

Abbreviations: HBP, His bundle pacing; LBBP, left bundle branch pacing; Sti‐­LVAT, stimulus to left ventricular activation time.

FIGURE 1 The intrinsic 12‐­lead ECG and the EGM recorded by the HBP and the LBBP lead: The intrinsic QRS duration was 69 milliseconds, Po His and Po LBB during the intrinsic rhythm with the potential to ventricle interval were 24 milliseconds and 12 milliseconds, respectively.

FIGURE 2 The 12‐­lead ECG and the EGM recorded by the HBP lead: The Po LBB was recorded through the anterograde conduction by HBP with a pacing stimulus to potential interval of 12 milliseconds. The Sti‐­LVAT was 52 milliseconds and the paced QRS duration was 69 milliseconds.

FIGURE 3 The 12‐­lead ECG and the EGM recorded by the LBBP lead: The Po His was recorded through the retrograde conduction by LBBP with a pacing stimulus to potential interval of 12 milliseconds. The Sti‐­LVAT was 40 milliseconds and the paced QRS duration was 74 milliseconds.

FIGURE 4 The 12‐­lead ECG and the EGM recorded by unipolar pacing from the ring electrode of the LBBP lead: The Po His was recorded through the retrograde conduction with a pacing stimulus to potential interval of 40 milliseconds. The Sti‐­LVAT was 78 milliseconds and the paced QRS duration was 104 milliseconds.

FIGURE 5 The fluoroscopic images of the HBP lead and the LBBP lead: A. Ventriculography through the sheath to show the right ventricular septum's edge (Arrow) and the LBBP lead's depth and direction inside the interventricular septum at right anterior oblique (RAO) 30°; (B) The positions of the leads at left anterior oblique (LAO) 30°.

FIGURE 6 The intraventricular septum stain by Lugol's iodine (5%): A. The locations of the HBP lead and the LBBP lead observed from the right septum; B. The LBB and Purkinje network were stained dark brown and the tip of the LBBP lead's helix (White arrow) could be seen around the LBB in sub‐­endocardium of the left septum.

AP19‐­00981

The risk factors of new‐­onset atrial fibrillation after pacemaker implantation

Xueying Chen, Zhaodi Wu, Yangang Su, Junbo Ge

Zhongshan Hospital of Fudan University, Shanghai Institute of Cardiovascular Diseases, China

Introduction:

We sought to determine the incidence of newly detected atrial fibrillation (AF) in patients following dual‐­chamber Pacemaker (PPM) implantation and to define the clinical predictors of newly AF in a Chinese cohort.

Methods:

We prospectively studied 219 patients without documented AF who underwent dual‐­ chamber PPM implantation for sick sinus syndrome (SSS) (n = 88) or atrioventricular block (AVB) (n = 131). Each patient was asked to follow‐­up on 1 month, 3 months and 6 months after the pacemaker implantation procedure, and once every six months afterwards. An atrial high‐­rate episodes (AHRE) ≥ 5 minutes and the atrial rate ≥ 180 bpm was defined as AF.

Result:

During follow‐­up of 884 ± 180 days, AF was detected in 56 (26%) patients. By using Kaplan‐­ Meier survival curves with log‐­rank test, SSS patients with Cum % VP ≥ 60% had a significantly higher rate of new‐­onset AF than AVB patients (P = .026) and SSS patients with Cum % VP < 60% (P = .018). On multivariate Cox regression analysis, higher Cum % VP independently predicts higher morbidity of new detected AF (HR 1.01; CI 1.00‐­1.02;P = .035) among SSS patients. Lager left atrial dimension (LA dimension) was a predictor of new detected AF (HR 1.06; CI 1.01‐­1.14; P = .046) in AVB patients.

Conclusion:

The incidence of AF after dual‐­chamber PPM implantation was relatively high in this Chinese cohort. High Cum % VP and larger LA dimension could independently predict newly AF after dual‐­chamber PPM implantation in SSS and AVB patients, respectively.

TABLE 1 Comparisons between SSS and AVB patients: Normal distributed variables were given as means ± SD and evaluated using Student t test. Non‐­normal distributed variables were provided as median and evaluated using Wilcoxon rank test. Dichotomous and categorical variables were shown as percentages and compared using Chi‐­square test.

SSS (n = 88)	AVB (n = 131)	P value
Age, years	68 ± 10	67 ± 13	.56
Male, N (%)	39 (44)	86 (66)	.02*
Smoking, N (%)	13 (15)	26 (20)	.37
Drinking, N (%)	7 (8)	12 (9)	.81
Cardiovascular disease, N (%)
HTN	49 (56)	90 (69)	.05
CAD	15 (17)	14 (11)	.17
CHF	1 (1)	1 (1)	.78
OMI	7 (8)	4 (3)	.1
DM	13 (15)	34 (26)	.05
Echocardiographic data
LVEF (%)	66 ± 7	67 ± 6	.21
LAD(mm)	41 ± 4	40 ± 5	.09
LVESD(mm)	30 ± 4	31 ± 4	.58
LVEDD(mm)	49 ± 4	49 ± 6	.81
MR
No MR	35 (28)	29 (34)	.69
Slight MR	55 (44)	37 (43)
Mild MR	29 (23)	18 (21)
Moderate MR	6 (5)	2 (2)
Medications post‐­PPM, N (%)
Beta‐­blocker	8 (9)	29 (22)	.01*
ACE inhibitor	19 (22)	33 (25)	.54
ARB	17 (19)	35 (27)	.21
Antiarrhythmic	8 (9)	2 (2)	.01*
Statin	26 (30)	24 (18)	.06
Anticoagulants	0 (0)	2 (2)	.52
Antiplatelet	30 (34)	37 (28)	.37

Abbreviations: HTN, hypertension; CAD, coronary artery disease; CHF, congestive heart failure; OMI, old myocardial infarction; DM, diabetes mellitus; LVEF, left ventricular ejection fraction; LAD, LA dimension; LVESD, the inner diameter of the left ventricular end‐­systolic; LVEDD, Left ventricular end‐­diastolic diameter; MR, mitral regurgitation; PPM, permanent pacemaker; ACE, angiotensin‐­converting enzyme; ARB, angiotensin II receptor blockers.

*P < .05

TABLE 2 Pacemaker Data at Baseline and Follow‐­Up between SSS and AVB group: Normal distributed variables were given as means ± SD and evaluated using Student t‐­test. Non‐­normal distributed variables were provided as median (25‐­75th percentiles were showed) and evaluated using Wilcoxon rank test. Dichotomous and categorical variables were shown as percentages and compared using Chi‐­square test

SSS (n=88)	AVB (n=131)	P Value
Pacing mode, DDD	88	131	‐­‐­‐­
Rate responsive (%)	80 (91)	104 (79)	.02*
Atrial sensitivity (mV)	0.84 ± 0.21	0.79 ± 0.21	.11
P‐­wave amplitude (V)	2.47 ± 0.21	2.49 ± 0.18	.54
Atrial high rate cut‐­off (bpm)	180	180	‐­‐­‐­
Upper rate (bpm)	128 ± 4	127 ± 4	.68
Lower rate (bpm)	58 ± 4	57 ± 4	.68
Cum % AP, median
(IQR)	58 (34,76)	22 (9,37)	<.001*
Cum % VP, median
(IQR)	17 (1,84)	99 (80,100)	<.001*

Abbreviations: bpm, beats per minute; Cum % AP, cumulative percentages of atrial pacing; Cum % VP, cumulative percentages of ventricular pacing; IQR, interquartile range.

*P < .05

TABLE 3 Comparison of Patients (between SSS group and AVB group) with and without AF: Normal distributed variables were given as means ± SD and evaluated using Student t‐­test. Non‐­normal distributed variables were provided as median and evaluated using Wilcoxon rank test. Dichotomous and categorical variables were shown as percentages and compared using Chi‐­square test.

	SSS			AVB
AF (n = 24)	No AF (n = 64)	P Value	AF (n = 32)	No AF (n = 99)	P Value
Patients’ Characteristics
Age, years	70 ± 11	67 ± 10	.25	65 ± 15	68 ± 12	.36
Male, N (%)	13 (54)	36 (56)	1	7 (22)	38 (38)	.13
Smoking	4 (17)	9 (14)	.75	6 (19)	20 (20)	1
Drinking	2 (8)	5 (8)	1	4 (13)	8 (8)	.49
Cardiovascular disease, N (%)
HTN	16 (67)	33 (52)	.24	22 (69)	68 (69)	1
CAD	8 (33)	7 (11)	.02*	5 (16)	9 (9)	.33
CHF	0 (0)	1 (2)	1	0 (0)	1 (1)	1
OMI	2 (8)	5 (8)	1	2 (6)	2 (2)	.25
DM	6 (25)	7 (11)	.17	9 (28)	25 (25)	.82
Echocardiographic data
LVEF (%)	67 ± 7	66 ± 7	.34	67 ± 6	67 ± 6	.89
LAD(mm)	42 ± 5	41 ± 4	.26	42 ± 5	40 ± 4	.05*
LVESD(mm)	31 ± 4	30 ± 4	.56	31 ± 4	31 ± 4	.94
LVEDD(mm)	50 ± 4	49 ± 4	.28	49 ± 4	49 ± 6	.88
MR
No MR	7 (29)	22 (36)	10 (33)	25 (26)
Slight MR	12 (50)	25 (40)	0.72	10 (33)	45 (47)	.7
Mild MR	4 (17)	14 (23)	7 (23)	22 (23)
Moderate MR	1 (4)	1 (2)	3 (10)	3 (3)
Medications post‐­PPM, N (%)
Beta‐­blocker	2 (8)	6 (9)	1	12 (38)	17 (17)	.03*
ACE inhibitor	5 (21)	14 (22)	1	7 (22)	26 (26)	.82
ARB	6 (25)	11 (17)	.55	11 (34)	24 (24)	.26
Antiarrhythmic	4 (17)	4 (6)	.21	1 (3)	1 (1)	.43
Statin	11 (46)	15 (23)	.07	7 (23)	17 (17)	.59
Anticoagulants	0 (0)	0 (0)	‐­‐­‐­‐­‐­	0 (0)	2 (2)	1
Antiplatelet	12 (50)	18 (28)	.08*	11 (34)	26 (26)	.38
Cum% AP median (IQR)	56 (34,76)	59 (34,81)	.58	15 (4,32)	24 (11,38)	.17
Cum% VP median (IQR)	79 (14,99)	12 (0,68)	.007*	99 (94,100)	99 (71,100)	.43
Follow up (days)	870 ± 170	900 ± 177	.46	900 ± 188	873 ± 187	.48
Laboratory tests
Leukocyte(10×9/L)	5.9 ± 1.5	5.6 ± 1.7	.51	6.2 ± 1.4	6.0 ± 1.5	.61

Hemoglobin(g/L)	133 ± 15	128 ± 13	.28	135 ± 14	130 ± 15	.16
Neutrophils (10×9/L)	3.6 ± 1.3	3.1 ± 2.0	.19	3.9 ± 1.2	3.8 ± 1.4	.72
Blood platelet(10×9/L)	165 ± 50	176 ± 48	.41	175 ± 49	179 ± 52	.74
hs‐­CRP (mg/L)	4.4	2.6	.13	4.9	3.2
LDH(U/L)	181	180	.51	187	193	.78
Urea nitrogen (mmol/L)	6.2 ± 1.7	5.9 ± 1.9	.52	6.4 ± 1.3	6.3 ± 2.4	.68
Creatinine (mmol/L)	79 ± 21	79 ± 27	.99	82 ± 21	80 ± 22	.75
Uric acid (mmol/L)	365 ± 79	342 ± 93	.29	385 ± 96	352 ± 105	.14
NT‐­proBNP(pg/mL)	276	123	.13	323	439	.95
cTnT(ng/mL)	0.095	0.06	.36	0.009	0.013	.22
HbA1c (%)	6.2 ± 1.0	5.8 ± 0.7	.17	6.1 ± 1.0	6.4 ± 1.4	.35
TC (mmol/L)	4.3 ± 0.8	4.3 ± 0.9	.97	4.1 ± 0.8	4.3 ± 1.0	.25
TG (mmol/L)	1.7 ± 1.1	1.4 ± 0.8	.17	1.6 ± 1.1	1.7 ± 1.6	.68
HDL‐­C(mmol/L)	1.3 ± 0.4	1.2 ± 0.3	.49	1.2 ± 0.2	1.2 ± 0.3	.69
LDL‐­C(mmol/L)	2.2 ± 0.8	2.5 ± 0.7	.17	2.3 ± 0.7	2.4 ± 0.8	.42
Lp(a)(mmol/L)	107	161	.01*	142	159	.55
D‐­ dimer (mg/L)	0.37	0.3	.64	0.3	0.41	.26
PT(s)	11.9 ± 1.3	12.0 ± 1.2	.93	12.3 ± 1.2	12.2 ± 1.5	.78
Fibrinogen (mg/dL)	278 ± 49	273 ± 50	.74	275 ± 73	287 ± 73	.47

Abbreviations: HTN, hypertension; CAD, coronary artery disease; CHF, congestive heart failure; OMI, old myocardial infarction; DM, diabetes mellitus; PPM, permanent pacemaker; LVEF, left ventricular ejection fraction; LAD, LA dimension; LVESD, the inner diameter of the left ventricular end‐­systolic; LVEDD, left ventricular end‐­diastolic diameter; MR, mitral regurgitation; ACE, angiotensin‐­converting enzyme; ARB, angiotensin II receptor blockers. Cum %AP, Cum % atrial paced, median (IQR); Cum %VP, Cum % ventricular paced, median (IQR); LDH, lactate dehydrogenase; NT‐­proBNP, N‐­terminal pro‐­B‐­type natriuretic peptide;cTnT, cardiac troponin T; HbA1c, glycated hemoglobin; TC, Cholesterol ;TG, Triglycerides ; HDL‐­C, high‐­density lipoprotein; LDL‐­C, low‐­ density lipoprotein; Lp(a), apolipoprotein (a); PT, prothrombin time.

*P < .05

TABLE 4 Results of the Cox regression analysis

	SSS			AVB
	HR	95% CI	P Value	HR	95% CI	P Value
Age, years	1.04	0.95‐­1.06	.88	0.99	0.96‐­1.01	.34
Male	1.15	0.48‐­2.75	.76	1.14	0.64‐­2.05	.66
CAD	0.75	0.27‐­2.12	.59	0.51	0.18‐­1.44	.20
LAD (mm)	1.07	0.97‐­1.18	.17	1.06	1.01‐­1.14	.046*
Cum% VP	1.01	1.00‐­1.02	.035*	1.00	0.98‐­1.02	.93
Antiplatelet	1.03	0.32‐­3.26	.97	‐­‐­‐­	‐­‐­‐­	‐­‐­‐­
Statin	0.13	0.01‐­30.84	.63	‐­‐­‐­	‐­‐­‐­	‐­‐­‐­
Beta‐­blocker	‐­‐­‐­	‐­‐­‐­	‐­‐­‐­	0.68	0.35‐­1.32	.25
Lp(a) (mmol/L)	0.99	0.97‐­1.01	.23	‐­‐­‐­	‐­‐­‐­	‐­‐­‐­

CAD, coronary artery disease; LAD, LA dimension; Cum %AP, Cum % atrial paced; Cum %VP, Cum % ventricular paced; HR, Hazard ratio; CI, confidence interval.

*P < .05

TABLE 5 Comparison between the 3 groups of patients

	No AF			P Value
	(1) No or AHREs AHREs<2mins	(2) 2mins≤AHREs and <5mins	(3) AF	(1) vs (2)	(2) vs (3)	(1) vs (3)
Total number	134	29	56	‐­‐­	‐­‐­	‐­‐­
Complications	4 (3)	7 (24)	4 (7)	.001*	.04*	.24
Antiarrhythmic	4 (3)	7 (24)	12 (21)	.001*	.79	<.001*
Antiplatelet	36 (27)	12 (41)	27 (48)	.18	.65	.007*
Beta‐­blocker	21 (16)	3 (10)	22 (39)	.57	.06	.001*
Anticoagulants	1 (1)	1 (3)	2 (4)	.33	1	.21

AP19‐­00984

The correlation between different left ventricular pacing sites using quadripolar lead and electrical mechanical synchronization index and acute hemodynamic change in CRT‐­D patients

Xueying Chen, Zhe Sun, Yangang Su, Junbo Ge

Zhongshan Hospital of Fudan University, Shanghai Institute of Cardiovascular Diseases, China

Introduction:

This study was designed to investigate correlation between electrical and mechanical synchronization index using a quadripolar lead cardiac resynchronization therapy.

Methods:

Interventricular conduction time, electrocardiographic and echocardiographic examinations were performed at baseline and three days after CRT during native heart rate in sinus rhythm. QRS duration (QRSd), aortic velocity time integral (VTI), PETd and Ts‐­12‐­SD were assessed in different pacing sites (D1, M2, M3, P4) and “No‐­pacing”. Relative parameter change (%Δparameter i.e. %ΔQRSd, %ΔVTI, %ΔPETd or %ΔTs‐­12‐­SD) was calculated. Then correlation between variables was analyzed with Pearson's coefficient.

Result:

This study included 19 consecutive enrolled heart failure patients in accordance with CRT implanting indications. There was no correlation between interventricular conduction time (P > .05). The RV‐­LV interventricular conduction time was not significantly correlated with either pacing QRS duration or %ΔQRSd (P > .05). But LVp‐­RV conduction time was obviously correlated with pacing QRS duration (r = 0.558, P < .0001) or %ΔQRSd(r = 0.453, P < .001). There was a negative correlation between %ΔVTI and LVp‐­RV conduction time (r = ‐­0.459, P < .0001).There was poor positive correlation between RVs‐­ LV conduction time and VTI(r = 0.278, P = .023), as well as between RVp‐­LV conduction time and VTI (r = 0.325, P = .007) or %ΔVTI(r = 0.266, P = .030). There was positive correlation between Ts‐­12‐­SD and LVp‐­RV conduction time(r = 0.302, P = .013).

Conclusion:

The longer conduction time of RV‐­LV may produce greater acute hemodynamic change, especially in RVp‐­LV state. And the shorter LVp‐­RV conduction time could emerge higher VTI value or narrower pacing QRSd or better LV intraventricular synchrony at the mean while.

