Author + information
- Received January 16, 2020
- Revision received February 19, 2020
- Accepted April 8, 2020
- Published online July 20, 2020.
- Nathalie Behar, MDa,∗ (, )
- Vincent Galand, MDa,
- Raphaël P. Martins, MD, PhDa,
- Peggy Jacon, MDb,
- Nicolas Badenco, MDc,
- Hugues Blangy, MDd,
- Christine Alonso, MDe,
- Benoit Guy-Moyat, MDf,
- Rim El Bouazzaoui, MDg,
- Alain Lebon, MDh,
- Cédric Giraudeau, MDi,
- Christelle Marquie, MDj and
- Christophe Leclercq, MD, PhDa
- aCHU Rennes, Service de Cardiologie et Maladies Vasculaires, Université de Rennes 1, CIC-IT 1414, and INSERM, U1099, Rennes, France
- bCardiology Department- University Hospital of Grenoble Alpes, CS 10217, France
- cAPHP, Hôpital Pitié Salpêtrière, Paris, France
- dCHRU Nancy, Département de Cardiologie, Vandoeuvre, France
- eAmbroise-Paré Hospital, Neuilly-sur-Seine, France
- fCHU Dupuytren, Service de Cardiologie, Limoges, France
- gUniversity Hospital of Montpellier, CHU de Montpellier, Montpellier, France
- hSaint Martin Private Hospital Center, Caen, France
- iPôle Santé Oreliance, Saran, France
- jCHU Lille, Hopital Cardiologique, Lille, France
- ↵∗Address for correspondence:
Dr. Nathalie Behar, Service de Cardiologie et Maladies Vasculaires, CHU de Rennes, 2 rue Henri Le Guilloux, 35000 Rennes, France.
Objectives The aim of this multicenter study was to characterize the efficacy and safety of subcutaneous implantable cardioverter-defibrillators (S-ICDs) lead extraction procedures.
Background S-ICDs have been developed to limit lead-related complications inherent to transvenous ICD devices. To date, no study has specifically investigated the safety and feasibility of S-ICD lead extraction procedures.
Methods Patients requiring S-ICD lead extraction between February 1, 2014, and February 28, 2019, were retrospectively included in 10 centers. The primary endpoint of the study was procedural success, defined as the removal of all the lead and lead material from the subcutaneous space. Secondary endpoints included procedural complications and the need for specific extraction tools.
Results S-ICD lead extraction procedures were performed in 32 patients (mean age 45.7 ± 13.8 years, 75.0% men, 65.6% in primary prevention). The median time from S-ICD lead implantation was 9.3 months (5.4 to 17.5 months). The primary endpoint, that is, complete removal of the material, was achieved in 96.9% of the patients, and only 1 procedural failure occurred (3.1%). Simple traction of the S-ICD lead was successful in 19 patients (59.4%), whereas 3 patients (9.4%) needed an additional incision and 9 patients (28.1%) required mechanical sheath to remove lead adhesions around the coil. No procedure-related complications occurred. Patients with successful simple traction extraction were implanted more recently (7.1 months [2.8 to 12.2 months] vs. 16.5 months [7.5 to 20.8 months]; p = 0.04) and had less prior history of sternotomy (2 [10.5%] vs. 5 [38.5%] patients; p = 0.09).
Conclusions S-ICD lead extraction is an efficient and safe procedure, but may require some specific tools like mechanical sheath, specifically when fibrotic adhesions developed around the parasternal coil.
Implantable cardioverter-defibrillator (ICD) is a well-established therapy to prevent sudden cardiac death in primary or secondary prevention (1,2). However, essentially due to the transvenous lead, ICD is associated with short- and long-term complications, such as endocarditis or lead dysfunction (3,4). Transvenous lead extraction (TLE) techniques have been described using a stepwise approach, and are now facilitated by the availability of a large number of extraction tools, making the procedure more successful and safer (5), although TLE remains a procedure with a non-negligible rate of both minor and major complications (6).
Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have been developed to limit lead-related complications, particularly in young patients with an expected longer lifetime with ICD therapy (7,8). Along with growing experience using S-ICD therapy, complications have been reported sometimes necessitating the subcutaneous lead to be repositioned or removed (9).
Although the S-ICD lead extraction procedure is expected to be safer and less challenging than a TLE procedure, no study has investigated its safety and feasibility thus far. Thus, the aim of this multicenter study was to characterize the efficacy and safety of S-ICD lead extraction procedures
This is a retrospective, multicenter, observational study of patients referred for S-ICD lead extraction with or without generator removal in 10 centers. All patients requiring S-ICD lead extraction with or without generator removal between February 1, 2014, and February 28, 2019, were included. The study was approved by local ethics committee, and all patients gave their informed consent to participate.
