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Aims: Optimal management of redundant or malfunctioning leads is controversial. We aimed to assess safety and efficacy of mechanical transvenous lead extraction (TLE) in patients with abandoned leads., Methods and Results: Consecutive TLE procedures performed in our centre from January 2009 to December 2017 were considered. We evaluated the safety and efficacy of mechanical TLE in patients with abandoned (Group 1) compared to non-abandoned (Group 2) leads. We analysed 1210 consecutive patients that required transvenous removal of 2343 leads. Group 1 accounted for 250 patients (21%) with a total of 617 abandoned leads (26%). Group 2 comprised 960 patients (79%) with 1726 leads (74%). The total number of leads (3.0 vs. 2.0), dwelling time of the oldest lead (108.00 months vs. 60.00 months) and infectious indications for TLE were higher in Group 1. Clinical success was achieved in 1168 patients (96.5%) with a lower rate in Group 1 (90.4% vs. 98.1%; P < 0.001). Major complications occurred in only 9 patients (0.7%), without significant differences among the two groups. The presence of one or more abandoned leads [odds ratio (OR) 3.47; 95% confidence interval (CI) 1.07-11.19; P = 0.037] and dwelling time of the oldest lead (OR 1.01 for a month; 95% CI 1.01-1.02; P < 0.001) were associated with a higher risk of clinical failure., Conclusion: Transvenous mechanical lead extraction is a safe procedure also in high-risk settings, as patients with abandoned leads. Success rate resulted a bit lower, especially in the presence of abandoned leads with long implantation time., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) does not require the insertion of any leads into the cardiovascular system., Objective: The aims of the study were to describe current practice and to measure outcomes associated with S-ICD or standard single-chamber transvenous ICD (TV-ICD) use after TV-ICD explantation., Methods: We analyzed all consecutive patients who underwent transvenous extraction of an ICD and subsequent implantation of an S-ICD or a single-chamber TV-ICD at 12 Italian centers from 2011 to 2017., Results: A total of 229 patients were extracted and subsequently reimplanted with an S-ICD (90; 39%) or a single-chamber TV-ICD (139; 61%). S-ICD implantation increased from 9% in 2011 to 85% in 2017 (P < .001). Patients reimplanted with an S-ICD were younger (53 ± 13 years vs 60 ± 18 years; P = .011) and more frequently had undergone extraction owing to infection (73% vs 52%; P < .001). The rates of complications at follow-up were comparable between groups (hazard ratio 0.97; 95% confidence interval 0.49-1.92; P = .940). No lead failures, systemic infections, or system-related deaths occurred in the S-ICD group. In the TV-ICD group, 1 lead fracture occurred and 2 systemic infections were reported, resulting in death in 1 case. In the S-ICD group, the rate of complications was lower when the generator was positioned in a sub- or intermuscular pocket (hazard ratio 0.21; 95% confidence interval 0.05-0.87; P = .048)., Conclusion: Our results show an increasing use of S-ICD over the years in patients undergoing TV-ICD explantation. An S-ICD is preferably adopted in young patients, mostly in the case of infection. The complication rate was comparable between groups and decreased when a sub- or intermuscular S-ICD generator position was adopted., (Copyright © 2018 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Introduction: Increasing device implantations, patient comorbidities, and longer life expectancy contribute to an increased need for lead extraction. Even if transvenous lead extraction (TLE) is a highly successful procedure, some serious procedural complications are reported. In order to identify those patients who are at higher risk, risk stratification scores were proposed. Areas covered: The major obstacles to lead extractions are represented by the body's response to the foreign implanted material and by the following development of fibrotic reaction between the lead and the vascular system. Several clinical factors and device features are associated with major complications and worse outcomes. Although different multiparametric scores predicting the safety and the efficacy of TLE procedures were reported, none of these scores were prospective evaluated. Expert commentary: A correct risk stratification is needed in order to refer complex patients to centers with proven experience and avoid futile procedures. Furthermore, the identification of high-risk patients allows to perform the extraction procedure in the operating room instead of electrophysiology lab. Albeit some risk scores able to predict adverse event in cardiac lead extraction were described, there are still several limitations to their use and reproducibility.