FIGURE 1 Quadripolar lead has four pacing sites, D1, M2, M3, P4 respectively and the maximum distance is about 47 mm

FIGURE 2 Comparison of interventricular conduction time. (A) RVp‐­LV conduction time was significantly longer than RVs‐­LV conduction time (*P = .016). (B) RVs‐­LV conduction time was similar to LVp‐­RV conduction time (P = .53, NS). (C) RVp‐­LV conduction time was significantly longer than LVp‐­RV conduction time (*P < .0001)

FIGURE 3 The correlation between LVp‐­RV conduction time and QRS duration (A) or %△QRSd (B). (A). LVp‐­RV conduction time was obviously correlated with pacing QRS duration (*P < .0001). (B). LVp‐­RV conduction time was obviously correlated with %ΔQRSd (*P < .001)

FIGURE 4 The correlation between interventricular conduction time and echo indices. (A) There was a negative correlation between %ΔVTI and LVp‐­RV conduction time (*P < .0001). (B) There was positive correlation between VTI and RVs‐­LV conduction time( *P = .023). (C) There was positive correlation between VTI and RVp‐­LV conduction time( *P = .007). (D) There was positive correlation between %ΔVTI and RVp‐­LV conduction time( *P = .030). (E) There was positive correlation between Ts‐­12‐­SD and LVp‐­RV conduction time (*P = .013)

TABLE 1 Basic characteristics of enrolled population

Patient characteristics	Total Subjects (N = 1 9 )
Gender (%)
Male	79%
Female	21%
Age(yea rs)	59.9 ± 6.1
NYH A (%)
class II	16%
class III	63%
class IV	21%
C a rdiomyopa thy
Ischemic	32%
Nonischemic	68%
Q RS dura tion (milliseconds)	175.89 ± 22.66
Echoca rdiogra phy Indices
LVEF(%)	25.84 ± 3.40
LVESD(mm)	60.89 ± 6.48
LVEDD(mm)	71.31 ± 7.60
VTI(m/s)	19.0 ± 5.8
Ts‐­12‐­SD(milliseconds)	57.9 ± 15.8
PETd(milliseconds)	45.7 ± 15.4

AP19‐­00985

Temporal trends, complications and outcomes of pacemaker implantations: a decade long single‐­centre analysis

Charles Yao‐Cheng Ho, Dean Boddington

Tauranga Hospital, Bay of Plenty District Health Board, New Zealand

Introduction:

Limited data exists regarding temporal trends, long term outcome and complication rates of permanent pacemaker (PPM) implantation. In 2008, PPM implantation services commenced at Tauranga Hospital, a secondary hospital in New Zealand providing for a population of over 250 000. An overall strategy of procedural safety was implemented with emphasis on cephalic vein access and ventricular septal lead placement whenever possible. We present our findings over the past ten years.

Methods:

Consecutive patients undergoing new single chamber (SS) or dual chamber (DD) PPM implantation at Tauranga Hospital from 2008‐­2018 were included in this retrospective analysis. Patient demographics, procedural characteristics, complications, short and long term outcomes were obtained from electronic records and device database. Cardiac resynchronization therapy were excluded.

Result:

876 patients identified, comprising DD 590 (67%), SS 286 (33%). Median age at implantation was 79y (IQR 72‐­85), predominantly European (90%) and male (61%). Device indications and presenting symptoms are shown in Figure 1. There is a trend of increasing proportion of DD implantation and decreasing SS (Figure 2). Patients with SS were older than DD (median 83 vs 77y) with more comorbidities (Figure 3) and lower LVEF (45 ± 10 vs 49 ± 7, P = .05). Those with DD had less Major Adverse Cardiac or Cerebral Event (MACCE) than SS (31% vs 63%, HR 0.44, CI 0.35‐­0.54, P < .001) and lower all‐­cause‐­mortality (17% vs 53%, HR 0.29, CI 0.22‐­0.37, P < .001). Short term procedural complications (≤12 weeks) occurred in 3.7%. Median time to complication was 10 ± 39 days. Most frequent complication was lead displacement in 16 (1.8%) patients, of which 11 were atrial leads. 5 (0.6%) developed subclavian venous thromboses, 4 (0.5%) pneumothoraces, 2 (0.2%) haematoma requiring evacuation, 2 (0.2%) infection requiring explantation and one pericardial effusion not requiring drainage. Long term complication rate (>12 weeks) was 1.1% including three cases of pacing cardiomyopathy occurring after one year. Cephalic vein access for ventricular lead was utilized in 78% of patients and was associated with lower complication rates compared to non‐­cephalic access (3.1% vs 6.8%, HR 0.45, CI 0.22‐­0.94, P = .033). 84% of ventricular lead was placed in the septal position. This was associated with less MACCE compared to patients with leads in the apical position (37% vs 62%, HR 0.70, CI 0.55‐­0.90, P = .005).

Conclusion:

Patients who receive single chamber PPM are older with more comorbidities and greater long term mortality. Over ten years, there is a trend towards greater proportion of dual chamber PPM being implanted. Despite being a relatively low volume centre, our overall procedural complication rates were acceptable. We attribute this to the specific strategy of cephalic access utilization and ventricular lead placement in the septal position.

AP19‐­00988

Relationship between membranous septal length and the risk of cardiac conduction disturbances in patients who have undergone transcatheter aortic valve replacement

Tomonori Miki, Keiraro Senoo, Takashi Okura, Hirokazu Shiraishi, Takeshi Shirayama, Satoaki Matoba

Kyoto Prefectural University of Medicine, Japan

Introduction:

Complication rates of transcatheter aortic valve replacement (TAVR) have decreased. However, new‐­onset conduction disturbances (CDs) are still common and the incidence of CDs is said to be higher for patients with a self‐­expandable valve (SEV) than for those with a balloon‐­expandable valve (BEV). We examined the occurrence of CDs and related factors for both types of valves.

Methods:

Among 190 consecutive patients who underwent TAVR, 127 (mean age, 85.5 ± 5.4 years; 98 females; 56 SEVs) were included. Cardiac CDs, defined as new‐­onset complete left bundle‐­branch block or the need for permanent pacemaker implantation, were assessed at the time of discharge.

Result:

Thirty patients had new‐­onset CDs after the procedure, and the incidence of CDs tended to be higher in patients with a SEV (28.5% for SEV and 19.7% for BEV, P = .24). The cutoff value of the area under the curve (AUC) for the membranous septum (MS) length was not different between SEV group (cutoff value, 6.3 mm; sensitivity, 0.81; specificity, 0.62; P < .001) and BEV group (cutoff value, 6.4 mm; sensitivity, 0.92; specificity, 0.63; P < .001). A multivariate analysis showed that the incidence of CDs was associated with MS length as a pre‐­procedure predictor (odds ratio [OR], 0.41; 95% confidence interval [CI], 0.27‐­0.63; P < .001) and with ΔMSID (defined as the difference between MS length and implantation depth) as a post‐­procedure predictor (OR, 0.46; 95% CI, 0.33‐­0.63; P < .001), but it was not related to the type of valve (OR, 0.85; 95% CI, 0.18‐­4.1, P = .83).

Conclusion:

MS length is a useful predictive factor for CDs, regardless of the type of valve. Pre‐­ procedural computed tomography assessment of MS anatomy could potentially reduce the risk of CDs.

AP19‐­00990

Impact of optimal implantable cardioverter‐­defibrillator programming using delayed detection on reduced inappropriate shock

Do Young Kim, Jong‐Il Choi, Ha Young Choi, Yun Young Choi, Ki Yung Boo, Yun Gi Kim, Kwang‐No Lee, Dong Hyeok Kim, Jaemin Shim, Sang Weon Park, Young‐Hoon Kim

Korea University Anam Hospital, South Korea

Introduction:

Inappropriate shocks are associated with increased mortality among patients who have implantable cardioverter‐­defibrillators (ICD). Randomized controlled trials have shown that optimal ICD programming reduces inappropriate shocks and mortality rates. However, there are a few real‐­world data regarding the impact of optimal ICD programming on these patients.

Methods:

We retrospectively investigated 83 patients who underwent ICD implantations in a tertiary medical center. Class I consensus statement recommendations include slowest tachycardia zone between 185 and 200 bpm or rate of ventricular tachycardia (VT) minus 10 (if VT is documented and target tachycardia rate should be less than 200 bpm), delayed arrhythmia detection duration (6‐­12 seconds or 30 intervals before detection) and VT morphology discrimination (coverage tachycardia faster than 200 bpm up to 230 bpm)

Result:

During 48.6 ± 19.2 months, 14 patients (16.9%) experienced more than one inappropriate shock. The common causes of inappropriate shocks were sinus tachycardia (n = 6) which was followed by atrial fibrillation (n = 5) and noises caused by external origins (n = 3). Kaplan‐­Meier analysis showed that subjects with delayed detection of tachycardia significantly reduced the rate of inappropriate shocks free survival compared to those with no delayed detection (Figure 1; log‐­rank P = .05). In the multivariate Cox regression model adjusted by beta‐­blockers, antiarrhythmic drug, age, atrial fibrillation and dual vs single‐­chamber ICD, only delayed detection remained as a variable that was significantly associated with a lower risk of inappropriate shock (HR 0.106, 95% CI 0.14‐­0.826; P = .032). Four (4.8%) patients experienced syncope following appropriate shocks. However, the incidence of syncope was not different between the delayed detection group and no delayed detection group. There was no mortality or morbidity related to under‐­sensing of VT or ventricular fibrillation events.

Conclusion:

This real‐­world data demonstrated that ICD programming with delayed detection for therapy was associated with reductions in inappropriate shocks and no adverse events.

AP19‐­00995

The incidence and predictors of newly detected atrial fibrillation in patients with hypertrophic cardiomyopathy following cardiac electrophysiological device implantation

Hiroshi Hayashi, Toshiki Arai, Masato Hachisuka, Rei Mimuro, Noriyuki Kobayashi, Yujin Maru, Yuhi Fujimoto, Eiichiro Oka, Kanako Hagiwara, Teppei Yamamoto, Akinori Sairaku, Kenji Yodogawa, Hiroshige Murata, Yuki Iwasaki, Wataru Shimizu

Nippon Medical School, Japan

Introduction:

Atrial fibrillation (AF) is an important prognostic parameter in patients with hypertrophic cardiomyopathy (HCM). However, the incidence and predictors of newly‐­detected AF in patients with HCM and cardiac implantable electrophysiological devices (CIEDs) has not been fully elucidated.

Methods:

Seventy‐­three patients (44 men, age 60 ± 16 years) with HCM who underwent CIED implantation (ICD n = 61, Pacemaker n = 11, CRTD n = 1) were enrolled in the study. The clinical parameters, incidence of newly‐­detected AF and impact on inappropriate shock were evaluated. During follow‐­up, patients were screened for adverse events including stroke, heart failure, or death.

Result:

Among the all patients, 56 (77%) patients had no previous history of AF at the time of implantation. During 6 ± 4 years of follow‐­up, AF was newly detected in 20 (36%) of 56 patients. Compared the patients who had newly‐­detected AF (Newly‐­detected AF group n = 20) and who did not (Non‐­AF group n = 36), patients in Newly‐­detected AF group had larger left atrial diameter (LAD) (45 ± 6 mm vs 38 ± 6 mm P < .01), higher prevalence of New York Heart Association (NYHA) (III/IV) (50% vs 17% P = .01) and more patients received percutaneous septal ablation (55% vs 28% P = .04) compared to Non‐­AF group. After Cox regression analysis, LAD (HR:1.11 per unit increase; 95% CI: 1.01‐­1.23) and concomitant NYHA (III/IV) (HR:3.90; 95% CI: 1.34‐­12.3) were the independent predictors of newly‐­detected AF. Compared the patients with AF (n = 37) and without AF (n = 36), the rate of appropriate therapy (25% vs 17%, log‐­rank P = .95) and inappropriate therapy (15% vs 8% log‐­rank P = .78) was similar between the two groups. However, all the cause of inappropriate therapy in patients with AF was false interpretation of tachycardic AF. During the follow‐­up, ischemic stroke was documented in only 1 patient without AF. Hospitalization due to heart failure was seen in 8 patients, amiodarone induced intestinal pneumonia was documented in 2 patients and death occurred in 3 patients.

Conclusion:

The incidence of newly‐­detected AF was high in patients with HCM who underwent CIED implantation. HCM patients with dilated left atrium and concomitant NYHA III/IV are at a high risk of newly‐­detected AF and careful follow up is recommended.

AP19‐­00999

Cardiac implantable electronic device implantation and follow up at Third State Central Hospital of Mongolia

Gerelmaa Tur, Mungun‐Ulzii Kh, D Batnaran, E Dosjan, Ts Saruul, M Purevjav, N Erdenekhuu, N Baasanjav

Third State Central Hospital, Mongolia

Introduction:

Background: Cardiac electronic implantable devices (CIED) implantation and follow up was officially licensed in December 2012 at the Third State Central Hospital of Mongolia. With the aid of the Luxembourg Government development project, the first arrhythmia specialist was prepared who have trained subsequent implanters and eventually Rhythmology team. After initiation of pacemaker implantation in December 2012, cardiac resynchronization therapy (CRT), implantable cardioverter defibrillator (ICD) and cardiac contractility modulation (CCM) therapies were introduced in 2015, 2016 and 2018 respectively. Objective: To analyze the current condition of CIED implantation and follow up in Mongolia

Methods:

We studied the medical history of all patients who have received CEID implantation at the Third State Central Hospital from 1st January 2013 to 31 December 2018. Basic medical information, dose area product (DAP) meter readings, fluoroscopy time, and complications of CEID recipients were analyzed.

Result:

Result: Out of 545 patients received CIED implantation, 5 subjects were excluded from the statistical analysis due to an inadequate recording of medical notes. A total of 540 patients (217 males and 318 females) with ages ranging from 5 to 97 (mean of 65 ± 14 years) were selected. In terms of diagnosis, 55% (n = 300) of patients had sick sinus syndrome, 33.7% (n = 184) had complete atrioventricular block, 3.8% (n = 21) had congestive heart failure and 1.1% (n = 6) had ventricular tachycardia. In 2013 ‐­ 2018, 510 pacemakers, 15 CRTs, 8 ICDs, and 2 CCMs were implanted at the Third State Central Hospital, and 6% of these cases developed complications. Major complications were pocket infection (56% or 18 cases), electrode mechanical damage (16% or 5 cases), hematoma (9% or 3 cases) and tension pneumothorax (12.6% or 4 cases) and cardiac perforation (6.4% or 2 cases). There was no procedure‐­related mortality. The mean fluoroscopy time was 206 ± 196 sec and the average x‐­ray dose was 10,425 ± 16,656 Gycm2. The mean fluoroscopy time was reduced from 659 sec in 2013 to 185 sec in 2018. X‐­ray dose was reduced from 25,088 Gycm2 in 2013 to 6,065 Gycm2 in 2018.

Conclusion:

Conclusion: Mongolian first results of CIED therapy shows that excellent improvement in CIED therapy of local professionals but improvements are needed for the pocket infection prevention.

AP19‐­01005

Absorption rate of subcutaneous air at one week after S‐­ICD implantation

Yuka Taguchi, Katsumi Matsumoto, Toshiyuki Ishikawa, Junya Hosoda, Masayoshi Kiyokuni, Masatoshi Narikawa, Tabito Kino

Yokohama City University hospital, Japan

Introduction:

The subcutaneous implantable cardioverter‐­defibrillator (S‐­ICD; Boston Scientific, Marlborough, MA, USA) is a useful tool to prevent sudden cardiac death without intra‐­cardiac lead related complications. However some inappropriate shock cases because of oversensing due to entrapped subcutaneous air early after implantation have been reported. We investigate the subcutaneous air absorption rate at one week after implantation by imaging computed tomography (CT).

Methods:

The patients who underwent S‐­ICD implantation received CT scan immediately after operation and one week after. We calculated the volume of subcutaneous air using a three‐­dimensional image analysis system to determine its absorption rate.

Result:

Of the patients who received S‐­ICD implantation at our hospital, seven consented patients were surveyed whose data was available. The mean age was 50.3 ± 19.0 years old (71% of men), and the mean body mass index was 23.6 ± 4.1. The conventional three incision method was performed in six patients and two incision method was in one patient. The mean subcutaneous air immediately after implantation and one week after were 28.1 ± 4.8 ml and 0.16 ± 0.18 ml, respectively, showing the absorption rate was 99%.

Conclusion:

The subcutaneous air was almost absorbed at one week after S‐­ICD implantation, suggesting a low occurrence of inappropriate shock due to entrapped air after a week after operation.

AP19‐­01016

Permanent pacemaker implantation in patient with sick sinus syndrome and dextrocardia: a unique technical challenges

Dicky Kurnia Gumilang, Giky Karwiky, Mohammad Iqbal, Januar Wibawa Martha, Muhammad Rizki Akbar

Hasan Sadikin General Hospital‐­UNPAD, Indonesia

Introduction:

Dextrocardia is a rare congenital heart disease in which the heart is located on the right part of the chest, with its apex pointed on the right side. The incidence of dextrocardia is 0.8 per 10.000 live births. The complex anatomy and different fluoroscopic orientation may pose challenges for transvenous Permanent Pacemaker Implantation (PPI). Here we present a case of Dextrocardia who underwent PPI due to Sick Sinus Syndrome (SSS).

Methods:

Reporting 35 yo male with chief complaint of syncope since 3 months before admission. Patient doesn't have any history of cardiac disease before. Echocardiography showed dextrocardia with normal ventricular function. Holter report showed Sinus tachycardia, sinus bradycardia with 7 seconds of pause and frequent runs of Atrial Tachycardia (AT) and paroxysmal Atrial Fibrillation (AF). Based on the report, we conclude that patient had SSS. The patient underwent dual chamber PPI with DDDR mode. The bipolar lead was placed in Right Atrium (RA) and apex of Right ventricle (RV). During procedure, we experienced difficulties when placing the atrial lead in Right Atrial Appendage (RAA). We decided to place the lead on septal wall of RA. No Phrenic Nerve Stimulation (PNS) were observed. One week after procedure, the patient felt upper abdominal discomfort, and we observed PNS on the patient. We decided to turn off the atrial lead in order to stop PNS. Post PPI Cardiac Ct Scan showed dextrocardia with atrial lead at posteroinferior wall of RA.

Result:

In dextrocardia with normal situs, both atria along with the appendages and connecting great veins retain their normal relationship, while ventricles are rotated to the right. Dextrocardia patients without intracardiac major anomalies can survive into adulthood and may presence with degenerative conduction diseases. Dextrocardia may pose major challenge, particularly how to guide the bipolar lead into RA and RV. Venous angiography via the second access may reveal important anatomical information regarding orientation of the septum, venous chambers morphology, and act as a roadmap to facilitates lead implantation. Since Dextrocardia with is a mirror image of normal heart, the use of flipped image and opposite angulated view (RAO instead of LAO and vice versa), have been suggested to facilitate implantation.

Conclusion:

PPI in dextrocardia needs certain technique for successful implantation. Venous angiography from second access and view‐­modified fluoroscopy is helpful in determining the route of endocardial catheter.

AP19‐­01020

Longevity prediction performance of pacemaker systems

Jihye Park, So‐Young Park, JI‐Young Lee, Euijae Lee, So‐Ryoung Lee, Myung‐Jin Cha, Eue‐Keun Choi, Seil Oh

Seoul National University Hospital, South Korea

Introduction:

One of the most important information to the patients with pacemaker is the remaining longevity of pacemaker generators. In general, we rely on the predicted battery life expectancy provided by pacemaker system manufacturers. However, there was little information for the reliability of longevity prediction.

