Transvenous lead extraction outcomes using a novel hand-powered bidirectional rotational sheath as a first-line extraction tool in a low-volume centre

Abstract

OBJECTIVES

Extraction of cardiovascular implantable electronic devices in low-volume medical centres with limited clinical experience and an evolving lead extraction programme may be challenging. We aimed to evaluate the safety and efficacy of stepwise transvenous lead extraction (TLE) using a novel type of hand-powered rotational sheath as a first-line tool for extraction of chronically implanted devices in a single, low-volume centre.

METHODS

Sixty-seven consecutive patients undergoing a TLE procedure using the novel Evolution^® RL rotational sheath as the first-line extraction tool between 2015 and 2019 at our institution were enrolled in the study. Their short-term and 30-day outcomes were observed.

RESULTS

Sixty-nine devices and 131 leads were explanted. Procedural and clinical success rates were 92.4% and 98.5%, respectively. Two procedures were classified as failures due to lead remnants >4 cm remaining in patients’ vascular systems. One major (1.5%) and 3 minor (4.4%) adverse events and no deaths were observed.

CONCLUSIONS

TLE procedures, performed in a stepwise manner, using the Evolution RL sheath as a first-line extraction device and conducted by an experienced, surgically well-trained operator, offer excellent results with clinical and procedural success rates comparable to those, achieved in dedicated, high-volume institutions. Opting for optimal lead extraction approach in low-volume centres or institutions with evolving TLE programmes, a stepwise extraction strategy using the Evolution RL sheath by skilled operator may provide the optimal scheme with an excellent ratio between clinical and/or procedural success and complications.

Expanded indications for implantable cardioverter defibrillator (ICD), cardiac resynchronization and permanent pacemaker (PM) therapy over the last 2 decades have led to a significant increase in the use of cardiovascular implantable electronic devices (CIEDs) and, consequently, to a likewise increment in the frequency of CIED-related complications, such as device or lead infections, malfunctions or recalls [1].

INTRODUCTION

Expanded indications for implantable cardioverter defibrillator (ICD), cardiac resynchronization and permanent pacemaker (PM) therapy over the last 2 decades have led to a significant increase in the use of cardiovascular implantable electronic devices (CIEDs) and, consequently, to a likewise increment in the frequency of CIED-related complications, such as device or lead infections, malfunctions or recalls [1]. Because a meaningful percentage of CIED-related adverse events demand complete removal of the system from the body, the requirements for CIED extraction have grown significantly in the last 10 years, becoming today one of the most decisive segments in CIED-related care of affected cardiac patients [1, 2].

Although several different extraction strategies, including simple traction, open heart surgery and transvenous lead extraction (TLE) techniques have evolved, TLE currently represents the cornerstone of CIED extraction, providing a complete, safe and highly effective minimally invasive mode of electronic system removal, especially in the hands of experienced and dedicated health care teams [3–5]. Diverse tools, ranging from mechanical dilator sheaths and femoral snares to powered traction tools such as laser sheaths or hand-powered rotational threaded tip sheaths, are available to clinicians, intended primarily for the extraction of chronically implanted CIEDs [3–5]. Evidence indicates that many different extraction devices are ideally synergistically combined to achieve optimal procedure-related outcomes as practiced in dedicated, high-volume centres with well-established TLE programmes and adequate reimbursement of relatively high procedure-related expenses [3–8]. However, in medium- or low-volume centres with evolving TLE programmes, limited clinical experience and restricted finances the rational choice of the best-suited management strategy with utilization of a single device set must often be made in order to optimize results and reduce medical costs [1, 5, 6].

Yet, which of the currently available device sets provides superior results in terms of the optimal ratio between clinical and/or procedural success and TLE-related complications in low-volume centres and institutions with limited experience with TLE remains inconclusive [3–6]. Our goal was to evaluate the safety and efficacy of a stepwise TLE strategy using a novel type of hand-powered bidirectional rotational sheath as a first-line tool for extraction of chronically implanted devices in a single, low-volume centre.

