Long- and short-term outcomes after transvenous lead extraction in a large single-centre patient cohort using the clinical frailty scale as a risk assessment tool.

BACKGROUND AND AIMS: The rate of cardiac implantable electronic device (CIED) implantations and the need for transvenous lead extraction (TLE) are growing worldwide. This study examined a large Swedish cohort with the aim of identifying possible predictors of post-TLE mortality with special focus on systemic infection patients and frailty. METHODS: This was a single centre study. Records of patients undergoing TLE between 2010 and 2018 were analysed. Statistical analyses were conducted to compare baseline characteristics of patients with different indications and identify risk factors of 30-day and 1-year mortality. RESULTS: A total of 893 patients were identified. Local infection was the dominant indication and pacemaker was the most common CIED. The mean age was 65 ± 16 years, 73 % were male and median follow-up was 3.9 years. Heart failure was the most common comorbidity. Patients with systemic infection were significantly older, frailer and had significantly higher levels of comorbidities. 30-day mortality and 1-year mortality rates were 2.5 % and 9.9 %, respectively. Systemic infection and chronic kidney disease (CKD) were independently associated with 30-day and 1-year mortality. Clinical frailty scale (CFS) 5-7 correlated independently with 1-year mortality in the entire cohort and specifically in systemic infection patients. CKD, cardiac resynchronization therapy and CFS 5-7 were significant risk factors for long-term mortality (death >1 year after TLE) in multivariable analysis. CONCLUSIONS: Systemic infection, kidney failure in addition to the novel parameter of frailty were associated with post-TLE all-cause mortality. These risk factors should be considered during pre-procedure risk stratification to improve post-TLE outcomes.

Transvenous Lead Extraction in the Left Ventricular Assist Device Patient.

The population of patients with advanced heart failure continues to increase steadily as does the need for mechanical circulatory support. Combination therapy with left ventricular assist devices (LVADs) and cardiovascular implantable electronic devices (CIEDs) is unavoidable. CIED complications in patients with LVADs are common and often necessitate device system revision and transvenous lead extraction. Despite this, management recommendations are limited, and guidelines are lacking.

Pacing and Defibrillation Consideration in the Era of Transcatheter Tricuspid Valve Replacement.

PURPOSE OF REVIEW: Tricuspid regurgitation is a commonly encountered valvular pathology in patients with trans-tricuspid pacing or implantable cardioverter-defibrillator leads. Transcatheter tricuspid valve interventions are increasingly performed in patients at high surgical risk. Implantation of these valves can lead to the "jailing" of a trans-tricuspid lead. This practice carries both short- and long-term risks of lead failure and subsequent infection without the ability to perform traditional transvenous lead extraction. Herein, this manuscript reviews available therapeutic options for lead management in patients undergoing transcatheter tricuspid valve interventions. RECENT FINDINGS: The decision to jail a lead may be appropriate in certain high-risk cases, though extraction may be a better option in most cases given the variety of options for re-implant, including leadless pacemakers, valve-sparing systems, epicardial leads, leads placed directly through prosthetic valves, and the completely subcutaneous implantable-defibrillator. A growing number of patients meet the requirement for CIED implantation in the United States. A significant proportion of these patients will have tricuspid valve dysfunction, either related to or independent of their transvenous lead. As with any percutaneous intervention that has shown efficacy, the role of TTVI is also likely to increase as this therapy advances beyond the investigational phase. As such, the role of the heart team in the management of these patients will be increasingly critical in the years to come, and in those patients that have pre-existing CIED leads, we advocate for the involvement of an electrophysiologist in the heart team.

Safety and efficacy of combined dilation/stenting of venous abnormalities, including complete obstructions, during lead extractions in patients with congenital heart disease.

INTRODUCTION: Management of transvenous leads in patients with congenital heart disease (CHD) can be complicated by venous obstructions and residual shunts. We present our experience performing concurrent lead extraction and dilation/stenting of venous pathways, including patients with complete venous obstruction. METHODS: All cases of concurrent lead extraction and recanalization of vena cavae/baffles between 2017 and 2021 at Boston Children's Hospital were retrospectively included and reviewed for safety and efficacy. RESULTS: Eight patients, 4 female, median 38.5 years of age (range 16.7-49 years) and 81.6 kg weight (range 41.3-97.8 kg) at time of procedure were included. All patients had CHD, a majority (n = 7) having transposition of the great arteries palliated via atrial switch. All leads were removed in their entirety, with most patients having two leads extracted (n = 7). Median lead dwell time was 13.8 years (range 3.6-35.3 years). Three patients had complete obstructions, three required stenting of their innominate veins and three required recanalization of their femoral vessels. Median procedure time was 9.8 h (range 5.4-12.8 h). Complications included blood transfusion (n = 2), arrhythmia (n = 3), pleural effusion (n = 1), and pressure ulcer (n = 1). There were no cardiac perforations, venous tears, or deaths. CONCLUSION: Lead extraction along with dilation and stenting of venous anomalies, though long in duration, proved effective with minimal complications. This combined procedure can safely and effectively resolve complete obstructions secondary to transvenous leads.