Baseline data, including demographic characteristics and data from the initial S-ICD implantation, were collected in a French prospective registry. Data regarding the extraction procedure were collected retrospectively from hospital medical charts for all enrolled patients.
S-ICD lead extraction procedures were performed in the electrophysiology laboratory or the operating room of each center under general anesthesia. After skin preparation, the pulse generator pocket was opened to release the lead from the can. Then, the xiphoidal wound (left or right, depending on initial electrode implantation side) was opened and the sleeve suture removed. The proximal part of the lead (between the can and the xiphoidal wound) was released by simple manual traction through the parasternal tunnelization. A third incision was performed to release the distal lead suture if a 3-incisions technique was used during the initial implantation. Then, parasternal tunnelization was approached. First, a simple manual traction on the S-ICD lead was attempted. If unsuccessful, other tools were used at physician discretion (mechanical sheath, additional incisions, and so on).
The primary endpoint of the study was the rate of procedural success defined as removal of all the lead and lead material from the subcutaneous space. Secondary endpoints included procedural complications and the need for specific lead extraction tools. Two groups were then defined and compared according to the S-ICD lead extraction technique: patients with successful S-ICD lead extraction using simple traction of the lead (simple traction group) and patients requiring additional tools: additional incisions, specific tools (unsuccessful simple traction group).
Qualitative variables are summarized with frequencies (percentage); continuous data as mean ± SD or median (interquartile range) depending on their distribution, which was assessed using the Kolmogorov-Smirnov test. Categorical variables were compared using the chi-square tests or Fisher exact test. Continuous variables were compared using Student’s t-test or the Mann-Whitney U test for 2-group comparisons. A p value <0.05 was considered statistically significant. The analyses were performed with the SPSS statistical package, version 11.0 (SPSS Inc., Chicago, Illinois).
During the study period, a total of 1,011 S-ICD were implanted in 10 French centers. Among these patients, 32 patients (3.2%) required S-ICD lead extraction.
Patient characteristics and data from the initial S-ICD implantation are summarized in Table 1. Mean age of the overall population was 45.7 ± 13.8 years, with a majority of men (75.0%). The S-ICD was mainly implanted in primary prevention (65.6%).
Implanted devices were primarily Boston Emblem S-ICD A209 with a 3401 lead (n = 28; 87.5%), although there were 3 first-generation Cameron SQ-RX with a Qtrack lead (9.4%) and 1 Boston Emblem S-ICD A219 with a 3501 lead (3.1%). The generator was positioned in an intermuscular, subcutaneous, and submuscular pocket in 25 (78.1%), 4 (12.5%), and 3 (9.4%) cases, respectively. In total, 26 leads were placed in a left parasternal position (81.2%). Most of the patients only had 2 incisions during the initial implantation, although a 3 incisions-implantation technique was performed in 6 cases (18.8%). Of note, a total of 7 patients had a history of sternotomy (6 prior to and 1 after S-ICD implantation).
S-ICD lead extraction procedure
The characteristics of S-ICD lead extraction procedures are summarized in Table 2. A total of 32 leads were extracted. The median delay from S-ICD lead implantation to extraction was 9.3 months (5.4 to 17.5 months). Indications for S-ICD lead extraction procedures were device infection for 9 patients (28.1%) (i.e., whole device infection [n = 4]; sleeve infection [n = 3], and generator pocket infection [n = 2]), heart transplantation for 7 patients (21.9%), a problem with the sensing vectors with or without inappropriate shock for 5 patients (15.6%), the need for a conventional transvenous ICD/resynchronization therapy for 5 patients (15.6%: 4 for antitachycardia pacing and 1 for cardiac resynchronization therapy), lead dislodgement for 4 patients (12.5%), and a technical issue in 2 patients (6.3%: 1 premature battery depletion and 1 abnormal lead impedance) (Figure 1). Interestingly, S-ICD extraction for device infection or heart transplantation tended to occur earlier than extractions for sensing vector or technical issues (Figure 2).