Methods:

We retrospectively reviewed the patients with pacemaker system who received generator replacement due to reaching elective replacement indicator (ERI) from January 1, 2013 to June 30, 2018. Patients had both records of one year of remaining longevity and ERI were selected. Patients without longevity or ERI records, and who received generator replacement due to reasons other than ERI were excluded. We calculated the time intervals between the date indicating one‐­year longevity remaining and ERI date (time from index to ERI, TIE).

Result:

A total of 170 patients received pulse generator replacement for any reason during the study period. Of these, 95 patients were excluded, and 75 patients were enrolled in the final analysis. [Age 68.4 ± 12.7 years, female 41 (54.7%), dual chamber device 41 (54.7%)]. The average expected longevity at 1 year was 12.3 ± 5.12 months and the TIE was 8.4 ± 4.22 months (minimum 1.8 months, maximum 23.3 months, Figure). Mean difference was 3.9 ± 6.63 months and it was statistically significant (P < .001). The dual chamber device and single chamber device showed 12.7 ± 6.68 months and 11.7 ± 2.04 months of TIE, respectively. TIEs were 3‐­4 months shorter than expected longevity (7.8 ± 3.06 months in dual chamber device (P < .001); 9.1 ± 5.25 months in single chamber device (P = .004)). Activation of rate response pacing mode (R‐­mode) did not affect the prediction ability of the device longevity (R‐­mode ON, 4.0 ± 7.01 months; R‐­mode OFF, 3.3 ± 3.33 months; P = .784).

Conclusion:

The longevity prediction of pacemaker systems was longer than the actual time interval from the date indicating 12 months of predicted longevity to the date of ERI. Therefore, the patients with pacemaker longevity < 12 months required more frequent and vigilant observation.

FIGURE Distribution plot for time from index to ERI

AP19‐­01026

Unusual electrogram pacemaker lead tracing of atrial paced event followed by dual ventricular sensed event due to late atrial pacemaker lead displacement

Angga Pramudita, Simon Salim, Muhammad Yamin

Indonesian Society of Internal Medicine, Indonesia

Introduction:

Lead displacement is an uncommon complication of cardiovascular implantable electronic device. The incidence of early displacements of atrial leads have been reported to be 3.8% in DDD pacemakers. Late displacements which occur after the first six weeks of implantation is a rare complication. Only significant displacements (macro‐­dislodgement) that causes malfunction will produce clinically relevant symptoms. This case describes a patient with a past history of dual chamber pacemaker implantation in 2012 who developed pacemaker syndrome only recently due to late atrial lead displacement of DDD pacemaker which was detected initially by an unusual electrogram (EGM) tracing of atrial paced event followed by a dual ventricular sensed event.

Methods:

N/A.

Result:

A 73 year old woman came to our clinic with symptoms of fatigue and mild shortness of breath on exertion for the last 3 months. She was previously active and had a history of dual‐­chamber pacemaker implanted in 2012 due to complete heart block and regularly attended the scheduled 6‐­12 monthly follow up which from previous reports showed no abnormal findings. Current EGM tracing revealed an unusual annotation of atrial paced event (AP) followed by a closely spaced dual ventricular sensed event (VS S) persistently occurring in DDD pacing mode (Figure 1). Simultaneous (during DDD) Electrocardiogram (ECG) was done and clearly showed atrioventricular (AV) dissociation in what appears to be “VVI” pacing mode (Figure 2). After comparing the current ECG with the previous ECG in September 2018 it was suggested that the atrial pacemaker lead was dislodged into the right ventricular (RV) apex. In the September 2018 ECG an atrial sensed event followed by ventricular paced event was evident indicating AV synchrony. The QRS complex had a rS pattern in lead II, III and aVF and qR pattern in lead I and aVL which suggest RV lead was implanted in RVOT mid‐­septum compared to current ECG which suggest RV lead implanted in RV apex due to QS complex in lead II, III and aVF and monophasic R wave morphology in I and aVL (Figures 2 and 3). Changing the pacing mode to VVI showed the QRS complex morphology to be the same as the QRS complex of the ECG in September 2018 (Figure 4). Probable explanation of the dual ventricular sensed event is pacing stimulus artifact from the atrial lead followed by the actual ventricular capture sensed by the ventricular lead. Chest radiograph confirmed our findings (Figure 5). Patient underwent atrial lead extraction and dual chamber pacemaker whole system replacement.

Conclusion:

Pacemaker lead tracing combine with 12 lead ECG recordings can be helpful in determining the cause of pacemaker malfunction. Atrial lead displacement (macro‐­dislodgement) with pacemaker malfunction albeit uncommon can still occur years after the initial device implantation.

AP19‐­01030

Utilization of implantable cardioverter defibrillators in heart failure with reduced ejection fraction patients in the specialized multidisciplinary outpatient clinic

Thanaporn Ratchataswan, Thiratest Leesutipornchai, Palapun Waitayangkoon, Sarinya Puwanant, Sarawut Siwamogsatham, Voravut Rungpradubvong, Anurut Huntrakul, Somchai Prechawat, Aekarach Ariyachaipanich, Supanee Sinphurmsukskul

Faculty of Medicine, Chulalongkorn University, Thailand

Introduction:

Prophylactic insertion of implantable cardioverter defibrillators (ICD) in patients with heart failure (HF) and reduced ejection fraction is lifesaving. Around one fifth of patients in randomized HF trials had ICD implanted. However, ICD utilization rate in the multidisciplinary clinics in Thailand is poorly defined. The aim of this study is to determine the rate of ICD implantation among patients with HF reduced ejection fraction in a specialized multidisciplinary clinic.

Methods:

We conducted a cross‐­sectional study of 344 patients with chronic heart failure treated in the multidisciplinary outpatient heart failure clinic in King Chulalongkorn Memorial Hospital between 2015 and 2019. Patients with left ventricular ejection fraction (LVEF) ≤ 35% at first visit and had minimal follow‐­up period of 12 months were enrolled in the study. ICD‐­eligibility (LVEF ≤ 35% and New York Heart Association (NYHA) Class II‐­III, or LVEF ≤ 30% and NYHA Class I) and utilization were reviewed through medical records during outpatient visits at 12‐­month follow‐­up. T‐­test and Chi‐­ square test or Fisher's exact test were used.

Result:

A total of 84 ICD‐­eligible patients enrolled in this study had mean age 51.8 ± 13.5 years, LVEF 24.5 ± 6.74% and 78.6% were men. ICDs were implanted in 51 (60.7%) patients. There was no statistical difference between ICD group and non‐­ICD group in age (53.2 ± 14.1 vs 49.7 ± 12.5; P = .58), male gender (82.4% vs 72.7%; P = .29), NYHA Class II/III (94.1% vs 90.3%; P = .67), coronary artery disease (47.1% vs 34.4%, P = .26) and comorbidities including diabetes mellitus (15.7% vs 25.0%; P = .30), hypertension (27.5% vs 34.4%; P = .50), cerebrovascular disease or peripheral arterial disease (7.80% vs 3.10%; P = .64), dyslipidemia (31.4% vs 28.1%; P = .75) and chronic liver disease (8.30% vs 22.2%; P = .21).

Conclusion:

From our multidisciplinary clinic setting, the rate of ICD utilization among heart failure with reduced ejection fraction patients who were eligible for ICD is over 60%. However, to improve utilization rates, further research is needed to explore the reasons behind higher proportion of ICD utilization in the multidisciplinary clinic compared to a general outpatient clinic.

AP19‐­01039

Utility of transthoracic impedance and novel algorithm for sleep apnea screening in pacemaker patient

Ruohan Chen, Keping Chen, Yan Dai, Shu Zhang

FuWai hospital, China

Introduction:

Pacing patients was revealed with a high prevalence of sleep disorder, but mostly undiagnosed. The pacemaker with transthoracic impedance sensor and novel algorithm could identify sleep apnea (SA) event. This study aimed to evaluate accuracy of pacemaker in sleep apnea diagnosis.

Methods:

This is a prospective study enrolled patients implanted with pacemakers integrated with transthoracic impedance sensor and SA identified algorithm (AP Scan). All patients underwent a polysomnography (PSG). The apnea and hypopnea index (AHI) of the PSG (PSG‐­AHI) and the respiratory disturbance index (RDI) of the pacemaker (PM‐­RDI) were recorded on the same night. The correlation between two methods was evaluated by the kappa coefficient, receiver operating characteristic (ROC) curves and Bland and Altman statistics.

Result:

Sixty‐­four patients were enrolled, who had never been diagnosed with SAS or underwent ₨PSG exam. After PSG examination, 76.4% patients were diagnosed as combining with SA (20% severe, 18.2% moderate, and 38.2% mild). RDI calculated by PM has a strong positive correlation with PSG‐­AHI (r = 0.76, P < .001, 95% CI: 0.61 ‐­ 0.85). The optimal cut off value of PM‐­RDI for advanced SAS (PSG‐­AHI ≥ 15) diagnosis was 26, with AUC of 0.89 (95% CI 0.77 to 0.96, P < .001). The best cut‐­off value for severe SA (PSG‐­AHI ≥ 30) identification was 41, with a sensitivity of 81.6%, a specificity of 88.6%.

Conclusion:

Pacemaker patients present a high prevalence of undiagnosed SA. Detection of SA by pacemaker is feasible and accurate in SA screening and monitoring.

FIGURE 1 Scatter plot. PM‐­RDI: respiratory disturbance index calculated by the ApScan algorithm; PSG‐­AHI: apnea‐­hypopnea index came from PSG

FIGURE 2 Bland‐­Altman plot. (x axis: the mean of the PM‐­RDI and PSG‐­AHI;Y axis: the difference between the PSG‐­AHI and the PM‐­RDI

FIGURE 3 The ROC curve for detection of SA at PSG‐­AHI≥30 (right) and PSG‐­AHI≥ 15 (left)

TABLE 1 Demographic and clinical characteristics

Characteristics	Total (N=55)	No or mile SA	Moderate or Severe SA	P
		(N=34)	(N=21)
Male	34 (61.9%)	20 (58.8%)	14 (66.7%)	.77
Age (year)	67.1 ± 9.8	66.5 ± 10.0	68.6 ± 10.3	.44
BMI (Kg/m2)	24.0 ± 4.2	24.5 ± 4.4	23.4 ± 3.6	.38
Smoker	17 (30.9%)	9 (26.5%)	8 (38.1%)	.38
PM indication
SSS	54	34	20	.382
AVB	1	0	1
Comorbidities
Hypertension	33 (60%)	20 (58.8%)	13 (61.9%)	.52
Diabetes	7 (12.7%)	2 (5.9%)	5 (23.8%)	.09
Coronary heart disease	16(29.1%)	7 (20.6%)	9 (42.9%)	.12
Atrial fibrillation	27(49.1%)	14 (41.2%)	13 (61.9%)	.17
LVEDD(mm)	47.4 ± 3.1	47.3 ± 3.3	47.4 ± 2.5	.83
LVEF(%)	63.7 ± 16.1	64.3 ± 4.3	63.5 ± 3.0	.46
ESS score(>10)	11 (20)	3(8.8%)	8(38%)	.008
PSG‐­AHI(events/h)	17.4 ± 16.5	7.4 ± 4.2	33.9 ± 15.4	<.001
PM‐­RDI(events/h)	32.3 ± 16.1	23.5 ± 11.9	44.4 ± 13.4	<.001

>Abbreviations: BMI: body mass index; LVEDD: left venricular end‐­diastolic dimension; LVEF: left ventricular ejection fraction; PSG‐­AHI: apnea‐­hypopnea index evaluated by PSG; ESS: Epworth Sleeping Scale; PM‐­RDI: respiratory disturbance index evaluated by the ApScan algorithm

TABLE 2 Effects of PM‐­RDI cutoffs on risk stratification performance

Index	PSG‐­AHI≥15	PSG‐­AHI≥30
PM‐­RDI≥26	PM‐­RDI≥41
Sensitivity (%[95%CI])	100.0 (83.9‐­100.0)	70.6 (52.5‐­84.9)
Specificity (%[95%CI])	67.7 (48.3‐­83.5)	82.1 (48.2‐­97.7)
Positive predictive value (%[95%CI])	88.6 (75.4‐­96.2)	64.3 (35.1‐­87.2)
Negative predictive value (%[95%CI])	100 (85.8‐­100.0)	95.1 (83.3‐­99.4)
Positive likelihood ratio (95%CI)	3.4 (2.7‐­4.2)	7.2 (5.3‐­9.7)
Negative likelihood ratio (95%CI)	0	0.21 (0.05‐­0.9)

AP19‐­01041

A retrospective analysis of > 11,000 CIED patients: 24/7 alert processing via a vendor‐­ neutral remote monitoring software system

Prashanthan Sanders,

Royal Adelaide Hospital, Australia

Introduction:

Remote monitoring (RM) of cardiac implantable electronic devices (CIEDs) allows for timely recognition of patient and device events requiring intervention. Most RM involves burdensome manual workflow that occurs exclusively on weekdays, during office hours. Automated software may reduce such burden, enabling RM of large patient groups. The purpose of this study was to assess the quantity and nature of CIED alerts in a large patient cohort, from multiple centres, remote monitored via an automated vendor‐­neutral software system with 24/7 processing of CIED alerts by IBHRE‐­certified technicians.

Methods:

We performed a retrospective analysis of 10,554 consecutive patients with a CIED who underwent managed RM between April and October 2018. Analysis included CIED type and all alerts according to gravity and device type. Red alerts signified a patient or device event requiring urgent review, while yellow alerts required non‐­urgent review.

Result:

Of the 10554 patients undergoing managed remote monitoring, 4432 (42%) patients had a permanent pacemaker (PPM), 3413 (32.3%) had an implantable cardioverter defibrillator (ICD), and 2709 (25.7%) had an implantable loop recorder (ILR). 18940 alerts were transmitted. 3210 (30.4%) of patients transmitted at least one alert. ICDs were responsible for 3258 (17.2%) alerts, PPMs for 2490 (13.1%) alerts, and ILRs for 13,192 (69.7%) [P < .001] alerts. 604 (3.2%) alerts were red, and 18336 (96.8%) were yellow. 386 (63.9%) red alerts were transmitted by ICDs, 128 (21.2%) by PPMs, and 90 (14.9%) by ILRs.

Conclusion:

In a large managed RM patient cohort, almost one‐­third of patients transmitted at least one device alert during a 6‐­month period, totalling over 18,000 alerts. ILRs were over‐­represented, transmitting 69.7% of alerts, despite accounting for only a quarter of all devices. 63.9% of red alerts were transmitted by ICDs. The enormity of the number of transmissions and the growing alerts from use of ILR highlight the need for a new approach to management of RM.

AP19‐­01045

Remote monitoring of implantable cardioverter defibrillators: A 6‐­month real‐­world experience of > 4000 patients

Catherine O'Shea

Royal Adelaide Hospital, Australia

Introduction:

Remote monitoring (RM) has been demonstrated to improve outcomes and mortality in patients with implantable cardioverter defibrillators (ICD) with and without cardiac resynchronisation therapy (CRT‐­D). However, the RM burden of monitoring ICDs is not well characterised. The purpose of this study was to assess alert burden and type in a large cohort of ICD patients undergoing managed RM.

Methods:

We retrospectively analysed all patients with a standard ICD, CRT‐­D or subcutaneous ICDs (S‐­ICD), from a large multi‐­centre cohort undergoing RM over a six‐­month time period. Analysis included specific device type, and all alerts according to type.

Result:

Of the 12,521 RM patients in our cohort, 4385 (35%) had an ICD in situ, comprised of 2202 standard ICDs (50.2% of the ICD cohort), 2079 (47.4%) CRT‐­Ds, and 104 (2.4%) S‐­ICDs. 1477 ICDs (33.7% of the ICD cohort) transmitted at least one alert. ICD alerts accounted for 17.4% (3110) of all alerts (17,839), transmitting 399 (58.3% of all) red alerts, and 2711 (15.8% of all) yellow alerts. 988 alerts for ventricular tachycardia (VT) and ventricular fibrillation (VF) were transmitted by 7% (306) of ICD patients, and 212 alerts for shock, transmitted by 2.6% (115) of ICD patients. There were 1403 alerts for atrial tachycardia/atrial fibrillation.

Conclusion:

In this large cohort of ICD patients undergoing managed RM, ICDs represented 35% of the RM cohort but contributed only 17.4% of all alerts, with only one‐­third of ICD patients transmitting an alert. Despite transmitting the majority of red alerts (58.3%), ICDs are generally under‐­represented in RM alert burden.

AP19‐­01047

Tip thrombosis during micra implantation as the cause of high impedance and threshold

Ridwan Rasyid Waliyuddin, Yoga Yuniadi

Faculty of Medicine, Universitas Indonesia, and National Cardiovascular Center Harapan Kita, Indonesia

Introduction:

Leadless pacemaker is the latest pacemaker technology that has several advantages compared to conventional transvenous pacemaker in prevention of lead and device's pocket complications. We report a case of thrombosis at the tip of MicraTM (Medtronic Inc) causing unnecessary device repositioning due to unacceptable pacing threshold and impedance during implantation. As this technology continues to mature, complications and device related problems need further investigations.

Methods:

A 65 years old female patient has a history of Long standing Persistent Atrial Fibrillation with frequent episodes of slow ventricle response. Echocardiography examination revealed no structural heart disease nor regional wall abnormality. Coronary CT angiography revealed non‐­significant stenosis. Patient was scheduled for MicraTM pacemaker implantation.

Result:

The procedure was performed by femoral venous access. Leadless pacemaker delivered to right ventricle and deployed to apical septal region and got electrically tested, high level of impedance and threshold were revealed; electrical impedance level was more than 800 Ω and measured threshold was never below 2 mV. The leadless pacemaker then retracted and repositioned to mid septal region, another electrical testing revealed another high impedance and threshold. The device was then repositioned one more time to more inferior part of apical region, similar results of electrical testing was gained. Operators then removed the device and catheter delivery system just to find thrombus covered entire tip portion of the device. The thrombus then was removed using syringe needle (Figure 1) and flushed with heparinized normal saline. The device was again inserted after bolus of 5000 IU of heparin and deployed to septal portion of apex region (previous site). Measurement showed impedance of 450 Ohm and threshold of 0.4 mV. “Pull and hold” test confirmed the fixation, the tether then removed and followed by the introducer.

Conclusion:

The presented case showed possible complication of latest pacemaker technology. Thrombus formation at the tip of the leadless pacemaker can lead to high impedance and threshold level than expected. Appropriate dose of heparin should always be given just after femoral vein puncture to prevent thrombus event.

AP19‐­01049

Pocket hematoma in the patients that undergo CIED implantation that currently used VKA and NOAC

Thanapol Olarnrachin, Sirin Apiyasawat

Ramathibodi Hospital, Thailand

Introduction:

The use of Cardiovascular Implantable Electronic Device (CIED) is increasing. Some of the patients undergoing CIED implantation have comorbidities that required to take anticoagulant and antiplatelet therapy. While the use of these medications provides cardiovascular benefits, the risk of bleeding increases. This study is aimed to evaluate the incidence and the impact of pocket hematoma in the patients undergoing CIED implantation who currently used oral anticoagulation.