Introduction: The implantation rate of cardiac implantable electronic devices has consistently increased in the last 20 years, as have the related complication rates. The most relevant issue is the removal of pacing and implantable cardioverter defibrillator (ICD) leads, which a few months after implantation tend to develop intravascular fibrosis, often making extraction a challenging and risky procedure. Areas covered: The transvenous lead extraction (TLE) scenario is constantly evolving. TLE is a key procedure in lead management strategies. Many efforts have been made to develop new TLE approaches and techniques allowing a safe and effective procedure for patients. The increasing rate of cardiac implantable electronic device (CIED) implantations and of CIED related complications highlight the importance of TLE. Lead related- and patient-related factors may change the future of extractions. We review the current status of TLE, focusing on the strategies available to perform the optimal procedure in the right patient and reducing procedure related complications. Expert commentary: Understanding the importance of an accurate TLE risk stratification is mandatory to optimize the procedural risk-to-benefits ratio. The use of adequate tools, techniques and approaches, and appropriate training are cornerstones for the achievement of safer procedures.

Introduction: Transvenous lead extraction (TLE) is the gold standard for lead removal. The increasing rate of cardiac implantable electronic device (CIED) implantations and of CIED related complications highlight the importance of transvenous lead extraction ., Areas Covered: The TLE scenario is constantly changing. Optimizing lead related technology and improving TLE practice across the world are the cornerstones to improving safety and efficacy. We review the state of the art in TLE, focusing on potential future implications and improvements in terms of skills and technologies. Expert commentary: The increased number of extractions will increase the necessity of safe and effective TLE. New technologies, techniques and appropriate training is warranted across the world.

Background: Riata (RT) and Sprint Fidelis (SF) leads were recalled by the United States Food and Drug Administration because of an increased rate of failure mainly due to conductor fracture or insulation abrasion. According to lead design and type of failure, extraction complexity may be different, potentially affecting procedural outcomes and indications., Objective: The purpose of this study was to assess the extraction profile of RT leads with and without cable externalization in comparison to SF leads., Methods: From January 1997 to April 2014, all consecutive RT and SF leads extracted transvenously were analyzed. Among 661 consecutive patients with 705 ventricular implantable cardioverter-defibrillator (ICD) leads extracted, 194 patients with 134 RT leads (RT group) and 61 SF leads (SF group) were identified. Removal indications often were infective (64%), and extracted leads had a prevalence of dual-coil design (89%). Baseline patients and lead characteristics were comparable between groups., Results: Success rate was high in both groups (97.8% RT vs 100% SF) without major complications. Mechanical dilation was comparable between groups, but RT leads often required larger sheaths (11.7 ± 1.4 vs 11.3 ± 1.4), a more frequent crossover to the internal transjugular approach (14% vs 3%), and a longer procedural time (23 ± 33 minutes vs 12 ± 16 minutes). Implantation time (odds ratio 4.84, 95% confidence interval 1.05-22.2, P = .042) and RT leads (odds ratio 1.04, 95% confidence interval 1.02-1.06, P <.001) were independent predictors of the internal transjugular approach., Conclusion: Extraction of RT leads is feasible and effective. However, extraction of RT leads is more complex than that of SF leads. Lack of coil backfilling and cable externalization in RT group may account for these differences., (Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Percutaneous removal of implantable cardioverter-defibrillator (ICD) leads is a difficult procedure because of the consequence of massive fibrous tissue growth along the lead., Objective: The purpose of this study was to describe the occurrence and location of fibrous adherences in ICD lead extraction and to identify potential predictors among patient and lead characteristics., Methods: We studied 637 consecutive patients who underwent transvenous extraction of 678 ICD leads from 1997 to 2013., Results: Procedural success rate was 99%, without major complications. Areas of adherence were found in the subclavian vein (78%), innominate vein (65%), superior vena cava (66%), and heart (73%). Dwell-time, passive fixation, and dual-coil lead design were independently associated with adherences. Dual-coil lead design was associated with adherences in the innominate vein and superior vena cava, whereas coil treatment (eg, expandable polytetrafluoroethylene-coated or medical adhesive back-filled strategies) prevented adherences. Passive fixation mechanism was associated with adherences in the heart., Conclusion: ICD leads, after long dwell-time, are affected by fibrous adherences uniformly distributed along the lead course. Lead features represent major predictors of the phenomenon. Careful lead selection is recommended at the time of implantation to prevent adherences. In addition, lead-related risk stratification is mandatory before a transvenous extraction procedure., (Copyright © 2014 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Aims: We report our 15 years experience of a mechanical single-sheath technique with a multiple venous entry-site approach. We evaluated the effectiveness and safety of this technique in implantable defibrillator (ICD) lead extraction and investigated the potential association between clinical and lead-related factors and procedural complexity., Methods and Results: The proposed technique consists of an initial attempt at manual traction, followed by mechanical dilatation performed through the venous entry-site and, if necessary, by crossover to the internal transjugular approach. The study cohort comprised 545 consecutive patients referred to our institution for transvenous lead extraction from January 1997 to December 2012. Initial manual traction resulted in the effective removal of 6% of leads. Mechanical dilatation increased the success rate to 89% when performed through the venous entry-site, and to 99% when subsequently attempted via the internal jugular vein. No major complications were associated with lead extraction. Dwell-time, a passive fixation mechanism and dual-coil lead design were independently associated with the need for mechanical dilatation. However, dwell-time was the only variable associated with crossover to the internal transjugular approach. Specifically, a dwell-time of 20 months best predicted the need for venous entry-site mechanical dilatation, while a value of 55 months predicted crossover to the internal transjugular approach., Conclusion: Mechanical transvenous extraction of ICD leads is a complex but safe and effective procedure. A longer lead dwell-time is associated with the need for mechanical dilatation and for crossover to the internal transjugular approach; this should be considered when planning the removal procedure. Moreover, passive lead fixation and dual-coil lead design predict a more challenging extraction procedure., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.)