PATIENTS AND METHODS

Study population

Our retrospective observational study comprised 67 consecutive patients undergoing TLE procedures using a short and/or long version of the second-generation hand-powered bidirectional rotational lead extraction sheath Evolution^® Shortie RL and/or Evolution RL Controlled-rotation dilator sheath set (Cook Medical, Bloomington, IN, USA) as the first-line extraction tool at the University Medical Centre, Ljubljana, Slovenia between January 2015 and December 2019. Indications for TLE were a CIED pocket and/or lead infection, left- or right-sided endocarditis, lead malfunction or CIED system up-grade or any other clinical condition demanding extraction of the system. Patients whose leads were not extracted using a hand-powered lead extraction set (simple traction before or after locking stylet implantation) and patients with large (>3 cm) lead vegetations were excluded from the trial. Study protocol was approved by the national medical ethics committee (0120-251/2020). Due to the retrospective nature of the study, informed consent was waived. The study protocol confirmed with the 1975 Declaration of Helsinki and complied with the principles of Good Clinical Practice guidelines.

Lead extraction strategy

All procedures were performed in an operating theatre by a dedicated, experienced cardiovascular surgeon, under general anaesthesia with invasive patient monitorization, continuous transoesophageal echocardiographic surveillance and with utilization of high-quality fluoroscopy for good visualization of implanted leads and proper evaluation of Evolution RL sheath set advancement.

Each TLE procedure was performed in a stepwise approach: first, the pulse generator pocket was opened, and the leads were dissected free from the scar tissue in the pocket. Next, the lead’s suture collar was removed; if present, the active fixation helix was retracted. Then, gentle manual traction was applied to all leads in order to remove those that were not adherent to endovascular or endocardial structures. When such ‘unsupported’ lead traction was unsuccessful, the lead was transected; the Liberator^® Beacon^® Tip locking stylet (Cook Medical) advanced into the electrode’s coil and locked at the tip of the electrode. Additionally, a One-Tie^® Compression Coil (Cook Medical) was used with each locking stylet to bind the proximal end of the electrode to the locking stylet itself. Next, more forceful manual traction of such a ‘supported’ lead was performed to potentially extract all leads with moderate adhesions to endovascular and endocardial structures. When this manoeuver was unsuccessful, the Evolution Shortie RL dilator sheath was used to overcome strong fibrotic or calcified tissue in the subclavicular region and to gain access to the subclavian vein and Evolution RL dilator sheath to further dissect strong adhesions in the superior vena cava, right atrium and right ventricle. The utilization of either a short or a long Evolution dilator sheath or even both during a TLE procedure was left to operator’s discretion. Free-floating leads and remnants after extraction or previous CIED-related procedures were snared with a Needle’s Eye^® Snare (Cook Medical) to secure a successful TLE via the right femoral vein. In leads demanding extension before extraction, a Bulldog™ lead extender (Cook Medical) was used. In pacing-dependent patients with CIED infection, a temporary epicardial pacing wire through a subxyphoid approach was implanted prior to TLE. In pacing-dependent patients without CIED infection, a new endocardial lead through the subclavian vein on the ipsilateral site was implanted prior to TLE.

Data collection, patient follow-up and definitions

Patient data and baseline clinical characteristics as well as basic CIED-related data (i.e. date of implantation, type of device, number of implanted leads, reason for system extraction) were obtained at the time of hospital admission for TLE. During the operation, procedural details (i.e. procedural success, clinical success, procedural failure, major and minor complications) were recorded. After the procedure, all patients were monitored in the intensive care unit for procedure-related complications for at least 6 h, and later on the hospital ward for at least 48 h. Finally, any late complication and 30-day survival data were obtained at the scheduled follow-up 1 month after the procedure. All data were collected by a dedicated medical professional and supervised by a TLE team leader.