Methods:

From February 2018 through January 2019, we enrolled 74 patients that currently used anticoagulant and underwent CIED implantation at Ramathibodi hospital. Baseline characteristics, underlying disease, anticoagulation used, discontinuation of anticoagulation before CIED implantation, concurrent use of antiplatelets, procedure type and the presence of pocket hematoma were collected form OPD card, electronic medical record, and procedure note. Association of pocket hematoma and oral anticoagulants were performed.

Result:

A total of 74 CIED implantation patients, 37 patients use vitamin K antagonist (VKA) and 37 patients use novel anticoagulation (NOAC). The baseline characteristics of the patients were age 31‐­92 yrs. (72.14 ?? 11.82 yrs.), male 38 patients (51.4%). The most common type of device implantation was pacemaker (N = 50, 67.6%), followed by CRT (N = 15, 20.3%) and ICD (N = 9, 12.2%). The majority of the implantation was new implantation (N = 59, 79.7%). The incidence of pocket hematoma was 10.8%. Only one patient (1.4%) was required drug interruption during the follow‐­up period. None needed surgical intervention and none developed pocket infection at 3 months. The incidence of pocket hematoma was not statistically different between interrupted and uninterrupted VKA and NOAC groups (22.2%, 7.1%, and 10.8% respectively, P = .448).

Conclusion:

The incidence of pocket hematoma after CIED implantation among the patients using VKA or NOAC was approximately 10%. Very few patients required drug interruption and none developed a pocket infection.

AP19‐­01064

Gender specific response to cardiac resynchronization therapy

Manish Ganwani, Narayanan Namboodiri

Sree Chitra Institute of Medical Sciences and Technology, India

Introduction:

Over the last few decades, cardiac resynchronization therapy (CRT) has emerged as a valuable treatment, substantially reducing morbidity and mortality in selected patients with heart failure. Intriguingly, sex differences have been noted in response rates. This study was designed with the hypothesis that gender‐­specific cardiac resynchronization therapy response rate represents primarily the body and heart size

Methods:

We aimed to assess CRT response rates between genders and the influence of BSA and LV mass on response between genders. Fifty‐­seven patients (41 males; mean age 55.11 ± 9.36 years) who underwent CRT implantation and cardiac MRI before it, were prospectively followed up. All patients underwent clinical evaluation, ECG, echocardiography, before and after the intervention

Result:

Amongst the study population, 14 (24.56%) patients had ischemic cardiomyopathy while 43 (75 .40%) had non‐­ischemic DCM. BSA was significantly higher in males as compared to females (1.72 ± 0.206 vs 1.55 ± 0.188 m²; P‐­value = .007). CRT‐­D devices were implanted more frequently in males as compared to females (60.90% vs 6.25%; P‐­value‐­.01). At baseline, the mean QRS duration was significantly higher in males as compared to females (173 milliseconds vs 158 milliseconds; P‐­value‐­.02). Males had larger LV end‐­systolic (57.56 ± 11.44 vs 48.50 ± 4.70 mm; P‐­0.003) and LV end‐­diastolic dimensions (67.20 ± 10.61 vs 59.38 ± 5.58 mm; P‐­value‐­.007) as compared to females. LVEF was significantly different between the sexes, with males having a lower LVEF as compared to females (28.54 ± 7.61% vs 34.25 ± 4.25%; P‐­value‐­ .007). All patients were treated according to guideline‐­directed medical therapy. On MRI evaluation, males had higher LV end‐­systolic (182.56 ± 108.86 ml vs 106.96 ± 41.23 ml; P‐­ value‐­.009) and LV end‐­diastolic volumes (234.44 ± 113.5 ml vs 152 ± 47 ml; P‐­value‐­ .007) as compared to females. Late gadolinium enhancement (LGE) was seen in 23 (40.35%) of the patients, while no LGE was noted in 34 (59.64%) of the patients. LGE was more commonly seen in males (48.78%) as compared to females (18.75%) which was statistically significant (P‐­value‐­ .038). Overall response rate was 75% which was comparable between sexes (Males‐­74.28%, females‐­78.57%; P‐­ value‐­.75). Among responders, females had a narrower QRS as compared to males (156.73 ± 8.73 vs 170.92 ± 23.32; P‐­value‐­.05). Amongst factors assessed only baseline QRS duration correlated with a poorer response (P‐­value .004). There was no significant effect of BSA and LV mass on response rates.

Conclusion:

Overall, wider QRS duration at baseline was associated with poor CRT outcomes. However, response rates were comparable between the genders. We also noted that the average QRS duration among female responders was lower as compared to their male counterparts. This gender difference was independent of lower body surface area and LV mass noted in females.

AP19‐­01071

Survival analysis without defibrillator shock in patients with renal failure

Marjurie Demo‐os

Changi General Hospital, Singapore

Introduction:

Patients with advanced chronic kidney disease (CKD) with heart failure suffer from high rates of mortality. The benefit of implantable cardioverter defibrillator (ICD) is unclear in this group of patients. Accordingly, we aim to evaluate the mortality risk without ICD shock in this high risk population.

Methods:

This was a retrospective study using ICD registry from 2009 to 2017. Advanced CKD is defined as eGFR < 30 mL/min/1.73 m². Survival analysis using Kaplan Meier was performed comparing those with and without advanced CKD.

Result:

A total of 269 patients received ICD in which 8.9% patients with advanced CKD. Mean follow up was 3.3 + 2.43 years. Comparing with and without advanced CKD patients, notably significant difference including mean eGFR (21.2 + 9.3 vs 55.6 + 8.7, P < .001), presence of hypertension (86.4% vs 58.3%, P = .003) and diabetes (77.3% vs 44.1%, P = .003). Mean cumulative survival was significantly lower in advanced CKD group vs without advanced CKD group (5.5 + 0.1 years vs 3.9 + 0.4 years, P < .001). Independent predictors of survival using cox regression was absence of atrial fibrillation (HR: 0.14, 95%CI: 0.05‐­0.38, P < .001). Majority of the cause of death were non cardiac/arrhythmic cause for both groups (advanced CKD: 75%, non‐­advanced CKD: 93.3%).

Conclusion:

Advanced CKD and heart failure patient without appropriate ICD shock had a significantly lower survival benefit as compared with patients without advanced CKD.

AP19‐­01076

Minimising radiation exposure during biventricular device implantation

Amitabh Yaduvanshi, Vipul Malpani, Vikas Kataria, Gautam Singal, Pritam Kitey, Mohan Nair

Holy Family Hospital, India

Introduction:

Complex intervention and device implantation procedures often require long fluoroscopy time and expose both the operator and patient to high levels of radiation. As part of a systematic study, we have assessed fluoroscopy time in complex interventions and taken protocol‐­driven steps to reduce radiation exposure; without any change in imaging equipment or procedure hardware. Here, we present our data on radiation exposure during Biventricular device implantation and the feasibility and reliability of biventricular device implantation with modified fluoroscopy protocols.

Methods:

Forty‐­one patients with heart failure underwent implantation of a cardiac resynchronization therapy (CRT) device with or without defibrillator (CRT‐­D; CRT‐­P) from January 2018 to June 2019. In September 2019 we changed our imaging protocols by incorporating many radiation lowering settings. This included lowering the Fluoroscopy frame rates from 15fps to 4fps, frequent use of ‘flurosave’ and decreasing cine frame rate from 15fps to 10fps. Of the 41 patients, 24 procedures were done before the change in imaging protocol (PRE‐­ Group A) and 17 procedures were done after (POST‐­Group B). Both groups were matched for age, sex, and type of device.

Result:

In Group A, the median fluoroscopy time was 42.9 min. Median Dose surface product (PKA) was 2493.5 mGy, and skin surface entry dose (KAR) was 23020μGym2. In Group B, the median fluoroscopy time was 25.45 min, Median Dose surface product (PKA) was 787.5 mGy, and skin surface entry dose (KAR) was 7985μGym2. There was a significant decrease in the radiation exposure as measured by Dose surface product (PKA), skin surface entry dose (KAR) after changing the imaging protocol (P values < .04 and < 0.03 respectively). There was no significant difference in the fluoroscopy time suggesting that clinically acceptable imaging could be achieved even after using very low frame rates during fluoroscopy.

Conclusion:

Keeping the radiation exposure to ‘as low as reasonable’ (ALAR) is the philosophy behind all interventional procedures. Our study shows that biventricular device implantation can be done using very low frame rate fluoroscopy and the radiation exposure can be decreased by almost two‐­thirds when compared to default imaging settings.

AP19‐­01077

Evaluation of cardiac synchrony in patients with left bundle branch pacing: insight from echocardiographic research

Cai Binni

EP, China

Introduction:

LBBP may be a new physiological pacing strategy, whether LBBP can both maintain cardiac electrophysiological and mechanical synchrony remains unclear. In this study, we aim to assess cardiac synchrony of LBBP by comparing the differences of QRS duration and some echocardiographic indicators between cardiac electrical self‐­conduction and LBBP in sick sinus syndrome (SSS) patients with normal cardiac function and narrow QRS duration.

Methods:

Patients diagnosed with sick sinus syndrome (SSS) and implanted dual chamber pacemaker from a single center with normal cardiac function and narrow QRS were included in the study. We selected 40 patients received LBBP and 38 patients received right ventricular pacing (RVP) as control. Patients with pacemaker implantation were programmed to ventricular pacing‐­on (LBBP capture or RVP capture) and ventricular pacing‐­off (self‐­conduction) modes for echocardiographic and electrocardiogram examinations. The QRS duration, the LV systolic dyssynchrony index (SDI) and Tsd‐­12‐­LV were measured to evaluated cardiac synchrony. Stroke Volume (SV) and degree of MR/TR were also assessed.

Result:

The QRS duration in LBBP capture is slightly wider than that in self‐­conduction mode (91.70 ± 14.88 milliseconds vs 100.15 ± 9.98 milliseconds, P = .020). All echocardiographic parameters of synchronization in the LBBP group showed no significant difference (P > .05) between LBBP capture and self‐­ conduction mode, while the RVP group showed significantly larger intraventricular synchronization parameters in the RVP mode than in the self‐­conduction mode (P < .0001), represents poor synchronicity. LBBP capture have no significant difference in SV and degree of MR/TR compared with self‐­conduction (65.45 ± 18.68 ml vs 64.08 ± 16.97 ml P = .24), while RVP capture mode have significant decreased SV (66.43 ± 14.33 ml vs 63.51 ± 13.72 ml P = .005) and more degree of MR/TR compared with self‐­conduction.

Conclusion:

This study showed that LBBP maintains a satisfactory cardiac electrical and intraventricular synchrony with no significant change in SV or degree of MR/TR when compared with self‐­conduction. So we confirmed that LBBP is a new physiological pacing strategy.

AP19‐­01079

The pacemaker lead over retraction phenomenon: a case report

Lalaj Ruchiranga Sembakuttige

National Hospital of Sri Lanka ‐­ Colombo, Sri Lanka

Introduction:

The pacemaker lead over retraction phenomenon is an uncommon cause of pacemaker lead dislodgement which is occurred due to an unknown mechanism.

Methods:

A 45 year old lady who underwent a dual chamber permanent pacemaker implantation with the indication of complete heart block, and presented after 4 months with twitchy movements of left upper chest region without having any evidence of syncope. The electrocardiogram showed right ventricular pacing at 60 beats per minute with underlying atrioventricular dissociation. Immediate fluoroscopic examination revealed complete recoiling of atrial lead inside the generator pocket resulting capture of the underling pectoral muscle fibers and intact right ventricular lead.

Result:

Initially, pacemaker atrial channel was set to inactive mode and subsequent pocket capsulotomy and atrial lead re‐­implantation with adequate tightening of atrial lead restored optimal function of the device.

Conclusion:

The pacemaker lead over retraction phenomenon can be identified as unusual cause of pacemaker malfunction. Chest X‐­ray or immediate fluoroscopy and electrocardiograms are the simple and cost effective first line investigations for its diagnosis.AP fluoroscopic view of pacemaker generator showing over‐­recoiling of the atrial lead

AP19‐­01083

Comparison of the effects between left bundle branch pacing and his bundle pacing in patients with heart failure

Yao Wang

The First Affiliated Hospital of Nanjing Medical University, China

Introduction:

His‐­Purkinje system pacing mainly refers to His bundle pacing (HBP) and left branch bundle pacing (LBBP). His‐­Purkinje system pacing is characterized by activating ventricle via the intrinsic conduction system, thus carrying out the ventricular synchronous contraction, improving cardiac function and reversing ventricular remodeling.

Methods:

The chronic heart failure patients (LVEF < 50%) who needed pacemaker therapy from September 2014 to December 2018 in the First Affiliated Hospital of Nanjing Medical University were included. They received HBP or LBBP. The data of two‐­dimensional echocardiography and electrocardiogram in the process of preoperative and postoperative follow‐­up were obtained, including left ventricular ejection fraction (LVEF), left ventricular end‐­diastolic dimension (LVDd), left ventricular end‐­systolic dimension (LVDs), and QRS duration (QRSd). The parameters of the pacemaker during and after the operation were recorded, including threshold and impedance. Preoperative and postoperative parameters of all patients were compared to analyze the effect of His‐­Purkinje system pacing on chronic heart failure. The parameters between HBP group and LBBP group were also compared.

Result:

The chronic heart failure patients (LVEF < 50%) who needed pacemaker therapy from September 2014 to December 2018 in the First Affiliated Hospital of Nanjing Medical University were included. They received HBP or LBBP. The data of two‐­dimensional echocardiography and electrocardiogram in the process of preoperative and postoperative follow‐­up were obtained, including left ventricular ejection fraction (LVEF), left ventricular end‐­diastolic dimension (LVDd), left ventricular end‐­systolic dimension (LVDs), and QRS duration (QRSd). The parameters of the pacemaker during and after the operation were recorded, including threshold and impedance. Preoperative and postoperative parameters of all patients were compared to analyze the effect of His‐­Purkinje system pacing on chronic heart failure. The parameters between HBP group and LBBP group were also compared.

Conclusion:

Conclusions: His‐­Purkinje system pacing could reverse left ventricular remodeling, and improve cardiac electrical synchrony in chronic heart failure patients. Both HBP and LBBP could improve cardiac function in chronic heart failure, and LBBP had an edge of lower and more stable lead threshold.

Keywords: Heart failure; His‐­Purkinje system; His bundle pacing (HBP); Left bundle branch pacing (LBBP).

AP19‐­01086

Comparison of repolarization indices between His bundle and biventricular pacing

Rakesh Sarkar, Daljeet Saggu, Sachin Yalagudri, Soumen Devidutta, Ashutosh Kumar, Sridevi Chennapragada, Calambur Narasimhan

CARE Hospital.Hyderabad, India

Introduction:

His bund pacing (HBP) has been shown to improve cardiac function in patients with LV dysfunction with comparable benefits of cardiac resynchronization therapy (CRT), however, there is limited information regarding their effect on cardiac repolarization playing role in arrhythmogenesis.

Methods:

We analysed the data of consecutive patients with left ventricular dysfunction who underwent HBP and CRT between January 2017 to January 2019. Patients undergoing HBP (Group 1) were compared to those undergoing conventional CRT (Group 2). The following ECG parameters were measured in all patients: QTc, T peak to end (Tpe) and Tpe/QTc. ECG measurements were done pre‐­ implant (PRE), immediately post‐­implant (IM POST) and > 6 weeks after implants (6W POST). All ECG parameters were measured from surface ECG and Cardiotek EP tracer.

Result:

There were 13 patients in Gr.1 and 16 in Gr.2. Baseline characteristics were similar except for a wider QRS in in Group 2 (109.77 ± 31.2 vs 162.56 ± 22.3, P = .025). Width of QRS were similar soon after the implant (106.77 ± 15.91 vs 123.87 ± 15.61, P = .7) in both the groups. At baseline, there was no significant difference in following repolarization parameters e.g. QTc, Tpe, Tpe/QTc between both groups (Table 1). In Group 1 there was a significant reduction in Tpe and Tpe/QT (90.54 ± 24.347 vs 69.62 ± 12.92, P = .007 and 0.203 ± 0.045 vs 0.151 ± 0.027, P = .002 respectively) immediately post implant and in Tpe/QTc (0.151 ± 0.027 vs 0.132 ± 0.041, P value‐­.05) 6 weeks after implant (Table 2). There was a significant difference in Delta1 Tpe/QTc (P value‐­.02) between Gr.1 and Gr.2 (Delta1 = difference between IM POST and PRE parameters) but Delta2 (showing the difference between IM POST and 6W POST value) of Tpe, Tpe/QTc and QTc do not differ significantly in between them. Over the median observation period of 11 months only 1 patients developed single episode of VT requiring therapy belonging to Gr 1 whereas from Gr.2, 6 patients developed total 11 episodes of VT requiring therapy for 2.

Conclusion:

Compared to conventional CRT, HBP reduced Tpe and Tpe/QTc intervals after implantation from the baseline. Further large prospective studies are needed to establish if these changes result in reduction of arrhythmic burden among patients undergoing HBP over CRT.

TABLE 1 Comparison of Baseline parameters between His Bundle Pacing and CRT group

HBP(n=13)	BiV Pacing(n=16)	P value
Age	58 ± 12.05	60 ± 24.3	Ns
CAD	5/13	6/16	Ns
DM	7/13	7/16	Ns
CKD	4/13	5/16	Ns
QRSd	109.77 ± 31.26	162.56 ± 22.39	<.05
EF	33.23 ± 8.78	26.63 ± 6.19	.08
QTc	445.77 ± 65.95	504 ± 56.43	.77
Tpe	90.54 ± 24.35	96.88 ± 25.78	.93
Tpe/QTc	0.203 ± 0.045	0.203 ± 0.045	.79

TABLE 2 Comparison of pre implant, immediate post implant and after 6 months parameters (Tpe,Tpe/QTc and QTc) between CRT and HBP group

	His Bundle pacing(mean±SD) n=13			CRT(mean±SD) n=16
Pre implant	Post‐­implant(immediate)	t test(P‐­value)	Pre implant	Post‐­implant(immediate)	P‐­value
Tpe	90.54 ± 24.347	69.62 ± 12.92	.007	94.75 ± 24.35	96.06 ± 12.92	.55
Tpe/QTc	0.203 ± 0.045	0.151 ± 0.027	.002	0.203 ± 0.045	0.15 ± 0.026	.702
QTc	445.77 ± 65.948	462.69 ± 12.92	.366	509.25 ± 65.95	485.38 ± 42.56	.132
Imm post‐­implant	>6 wksimplant	P value	Imm post‐­implant	>6 wksimplant	P value
Tpe	69.62 ± 12.92	62.34 ± 13.97	.08	96.06 ± 12.92	88.56 ± 16.54	.09
Tpe/QTc	0.151 ± 0.027	0.132 ± 0.041	.05	0.15 ± 0.026	0.143 ± 0.032	.11
QTc	462.69 ± 12.92	454.8 ± 15.43	.24	485.38 ± 42.56	466.75 ± 43.88	.13

AP19‐­01114

Unavoidable multiple inappropriate shocks of a subcutaneous implantable cardioverter‐­ defibrillator system in a patient of Brugada syndrome; a limitation and a pitfall of the Smart pass algorithm

Masahiro Mizobuchi, Jun‐Ya Matsumoto, Tomoki Yamashita

Kyoto‐­Katsura Hospital, Japan

Introduction:

Inappropriate shocks (IAS) due to T wave over‐­sensing (TWOS) remains to be one of the major safety issues of the subcutaneous implantable cardioverter‐­defibrillator (S‐­ICD) system. It has limitations for discriminating R wave from other cardiac signals because detectable cardiac signals are limited to 3 selectable sensing vectors of subcutaneous ECG. To reduce IAS, the smart PASS (SP) algorithm of a high‐­pass filter of 9 Hz was developed and incorporated with current S‐­ICD system to minimize TWOS. However, the validity and limitation of SP algorithm is not well‐determined. We demonstrate a case of multiple IAS with a S‐­ICD system due to unexpected deactivation of SP algorithm as a limitation and a pitfall of S‐­ICD management.

