Abstract
Introduction
Restoring physiological cardiac electrical activity in patients with conduction disease can be crucial for the survival and quality of life. Conduction system pacing (CSP) is a valuable option, although it is limited by technical challenges in difficult anatomies. 3D electroanatomical mapping (3D-EAM) can support CSP ensuring high electro-anatomical precision and low fluoroscopy.
Objectives
We evaluated the feasibility and effectiveness of a systematic 3D-EAM use to guide CSP in difficult anatomical scenarios (highly dilated atria, congenital cardiomyopathies, failed biventricular implants (BiV) and pacing-induced cardiomyopathy (PICM)).
Methods
Forty-three consecutive patients (27 males, 75 ± 10 years old) with standard pacing indications and difficult anatomical scenarios were included. The right atrium, His cloud, and atrio-ventricular septum were reconstructed by 3D-EAM. The His bundle (HB) was the initial target, while left bundle branch area pacing (LBBAP) was aimed at in case of unsatisfactory parameters, sub-optimally paced QRS, or impossibility of reaching the HB.
Results
CSP was successful in 37 (86%) patients (15 HBP; 22 LBBAP). Mean mapping, fluoroscopy, and procedural times were 18 ± 7 min, 7 ± 5 min, 98 ± 47 min, respectively. The mean pacing threshold, R wave sensing, and pacing impedance of CSP lead were 1.2 ± 0.5V@0.5ms, 11.4 ± 6.2 mV, 736 ± 306 Ω, respectively. Baseline and paced QRS were 139 ± 38 ms and 114 ± 23 ms, respectively. No procedural complications were observed.
Conclusions
3D-EAM allowed the accurate definition of the His cloud and high ventricular septum and effectively guided CSP. It facilitated CSP in complex anatomies, with a procedural success rate of 86%. The results were satisfactory and reproducible, with acceptable fluoroscopy and procedural times.
1. Introduction
Traditional right ventricular apical (RVA) pacing produces dyssynchronous ventricular activation, which might lead to pacing-induced cardiomyopathy (PICM) in a non-negligible proportion of patients [1], thus increasing the risk of atrial fibrillation (AF), heart failure (HF), and associated death [2]. Conduction system pacing (CSP) can maintain physiological ventricular activation in patients with narrow QRS or restore natural synchronicity in patients with bundle branch block (BBB) [3]. It includes both His bundle pacing (HBP) and the more recent technique of left bundle branch area pacing (LBBAP). A growing body of clinical experience shows that CSP can effectively treat all different conduction disturbances, including infra-hisian atrio-ventricular (AV) blocks, and that it corrects BBB in many cases [[4], [5], [6]]. Moreover, CSP has been indicated as an alternative to biventricular pacing (BiV) [7,8]. While several studies have demonstrated the feasibility and safety of the HBP [6], the LBBAP is a relatively new technique that is able to correct the most distal blocks at the left bundle branch level [9]. Furthermore, LBBAP could potentially overcome some limitations of HBP, such as high capture thresholds, crosstalk, and technical challenges with a relatively long learning curve [10], as it provides optimal pacing and sensing parameters. The main concerns related to the widespread use of CSP are the inability to target the conduction bundle with the lead or the uncertainty regarding long-term lead stability and electrical parameters. These pitfalls can be encountered more frequently in patients with dilated atria and congenital cardiomyopathies where the His bundle can be displaced from the expected position [11]. Another critical condition can occur in the case of PICM or after a failed BiV implant when an upgrade to CSP is planned. The currently available tools are helpful for successfully completing most of the procedures, but developing technologies are expected to easily target CSP in complex anatomies. The 3D electro-anatomic mapping system (3D-EAM) is widely used in the diagnosis and treatment of cardiac arrhythmias. In recent years, it has also been used for positioning and optimizing the placement of the coronary sinus (CS) pacing lead in BiV implants [12]. However, there is still little clinical experience with regard to CSP available [[13], [14], [15]].
The present study aimed to evaluate the feasibility and effectiveness of the systematic utilization of 3D-EAM to guide the lead implant on the conduction system (HBP and LBBAP) in patients with characteristics that allowed to define aspects of anatomical complexity at baseline and expected low probability of success when exclusive fluoroscopic guidance was applied. Left atrium area > 40 cm2, upgrade post-PICM, CSP upgrade after failed BiV implant, and congenital heart disease were regarded as elements of anatomical complexity. Our objective was also to standardize the technique of the 3D-EAM-guided CSP implants. The study was approved by the local ethics committee, and all patients provided written consent.