The stepwise approach for S-ICD lead procedure is summarized in Figure 2. First, a generator pocket incision was performed, and the lead was removed from the can. Then, the xiphoidal wound (left or right) was opened, and a simple traction of the lead was performed to remove the lead from the generator pocket to the xiphoidal wound. In all cases (n = 32), this first step was straightforward, and the horizontal portion of the lead was easily removed. Then, the parasternal tunnelization was approached. For patients with a 3-incisions technique at the initial S-ICD implantation (n = 6), the superior parasternal wound was opened and the suture at the tip electrode was released. For 19 patients (59.4%), a simple traction on the lead permitted a complete S-ICD lead extraction. One patient had a sternotomy for heart transplantation after S-ICD implantation, and during the surgery, the lead was inadvertently trapped into a sternotomy wire. The subsequent extraction procedure was a failure because the lead could definitely not be extracted. Three patients (9.4%) needed an extra superior parasternal incision to allow a forward and backward movement to release the S-ICD lead from parasternal adhesions. For the last 9 patients (28.1%), some specific tools were required to remove the lead adhesions around the coil. These tools were passive mechanical sheaths used for TLE: regular Byrd dilatator sheath (Cook Intravascular, Leechburg, Pennsylvania) for 8 patients and Visisheath S (Spectranetics, Colorado Springs, Colorado) for 1 patient. The dilatator sheath was placed around the S-ICD lead and was pushed forward while a gentle counter-traction was performed on the lead (Central Illustration). Eventually, the S-ICD lead extraction procedure was completely successful in 31 (96.9%) patients. No procedure-related complication was reported.
Table 3 summarized the comparison between the simple traction and unsuccessful simple traction groups. Both groups were similar regarding age, male sex, and technique of the initial S-ICD implantation (number of incisions and S-ICD lead position). The S-ICD leads were older in the unsuccessful simple traction group compared with the simple traction group with a median delay from implant of 7.1 months (2.8 to 12.2 months) versus 16.5 months (7.5 to 20.8 months) (p = 0.04). Patients with a previous median sternotomy tended to be more prevalent in the unsuccessful simple traction group (n = 5 [8.5%] vs. n = 2 (10.5%); p = 0.09).
Management after S-ICD lead extraction
Among the study population 14 patients underwent an immediate reimplantation at the time of extraction: 7 were implanted with a transvenous ICD while 7 received a new S-ICD (including 2 patients for whom the parasternal side of tunnelization was changed). In the remaining 18 patients, 8 previously infected patients were lately implanted with a new device (including 5 transvenous ICD and 3 S-ICD), and 10 patients did not receive any new device. Indeed, 7 patients had a heart transplantation, and 3 patients with infected devices either did not meet an indication for ICD implantation or did not consent to ICD reimplantation despite a guideline indication.
To the best of our knowledge, this is the first multicenter observational study to specifically investigate S-ICD lead extraction procedures. The main results of the study are: 1) a simple traction of the S-ICD lead through the xiphoidal incision is sufficient to remove the lead in up to 60% of patients; 2) in one-third of the procedures, mechanical sheaths are required to remove fibrotic adhesions around the coil; 3) a stepwise approach results in a very high success rate of extraction, and only external factors were responsible for extraction failure in our study (S-ICD lead tighten in sternotomy steel wires); and 4) the procedure is safe and no procedure-related complications occurred.
ICD lead extraction
With 50 years of experience, a stepwise approach is used for TLE extraction, starting with simple traction, followed by the use of nonpowered tools and eventually powered tools or femoral approach (5). A recent review demonstrated that such a stepwise approach can reach a clinical success extraction rate of 100% (10). Simple manual traction is often effective to remove leads implanted in the previous 12 months, but often not sufficient to remove chronically implanted leads, and additional extraction tools are often needed. According to Buiten et al. (10), TLE clinical success is reached in only 32% of leads with simple traction, 44% with a locking stylet, 71% with a mechanical dilatator, and 97% when a femoral approach is attempted. Regarding the use of powered sheath, TLE clinical success is reported in 95% of patients when a Laser sheath is used (10) and in 95% to 100% when a rotating mechanical sheath is used (11,12).
TLE is a safe procedure in most cases, but still carries a significant risk of extraction failure and also a non-negligible risk of mortality, mostly related to tearing of the great vessels and cardiac structures (13). Last, indications for TLE are mostly infectious, and especially endocarditis. Indeed, in the ELECTRa (European Lead Extraction ConTRolled) registry, noninfectious indications represented 47% of procedures, whereas in the present study, noninfectious indications represented 71.9% of procedures (14).
Specific issues related to S-ICD extraction
In some cases, fibrosis can develop around ICD leads, mainly at the parasternal site around the coil avoiding the extraction of S-ICD lead by a simple traction through the xiphoidal incision. In the present study, as no specific approach for S-ICD lead extraction was recommended at the time of the procedure, several approaches were attempted by operators. The most efficient and less aggressive one was the use of a nonpowered mechanical sheath to release the fibrotic adherences around the coil at the parasternal site. This mechanical approach should be attempted before performing additional incisions. The only procedural failure was the consequence of a particular condition, that is, the S-ICD lead blocked into steel sternotomy wires. Such a situation could be easily avoided by removing the S-ICD during the heart transplant procedure.