Methods:

A 35‐­year old male of survived Brugada syndrome patient was found suitable for S‐­ICD system based on the pre‐­implantation ECG screening. A S‐­ICD was uneventfully implanted and the primary sensing vector was incorporated because both of primary and secondary sensing vectors were considered to be optimal based on the verification of the surface ECG recorded on the S‐­ICD system.

Result:

He complained of multiple shocks without loss of consciousness on the next day of the operation. Device interrogation revealed multiple IAS due to TWOS In order to avoid IAS, the primary sensing vector was switched to the secondary vector, and the SP algorithm was activated. However, he complained of multiple shocks again after three months. We found that multiple IAS were resulted from double or triple counts of cardiac signals owing to TWOS. According to the device interrogation, we found that the SP algorithm was automatically deactivated because of further attenuation of R wave amplitude below the threshold (<0.25 mV) for more than 1.4 seconds. Even after the manual re‐­activation of the SP and the change of unconditional zone up to 240 ppm, subsequent recurrence of IAS could not be avoided because of multiple over‐­sensing of cardiac signals owing to repeatedly deactivated SP algorithm. Screening ECG of right precordial side found to be also ineffective to discriminate T wave. Since we concluded diurnal variation of R wave in this patient was the limitation for utilization of the SP algorithm, the S‐­ICD was retrieved and a conventional TV‐­ICD was implanted. No more IAS was recorded during 1‐­year observation via the remote monitoring system.

Conclusion:

The SP algorithm could be turned off automatically if sensed R wave amplitude was too low (<0.25 mV). Although recent studies regarding SP demonstrated favorable results for reducing IAS, it still has limitations to avoid IAS especially in patients with variable and/or reduced R wave amplitude such as Brugada syndrome or progressive myocardial diseases.

AP19‐­01118

Magnetic resonance imaging scanning on different body regions at 3.0 Tesla in patients with pacemakers

Xiaohui Ning, Xiaofei Li, Xiaohan Fan, Keping Chen, Wei Hua, Zhimin Liu, Xiuyu Chen, Minjie Lu, Shihua Zhao, Shu Zhang

State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular D, China

Introduction:

Magnetic resonance imaging (MRI) at 3.0 tesla (3.0T) is becoming more common, but the information afforded by 3.0T MRI scanning of different body regions, including the heart, in patients implanted with cardiac pacemakers is still not well known. This study aimed to evaluate the safety and practical concerns of 3.0T MRI assessment for patients with MR‐­conditional pacemakers.

Methods:

Fourteen consecutive patients with an MR‐­conditional pacemaker were involved. A rigorous standardized workflow was jointly developed by electrophysiologists, pacemaker engineers and radiologists. Pacemaker interrogation was performed immediately before and after MRI scanning. Significant changes in parameters were defined as a lead threshold increase > 1V, sensing amplitude drop >50% and impedance value change > 50 Ω. Scan‐­related adverse events were documented, and imaging qualities were evaluated by radiologists.

Result:

A total of 16 MRI examinations of different body regions (brain = 8, lumbar spine = 3, cervical spine = 2, and heart = 3) were successfully completed. No significant changes in interrogation parameters were noted except two ventricular impedance values change > 50 Ω in cardiac MRI scans. No adverse events were detected. Artifacts of the pulse generator and leads were observed in 3 cardiac MRI scan, with 2 pacemakers in the right pectoral and 1 in the left pectoral. The imaging quality was classified as grade 2 according to the grading criteria, with interpretable diagnostic value.

Conclusion:

A standardized workflow allows patients with MR‐­conditional pacemakers to safely undergo 3.0T MRI scanning of different body regions. For 3.0T cardiac MRI assessment, right‐­ and left‐­ sided pacemakers may both yield interpretable imaging quality.

TABLE 1 Logistic regression analysis for variables predicting VT/VF development

Variables	Univariate analysis		Multivariate analysis
	OR (95%CI)	P value	OR (95%CI)	P value
Big ET‐­1	5.24 (2.46‐­11.1)	.000	4.06 (1.77‐­9.28)	.001
Big ET‐­1>median	5.00 (2.27‐­11.0)	.000
NT‐­proBNP	1.00 (1.00‐­1.01)	.000
NYHA III‐­IV	5.18 (2.56‐­10.5)	.000	4.32 (1.83‐­10.2)	.001
LVEF	0.94 (0.90‐­0.98)	.003
LVEF≤35%	2.58 (1.29‐­5.17)	.007
LVEDD	1.08 (1.03‐­1.13)	.001
LVEDD>60	3.68 (1.80‐­7.54)	.000	3.14 (1.32‐­7.49)	.022
Multivessel disease	0.47 (0.23‐­0.96)	.037
Mitral regurgitation	2.16 (1.10‐­4.24)	.025

TABLE 2 Cox regression analysis of VT/VF attack, cardiovascular and all‐­cause mortality in 222 PI‐­LVA patients

	VT/VF attack				Cardiovascular mortality				All cause mortality
	Univariate		multivariate		Univariate		multivariate		Univariate		multivariate
	HR (95%CI)	P	HR (95%CI)	P	HR (95%CI)	P	HR (95%CI)	P	HR (95%CI)	P	HR (95%CI)	P
Big ET‐­1	2.8 (1.7‐­4.9)	.00	2.5 (1.4‐­4.5)	.00	2.3 (1.4‐­3.5)	.00	2.2 (1.4‐­3.4)	.00
Big ET‐­1>median	2.6 (1.2‐­5.7)	.02			2.1 (1.0‐­4.2)	.05			2.0 (1.0‐­3.9)	.05
NT‐­proBNP	1.0 (1.0‐­1.0)	.02			1.0 (1.0‐­1.0)	.00	1.0 (1.0‐­1.1)	.00	1.0 (1.0‐­1.2)	.00	1.0 (1.0‐­1.2)	.00
LVEDD	1.0 (1.0‐­1.1)	.02			1.1 (1.0‐­1.2)	.00			1.1 (1.0‐­1.1)	.00
LVEDD>60	3.0 (1.3‐­6.6)	.01			2.6 (1.3‐­5.1)	.01			2.5 (1.5‐­4.8)	.01
LVEF	0.9 (0.9‐­1.0)	.04			0.9 (0.9‐­1.0)	.01			0.9 (0.9‐­1.0)	.00
LVEF≤35%	3.2 (1.6‐­5.9)	.00	2.4 (1.1‐­5.4)	.02	2.5 (1.3‐­4.9)	.01	2.2 (1.1‐­4.4)	.02	2.3 (1.2‐­4.4)	.01	1.1 (1.0‐­1.1)	.03
NYHA III‐­IV	2.2 (1.0‐­4.7)	.04			2.6 (1.4‐­5.1)	.01			2.6 (1.4‐­4.9)	.00
Mitral	2.0 (0.9‐­4.2)	.06			2.7 (1.4‐­5.4)	.01			2.6 (1.4‐­5.1)	.01

AP19‐­01122

“Bi‐­bundle branch pacing” for persistent atrial fibrillation and third‐­degree atrioventricular block

Zhao Wang, Xiaofei Li, Xiaohui Ning, Xiaohan Fan

National Center for Cardiovascular Diseases, FuWai Hospital, Chinese Academy of Medical Sciences and, China

Introduction:

Left bundle branch area pacing (LBBAP), as a novel pacing strategy, might be an alternative physiological pacing approach. However, in patients with normal His‐­Purkinje activation, LBBAP might cause pacing‐­induced right bundle branch block. Recently, we achieved “bi‐­bundle branch pacing” for a patient with persistent atrial fibrillation and third‐­degree atrioventricular block (AVB) with normal QRS duration (QRSd) during the LBBAP procedure.

Methods:

A 68‐­year‐­old male patient had ten years of bradycardia history and palpitation for 4 months. Holter had showed persistent atrial fibrillation (AF) with third‐­degree AVB, presented with 1459 episodes of arrest over 2s and longest R‐­R interval 4.7s. Bi‐­atrial enlargement (LA 44 × 47 × 60 mm, RA 48 × 64 mm) and normal LV function (LVEDD 49 mm, LVEF 55%) was shown in echocardiography evaluation. Another 24 h‐­Holter examination in the next week was presented with 322 episodes of cardiac arrest (over 3s), and the longest R‐­R was 5.4s (8:47 AM). He also had a history of hypertension and cerebral infarction. The patient was indicated for pacemaker implantation and LBBAP procedure was achieved.

Result:

During the procedure, the intrinsic heart rate was 40 bpm and QRSd was 92 milliseconds (Figure 1A). Transseptal route by 3830 pacing lead and C315 His sheath (SelectSecure, 69 cm, Medtronic, Minneapolis, Minnesota) via left axillary vein access was attempted. When the pacing lead reached the chosen site, pace‐­mapping at 2 V at 0.4 milliseconds was performed, the paced QRSd in lead V1 was 144 milliseconds (Figure 1B). After 4 rounds of rotation in this site, paced QRS complex in lead V1 was displayed incomplete RBBB morphology, with stimulus to peak left ventricular activation time (S‐­PLVAT) of 98 milliseconds (Figure 1C). Another 2 rounds of rotation was screwed and S‐­PLVAT was deceased from 98 milliseconds to 78 milliseconds and remained stable at different outputs (2V/0.4 milliseconds and 5V/0.4 milliseconds, Figure 2A and 2B). Paced QRSd was 114 milliseconds and LBB potential was recorded in IEGM (Figure 2C and 2D). The final position of the lead was shown in Figure 3. The final pacing parameters were as follows: the sensing amplitude was 16.6 mv and the impedance was 577 ohm. Routine optimization was performed after the procedure. Unipolar pacing strategy was shown that typical pacing induced incomplete RBBB pattern (Figure 4B). However, when the pacing strategy was changed to bipolar pacing at a output of 0.5V/0.4 milliseconds, pacing induced RBBB was disappeared and QRS morphology and axis was similar to the intrinsic rhythm (Figure 4A and 4C).

Conclusion:

LBB Pacing‐­induced RBBB could be corrected by bi‐­bundle branch capture at the strategy of bipolar pacing at a low and stable output.

P19‐­01133

Trans‐­jugular approach for permanent pacemaker implantation in octogenarian

Alexander Edo Tondas, Rido Mulawarman, Muhammad Hatta

Mohammad Hoesin General Hospital, Indonesia

Introduction:

In an attempt to implant a permanent pacemaker, the internal jugular vein access can serve as a bail out technique when the conventional subclavian/axillary/cephalic veins are not available.

Methods:

Our case report described a single chamber pacemaker implantation in an octogenarian using trans‐­jugular approach without surgical cut‐­down of the internal jugular vein.

Result:

A 83‐­year‐­old man was referred from another province to our center with complaints of chest pain 3 days before admission. He also had several repeated episodes of syncope since 5 months ago, most frequent 10 days before hospitalization, up to 8 times of fainting in a day. Previous history of hypertension was noted but he denied having diabetes mellitus. ECG showed total AV block (TAVB) with junctional escape of 35x/minute. Laboratory findings revealed normal cardiac enzyme level, and echocardiography exam showed normal LV contractility (LVEF > 55%) without regional wall motion abnormality which excluded acute coronary syndromes. Coronary angiography only demonstrated non significant coronary disease, implying a TAVB with degenerative origin. A single chamber permanent pacemaker implantation was planned, after temporary pacemaker backup. An initial attempt to access the left axillary vein failed due to vein collapse and an apparent stenosis in the proximal part. Cephalic vein isolation was not tried due to an apparent severe stenosis and irregularities from venography result. Subclavian puncture resulted in air inside the syringe that indicated a risk of pneumothorax was imminent, luckily the oxygen saturation did not drop. The right deltopectoral area was prepared, but venography from this side showed a large thrombus causing a near total occlusion of the axillary vein. Therefore we tried to puncture the internal jugular vein (IJV) using Seldinger technique without cut down. A guide wire was inserted to the puncture needle until it reached the IVC and the needle was removed. A 7F peelaway sheath was inserted then the pacemaker lead was directed and fixated to the right ventricular apex. The access site was blunt dissected and a smaller pocket was created to fit the sleeve which was then stitched. Another standard pocket was created on the right deltopectoral area. From this pocket we tunneled the skin using arterial forceps above the clavicle up to the jugular access site and grabbed the lead connector tip, then pulled it into the deltopectoral pocket. Lead test were acceptable: R wave of 17.1 mV, current 1.4 mA, impedance 619 Ω and threshold of 0.8V. Pneumothorax was not seen from the next day chest X‐­ray, and therefore the patient was discharged safely on the third day after procedure.

Conclusion:

In urgent situation where the upper limb veins cannot be accessed, the internal jugular vein can be an alternative approach for permanent pacemaker implantation, without a surgical cut down or extensive dissection for tenneling.

AP19‐­01135

Mid‐­term clinical outcomes of patients received leadless cardiac pacemaker in a single center

Masateru Kondo, Hideaki Endo, Tubasa Hatakeyama, Ayumu Adati, Yusuke Yamada, Kaito Yamada, Yuta Kagaya, Hiroki Saito, Kenjiro Sato, Masanori Kanazawa, Masanobu Miura, Akihiro Nakamura, Eiji Nozaki

Iwate Prefectural Central Hospital, Japan

Introduction:

Leadless pacemaker (LP) is a new technology that enables us to prevent the lead or pocket related complications such as hematomas, skin erosion. The aim of the present study was to examine the clinical outcomes of patients (pts) who were received the LPs in our hospital.

Methods:

We enrolled a total of 18 consecutive pts (11 men, 7 women; 84.1 ± 5.6 years) from September 2017 to December 2018, and examined clinical characteristics and device parameters.

Result:

LP implantation procedure was successfully performed in all pts. Pts with chronic fibrillation were 61% (n = 11), pts with brady‐­tachycardia syndrome were 28% (n = 5), and all pts had a Class I indication for pacing. This study included the following high risk pts; elderly pts (age > 85 years) (n = 10, 56%) and pts showing lower body mass index (<20) (n = 4, 22%). During the initial implant procedure, the R‐­wave amplitude was 7.2 ± 2.4 mV, the capture threshold at 0.24 milliseconds was 0.70 ± 0.4 V and impedance was 595 ± 112.2 Ω. There were no intraprocedural acute major complications. The median follow‐­up time was 10 months (range 0‐­14 months), and electrical performance has shown to be stable condition in 16 pts (89%) during this period, however, one patient showed the elevated pacing thresholds and the rapid depletion of the battery due to depend pacing, and one patient died due to unrelated cause during the follow‐­up time.

Conclusion:

LPs have been implanted safely and effectively in our hospital.

AP19‐­01137

Comparison of ventricular pacing dependency rate by the difference of pacing mode in patients with pacemaker implantation after trans‐­catheter aortic valve implantation

Mitsuru Yoshino, Hata Reo, Masatomo Ozaki, Hiroshi Tasaka, Kazushige Kadota

Kurashiki Central Hospital, Japan

Introduction:

Transcatheter aortic valve implantation (TAVI) has the potential to cause complications including the occurrence of atrioventricular conduction disturbance (AVCD) requiring pacemaker (PM) implantation. AVCD after TAVI may be transient but there are few reports on long‐­term investigations of patient after PM implantation.

Methods:

We enrolled retrospectively consecutive patients who had undergone TAVI from June 2010 to June 2018. The TAVI procedures were performed using self‐­expandable or balloon‐­expandable bioprosthetic TAVI systems, that is, the Medtronic CoreValve (Medtronic Inc., Minneapolis, MN) or Edwards SAPIEN valve (Edwards Lifesciences Corp., Irvine, CA), respectively. Pacemaker implantation was performed when bradycardia such as a third‐­degree atrioventricular block (AVB) and type II second‐­ degree AVB was seen, including during the follow‐­up period. Patients implanted for sick sinus syndrome were excluded from our study. Pacing mode was selected as conventional DDD or AAI‐­DDD mode switch algorism. VVI mode was selected for patients with chronic atrial fibrillation.

Result:

216 patients had enrolled during the study period, and 21 patients (9.7%) received new PM implantation after TAVI. One patient was excluded because of sick sinus syndrome. Finally, implanted PM mode programming at hospital discharge were as follows; conventional DDD (N = 8), AAI‐­DDD mode switch algorithms (N = 8), and VVI (N = 4). In each group, there was no difference of characteristics in average age and gender and PQ interval and QRS width of ECG just before TAVI procedure. PM checks were performed one month and one year later, respectively. The ventricular pacing dependency rate in each group ware as follows: conventional DDD (after one month 77.0%, after one year 52.9%), AAI‐­DDD mode switch algorithms (after one month 0.87%, after one year 0%), and VVI (after one month 58.3%, after one year 41.6%).

Conclusion:

During the follow‐­up period, the ventricular pacing dependency rate had lowered gradually in the cases of our Hospital. Particularly, the ventricular pacing dependency rate in AAI‐­DDD mode switch algorithms was extremely low. Many clinical studies have shown that unnecessary ventricular pacing can cause adverse effects, including decreased left ventricular ejection fraction and increased risk of heart failure in patients with intact atrioventricular conduction. It was suggested that the AAI‐­DDD mode switch algorithms might be more effective than DDD mode for the AVCD patient after TAVI.

AP19‐­01141

The clinical application value of current of injury in left bundle branch pacing

Weijian Huang, Lan Su, Tiancheng Xu

The First Affiliated Hospital and Key Lab of Cardiovascular Disease of Wenzhou, Wenzhou Medical Uni, China

Introduction:

Left bundle branch pacing (LBBP), a new transvenous technique for LBB pacing using a transseptal approach has been used for the development of conduction bundle pacing. Although the primary criteria of capture bundle have been refined recently, it still needs measurements and verification repeatedly, especially for those with insufficient experience performers. Several studies have demonstrated that current of injury (COI) of His bundle pacing is associated with the lower capture threshold and long‐­term stability. The aims of this study were to explore whether COI of LBB can predict (a) LBB capture directly, (b) lead long term stability.