2. Methods
Patients with standard indications for pacemaker (PM)/defibrillator (ICD) implantation according to the current European Society of Cardiology (ESC) guidelines [16] who presented baseline characteristics of anatomical complexity were selected for a 3D-EAM-guided CSP approach. The anatomical complexity was defined based on preoperative data indicating that the conventional fluoroscopic- and electrograms-guided approach may have been insufficient to successfully guide the lead in the target site. In detail, we included: 1) Left atrium area> 40 cm2 [17], 2) upgrade post-PICM, 3) upgrade post failed BiV implants, and 4) congenital heart disease. The 3D-EAM systems utilized were the EnSite™ Precision Cardiac Mapping System (Abbott, St. Paul, Min, US) and the CARTO® 3 (Biosense Webster Inc.). Patient and procedural data were entered into the “Polesine Registry”, a prospective observational registry that was approved by the local Ethical Board and included all consecutive CSP procedures carried out at Santa Maria della Misericordia General Hospital, Rovigo, Italy since 2018. Baseline characteristics of patients, such as age, gender, and comorbidities, were collected in the registry and are shown in Table 1.
Table 1.
Baseline characteristics of the population. LVEF: left ventricular ejection fraction; PICM: pacing-induced cardiomyopathy; CS: coronary sinus.
| Baseline Characteristics | |
|---|---|
| Number of patients | 43 |
| Age (years), mean ± SD | 75 ± 10 |
| Male gender, n (%) | 27 (62.7%) |
| Hypertension, n (%) | 31 (72.0%) |
| Diabetes, n (%) | 16 (37.2%) |
| Ischemic cardiomyopathy, n (%) | 24 (55.8%) |
| Severe chronic kidney disease, n (%) | 6 (13.9%) |
| Baseline LVEF (%), mean ± SD | 38 ± 16% |
| Baseline QRS (ms), mean ± SD | 139 ± 38 |
| Bundle branch block, n (%) | 25 (58.1%) |
| Anatomical complexity characteristics | |
| Dilated atria, n (%) | 17 (39.5%) |
| Upgrade post PICM, n (%) | 10 (23.2%) |
| Upgrade post CS lead implant failure, n (%) | 14 (32.5%) |
| Congenital cardiac disease, n (%) | 2 (4.6%) |
2.1. Implant procedure
The procedure protocol was systematically applied as follows and illustrated in Fig. 1, Panels A–F:
Step 1: Anatomical reconstruction.
Fig. 1.
3D-EAM implant procedure step-by-step. Panel A shows the left anterior oblique view and Panel B shows the right anterior oblique view of the right atrium reconstructed by the mapping catheter. The mapping catheter is connected to both the mapping system and the EP recording system. Red traces in Panels A and B show the electrical signals visualized on the 3D-EAM. "His cloud" is the map of the entire HB potentials recorded. Panels C, D, E: 12-lead ECG together with the electrical signals recorder from the decapolar mapping catheter as visualized in the EP recording system. Based on the A:V ratio and the HV interval, the proximal, medium, and distal parts of the His Bundle were distinguished and different colors in the His cloud were assigned correspondingly. Panel F: 12-lead ECG and “ENDO” signals, which is the unipolar signals recorded from the tip of the pacing lead positioned on the His cloud. The lead is also visualized in Panels A and B as the green tip and the terminal part of the catheter. Panel G: the pacing maneuvers at implant. Starting from high voltage (5V@0.5ms), the output is decreased until the loss of capture (1.1V@0.5 ms) is reached. At 1.3V@0.5 ms corresponds to QRS-paced morphology change, which identify non-selective His Bundle capture. Baseline QRS duration is 108 ms, paced QRS during non-selective HBP is 110 ms. CS: coronary sinus; SVC: superior vena cava; IVC: inferior vena cava; TV: tricuspid annulus. A: atrial signal; H: His signal; V: ventricular signal.
Venous accesses are gained mainly by puncture of the axillary vein. A decapolar mapping catheter is connected to both the mapping system and the EP recording system and is advanced into the heart to reconstruct the right atrium anatomy without fluoroscopy. The CS, the superior vena cava (SVC), the inferior vena cava (IVC), and the tricuspid annulus are always depicted. The high right ventricular septum is also traced.