The effectiveness of TLE was divided into 3 categories according to the current consensus of the Heart Rhythm Society and the European Heart Rhythm Association: procedural success, clinical success and procedural failure [1, 2]. Procedural success was defined as removal of all targeted leads and all lead material from the vascular space without permanently disabling complications or procedural-related death. Clinical success was defined as the removal of all targeted leads and lead material from the vascular space or the retention of small lead remnants (<4 cm) that did not negatively impact the clinical outcome of the procedure. Procedural failure was defined as the inability to achieve either complete procedural or clinical success, the development of any permanently disabling adverse event or procedure-related death. For each removed lead, efficacy was determined as complete or incomplete lead removal. Complete lead removal was defined as lead extraction with removal of all targeted lead parts and material; incomplete removal was defined as extraction where a part of the lead remained in the patient’s vascular or extravascular space. A major complication was defined as any outcome related to the procedure that created a life-threatening situation and required immediate medical/surgical intervention or resulted in procedure-related death. A minor complication was defined as any undesired procedure-related event that required minor medical/surgical intervention and did not persistently and significantly limit the patient’s function or threaten life or cause death.

Statistical analyses

Data analysis was performed using IBM SPSS Statistics for Windows, version 22.0 (IBM Corp., Armonk, NY, USA). Baseline characteristics are expressed as mean ± standard deviation for normally distributed, as median (interquartile range) for non-normally distributed continuous variables and as frequency (percentage) for categorical variables. Between-group differences were appraised by a t-test for normally distributed variables and by the Mann–Whitney U-test for non-normally distributed variables, and proportions were compared using the χ² test. To provide clinically intuitive associations between implanted lead characteristics and lead extraction failure, odds ratios (ORs) with respective 95% confidence intervals (95% CIs) for prediction of lead extraction failure were derived using univariable binary logistic regression model with lead extraction failure as the dependent outcome, and dwell time, previous injury to the lead, defibrillator lead and passive fixation, respectively, as predictors. Two-tailed P-values ≤0.050 were considered statistically significant.

RESULTS

Patients

From 2015 to 2019, 67 patients with a total of 69 pulse generators and 137 implanted leads underwent TLE with the short and/or long version of the new generation bidirectional Evolution RL sheath set as a first-line tool for extraction of chronically implanted CIEDs in our centre, with a total of 69 pulse generators and 131 leads extracted. Patient basic demographic data and implanted CIED characteristics are detailed in Table 1.

Table 1:

Basic patient (n = 67) and implanted CIED characteristics (n = 69)

Age at implantation (years)	56.1 ± 19.4
Age at explantation (years)	61.9 ± 19.4
Male gender	50 (75)
Implanted CIED typea
PM	49 (71)
ICD	15 (22)
CRT	5 (7)
Number of implanted leads	137
Number of implanted leads per patient
1	17 (25)
2	34 (51)
3	13 (19.5)
4	2 (3)
5	1 (1.5)
Number of implanted leads per patient, mean ± SD (range)	2.04 ± 0.84 (1–5)
Type of implanted lead
Atrial	52 (38)
Ventricular	65 (47)
Defibrillator	16 (12)
Coronary sinus	4 (3)
LE indication
Pocket infection	29 (43.5)
Endocarditis	17 (25.5)
Malfunction	19 (28)
System upgrade	1 (1.5)
Other	1 (1.5)
Number of patients requiring new CIED following LE	64 (95)

Values are presented as mean ± SD, median (IQR) or n (%).

^aOne patient had PM and CRT implanted and 1 patient had PM and ICD implanted.

CIED: cardiovascular implantable electronic device; CRT: cardiac resynchronization therapy; ICD: implantable cardioverter defibrillator; IQR: interquartile range; LE: lead extraction; PM: pacemaker; SD: standard deviation.