Methods:

This study was a single‐­center, retrospective registry. The patients were included from September 2018 to March 2019 if they met the criteria of pacemaker indications and QRS < 120 milliseconds. LBBP was performed using the 3830 lead with C315His sheath. LBB potential electrogram (EGM) was recorded in a unipolar vector from the lead tip using PSA and electrophysiology recording systems. The criteria of LBB capture was defined as paced RBBB pattern, recorded LBB potential and at least one of criteria as follow: constant and shortest pacing stimulus to left ventricular activation time (stim‐­ LVAT) or abruptly shortened stim‐­ LVAT, selective or nonselective LBBP. Parameters and complications were documented at implant and during the F/U of 6 months.

Result:

77 patients tried LBBP and recorded LBB potential. LBB COI was recorded in 54 (70%) patients while 23 (30%) patients did not recorded LBB COI. The conduction bundle was captured below 3V/0.5 milliseconds in all patients with COI, which is significantly higher than patients without COI (100% VS 82.6%, P = .002). COI sensitivity for capture was 74% and specificity was 100%. Selective LBBP is more common in patients with COI than patients without COI (48.1% VS 5.3%, P < .001). The immediate capture LBB threshold were lower in patients with COI compared to patients without COI (0.45 ± 0.15V VS 0.6 ± 0.17V, P < .001). 67 patients (47 COI; 21 no COI) finished 6 months F/U and there was no significant difference in parameters including impedance and V wave amplitude between the two groups. The thresholds in the COI group became the same as that in the group without COI after 6 months F/U (0.61 ± 0.19V VS 0.6 ± 0.15V, P = .767). LVEF and LVEDD improved in two groups without significant growth differentials. There were neither perforation nor dislocation in both groups.

Conclusion:

(a) COI of LBB can be recorded during LBBP in 70% of population, which is more than HB COI reported in the literature. (b) LBB COI can be a bonus marker of LBB capture and more common in selective LBBP at implantation. (c) No serious complications and parameters are safe in both groups during 6 months F/U.

AP19‐­01150

Anti‐­tachicardia pacing therapies for fast ventricular arrhythmias: results from the international randomized ADVANCE III Trial

Maurizio Gasparini, Alessandro Proclemer, Axel Kloppe, Maurizio Lunati, José Bautista Martìnez Ferrer, Ahmed Hersi, Marcin Gulaj, Maurits C.E.F. Wijffels, Andrea Grammatico, Lorenza Mangoni di Santo Stefano, Laura Manotta, Angel Arenal

Humanitas Research University Hospital, Italy

Introduction:

The purpose of this retrospective analysis was to assess efficacy of anti‐­tachycardia pacing (ATP) therapies to terminate fast arrhythmic episodes avoiding unnecessary shocks in patients implanted with an Implantable Cardioverter Defibrillator (ICD).

Methods:

The ADVANCE III trial enrolled 1902 patients with standard ICD or cardiac resynchronization therapy (CRTD) indications between 2008 and 2010 in 94 centers in Europe, Middle East, South Africa and Russia. Patients were randomized to be programmed with a number of intervals to detect (NID) 30/40 or 18/24. Devices in both arms were programmed with ATP During Charging before shocks for episodes with 200 milliseconds≤Cycle Length (CL) ≤ 320 milliseconds and shock only for episodes with CL < 200 milliseconds. Secondary prevention was indication for 25% of the cases. All arrhythmic episodes were reviewed by an independent blinded committee. GEE adjusted analysis has been performed to account for patients with multiple episodes.

Result:

During a mean follow up of 12 months, 346 episodes with mean CL between 320 milliseconds and 200 milliseconds received at least an ATP in 169 patients. Details on overall ATP efficacy based on CL are shown in table 1. In 48.5% and 67.8% of the episodes with 200 milliseconds≤CL ≤ 280 milliseconds and 290 milliseconds≤CL ≤ 320 milliseconds, an unnecessary shock was avoided by programming ATP during charging. ATP efficacy is comparable with historically published data for arrhythmias with mean CL between 290 milliseconds and 320 milliseconds even when used after a long detection. When considering fast/very fast arrhythmias (episodes with mean CL between 280 milliseconds and 200 milliseconds), ATP was successful in terminating the arrhythmia in 85 cases (48.5%) (60 (54.3%) episodes in 34 patients in the 18/24 arm and 25 (38.5%) episodes in 22 patients in the 30/40 arm).

Conclusion:

In the multicentre, international, randomized ADVANCE III Trial, ATP were effective for sustained ventricular arrhythmia even with very fast cycle lengths, decreasing the number of unnecessary shocks. Therefore, ATP should be preferred as first‐­line therapy in ICD patients.

TABLE 1 ATP success by cycle length

Arm	Number of treated episodes (number of patients)	Number of successes(number of patients)	Raw Efficacy (%) (95%CI)	Adjusted Efficacy(%) (95%CI)
Episodes terminated by ATP (200‐­280)
Overall	176 (104)	85 (56)	48.3 (40.9 ‐­ 55.7)	48.5 (39.6 ‐­ 57.6)
18/24	103 (60)	60 (34)	58.3 (48.7 ‐­ 67.8)	54.3 (42.0 ‐­ 66.1)
30/40	73 (44)	25 (22)	34.2 (23.3 ‐­ 45.2)	38.5 (26.8 ‐­ 51.7)
Episodes terminated by ATP (290‐­320)
Overall	170 (92)	117 (71)	68.8 (61.8 ‐­ 75.8)	67.8 (59.1 ‐­ 75.5)
18/24	105 (65)	70 (52)	66.7 (57.6 ‐­ 75.7)	69.1 (58.6 ‐­ 78.0)
30/40	65 (27)	47 (19)	72.3 (61.3 ‐­ 83.3)	64.6 (47.8 ‐­ 78.5)

AP19‐­01157

Late presenting permanent pacemaker associated infection

Mohammad Iqbal, Ermina Widiyastuti, Giky Karwiky, Mohammad Rizki Akbar, Januar W Martha

Universitas Padjadjaran, Indonesia

Introduction:

Permanent pacemakers (PPMs) implantation for the prevention and treatment of various cardiac rhythm disturbances are increasingly used worldwide. Infection in a permanently implanted PM is a serious complication. It may occur either as a surgical site infection (SSI), occurring within 1 year after implantation, or as late‐­onset lead endocarditis. This report illustrates a case of late onset exit site infection occurring 2 years after PPM implantation.

Methods:

A case report.

Result:

A 76 years old male presented with erosion at the pocket site of the PPM implantation. He had slight fever two weeks before, with unremarkable sign of infection, followed by inflammation and erosion on the right side of his upper chest wall. A dual chamber rate‐­adaptive pacemaker (DDDR) was implanted 2 years ago subcutaneously by an experienced physician. Three months after his PPM implantation he had three episodes of stroke and unable to communicate effectively afterwards. He was then treated with oral anticoagulant (Rivaroxaban), and had no more episode of stroke. He had no prior sign or symptoms of any infection for the past two years, and showed no deterioration of his health condition. He has no history of diabetes, and not taken any medications that would suppress his immune system. His white blood cell count was 5100/mm³, blood culture was negative, lab tests were relatively normal, and there was no clinical evidence for endocarditis. Surgical tissue debridement was performed and staphylococcus aureus grew in its culture, suggesting a contamination. Pocket infection being regarded as the primary diagnosis, and he was then treated with intravenous antibiotics.

Conclusion:

Even though no apparent signs and symptoms of any infections related to PPM implantation for the past two years after surgery, the potential for development of pocket infection was still possible. Age related infection after PPM implantation despite of other possible risk factors could be the case of this patient.

AP19‐­01163

Feasibility of leadless pacemaker therapy after transvenous extraction of infected cardiac implantable electronic devices

Momiji Sakaguchi, Masahiko Goya, Tetsuo Sasano

Tokyo Medical and Dental University, Japan

Introduction:

The incidence of cardiac implantable electronic device (CIED) infections is increasing because the numbers of CIED implantation procedures and generator replacements are growing, owing to widening indications and aging device recipients. Leadless pacemaker (LPM) is an alternative strategy to conventional pacing systems after pacemaker extraction, but safety and feasibility of its use after CIED infection have not been confirmed. In this study, we sought to assess the safety and efficacy of LPM implantation after extraction of infected CIEDs.

Methods:

We retrospectively analyzed data from consecutive patients who underwent LPM (Micra, Medtronic, Mineapolis, MN) implantation after transvenous lead extraction (TLE) to treat pacemaker infection in a single tertiary care center.

Result:

A total of 17 patients were identified and included in the present analysis. The mean age of the patients was 85 ± 6 years. The indications for pacing were sinus node dysfunctions in eight, atrioventricular conduction block in seven, and bradycardia associated with permanent atrial fibrillation in two patients. The mean age of the pacing leads was 90 ± 60 months. All but one of the 17 patients were diagnosed with local pocket infection, while the remaining patient had pocket infection with concomitant bacteremia. Wound cultures were positive for Staphylococcus aureus in six, Corynebacterium in three, Pseudomonas aeruginosa in two, Coagulase‐­negative Staphylococcus in two, and other bacteria in three patients. The patient with bacteremia suffered Staphylococcus aureus infection. Complete removal was achieved for all leads without any major complications. LPM was implanted successfully without any adverse events 12 [Interquartile range: 10‐­16] days after the TLE procedure. No patient experienced LPM or pocket related re‐­infections during a mean follow‐­up of 9.2 ± 6.8 months. Device electrical parameters remained stable throughout this period. Three patients died during follow‐­up. The causes of death were unrelated to any recurrent infection or LPM therapy.

Conclusion:

LPM implantation after TLE to treat CIED infections is safe and effective. This approach presents a feasible alternative to conventional transvenous pacing system in patients with pacemaker infection.

AP19‐­01167

Baseline knowledge and experience of general population about automated external defibrillator: what our society know about it?

Wendy Wiharja

Universitas Pelita Harapan, Indonesia

Introduction:

Sudden cardiac arrest (SCA) can occur unexpectedly. The problem arises when SCA occurred at out‐­of‐­hospital setting when there are no medics/paramedics. Emergency management includes cardiopulmonary resuscitation (CPR) and use of automated external defibrillator (AED). When both of these performed, survival rate is 75% higher than CPR alone. Bystander's adequate knowledge about CPR and AED could save one's life while professional health care workers are on their way. Our study aimed to find out how far our general population knows about AED.

Methods:

Online Questionnaire was created using Google Sheet Form, link: https://goo.gl/eQZ0N. This link was broadcasted using LINE, WhatsApp, and BBM application as media. Simple randomized sampling was used. There was a “only for a non‐­medic society” note inside the questionnaire, for limiting sample bias. There were 303 responders (160 male, and 143 female), age > 17 y.o. Majority of responder's last educational level were high school (58%) and undergraduate (38%), others (4%). AED knowledge was tested using 4 questions: (a) Who are allowed to use AED?; (b) Have they seen AED in public places?; (c) Where do they see professional health care workers used AED?; (d) Does AED may be used directly to unconscious person? We asked them to answer based on their knowledge and daily experiences.

Result:

On first question, 198 (65.3%) respondents answered ‘only paramedics are allowed to use AED’. Second, 251 (82.8%) respondents have seen AED in public places. Many of them have seen AED at hospital, airport, and mall. About 261 (86.1%) respondents have seen health care workers used AED. On last question, 190 (62.7%) respondents know that AED should not be used directly to unconscious person.

Conclusion:

Expectedly, 198 (65.3%) responders think that they have no authorities for using AED. Many of responders (251/82.8%) has saw AED on public place, this means their awareness and eagerness to know what is AED. A campaign or seminary about utilization of AED for general/non‐­medic society should be encouraged.

AP19‐­01178

Sudden cardiac death risk stratification in anomaly of right coronary artery: when is implantation needed?

Audrey Hadisurya, Wendy Wiharja, Bertha Bertha, Sabrina Aswan, Nixie Liono, Jeremiah Suwandi

Universitas Pelita Harapan, Indonesia

Introduction:

An anomalous origin of the right coronary artery (RCA) from the left sinus is a very rare anomaly, and its incidence is 0.019%‐­0.49% on coronary angiography. However, recent angiographic studies have reported a relatively high incidence (5.6%) of coronary artery anomalies and anomalous RCA origins from the left sinus (0.92%). 19‐­33% of sudden cardiac deaths in the young population is attributable to coronary artery anomalies. ARCA causes fixed obstruction and limits coronary blood flow, causing ventricular ischemia predispose to lethal arrhythmia during exertion.

Methods:

CASE REPORT 41 y.o male with complain of easily fatigued since 3 years before. Dyspnea on exertion (walking > 100 meters, jogging), there was no chest discomfort. Patient was treated with Bisoprolol for 3 years, before discontinued by his initiative. Physical examination is within normal limit. Coronary Computed Tomography Angiogram with contrast and calcium scoring test was done in 2014, suggestive of high riding and anomalous origin of Right Coronary Artery. Calcium Score was normal. Patient underwent Dobutamine Stress Echocardiography without any abnormal wall motion, no abnormal rhythm noted. Ejection Fraction was 68% with good contractility of both ventricles. Medical treatment with B‐­Blocker was chosen over Implantable Cardioverter Defibrillator (ICD) implantation.

Result:

Sudden cardiac death is the most feared complication in patient with ARCA. This condition may develop during exertion or heavy psychological stress. Treadmill ECG or Dobutamine stress test may be chosen depending on patient's condition, to differentiate between a high‐­risk and low risk patient. If arrhythmia and heart attack occurred during stress test, then Implantable Cardioverter Defibrillator should be considered as sudden death prevention for patient. As from the case, neither abnormal wall motion nor rhythm was noted, conclude that this patient has low risk of sudden death, which mean conservative treatment using Beta Blocker can be used.

Conclusion:

Although ARCA is rare, its complication is devastating. If not diagnosed and treated carefully, sudden cardiac death may come like a grim reaper. Modalities of therapy should be chosen depending on patient's risk stratification using stress test which is the most important diagnostic tool.

AP19‐­01180

Elementary analysis of His‐­Purkinje system pacing in patients who underwent cardiac resynchronization therapy with failure of the LV lead placement via coronary sinus

Hongxia Niu, Yiran Hu, Min Gu, ; Wei Hua

Fuwai Hospital, Afghanistan

Introduction:

His‐­Purkinje system pacing (HPSP) is a physiological pacing therapy. We aimed to explore the clinical application of in patients who underwent cardiac resynchronization therapy (CRT) with failure of the LV lead placement via coronary sinus (CS).

Methods:

Pacing parameters and cardiac function indicators of 7 CRT patients undergoing HPSP with failure of the LV lead placement successfully from December 2017 to March 2019 were retrospectively analyzed in this study.

Result:

Among them, 3 underwent His‐­bundle pacing, another 4 underwent left bundle branch area pacing. The His‐­bundle (HB) capture threshold was 2.03 ± 0.42V/1.0 milliseconds at implant and 2.00 ± 0.35V/1.0 milliseconds at 3‐­month follow‐­up. However, the LBBAP capture threshold was 0.75 ± 0.25V/0.4 milliseconds at implant and 0.63 ± 0.10V/0.4 milliseconds at 3‐­month follow‐­up. Besides, the average QRS duration (175.7 ± 13.5 vs 125.4 ± 9.6 milliseconds; P < .001), left ventricular ejection fraction (31.7 ± 6.6 vs 41.0 ± 6.4%; P = .005), left ventricular end‐­diastolic diameter (71.0 ± 6.9 vs 63.0 ± 7.4 mm; P = .001) and six‐­minute walk distance test (306.6 ± 32.5 vs 391.9 ± 69.8 m; P < 0.001) were significantly improved at 3‐­month follow‐­up.

Conclusion:

HPSP, as an alternative for patients undergoing CRT with failure of LV lead placement, can ameliorate electrical dyssynchrony and improve cardiac function in patients with heart failure.

AP19‐­01187

Risk factors of all‐­cause mortality in patients with hypertrophic cardiomyopathy after pacemaker implantation

Xuhua Chen

Fuwai Hospital, China

Introduction:

Our study is aimed to investigate the predictors of long‐­term all‐­cause mortality in patients with hypertrophic cardiomyopathy (HCM) after pacemaker implantation.

Methods:

We retrospectively examined 103 patients who were diagnosed with HCM and underwent pacemaker implantation from November 1,2002 to June 1,2013. Demographic parameters, clinical data including affiliated diseases, laboratory examination, echocardiographic parameters and medications at baseline were analyzed.

Result:

One hundred and three patients (52 males, mean age 57.0 ± 15.9 years) were included. Atrial fibrillation (42.5%), hypertension (27.7%) and diabetes mellitus (13.8%) were the most common affiliated diseases at baseline. During a mean follow‐­up of 7.3 ± 3.4 years, 9 patients upgraded to implantable cardiac defibrillators (ICD) and 25 patients died, 17 of whom were due to cardiovascular diseases. Dual‐­chamber pacemaker were implanted in 88 patients (85.4%) received, 85 of whom (96.8%) received consecutive right ventricular apical pacing. In univariate Cox regression models, ischemic heart disease (IHD), left ventricular outflow tract obstruction (LVOTO), left atrial diameter (LAD), left ventricular end‐­diastolic diameter (LVEDD), left ventricular ejection fraction (LVEF), heart rate (HR), warfarin usage and dual‐­chamber pacing were associated with all‐­cause mortality (P < .10). In multivariate analysis, only IHD (HR = 4.751; 95% CI = 1.206‐­18.717; P = .026) was an independent risk factor of all‐­cause mortality.

Conclusion:

IHD was a significant risk factor of all‐­cause mortality in HCM patients after pacemaker implantation.

AP19‐­01205

A case of implanting CRTD for CS with draining to the right atrium independent from PLSVC

Hirotaka Murase, Tomoki Kubota, shinji Yasuda, Shinsuke Ojio, Kazuhiko Nishigaki, Shinya Minatoguchi

GIfu municipal hospital, Japan

Introduction:

A 70‐­year‐­old lady felt dyspnea on exertion and orthopnea breathing at night and was admitted to our hospital. She was diagnosed as dilated cardiomyopathy by myocardial biopsy, she has been treated with medication and adaptive servo ventilation. But she was hospitalized for congestive heart failure again, and underwent a cardiac resynchronization therapy defibrillator (CRTD).

Methods:

We planned to implant CRTD from the left side. But left subclavian venography revealed persistent left superior vena cava (PLSVC), so we changed to implant CRTD from the right side. An angiographic catheter was inserted into PLSVC from the right atrium and left superior venography was performed. PLSVC and coronary sinus (CS) had different draining to the right atrium, and CS was narrowed. It made difficult to insert a CS vascular sheath into CS. Therefore, we inserted the CS electrode first as a guide of the sheath.

Result:

Finally, we could insert a left ventricular lead into the CS lateral branch. Although many PLSVCs drain to the right atrium through CSs.

Conclusion:

PLSVC and CS may drain to the right atrium independently as in this case.