Nakhla et al. (15) reported their experience on removal of subcutaneous defibrillator shocking coil in 21 patients. The median age of subcutaneous defibrillator shocking coil was 177 days. One device extraction was performed surgically, while 20 were completed percutaneously; 3 of the patients required additional incisions and 1 the use of a laser sheath. There was no procedural complication. A case report by Ip (16) of an S-ICD lead extraction procedure in a 72-year-old patient, performed 1,059 days after implantation. The author described a technique similar to the one used in the present study, with a Byrd dilatator sheath used to disrupt fibrotic adhesions along the coil. During the 6 years of follow-up in the initial Dutch S-ICD cohort including 118 patients (17), some data regarding S-ICD extraction were provided: the S-ICD was extracted in 10 patients (8%), 8 of which as a consequence of device infection. As in the present study, the procedure did not result in any complications. Theuns et al. (18) reported the long-term follow-up of the European regulatory trial cohort consisting in 55 patients with a median 5.8 years follow-up. Five patients (9%) were explanted: 1 for infection and 4 for transvenous ICD implantation. In the EFFORTLESS registry (19), 10 (1.0%) patients required an S-ICD extraction for a transvenous ICD implantation and 24 (2.4%) patients for device infection. However, in all of the studies reported in the previous text, no data were provided regarding the S-ICD extraction procedure per se.
In our study, those leads extracted by a simple traction were implanted more recently than those requiring mechanical sheaths. Similar results were observed for transvenous leads (20). Indeed, fibrotic adhesions may increase with the age of the S-ICD lead. Fibrotic adherences were mostly located around the coil lead, in the parasternal area. Conversely, there was no fibrosis around the proximal part of S-ICD lead (i.e., in the left subcutaneous laterothoracic area). Indeed, operators did not experience any issue to remove the proximal portion of the lead, while every lead extraction failure was related to the parasternal lead location. Furthermore, more than one-third of the patients requiring mechanical tools for lead extraction had a history of median sternotomy, which may represent a potential factor increasing local fibrosis due to scar tissue formation and hampering an easy extraction of the lead. As previously explained, 1 patient had a sternotomy for heart transplantation after S-ICD implantation, during which the lead was inadvertently trapped into a sternotomy wire. The subsequent extraction procedure failed. Such patients should be carefully managed by cardiac surgeons and the parasternal lead removed at the time of heart transplant. Further studies, including a larger number of patients, are warranted to precisely determine the predictors of challenging or failed procedures. Nevertheless, it seems crucial that such procedures should be performed by experienced operators because they may require dedicated extraction tools and appropriate skills.
First, the analysis was performed as a retrospective review of a cohort of patients requiring S-ICD lead extraction procedure.
The main limitation of this study is the relatively small sample size, despite being the only and largest study reported considering the rare incidence of S-ICD lead extraction.
Furthermore, the median delay from S-ICD lead implantation was 9.3 months (5.4 to 17.5 months), which may sound relatively short, but is a consequence of the recent availability of S-ICDs.
Additionally, S-ICD recipients are different than those patients implanted with transvenous ICD leads; consequently, risk factors for complications or failed extraction are probably different, and further studies will be required to better define this specific population, complications, and risk factors.
Last, no data has been published so far regarding older S-ICD leads (i.e., implanted longer than 5 years), and new technical problems may emerge, requiring specific technics or tools for complete removal of the material.
S-ICD lead extraction is an efficient and safe procedure when using a stepwise strategy. A simple traction of the lead through the xiphoidal incision is sufficient to remove the lead in up to 60% of the cases, but may require some specific tools like mechanical sheath when fibrotic adhesions are present around the parasternal coil. Further studies are needed to prospectively assess the factors resulting in more challenging procedures and the efficacy of such a stepwise strategy in older S-ICD leads.
COMPETENCY IN MEDICAL KNOWLEDGE: This is the first multicenter observational study to specifically investigate S-ICD lead extraction procedures. A simple traction of the S-ICD lead through the xiphoidal incision is sufficient to remove the lead in up to 60% of patients. In one-third of the procedures, mechanical sheaths are required to remove fibrotic adhesions around the coil. A stepwise approach results in a very high success rate of extraction. The procedure is safe, and no procedure-related complications occurred.
TRANSLATIONAL OUTLOOK: Further studies are needed to prospectively assess the factors resulting in more challenging procedures and the efficacy of such a stepwise strategy in older S-ICD leads.
Drs. Behar, Blangy, and Marquie have served as consultants for Boston Scientific. Dr. Leclercq has served as a consultant to Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Abbreviations and Acronyms
- implantable cardioverter-defibrillator
- subcutaneous implantable cardioverter-defibrillator
- transvenous lead extraction
- Received January 16, 2020.
- Revision received February 19, 2020.
- Accepted April 8, 2020.
- 2020 American College of Cardiology Foundation
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