The average age of the patients in our cohort was 61.9 years. Our subjects were predominantly men. The extracted device system was predominantly a PM (71%), followed by an ICD (22%) and a cardiac resynchronization device (7%). One patient in our study group had both a PM and a cardiac resynchronization device implanted concomitantly, and 1 patient a PM and an ICD device; thus, a total of 69 devices were extracted during the study. The mean number of implanted leads was 2.04 per patient, and the majority of subjects (52%) had 2 implanted leads. Only 1 patient had 5 implanted leads in his cardiovascular system. The most frequent indication for TLE was CIED pocket infection (43.5%), followed by system malfunction (28%) and endocarditis (25.5%). Sixty-four patients (95%) required new CIED implants following TLE.

Lead extraction

During the study, a total of 131 leads were extracted using the Evolution sheath set, whereas the remaining 6 leads functioned normally and were uninfected; therefore, they did not need to be extracted and were left intact and further used for patient treatment (Table 2). The mean number of extracted leads was 1.96 with a mean dwell time of 6.25 years, ranging from 1 to 18 years (Table 2). The majority (60%) of extracted leads were implanted in the right ventricle; 80% of these were simple sense-pace leads and the remaining 20% were defibrillator leads. All 16 extracted defibrillator leads were dual coil, and only 25% of them had active fixation. In fact, only 10% of all extracted leads in our cohort of patients were active fixation leads.

Table 2:

Characteristics of leads extracted using our stepwise lead extraction strategy using the new hand-powered bidirectional dilator sheath set

Numbers of extracted leads	131
Mean number of extracted leads per patient, mean ± SD (range)	1.96 ± 0.73 (1–4)
Number of extracted leads per patient
1	18 (27)
2	35 (52)
3	13 (19.5)
4	1 (1.5)
Mean dwell time of extracted leads (years), mean ± SD (range)	6.25 ± 4.13 (1–18)
Distribution of extracted leads dwell time (years)
<2	19 (14.5)
3–4	24 (18)
5–6	45 (34.5)
7–8	17 (13)
9–10	9 (7)
>10	17 (13)
Extracted lead type
Atrial	49 (37.5)
Ventricular	63 (48)
Defibrillator	16 (12)
Coronary sinus	3 (2.5)
Extracted leads fixation type
Active	13 (10)
Passive	118 (90)
Remnants demanding snare extraction	6 (4.6)
Procedural success per lead/per patient	121 (92.4)/58 (86.6)
Clinical success per lead/per patient	129 (98.5)/65 (97)
Procedural failurea per lead/per patient	2 (1.5)/2 (3)
Minor complications	3 (4.4)
Major complications	1 (1.5)
Number of deaths	0

Values are presented as mean ± SD or n (%).

^a>4 cm lead remnant.

SD: standard deviation.

Overall, we completely extracted 121 leads (92.4%), which represents the procedural success rate of our study. Of these, 6 leads (4.9%) required the use of an additional femoral snare for complete extraction. During the TLE of 8 leads (6.2%), we were unable to extract short lead remnants (fragments <4 cm: 3 atrial, 4 ventricular and 1 coronary sinus lead tips). However, since the retention of these small lead remnants did not negatively impact the outcome of the procedure, the calculated clinical success rate in our study was 98.5%.

In 2 subjects, longer remnants (fragments >4 cm) of 2 ventricular leads remained in the vascular system after utilization of the Evolution sheath set and the Needle’s Eye^® femoral snare, which was considered a procedural and clinical failure. The leads of both patients were damaged during previous CIED-related surgical procedures performed before 2015, when TLE procedures were not routinely performed at our institution. Thus, the extraction with the Evolution sheath set was effective until we reached the tear point in previously damaged leads. Unfortunately, the lead remnants, although being >4 cm in length, were too short to be extracted with the Needle’s Eye femoral snare.