AP19‐­01213

Efficiency of a hybrid approach for cardiac implantable electronic device infections

Miki Amemiya, MAsahiko Goya

Tokyo Medical and Dental University, Medical Hospital, Japan

Introduction:

Transvenous Lead Extraction (TLE) procedures are recommended for cardiac implantable electronic device (CIED) infections as class I and the efficiency has been established. However, there are often cases in which it is difficult to perform TLEs. Therefore, a hybrid approach (HA) for lead extractions may be required in elective cases. We verified the efficiency of the HA, because the procedure has still not been established. The HA was defined as a TLE performed by an electrophysiologist with the support of a cardiac surgeon in the same operation.

Methods:

From 2013 to September 2018 among the 200 patients referred to our institution for TLEs, we performed 7 HA procedures (6 males, median age 64.3, pacemaker [PM] 1, cardiac defibrillators [ICDs] 4, cardiac resynchronization therapy [CRT] 2). The HA was performed in 4 cases for big vegetations (≧3 cm), failed TLEs in 2 cases, and unable to perform the TLE due to a tricuspid annuloplasty (TAP) in 1 case. All procedures were performed in the operating room. We detached the leads from the subclavian vein to the superior vena cava (SVC) and high right atrium with an excimer laser sheath. We performed a thoracotomy from the SVC to the RA and right ventricle (RV).

Result:

Six cases were performed during one procedure and 1 during two. For a total of 16 leads (RA leads 4, RV leads 5, ICD leads 6, left ventricle [LV] lead 1), complete HA procedural success was achieved. One case underwent a CRT implantation with a simultaneous HA, and the remaining 6 cases underwent a CIED implantation after treatment of an infection.

Conclusion:

We performed 7 HAs and used this HA in high risk patients in order to increase the overall safety of the procedure. The HA was useful in difficult TLE cases.

AP19‐­01217

Provocative case: defibrillation threshold testing at generator change – not so SIMPLE

Adam Lee, Zian Tseng

UCSF, United States

Introduction:

Omission of defibrillation threshold (DFT) testing and programming of prolonged detection intervals is common in contemporary management of implantable cardioverter‐­defibrillators (ICDs).

Methods:

We present a case scenario in which DFT testing and short detection intervals are warranted. The utility of testing an alternative manufacturer's generator in the event of inadequate VF sensing is demonstrated.

Result:

A 52 year old female presented for generator replacement of a dual chamber ICD, implanted for secondary prevention of idiopathic VF. The system consisted of a Boston Scientific Teligen 100 (E110) generator, Fineline II Sterox EZ (4470) RA lead and Endotak Reliance G (0185) integrated bipolar RV/ICD lead. Parameters at recent interrogation were stable (sensing/threshold/impedance: 5.2 mV, 1.2V @ 0.4 milliseconds, 403 Ω [RA], 7.1 mV, 1.6V @ 0.4 milliseconds, 459 Ω [RV]). However, the measured R‐­ waves during intra‐­operative testing were only 3.5 – 5.5 mV. Accordingly, following generator replacement (Boston Scientific Dynagen), VF induction was performed to confirm adequacy of VF sensing. VF induction was performed at least sensitivity (1.5 mV) with nominal detection (1 s) in the VF zone. Gross undersensing was evident with complete failure to detect VF necessitating a rescue shock to restore sinus rhythm (Panel A). VF induction was repeated at a higher sensitivity (1.0 mV). There was significant initial undersensing, though VF was ultimately detected. However, there was immediate charge diversion due to undersensing followed by VF redetection, a committed but unsuccessful shock (at 21 J), then gross VF undersensing, necessitating another external rescue shock (Panel B). As the nominal sensitivity was 0.6 mV, an adequate safety margin of VF sensing had not been demonstrated. Lead extraction was not an acute option and lead revision with abandonment of the prior lead was not appropriate given her age. A alternative manufacturer's generator was tested. VF induction was repeated with a Medtronic Evera XT at least sensitivity (1.2 mV) with prolonged detection (30/40 intervals) in the VF zone. Despite initial undersensing, VF was detected with successful defibrillation (15.1J) to SR (Panel C). VF induction was retested at nominal sensitivity (0.3 mV) with prolonged detection demonstrating appropriate VF sensing and DFTs (Panel D). The Medtronic generator was programmed with a single VF zone from 188 bpm with shortened detection intervals (18/24) to allow for potential VF undersensing. The patient will undergo elective RV/ICD lead extraction and re‐­implantation

Conclusion:

The presence of poor R‐­wave sensing in SR (<5‐­7 mV), should prompt VF induction testing. In the event of VF undersensing, an alternative manufacturer's generator may be a reasonable bridging solution if an adequate safety margin is achievable. Prolonged interval detection should not be programmed in patients with unreliable VF sensing.

AP19‐­01219

The patterns and management of cardiovascular implantable electronic device (CIED) related infections: study from a tertiary care center in South India

Ravikanth Telikicherla

Sreechitra Tirunal Institute for Medical sciences and Technology, India

Introduction:

CIED related infection is a serious complication. CIED implantation rates are on the rise worldwide. The debridement of the site and explant of the device are the gold standard treatment modalities. But, some patients can be managed without device explantation. There are only few studies to identify who can be managed without device explantation.

Methods:

Our study is a Retrospective, observational study done at a Tertiary care center in South India. The study population includes the patients who were diagnosed and managed with CIED related infections in our Institute over the past 10 years (i.e. from 2010 to 2019).

Result:

A total of 32 patients were included in the study (22 patients underwent device insertion from our Institute). The mean age was 52.38 years (SD = 19.27 years). Males were 23 patients (71.9%). 21 devices were PPI, 6 were AICD and 5 devices were CRT. The commonest presentation was Pus from the Pocket site (20 patients). Other presentations are fever, Heart failure, Erosion of the PG. 1 had vegetation over the tricuspid valve. 13 patients (40.6%) had an evidence of systemic infection. Blood culture has grown positive in only 3, of which 2 had growth of Staph, one had growth of Candida parapsilosis. Culture of the Pus from the PG site was positive in 22 patients (68.8%). The commonest organism was Staphylococcus species (11 patients). Other organisms grown are Acinetobacter, Klebsiella species, Pseudomonas aeruginosa, Burkholderia Cepacia which grown in 2 patients each and Achromobacter, Atypical mycobacterium, Serratia grown in one patient each. The corner stone of the management of CIED infection is antibiotics. Out of the 32 patients, 23 (71.9%) were managed with PG Explantation. But Lead Explantation was done only in 15 patients (46.8% of the total population). TPI was done prior to Reimplantation in only 5 patients, out of which Jugular pacemaker was inserted in 3 patients Reimplantation of the device was done in 14 patients and it was advised in additional 6 patients. 30 patients had successful outcome. Whereas one patient died at the time of Anesthesia induction prior to Wound debridement. One patient had recurrence of infection, which was treated successfully with PG and Lead Extraction. Six patients were on OAC therapy, and six were on antiplatelets. 9 patients stopped the medication prior to the procedure. Rest of the three patients underwent the procedure continuing the medication.

Conclusion:

CIED infection is a serious concern. But, the rates of systemic infection are less. The commonest organism isolated was Staph species. Antibiotic therapy is the corner stone in the management of CIED related infection. But, it will require extraction of the Device completely. However, in the absence of systemic infection, it can be managed successfully without Lead Extraction.

AP19‐­01223

Virtual computer simulation modeling for prediction of response to cardiac resynchronization therapy

Jae‐Sun Uhm, Min‐Cheol Park, Min Kim, In‐Soo Kim, Moo‐Nyun Jin, Hee Tae Yu, Jaewon Oh, Chan‐Joo Lee, Tae‐Hoon Kim, Boyoung Joung, Hui‐Nam Pak, Seok‐Min Kang, Minki Hwang, Moon‐Hyoung Lee, Eun Bo Shim

Severance Hospital, South Korea

Introduction:

Although cardiac resynchronization therapy (CRT) is an effective treatment strategy in patients with heart failure, it still has a problem in identifying non‐­responder to CRT. We recently developed the in‐­silico CRT modeling. The objective of this study was to validate the accuracy of the in‐­silico model.

Methods:

We retrospectively included 14 patients (age, 66.1 ± 10.7 years, 4 men) with CRT who underwent cardiac computed tomography (CT) and magnetic resonance (MR) before CRT implantation. To construct the in‐­silico CRT model, we combined the 3D image using cardiac CT and MR images, based on electromechanical ventricular model with a lumped model of the circulatory system and electric pacing device (Figure). In‐­silico CRT response was defined as Δleft ventricular end‐­systolic volume (LVESV) = [LVESVpre‐­CRT–LVESVpost‐­CRT] × 100/LVESVpre‐­CRT ≥ 15%. We compared in‐­silico CRT response with clinical CRT response.

Result:

In the in‐­silico model, 8 in 14 patients were CRT‐­responders. In clinical observation, 5 in 14 patients were CRT‐­responders. Positive and negative predictive value and accuracy rate of the in‐­silico model were 62.5%, 100%, and 78.6%, respectively. Agreement of CRT‐­responder between the in‐­silico model and clinical observation was moderate (Cohen's κ coefficient = 0.588, P = .016).

Conclusion:

The present in‐­silico CRT modeling was feasible in identifying CRT‐­responders.

AP19‐­01226

The effectiveness of cardiac resynchronization therapy in non‐­ambulatory NYHA class IV patients

Seong Soo Lee, Youngjun Park, Hee‐jin Kwon, June Soo Kim, Young Keun On, Kyoung‐Min Park, Seung‐Jung Park

Samsung Medical Center, South Korea

Introduction:

The effectiveness of cardiac resynchronization therapy (CRT) in non‐­ambulatory NYHA class IV (Nam‐­IV) patients are not well established. We evaluated the role of CRT as a treatment option for Nam‐­IV patients in terms of clinical, electrocardiographic and echocardiographic improvement.

Methods:

From October 2005 to December 2017, a total of 159 patients had undergone de novo CRT implantation at our institute. Nam‐­IV was defined as following criteria: (a) resting dyspnea, (b) dependent on intravenous (IV) inotropes, vasopressors, diuretics, or vasodilators and/or mechanical support, (c) at least one episode of tapering failure of IV drugs or weaning failure of mechanical supports, and (d) non‐­elective CRT procedure. According to the criteria, 17 were classified as Nam‐­IV patients. We evaluated the effectiveness of CRT in terms of survival rate, symptom improvement, duration of IV drug use, annual rehospitalization, electrocardiographic and echocardiographic parameters.

Result:

Baseline characteristics and change of clinical parameters are shown in Table 1 and Table 2. During the index hospitalization, 3 patients were died due to heart failure (HF) progression. Among 14 survivors, 12 patients showed symptom improvement to NYHA class II and 2 patients to NYHA class III before discharge and significant reduction of duration of IV drug use before and after the procedure (10.4 ± 6.9 days vs 5.2 ± 5.3 days, P = .037). There was marked improvement of QRS duration (166.1 ± 29.0 msec vs 151.9 ± 20.5 msec, P = .01). Only 1 patient undergone heart transplantation at 3 months after CRT implantation. The number of annual hospitalization associated with HF aggravation was significantly reduced before and after CRT implantation among 13 survivors at 12 months (1.9 ± 1.6 vs 0.3 ± 0.6, P = .002). Although there was no significant reduction of LV chamber size, LV ejection fraction was markedly improved at 12 months (20.6 ± 6.7% vs 29.3 ± 13.2%, P = .029).

Conclusion:

CRT could be considered as a treatment option for Nam‐­IV patients. The effectiveness of CRT in such severely ill patients group was observed in acute phase and also through 12 months after CRT implantation.

TABLE 1 Baseline characteristics

Non‐­ambulatory NYHA class IV (n = 17)
Age (years)	66.3 ± 13.4
Male (%)	11 (64.7%)
Non‐­ischemic	15 (88.2%)
AF
Paroxysmal	3 (17.6%)
Persistent/Permanent	6 (35.3%)
Comorbidities
Hypertension	9 (52.9%)
DM	6 (35.3%)
CKD	5 (29.4%)
MI	1 (5.9%)
PCI/CABG	2 (11.8%)
Medication
Beta blocker	6 (35.3%)
ACEi/ARB	10 (58.8%)
Aldosterone antagonist	11 (64.7%)
Diuretics	17 (100%)
Digoxin	6 (35.3%)
Number of IV drugs used per patient	2.2 ± 1.3
Pre‐­CRT hospital days	17.0 ± 9.7
Pre‐­CRT duration of IV drug use	11.3 ± 4.1
Number of tapering failure (pre‐­CRT)	2.6 ± 1.8
Mechanical support (ECMO or CRRT)	3 (17.6%)
Admission route
ER	3 (17.6%)
OPD	7 (41.2%)
Transfer	7 (41.2%)
Baseline ECG
HR (bpm)	82.5 ± 19.8
QRS duration (msec)	166.1 ± 29.0
QTcB (msec)	508.8 ± 78.8
LBBB	15 (88.2%)
Baseline echocardiography
LVEF (%)	21.0 ± 6.4
LVEDV (mL)	265.0 ± 92.7
LVESV (mL)	207.2 ± 77.4
LVIDd (mm)	70.6 ± 11.9
LVIDs (mm)	60.8 ± 11.3
LAVI (mL/m2)	83.1 ± 37.4
Moderate ˜ severe MR	7 (41.2%)
Moderate ˜ severe TR	4 (23.5%)
Immediate symptom change after CRT
NYHA II/III/IV	12(71%)/2(12%)/3(18%) Procedure type
De novo	14 (82.4%)
Upgrade	3 (17.6%)
Device type
CRT‐­D	15 (88.2%) CRT‐­P
Lead position
LV
RAO : Apical / Non‐­apical	6 (35.3%) / 11 (64.7%)
LAO : Lateral / Non‐­lateral	17 (100%) / 0 (0%)
RV
RAO : Apical / Non‐­apical	3 (17.6%) / 14 (82.4%) Biventricular pacing (%)* 97.3 ± 5.7

Abbreviations: ACEi, angiotensin converting enzyme inhibitor; ARB, angiotensin II receptor blocker; CABG, coronary artery bypass graft surgery; CKD, chronic kidney disease; CRRT, continuous renal replacement therapy; CRT‐­D, cardiac resynchronization therapy‐­ defibrillator; CRT‐­P, cardiac resynchronization therapy‐­pacemaker; DM, diabetes mellitus; ECG, electrocardiography; ECMO, extracorporeal membrane oxygenation; ER, emergency room; HR, heart rate; IV, intravenous; LAO, left anterior oblique; LAVI, left atrial volume index; LBBB, left bundle branch block; LVEDV, left ventricular end‐­diastolic volume; LVEF, left ventricular ejection fraction; LVESV, left ventricular end‐­systolic volume; LVIDd, left ventricular internal dimension at diastole; LVIDs, left ventricular internal dimension at systole; MI, myocardial infarction; MR, mitral regurgitation; OPD, outpatient department; PCI, percutaneous coronary intervention; RAO, right anterior oblique; TR, tricuspid regurgitation

*available in 12 patients (1 patient; no follow‐­up interrogation)

TABLE 2 Survivors at 12 months after CRT implantation (n = 13)

Pre CRT	Post‐­CRT at 12 months	P‐­value
LVEF (%)	20.6 ± 6.7	29.3 ± 13.2	.029
LVEDV (mL)	280.8 ± 93.2	262.2 ± 115.2	.280
LVESV (mL)	221.7 ± 79.6	200.3 ± 106.2	.220
LVIDd (mm)	73.5 ± 11.0	71.2 ± 13.3	.217
LVIDs (mm)	64.1 ± 9.6	59.2 ± 16.0	.120

Abbreviations: CRT; cardiac resynchronization therapy; LVEDV, left ventricular end‐­diastolic volume; LVEF, left ventricular ejection fraction; LVESV, left ventricular end‐­systolic volume; LVIDd, left ventricular internal dimension at diastole; LVIDs, left ventricular internal dimension at systole

AP19‐­01234

Wound care management: infected implantation permanent pacemaker devices

Rubiyanto Warja, Doni Yogo, Yoga Yuniadi, Sunu Budi Raharjo, Dicky Armein Hanafy

INKAVIN & INWCCA, Indonesia

Introduction:

The benefit of cardiac pacemaker is unquestionable, but it also comes with several complications. One of the most undesirable complications is infection. The incidence of implantable cardiac devices is around 1.7% in 6 months with mortality rate ranging from 5% to 15%. Wound care after debridement of infected cardiac devices needs special attention. Otherwise infected wound would prolong patient's hospitalization and increase the risk of systemic infection. Maintaining a moist environment is a good method in dealing with wound that has a breakdown in skin integrity.

Methods:

Here in, we present a case of 59 year‐­old male with history of dual chamber pacemaker implantation 5 month prior admission. He came to the emergency department with complain of a tenderness around the implantation site. A hole was noticed on the prior stitched scar on the skin. He undergone debridement soon afterwards. All necrotic tissues and pus was cleaned and a numerous saline flush was applied to the wound. Wound was closed partially and a drain was left. After debridement, wound care was done using acticoat silver dressing. Dressing was changed every 3 to 4 days, and systemic ampicillin/sulbactam was given intravenously in 10 consecutive days. After 25 days, the wound was healed.

Result:

The wound care management with moist concept could be done to minimize wound healing process. TIME concept (Tissue management, Infection and inflammation control, Moisture balance, and Ephitelial edge) could be used in dealing with infected pacemaker wound. Tissue management with debridement should removes all non‐­viable tissues and all parts of the device, because the device is considered as the source of infection. Infection and inflammation should be controlled using antimicrobial topical dressing, such as silver acticoat. Transparent film dressing could be applied over the wound to reduce inflammation. A balanced moisture should be kept over the wound using allevyn hydrofoam and calcium alginate dressing to absorb fluids or exudates. Keeping a moist environment also prevent maceration at epithelial edge on the skin barrier. A systemic antibiotic for positive and negative grams should also be used.

Conclusion:

Wound Care Management using TIME concepts could be used in managing patients with infected cardiac implantable devices. By promoting faster healing process, complications like systemic infection and wound dehiscence could be avoided.

AP19‐­01242

Implementation of a HIS bundle pacing program at two Australian centres: learning curve and initial experience

Luke Dawson, Julie Cadden, Derk Pol, Irene Stevenson

Royal Melbourne Hospital, Australia

Introduction:

HIS Bundle Pacing (HBP) has emerged as a promising technology to avoid pacing complications associated with dyssynchrony in right ventricular (RV) pacing. There are limited Australian data on HBP and most international data are limited to experienced operators and centres. We aimed to evaluate the implementation and outcomes of an HBP program in an Australian setting.

Methods:

Data were retrospectively collected on 45 consecutive HBP procedures at two Victorian centres from commencement of the program in March 2018 to February 2019. The cohort was divided into three groups (cases 1‐­15, 16‐­30, and 31‐­45) to determine changes in procedural success over time in relation to operator experience.