Step 2: His cloud characterization.
The decapolar lead is then directed to the AV junction and a detailed map of the HB potentials is acquired: one tag point is placed into the map every time an His potential is recorded on the decapolar lead (Fig. 1, Panel A–E). The total area of the drawn tags constitutes the His cloud. Different colors were arbitrarily assigned to distinguish proximal His, medium His, or distal His based on the A:V ratio and HV interval (Fig. 2, Panel A-B). The hypothetic target site for LBBAP is also tagged, 1–2 cm from the distal His region along the RV septum, allowing it to easily shift to LBBAP in case of suboptimal results with HBP.
Step 3: Lead positioning in His cloud.
Fig. 2.
The His cloud is represented by multiple tags in different colors to distinguish His proximal, His medium, and His distal based on the HV duration and the A:V ratio of the recorded electrical signals. Panel A is the left anterior oblique view, and panel B is the right anterior oblique view of the anatomical reconstruction of the right atrium. The yellow tags correspond to His proximal, where the HV interval is measured at 101 ms. Green tags correspond to His distal, where HV interval is measured at 64 ms.
The mapping catheter is then removed and the system, including the sheath and the lead inside, is inserted through the same point of access. Fluoroscopy was used only in case of resistance while advancing the system into the venous axis. In the present study, all the currently available delivery sheaths specifically designed for CSP were utilized, and both lumenless and stylet-driven leads were implanted (Table 2). The pacing lead was connected to the 3D-EAM by means of cables with alligator clips in unipolar configuration (with the black clip connected to the tip of the pacing lead and the red clip to the patient's skin). Direct connection to the 3D-EAM allowed real-time visualization, navigation, mapping, and pacing from the pacing lead without fluoroscopy (Fig. 1, panel F). The delivery of the system (sheath and lead inside) toward the RV is performed under continuous 3D-EAM monitoring (with the tip of the lead slightly out of the sheath) so that the lead can be visualized. When the Agilis HisPro™ (Abbott, St. Paul, Min, US) sheath is used, the tip of the lead can remain inside the sheath since the outer electrodes guide the navigation. The lead is directed to the His cloud and preferentially targets distal sites. The lead is screwed in accordance with the specifications of the different manufacturers. The sheath is retracted by 3 or 4 cm to allow electrical/stability tests. Furthermore, the pacing maneuvers are performed in unipolar fashion under 12-lead ECG monitoring starting at a high voltage (5V@0,5 ms), decreasing output until morphology changes and/or loss of capture (Fig. 1, panel G). All the changes in QRS morphology, His and RV pacing thresholds, and BBB correction thresholds are stored and evaluated for the final site confirmation and the programming of the device. Measurements for lead impedance and sensing are also performed. A HBP threshold of less than 1,5V@0,5 ms in narrow QRS or less than 2V@0,5 ms to correct BBB are accepted. When the electrical parameters are stable and satisfactory, the sheath is cut under fluoroscopic control. In the case of unacceptable pacing results or non-satisfactory QRS morphology, the lead is unscrewed, and a different position is tested. The 3D-EAM also allows to trace a detailed map of all tested lead positions.
Step 4: Lead positioning in the left bundle branch area.
Table 2.
Procedural data. CSP: conduction system pacing; SR: single chamber device; DR: dual chamber device; TRI: triple chamber device. 3D-EAM: 3D-electroanatomical mapping.
| Procedural data | |
|---|---|
| Mapping time (min), mean ± SD | 18 ± 7 |
| Procedural time (min), mean ± SD | 98 ± 47 |
| Fluoroscopy time (min), mean ± SD | 7 ± 5 |
| CSP successful implant, n (%) | 37 (86%) |
| failure implant, n (%) | 6 (14%) |
| Procedural complications, n (%) | 0 (0%) |
| Device | |
| PM | 25 (58%) |
| ICD | 18 (42%) |
| Device | |
| SR | 1 (2.3%) |
| DR | 18 (41.9%) |
| TRI | 24 (55.8%) |
| Lead | |
| Lumenless lead | 30 (70%) |
| Stylet-driven lead | 13 (30%) |
| Sheath | |
| C315 Medtronic | 28 (65.1%) |
| Selectra 3D Biotronik | 9 (21%) |
| AgilisHisPRO Abbott | 4 (9.3%) |
| SSPC Boston Scientific | 2 (4.6%) |
| 3D-EAM | |
| CARTO, n (%) | 7 (16%) |
| NAvX, n (%) | 36 (84%) |
To pace the LBB area, the lead is moved toward the septum to the previously tagged site. Paced QRS morphology is tested before screwing the lead, looking for “W” morphology or negative QRS in V1. 3D-EAM allows real-time visualization of the lead while it penetrates the septum (supplementary video 1). Shifting the connection from unipolar to bipolar, the whole dipole of the lead is visible so that the perpendicular orientation to the septum can be better evaluated. 3D-EAM also allows measurement of the distance from the HB cloud and the length of the penetrating part of the lead into the septum.