A total of 4 adverse events (5.9%) occurred in 67 patients. Of these, 3 were minor adverse events (4.4%) that included worsening tricuspid valve regurgitation from none to mild regurgitation not necessitating any further treatment in 1 patient and subclavian vein thrombosis with arm swelling in 2 subjects treated with anticoagulation therapy for 3 months. The 1 major complication (1.5%) was observed in a patient with an ICD in whom 2 ventricular defibrillator electrodes implanted for >10 years caused moderate tricuspid valve regurgitation that worsened to severe after traumatic septal leaflet detachment occurred during an otherwise uneventful TLE, necessitating surgical valve replacement within 14 days after the CIED extraction. There were no patient deaths in our cohort.

It is worth mentioning that an analysis of a subgroup of patients with any lead remnants (fragments <4 and >4 cm) after TLE showed that these individuals had a significantly longer mean dwell time (P = 0.01) and a higher rate of previous injury to the lead (P < 0.001) as compared to individuals with no remnants after TLE (Table 3). Focusing our research question on lead characteristics (which are clinically independent of, and therefore assumably uncorrelated to, patient-specific characteristics), we built a univariable binary logistic regression model to provide associations between TLE failure and preselected lead characteristics (i.e. dwell time, previous injury to the lead, defibrillator lead and passive fixation). In this model, dwell time (OR 1.246, 95% CI 1.090–1.424; P < 0.001) and previous injury to the lead (OR 65.1, 95% CI 11.6–366.4; P < 0.001), but not defibrillator lead (OR 0.785, 95% CI 0.093–6.644; P = 824) or passive fixation (OR N/A, P = 0.999), have been proven to be univariable predictors of TLE failure.

Table 3:

Selected patient and lead characteristics in groups of patients with and without lead remnants after extraction of CIEDs

	No remnants after CIED extraction (n = 121)	Remnants after CIED extraction (n = 10)	P-value
Age at implantation	56.2 ± 19.7	48.5 ± 18.6	0.24
Leads implanted in women	32 (26)	2 (20)	0.49
Defibrillator lead	15 (12.4)	1 (10)	0.62
Passive fixation	108 (89)	10 (100)	0.27
Dwell time	5.9 ± 3.8	10.8 ± 4.6	0.010
Previous injury to the lead	7 (5.8)	8 (80)	<0.001

Values are presented as mean ± SD or n (%).

CIED: cardiovascular implantable electronic devices; SD: standard deviation.

DISCUSION

The main finding of our low-volume centre study is that TLE procedures, performed in a stepwise manner, using a second-generation Evolution extraction sheath as a first-line extraction device, and conducted by an experienced and surgically well-trained operator, offer excellent results with clinical and procedural success rates comparable to those achieved in dedicated, high-volume institutions.

TLE is currently considered the first-line surgical strategy for management of CIED-related adverse events in the majority of patients with chronically implanted devices, regardless of the aetiology of the adverse events or the level of evidence for the extraction of the electronic system [3–5]. Several different technical solutions, ranging from mechanical dilator sheaths and femoral snares to powered traction tools including laser sheaths, hand-powered rotational threaded tip sheaths and electrosurgical dissection sheaths, are available nowadays. Accumulated evidence indicates that, in dedicated, high-volume centres with well-established TLE programmes and effective reimbursement of the relatively high procedure-related expenses, many different extraction devices are combined synergistically to achieve optimal procedure-related outcomes [7–11]. However, in low-volume centres or institutions with evolving TLE programmes, the rational choice for a management strategy based on a single device set must often be made in order to optimize results, to shorten the operator’s learning curve by enabling him or her to comfortably master 1 device set, to assure sufficient experience with device properties for the remaining surgical personnel and to optimize medical costs [2, 4, 6]. Thus, for practicing clinicians in these institutions, the fundamental question remains which of the currently available device sets has the ability to provide supreme results in terms of an optimal ratio between clinical or procedural success and TLE-related complications and could thus serve as an optimal first-line tool for CIED extractions in their clinical practice [3].