Result:

Mean age was 70 ± 18 years, 69% were male. Impaired LV function was present in 27%, atrial fibrillation in 47%, 13% had a previous device, and 5% and 30% had a pre‐­existing right or left bundle branch block (BBB) respectively. Mean QRSD pre‐­HBP was 121 ± 35 milliseconds, mean procedure time was 120 ± 53 minutes, and mean fluoroscopy time was 21 ± 18 minutes. HBP was successful in 82% of procedures, but was less likely to be successful if AV block was the indication (70% vs 100%, P = .02). QRSD decreased by 5 ± 13 milliseconds overall (increasing by mean 10 ± 19 milliseconds in patients without BBB, while decreasing by mean 21 ± 44 milliseconds in patients with BBB). Rates of procedural success, QRSD improvement, and use of an RV backup lead were 80%, 50%, and 40% respectively for cases 1‐­15, and 93%, 78% and 27% respectively for cases 31‐­45. Across the three groups, both procedural and fluoroscopy time changed reflecting operator experience (procedural time 114 ± 30 minutes for cases 1‐­15, 143 ± 64 minutes for cases 16‐­30, and 90 ± 45 minutes for cases 31‐­45, P = .05; fluoroscopy time 15 ± 7 minutes for cases 1‐­15, 28 ± 22 minutes for cases 16‐­30, and 8 ± 3 minutes for cases 31‐­45, P < .001). Figure 1 demonstrates an electrocardiograph with no change in QRS duration prior to HIS pacing (panel A) and following HIS pacing (panel B) in a patient with atrial fibrillation.

Conclusion:

HBP has a high success rate and is feasible in an Australian setting with improvements in procedural performance and outcomes seen with operator experience. BBB appears to affect procedural success.

AP19‐­01274

Evaluation of paced QRS reduction with alternative right ventricular site pacing

Balbir Singh, Sumit Anand, Chander Mohan Thakur, Anushreeta Borah

Medanta‐­The Medicity, India

Introduction:

Direct His‐­Bundle pacing (DHBP) and RV Septal pacing provides most physiological form of ventricular activation when compared to RV Apical pacing. The purpose of this data collection was to share our experience on QRS narrowing with DHBP and Modified high RV septal pacing (mRVSP) at our Institute using conventional screw‐­in leads since additional tools required for accessing these sites would raise overall cost of procedure.

Methods:

We performed 12 consecutive cases in this series; DHBP and mRVSP (6 each) using conventional active fixation leads. All patients had conventional Atrio‐­ventricular synchronous pacing indication. HB was approached using standard Abbott pacing lead Tendril STS 2088TC‐­58 by reshaping conventional stylet to precisely position lead at a site near HB with support from fixed shape CPS DirectTM Universal Outer Catheter (DS2C019) from Abbott. The HIS potential was confirmed electrophysiologically by demonstrating largest His deflection on Prucka GE CardioLab Electrophysiology Recording System and confirmed using unipolar signals in Merlin Pacing System Analyser EX3100 from Abbott. The helix was extracted to maximum while maintaining a counter clockwise torque in the stylet. mRSVP technique ensures highly accurate reproducible stable positioning and relies on anatomical identification of target zone in LAO view fixed shape CPS DirectTM Universal Outer Catheter (DS2C019) from Abbott. We used Abbott 7Fr. Therapy Ablation catheter (83456) to stabilise sheath and tried penetrative force to allow catheter to partially puncture Ventricular septum. We used standard Abbott pacing lead Tendril STS 2088TC‐­58 and did deep penetration using maximum screw in turns while maintaining the clockwise torque on catheter to maintain orientation of lead tip perpendicular to septal surface and provide adequate support to rapidly screw‐­in lead into septum.

Result:

All 6 patients in DHBP had capture threshold < 2.5 V at 0.4 milliseconds. Patients in mRVSP showed relatively high acute thresholds 1.5‐­2.5 V at 0.5 milliseconds which stabilised to < 1.0 V at 0.5 milliseconds on subsequent day of implant. Post‐­implant QRS duration was reported to be 105‐­135 milliseconds and 110‐­140 milliseconds in DHBP and mRSVP patients respectively. We found 9 out of 12 patients had QRS narrowing at first attempt while 3 patients were switched to alternate site pacing.

Conclusion:

From our experience, mRVSP positioning was relatively easier to achieve than DHBP. Both techniques demonstrated reduction in Paced QRS. The current tools are not best suited for either techniques and would require further learning. Long term follow‐­up data would be needed to confirm which technique helps to achieve stable thresholds and long term clinical outcome.

AP19‐­01275

Contralateral pneumothorax and pneumopericardium: An unanticipated complication of intracardiac device implantation

Nitin Parashar, Siddharthan Deepti, Mumun Sinha

All India Institute of Medical Sciences, New Delhi, India

Introduction:

The development of contralateral pneumothorax after intracardiac device implantation is a rare complication with the association of contralateral pneumothorax and pneumopericardium being unexpected and even rarer. We present such a case of concomitant right‐­sided pneumothorax and pneumopericardium following left‐­sided pacemaker implantation.

Methods:

A 62‐­year‐­old man presented with complaints of recurrent episodes of presyncope for nine months. The baseline electrocardiogram (ECG) showed trifascicular block. Twenty‐­four‐­hour Holter monitoring further revealed intermittent high‐­grade second degree atrioventricular (AV) block. Echocardiography did not reveal any structural heart disease with normal biventricular function. For this symptomatic AV block, a dual‐­chamber permanent pacemaker was implanted via left axillary venous access with active fixation leads in right atrium (RA) and right ventricle (RV). Pacing parameters were normal and patient was stable after the procedure. Chest radiograph done two hours after the implantation showed normal lead position and no pneumothorax. There was no pericardial effusion on echocardiogram.

Result:

About seven hours after the procedure, the patient complained of sudden onset central chest pain that worsened with inspiration. Vitals, chest auscultation, heart sounds, bedside anteroposterior chest radiograph, device interrogation and repeat echocardiogram were within normal limits and the patient was given symptomatic treatment. The pain persisted and decrease in the breath sounds was detected on the right side of the chest with appearance of mediastinal crunch. There was pneumopericardium (white arrow) and right‐­sided pneumothorax (white asterisk) with partial collapse of right lung on non‐­contrast CT with probable extrusion of the helix of the RA lead (Figure 1). The pneumothorax was managed by inserting an intercostal drainage tube. The patient remained stable and one week later, the chest radiograph showed no abnormality. RA lead repositioning was not required.

Conclusion:

Contralateral pneumothorax with or without pneumopericardium is an extremely rare complication of intracardiac device implantation and may be missed on an initial radiograph. Caution should be exercised in screwing of the atrial lead during placement and an early CT is warranted in cases with high suspicion.

AP19‐­01278

Threshold and current differences between lead placement in right ventricular outflow tract and right ventricular apex

Miftahurrahmah Galuh Mayang Sari, Agung Fabian Chandranegara, Chyntia Monica Gultom

Pasar Rebo General Hospital, Indonesia

Introduction:

Permanent Pacemaker (PPM) has been shown to improve outcomes in patient with bradycardia. Although no substantial evidence from studies that shown an advantage in lead placement, right ventricular outflow tract (RVOT) pacing has become the preferred pacing site. This study was to analyze threshold and current from lead placement in RVOT and RVA in Pasar Rebo General Hospital.

Methods:

We retrospectively reviewed patients who underwent PPM from January 2018 to July 2019. We collected gender, ages, indication, threshold (V) and current (mA), from lead placement in RVOT and RVA.

Result:

We managed to collect 26 patients, 21 patients of which lead placement were at RVOT and 5 patients at right ventricular apex (RVA). From the RVOT pacing group, we collected mean age was 70.62 ± 11.76 years, male percentage was 57.1%, mean threshold was 0.56 ± 0.1 V, mean current was 1.04 ± 0.43 mA. Variety indication of RVOT pacing were sick sinus syndrome (42.9%), bradycardia symptomatic (28.6%), total AV block (23.8%), and 2nd degree AV block (4.8%). From RVA pacing group we collected mean age was 78 ± 2.3, male percentage was 40%, mean threshold was 0.64 ± 0.23 V, mean current was 1.06 ± 0.4 mA. Variety indication of RVA pacing group were, bradycardia symptomatic (80%), and total AV block (20%).

Conclusion:

From the collected data the mean threshold was lower than the previous reports from other studies. There was no differences from threshold and current between lead placement in RVOT and RVA (P > .5). Majority indication of patient who underwent PPM were sick sinus syndrome and bradycardia symptomatic.

Keywords: Permanent pacemaker, Right ventricular outflow tract, Right ventricular apex, threshold, current.

AP19‐­01285

Retrieval of chronically implanted nanostim leadless pacemaker single center experience

Kentaro Minami, Jan Petr, Vivek Y. Reddy, Petr Neuzil

Division of Cardiology, Czech

Introduction:

Leadless cardiac pacemakers (LCP) have an effective clinical benefit and a safety profile that allow alternative use to transvenous pacemakers for patients indicated for single‐­chamber ventricular pacing. However much remains to be clarified about the exchange of chronically implanted LCP and there are limited reports about elective retrieval of LCP. Herein we report our single center experience with chronically implanted LCP retrieval and investigate the factors which contribute to the challenging procedures.

Methods:

The present study included 33 patients with already implanted LCP (Nanostim) device in right ventricular active fixation LCP as a clinical trial conducted at our institution from December 2012 to January 2014. The presence of any serious adverse device effects up to 30 days after the LP extraction was documented.

Result:

This study included 33 patients who were implanted LCP chronically (1570 ± 479 days) and who subsequently received a device retrieval in our institution. The success rate of LP retrieval was 85% (n = 28/33). In 25 patients, new LCP device was implanted immediately right after the previous LCP retrieval. There were no procedure‐­related adverse events at 30 days after retrieval and replacement. By fluoroscopic imaging, we divided the patients with the LCP into 2 groups: those LCP with remarkable swing movement of the docking button part (SM group) and those LCP without swinging movement (No‐­ SM group). Successful LCP retrieval rate was significantly higher in the SM group than the No‐­SM group. (24/24, 100%, vs 4/9, 56%, n < 0.001) In the SM group, the LCPs implanted at the RV apex were significantly observed than the No‐­SM group. (n = 19, 79% vs n = 1, 11%, n = 0.0016)

Conclusion:

This study demonstrated the feasibility and safety of percutaneous retrieval of chronically implanted LCP, which indicates possibility of safe elective replacement to a new LCP. LCP retrieval can be considered as an effective option for the LCP with swinging movement of the docking part and located in right ventricular apex.

AP19‐­01286

Bipolar transseptal pacing reduces left ventricular dyssynchrony compared with unipolar para‐­left bundle branch pacing

Hai Jo Jo, Jonathan Fang, Hung Fat Tse

The University of Hong Kong, Hong Kong

Introduction:

Right ventricular (RV) apical pacing is associated with reduced left ventricular dysfunction. In this regard, electrophysiologists have gained enormous interest in physiological pacing by targeting the conduction system. However, His bundle pacing is often associated with high pacing threshold that requires placement of an extra lead in dependent patients. Recently, researchers have found it feasible to capture the left bundle branch (LBB) transseptally. Positioning of pacing lead at the LBB is largely anatomical as the LBB potential cannot be mapped. In published case series, a LBB potential was only seen in two‐­thirds of the patients. On the other hand, the absence of LBB potential did not appear to affect the pacing electrocardiographic morphologies or the QRS width, suggesting that the LBB could be involved by direct capture or retrograde penetration during unipolar pacing when the distal electrode is positioned near the LBB. The direction of current flow in bipolar pacing differs from that in unipolar pacing. When a pacing lead is screwed into the para‐­LBB region transeptally, a bipolar current flow across the septum may improve capturing of the LBB, and may also capture the right bundle branch (RBB). We hypothesize that bipolar transseptal pacing was associated with increased engagement of the conduction system and thus reduced dyssynchrony than unipolar para‐­LBB pacing. Here, we study the effect of unipolar and bipolar transseptal pacing at different outputs on left ventricular (LV) dyssynchrony by echocardiographic strain analysis.

Methods:

A total of 16 consecutive patients who had a normal LV systolic function and attended our institution in April to June 2019 for symptomatic bradycardia requiring a high rate of RV pacing were recruited. A specialized pacing lead with the distal electrode located at the screw tip was advanced to the proximal or mid septum and screwed in by turning the lead body clockwise until an R’ was seen at V1 during unipolar pacing. One patient who failed to achieve a transseptal pacing after 5 attempts was excluded. The primary endpoint, time‐­to‐­peak‐­strain‐­standard deviation (TPS‐­SD), and secondary endpoint, global longitudinal strain (GLS), were assessed one month after implantation during unipolar and bipolar pacing at threshold, twice threshold, nominal, 5 V and maximum outputs.

Result:

Of the 15 patients [male: 9 (60%), age: 72 ± 16 years] who were included in this study, 7 (47%) had hypertension, 3 (20%) had diabetes and 6 (40%) had coronary artery disease. Complete or advanced secondary degree atrioventricular block were found in 11 (73%) patients. Overall, bipolar pacing was associated with a shorter QRS width than unipolar pacing (126 ± 24 vs. 143 ± 20 milliseconds, P < .01). After adjusted for demographics, comorbidities and indications, bipolar pacing was independently associated with a lower TPS‐­SD (beta = −0.17, t = −2.5, P = .01). TPS‐­SD (beta = 0.76, t = 9.37, P < .01), but bipolar pacing itself, (beta = −0.01, t = −0.03, P = .98), was associated with an improved GLS.

Conclusion:

Bipolar transseptal pacing was associated with reduced LV dyssynchrony, as evidenced by a reduced TPS‐­SD, compared with unipolar para‐­LBB pacing.

AP19‐­01297

Performance of the Micra transcatheter pacemaker in Chinese patients: a comparison to the global experience

Shu Zhang, Keping Chen, Liqun Wu, Xingbin Liu, Yangang Su, Yujie Zhou, Jiangang Zou, Xiaofeng Hou, Jianan Wang, Meixiang Xiang, Chengjun Guo, Xuejun Ren, Shufeng Liu, Fenglin Zhu, Ming Zhang, Kejiang Cao

State Key Laboratory of Cardiovascular Disease, Arrhythmia Center, Fuwai Hospital, National Center f, China

Introduction:

Previous results from the global Micra clinical trials demonstrated a high implant success rate and excellent safety and efficacy. However, whether this performance is consistent in the Chinese population is unknown. We compared the patient characteristics and performance results of the Micra transcatheter pacemaker from the China Micra Transcatheter Pacing Study with those from the global trials.

Methods:

The purpose of the prospective, multi‐­site, single arm China Micra Transcatheter Pacing Study is to confirm the safety and efficacy of the Micra Transcatheter Pacing System for human use in Chinese patients. The primary objective is freedom from system or procedure related major complications through 6 months post‐­implant (with prespecified performance goal of 83%). Patient baseline characteristics, procedural information, and safety and electrical performance through 6 months were summarized and compared with data from the global trials including the Micra Investigational trial and Post Approval Registry. Micra performance after medically‐­indicated MRI scans was also characterized.

Result:

Micra was successfully implanted in 81 (98.8%) of 82 patients recruited from 7 participating centers in China and followed for a mean of 8.7 ± 1.5 months. Chinese patients were smaller, more often female, and less frequently had a primary pacing indication associated with atrial fibrillation compared with Micra patients from the global trials. Through 6‐­months post‐­implant, a total of 2 major complications (arteriovenous fistula and pyrexia, both resolved) occurred in 2 patients, for a major complication free rate of 97.6% (95% CI: 90.6%‐­99.6%), exceeding the prespecified performance goal and meeting the primary endpoint. The major complication rate was in‐­line with previously reported rates from the Micra Investigational trial and Post Approval Registry (2.4% vs. 3.7% and 2.8%, respectively, P = .50; Figure). A total of 14 patients underwent 3T MRI scans, including 9 thoracic, 4 cerebral, and 1 spinal. Electrical performance remained unchanged with mean pre and post MRI pacing thresholds of 0.5 ± 0.1 V. No MRI‐­related device performance issues were observed.

Conclusion:

In the hands of new operators in China, the Micra pacemaker was implanted successfully with a very low complication rate. Although Chinese Micra patients were on average of smaller stature and the majority had a pacing indication not associated with atrial fibrillation, Micra performance was excellent and in‐­line with the global trial experience.

AP19‐­01298

Atrioventricular synchronous pacing using a leadless ventricular pacemaker: Primary results from the MARVEL 2 study

Surinder Kaur Khelae, Larry Chinitz, Christophe Garweg, Joseph Yat Sun Chan, Philippe Ritter, Jens Brock Johansen, Venkata Sagi, Laurence Epstein, Jonathan P. Piccini, Mario Pascual, Lluis Month, Todd Sheldon, Vincent Splett, Kurt Stromberg, Nicole Wood, Clemens Steinwender

Institut Jantung Negara, Malaysia

Introduction:

Leadless pacemakers have only provided single chamber rate responsive pacing; however, most patients are not recommended for VVI pacing alone. Prior proof of concept studies demonstrated that accelerometer‐­based AV synchronous pacing is feasible using a leadless ventricular pacemaker. We report first in human experience of a leadless pacemaker with enhanced accelerometer‐­ based algorithms to provide AV synchronous pacing.

Methods:

The prospective, single‐­arm investigational device exemption download study was designed to assess the safety and efficacy of an accelerometer‐­based atrial sensing algorithm downloaded for up to 5 hours in patients implanted with a Micra leadless pacemaker. The enhanced Micra Atrial tRacking using a Ventricular accELerometer (MARVEL) algorithm uses the Micra device accelerometer to mechanically detect atrial contraction and allows automaticity in programming. In addition, two mode‐­ switching algorithms allow automatic switching to VVI 40 and to rate adaptive pacing. Patients with documented history of AV block and implanted with or expected to be implanted with a Micra device were eligible for inclusion. The primary efficacy objective was to demonstrate the superiority of the MARVEL 2 features to provide AV synchronous pacing relative to Micra VVI pacing in subjects with normal sinus node function and complete heart block at rest. AV synchrony was measured during 20 minutes of rest and during VVI pacing using continuous device telemetry and ECG via Holter. The primary safety objective was to demonstrate that the algorithm did not have episodes of oversensing induced pacing above 100 bpm. The secondary objective was to demonstrate an increase in stroke volume with AV synchronous vs. VVI pacing.

Result:

A total of 75 subjects (age 77.5 ± 11.8 years, 40% female, median time since Micra implant 9.7 months) from 12 centers in Hong Kong, Malaysia, Europe and the United States were enrolled from 22 January 2019 through 14 June 2019 and received a software download of the accelerometer‐­based algorithm to their pre‐­existing leadless pacemakers. Of these enrolled subjects, 25 (33%) were from the Asia Pacific region. Overall, 40 (53.3%) had normal sinus rhythm with complete heart block and were eligible for the primary efficacy objective analysis. The study database will be locked in August 2019, with primary efficacy and safety results available for the AHA presentation.

Conclusion:

The performance of a novel, enhanced algorithm designed to achieve AV synchrony using the accelerometer of a leadless pacemaker implanted in the right ventricle will be reported.