The sheath's cutting and adequate lead slack are provided under minimal fluoroscopy. Atrial leads and high-voltage leads are implanted when required, with use of minimal fluoroscopy.
3. Statistical analysis
Descriptive statistics of clinical and instrumental parameters are reported as the mean and standard deviation or number and percentage for continuous variables and categorical variables, respectively.
4. Results
Forty-three patients (27 males, mean age 75 ± 10 years) were included in the study. Baseline characteristics of patients and procedural data are shown in Table 1. Thirteen patients (30%) had previously failed BiV implants or PICM that had been referred by other centers for CSP upgrade. The lead was successfully implanted in the His bundle in 15 patients. In 22 cases, HBP was suboptimal despite multiple attempts at different sites (mean tested HB positions 4 ± 2 per patient), and the lead was then effectively implanted to LBBAP. In the remaining 6 cases, CSP failed, and the lead was eventually implanted in the CS (4 patients) or in the mid-septum (2 patients).
The reasons for failure were: 1) Unacceptably high CSP threshold in two cases; 2) Failure to penetrate the septum in one case; 3) Wide paced QRS without evidence of CSP capture in three patients.
The exposed fixed screw 3830 lead was implanted in 20 patients, and standard stylet-driven leads were implanted in 23 patients. In 16 (37%) procedures, multiple delivery sheaths were used, and in 4 (9%) cases, the pacing lead was changed intraoperatively. Twenty-three and twenty patients, respectively, were implanted with PM and ICD (1/18/24 single/dual/three-chamber devices). No acute procedure-related complications were reported. The CARTO® 3 (Biosense Webster Inc.) system was used in 7 patients and EnSite™ Precision Cardiac Mapping System (Abbott, St. Paul, Min, US) in 36 patients. The mapping time required for the 3D-EAM reconstruction of the right atrium, His cloud, and the septal area was 18 ± 7 min. The procedure time was 98 ± 47 min and fluoroscopy time 7 ± 5 min. The mean threshold of the CSP lead was 1.2 ± 0.5 V@0.5ms, sensing 11.4 ± 6.2 mV and impedance 736 ± 306 Ω. The baseline and paced QRS were 139 ± 38 ms and 114 ± 23 ms, respectively. Post-operative chest X-ray revealed a stable lead position in all cases. The electrical parameters were checked after 24 h and pre-discharge, and these parameters turned out to be stable.
5. Discussion
In our study, CSP implants in difficult cardiac anatomies were successful in 86% of cases when guided by 3D-EAM. Conventionally, CSP is guided by unipolar electrograms (EGM) recorded from the tip of the lead combined with fluoroscopic images. Highly dilated atria and congenital heart disease are difficult scenarios where the HB can be displaced from the expected position [11], leading to a prolonged fluoroscopic and procedural time. Device upgrade in the case of PICM or after previously failed CS lead implants were also considered difficult scenarios. BiV implants are typically more challenging when compared to dual-chamber devices because of interpatient variation in CS and venous branches, which are often associated with lower procedural success rate, longer procedure times, and higher complications rate [[18], [19], [20]]. As a tertiary center, we receive from other Hospitals failed BiV implants or PICM with a CSP upgrade indication. In fact, the present study population includes 13 (30%) patients referred from other centers. In complex anatomical scenarios, the standard tools may not be sufficient for guiding the lead to the conduction system, potentially requiring long radiation exposure for patients and operators. The 3D-EAM clearly shows the target sites and provides highly detailed information on the HB anatomy combined with the local activation patterns. Thus, 3D-EAM could reduce fluoroscopy and procedural times. Preliminary studies documented the feasibility and safety of 3D-EAM-guided procedures with a significant reduction in fluoroscopy exposure [15]. 