In recent years, Evolution RL, a novel type of hand-powered rotational sheath that enables bidirectional rotation, possesses a newly designed and less traumatic sheath tip and exists in 2 different lengths (with the short version also being stiffer), has been introduced [12, 13]. Promising results regarding device safety and efficacy have been recently reported by dedicated, high-volume centres [14–16]. However, whether this tool has the potential to provide superior results as a first-line device also in low-volume centres remained unanswered [3, 6].

In our study, a short and/or a long version of the Evolution RL sheath were used in a stepwise strategy in all patients, enabling us to superiorly address 3 major principles during every TLE performed: dissection of dense fibrotic or calcific adhesions in the subclavicular region with a shorter and stiffer variation of the Evolution extraction device (known as Evolution Shortie RL), control of the lead body throughout the procedure by avoiding the ‘lead wrapping’ phenomenon due to bidirectional rotation of both the short and the long variation of the Evolution sheath and provision of countertraction at the tip of the lead when reaching the myocardial wall with the device. By following a stepwise strategy using the novel Evolution sheath in our study, we achieved a procedural success rate of 92.4%, a clinical success rate of 98.5%, an overall adverse event rate of 5.9% and 0% mortality rate, all of which are in line with previously reported excellent results with the novel Evolution sheath used in dedicated, highly experienced high-volume centres. The remarkably consistent findings in the low- and the high-volume series indicate that the device not only possesses technically favourable properties but also enables skilled handling after a short learning curve and after performing only a limited number of procedures. The finding that an extraction device can provide superb results in both low- and high-volume settings is of utmost importance mainly for the health care teams performing TLEs in institutions with evolving programmes and limited extraction experience, since several other devices so far have failed to provide comparable results in such settings due to difficult handling and extremely long learning curves [6, 9, 17].

Furthermore, by consistently achieving superior results throughout our study in various clinical scenarios, ranging from endocarditis with small- and medium-scale vegetations to passive dual coil defibrillator leads with extremely long dwell times, we can reasonably speculate that the safety and efficacy of our TLE strategy using the novel Evolution sheath as a first-line device is not limited by diverse clinical and technical settings met in everyday clinical practice. In our opinion this finding represents another proof of the versatile potential of the new Evolution sheath, making it an extremely appealing tool for use in institutions that must choose a management strategy based on a single optimally selected device set [3, 6].

Because TLEs were not routinely performed at our institution before 2015, many patients in our cohort have had their leads transected at the level of entry into the subclavian vein (leaving virtually no visible lead remnant in the device pocket, necessitating more extensive dissection of scar tissue in the subclavicular region to access the free end of the lead during TLE) or damaged along the body of the lead (due to forceful traction during the previous CIED-related surgical procedure), making TLE in such settings significantly more challenging and technically more demanding. However, our procedural success rate of 92.4% indicates that our stepwise TLE strategy using the novel Evolution sheath enables effective system extraction even under such complicated and precarious conditions, which is an additional proof of the versatile potential of the new Evolution extraction tool.

Although our results indicate that the new Evolution sheath may be one of the most versatile and efficient devices currently available, we were unable to completely extract a certain number of leads in our cohort. When we analysed this subgroup of patients separately, we found that both a long dwell time and previous injury to the lead were associated with a greater possibility of incomplete lead extraction. In our cohort of patients, every 1-year increase of dwell time was associated with a ∼1.25-fold increase in incomplete lead extraction, and injury to the lead during previous surgical procedures with a ∼65-fold increase in the possibility of lead remnants after the TLE procedure. Thus, our results suggest that extremely long dwell times and presence of leads that were damaged during previous extraction attempts are both associated with incomplete lead extraction, even if highly efficient devices such as the novel Evolution RL are used. In such clinical scenarios, the increased possibility of incomplete lead extraction must be considered and explained to each patient when different extraction approaches are considered and offered to such high-risk individuals.