Background: The aim of this study was to evaluate procedural outcomes of coronary sinus (CS) lead extraction, focusing on predictors and need for mechanical dilatation (MD) in the event that manual traction (MT) is ineffective., Methods: The study assessed results in 145 consecutive patients (age 69 ± 10 years; 121 men)--a total of 147 CS pacing leads--who underwent transvenous CS lead removal between January 2000 and March 2010., Results: All leads but one (99%) (implantation time 29 ± 25 months) were successfully removed. MT was effective in 103 (70%), and MD was necessary in the remaining 44 (30%) procedures. In multivariate analyses, unipolar design (odds ratio [OR] 3.22, 95% confidence interval [CI] 1.43-7.7; P = 0.005) and noninfective indication (OR 4.8, 95% CI 1.8-13, P = 0.002) were independent predictors for MD (P < 0.0001), with a predictive trend for prior cardiac surgery (OR 2.2, 95% CI 0.98-5.26; P = 0.06). Five (3.4%) complex procedures required a transfemoral vein approach (TFA) or repeat procedure. No deaths occurred, and there was one major complication (0.7%), cardiac tamponade, after MT. No complication predictors were identified., Conclusions: CS leads were safely and effectively removed in nearly all patients, and 70% were removed with MT alone; 30% required MD. Preoperative predictors suggesting the need for MD or TFA were noninfective indication and unipolar lead design. Complications were rare, and there was no predictable pattern among MT or MD removal techniques., (©2011, The Authors. Journal compilation ©2012 Wiley Periodicals, Inc.)

Background: In the Endotak Reliance G defibrillating leads (Guidant Corporation, St. Paul, MN, USA), coils are covered with expanded polytetrafluoroethylene (ePTFE) to prevent tissue ingrowth. The aim of the study was to evaluate transvenous extraction performance, outcomes, and fibrotic adherences rate of ePTFE defibrillating leads in comparison to traditional non-ePTFE cardiac defibrillator (ICD) leads., Methods: Seventeen consecutive ICD recipients (ePTFE Group A, 16 men, mean age 66 ± 12 years) with 17 Endotak Reliance G dual-coil ICD leads (mean implantation time 23 ± 26 months) underwent a transvenous removal procedure. They were compared with two control groups, including 20 Sprint Quattro 6944 (non-ePTFE Group B; Medtronic Inc., Minneapolis, MN, USA) and 36 Riata 1570 ICD leads (non-ePTFE Group C; St. Jude Medical, St. Paul, USA). The indication for lead extraction was local infection in 35 patients (48%), sepsis in 24 patients (33%), and lead malfunction in 14 patients (19%)., Results: In all groups, all leads were successfully and completely removed without major complications. Overall manual traction was effective in six patients (8%) and more effective in the ePTFE Group (29%) compared to Group B (0%) and Group C (3%) (P = 0.001). Sixty-seven leads (92%) required mechanical dilatation by the venous entry site approach, with a shorter extraction time in the ePTFE Group (5 ± 11 min) compared to Group B (21 ± 22 min) and Group C (16 ± 22 min) (P = 0.003). ePTFE leads showed a lower rate of fibrotic adherences at the superior vena cava level (P = 0.01) without statistically significant differences in the other sites., Conclusions: ePTFE-covered leads may be removed more easily and quickly than non-ePTFE leads, requiring less frequently mechanical dilatation., (©2010, The Authors. Journal compilation ©2010 Wiley Periodicals, Inc.)