3D-EAM enables exploration of the CS and its collateral branches, detecting local activation time and electrical delay from QRS onset, to find the best position for the LV lead and to increase the probability of response in CRT, thus avoiding medium contrast and reducing fluoroscopy time [12; [12], [21], [22]]. In the experience reported by Huang et al., 3D-EAM guided BiV implants resulted in 86% reduction in fluoroscopy time (5.47 ± 2.1 min vs. 37.2 ± 15.4 min; P = 0.00003) compared to conventional fluoroscopic approach with no significant difference in total procedure time [23]. The 3D-EAM can help to mitigate the anatomical difficulties encountered in patients with congenital heart disease where the relationship of anatomical structure can be hard to interpret. Cano et al. described 75% of successful CSP procedures in congenital heart disease in a multicenter experience, but prolonged procedure and fluoroscopy times (126 ± 82 min and 27 ± 30 min respectively) were required [11]. In our experience, the procedural success rate was 86%. The limited procedure and fluoroscopy time underscores the additional benefit of 3D-EAM, together with the use of different tools now available. Compared to previous experiences, the availability of dedicated sheaths and different leads, lumenless or stylet driven, has increased the probability of implants being successful, allowing CSP to be tailored on a case-by-case basis. 3D-EAM can be utilized to easily visualize the HB cloud and the high septum, predetermining potential target sites to deploy the lead. In our experience, 3D-EAM allowed reproducible lead navigation in the conduction system in challenging anatomical scenarios otherwise difficult to manage without prolonged radiation exposure. The electroanatomical map of the conduction system area allowed intraoperative decisions to shift from HBP to LBBAP when suboptimal results were obtained. Sharma et al. also reported lower HBP capture thresholds for EAM-guided HBP compared with conventional fluoroscopic implantation based on a more detailed HB map [15]. Furthermore, Orlov et al. showed that pacing could determine the presence of potential target sites with selective and non-selective HB capture while mapping the His from a diagnostic catheter [13]. Over recent years, multiple case reports on 3D-EAM utilization to guide CSP have been reported with positive results, even in centers with little experience. The 3D-EAM was utilized in different ways and for various functions. Recently, Bastian et al. [24] evaluated the performance of the surface lead morphology match algorithm on the EnSite AutoMap Module (Abbott, St. Paul, Min, US) for automated classification of the pacing response (S-HBP; NS-HBP; myocardial right ventricular stimulation) in patients with narrow QRS undergoing 3D-EAM-guided HBP. The accuracy of the His site can also be checked by evaluating the pace score mapping between the intrinsic ventricular QRS and the paced QRS at a low output. A score map was performed to track the percentage of similarity of the paced QRS morphology to the basal one in the 12-leads in all the different locations of the Hisian region. Pacemapping was performed to define the locations with successful HB capture and QRS narrowing in patients with baseline bundle branch block. Finally, the 3D-EAM allows a detailed map of all tested lead positions to be traced, avoiding repeated unsuccessful attempts in the same position, thus saving procedural and fluoroscopy time [25].
6. Limitations
This is a non-randomized single-center study presenting the experience from a limited case series. The increased cost of the electroanatomic mapping-guided procedure must be weighed against its benefits. However, the reduction in X-ray exposure in difficult procedures can justify this approach. The potential benefits of minimizing procedure and fluoroscopy times during the learning curve are confirmed by Imnadze et al. using His voltage mapping to guide lead positioning [26]. In addition, 3D-EAM allows for a better understanding of the individual anatomy that may be crucial in challenging cases.
7. Conclusions
A 3D-EAM-guided approach for CSP device implantation can be a feasible option in patients with complex anatomical scenarios. In our experience, 3D-EAM provided a number of additional benefits during CSP implants: it ensured the precise localization of the target for CSP lead and helped in lead position optimization in difficult anatomies; it allowed low fluoroscopy time exposure for patients and operators, and it avoided repeated attempts in the same unsuccessful position. These benefits can reasonably balance out the additional costs for selected patients.
Conflicts of interest
Dr. Zanon has some conflicts of interest, having received modest speaker fees from Boston Scientific, Medtronic, Abbott, and Biotronik. The other authors report no disclosures.
Footnotes
Peer review under responsibility of Indian Heart Rhythm Society.
Supplementary data to this article can be found online at https://doi.org/10.1016/j.ipej.2023.08.006.
Appendix A. Supplementary data
The following is the Supplementary data to this article:
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