Although this study describes our superb results using the new bidirectional rotational sheath, it is worth mentioning that during the last few years, several other promising TLE devices have entered the market and have shown themselves to be safe, effective and reliable extraction tools in selected clinical scenarios. Laser sheaths, such as the Spectranetics Laser Sheath II™ (Spectranetics, Colorado Springs, CO, USA), deliver cool cutting laser energy to the distal end of the sheath, allowing for cutting of the surrounding tissue without damaging the veins or the insulation of the lead [18]. Although lead extraction using laser sheaths is an established method with abundant positive data, especially in high-volume centres, evidence indicates that the mortality rates associated with this extremely costly strategy are up to 10 times higher than those associated with mechanical rotational sheaths [9]. Further, the TightRail™ (Spectranetics) bidirectional rotational hand-powered dilator sheath offers a design similar to that of the Evolution RL extraction kit and features a shielded atraumatic tip and extremely flexible outer shaft, supposedly allowing for a safe progression through the vessel and a higher coaxiality to the lead, reducing the risk of lead fracture [19, 20]. Although limited reports from small series indicate that the TightRail provides satisfactory results, the majority of operators included in those trials have additionally used the Evolution dilator sheath at their own discretion to achieve complete lead extraction due to the too flexible design of the TightRail device [19, 20]. However, a direct comparison between the 3 TLE techniques is not yet available, and further studies are warranted to determine if there may be a preferable strategy in specific subsets of patients or unique clinical scenarios.

Limitations

Our study has several limitations. First, although our institution serves as a tertiary referral medical centre, the number of TLEs performed is limited; thus, the number of patients included in our analysis is relatively small. Second, the relatively high number of leads damaged during previous CIED-related surgical procedures in our cohort makes our results hard to compare to the results of other studies that have not faced similar lead impairments, because destruction of a lead’s integrity has a significant impact on the ability of the Evolution RL sheath to completely extract a CIED system. Third, all TLEs at our study were performed by an experienced cardiovascular surgeon rather than by a cardiologist. The cardiovascular surgeon’s learning curve was short because of the ease of mastering the device and the required surgical skills after only a small number of procedures. Although this fact is a strength of TLE procedures performed at our institution rather than a limitation of the study, it is important that this key element of our TLE strategy is being taken into consideration when the results of our study are interpreted, compared to other works or incorporated into everyday clinical practice.

CONCLUSION

The main finding of our low-volume centre study is that TLE procedures, performed in a stepwise manner using a second-generation Evolution rotational sheath as a first-line extraction device and conducted by an experienced, and surgically well-trained operator, offer excellent results with clinical and procedural success rates comparable to those achieved in dedicated, high-volume institutions. In such settings a high procedural and clinical success rates can also be achieved in technically more demanding settings, such as previously transected and damaged leads, passive dual-coil leads with long dwell times and heavily calcified subclavicular scar tissue. Opting for an optimal lead extraction approach in low- and medium-volume centres or institutions with evolving TLE programmes, a stepwise extraction strategy using a second generation Evolution sheath handled by a skilled operator might provide the optimal scheme with superior results and an excellent ratio between clinical and/or procedural success and procedure-related complications.

Conflict of interest: none declared.

Author contributions

Jus Ksela: Conceptualization; Writing—original draft; Writing—review & editing. Jan Prevolnik: Data curation; Investigation; Writing—review & editing. Mark Racman: Data curation; Investigation; Writing—review & editing.

Reviewer information

Interactive CardioVascular and Thoracic Surgery thanks Andreas A. Böning, Steven Hunter, Sofia Martin-Suarez and the other, anonymous reviewer(s) for their contribution to the peer review process of this article.

Abbreviations

ICD

Implantable cardioverter defibrillator

OR

Odds ratio

PM

Pacemaker

TLE

Transvenous lead extraction