Poorer outcomes associated with more invasive lead management strategies for Abbott Riata® leads: a large, multicenter experience.

BACKGROUND: Over 100,000 Abbott Riata® were implanted in the United States before they were recalled in 2010. There are still a significant number of Abbott Riata® leads in use, and it is unclear how these leads should be managed at the time of generator change or lead malfunction. Although data comparing both Sprint Fidelis® and Abbott Riata® leads in this setting is available, there are no multicenter comparative studies of outcomes for various lead management strategies, including lead extraction (LE), lead abandonment/revision (LA), and generator change (GC) only at the time of device at elective replacement interval (ERI) for Abbott Riata® leads. METHODS: A retrospective, multicenter study was undertaken to compare short-term outcomes (major complications-MC, death, extended or re-hospitalizations within 60 days-RH, lead malfunction-LM) and total outcomes (short-term outcomes & lead malfunction during follow-up) of patients with Riata® leads undergoing LE, LA, or GC. RESULTS: 152 patients (65 ± 13 years, 68% male) were followed for a mean 33 ± 30 months following intervention. Out of 166 procedures, 13 patients underwent LE, 16 patients underwent LA, and 137 patients underwent GC. There was 1 major complication in each group, yielding an event rate of 7.7% for LE, 6.3% for LA, and 0.7% for GC cohorts. There were significantly more short-term and total adverse outcomes in the group of patients getting LE and LA versus GC only (38.5% & 31.3% vs 7.3%, P < 0.001). Total Riata® lead dwell time follow-up was 17,067 months. A total of 3 Riata® lead malfunctions were noted during long-term follow-up. Inappropriate shocks were similar between LE 7.7% (1/13), LA 6.3% (1/16). and GC 11.0% (4/136); P = 0.57. CONCLUSIONS: There were more short-term and total adverse outcomes in more invasive management strategies (LE and LA) versus GC alone. The failure rate of Riata® leads was substantially lower compared to previous reports. Therefore, we recommend only performing battery exchange when a device with an active Riata® lead is at ERI, unless there is malfunction of the Riata® lead noted on testing. There were significantly more short-term adverse outcomes in the lead extraction (5/13) and lead abandonment/revision (5/16) groups than the generator only (8/137) group (P < 0.001). GIB - Gastrointestinal bleed, CHF - congestive heart failure, NSTEMI - non-ST elevation MI.

Procedural outcome & risk prediction in young patients undergoing transvenous lead extraction-a GALLERY subgroup analysis.

Background: The prevalence of young patients with cardiac implantable electronic devices (CIED) is steadily increasing, accompanied by a rise in the occurrence of complications related to CIEDs. Consequently, transvenous lead extraction (TLE) has become a crucial treatment approach for such individuals. Objective: The purpose of this study was to examine the characteristics and procedural outcomes of young patients who undergo TLE, with a specific focus on identifying independent risk factors associated with adverse events. Methods: All patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) were categorized into two groups based on their age at the time of enrollment: 45 years or younger, and over 45 years. A subgroup analysis was conducted specifically for the younger population. In this analysis, predictor variables for all-cause mortality, procedural complications, and procedural failure were evaluated using multivariable analyses. Results: We identified 160 patients aged 45 years or younger with a mean age of 35.3 ± 7.6 years and 42.5% (n = 68) female patients. Leading extraction indication was lead dysfunction in 51.3% of cases, followed by local infections in 20.6% and systemic infections in 16.9%. The most common device to be extracted were implantable cardioverter-defibrillators (ICD) with 52.5%. Mean number of leads per patient was 2.2 ± 1.0. Median age of the oldest indwelling lead was 91.5 [54.75-137.5] months. Overall complication rate was 3.8% with 1.9% minor and 1.9% major complications. Complete procedural success was achieved in 90.6% of cases. Clinical procedural success rate was 98.1%. Procedure-related mortality was 0.0%. The all-cause in-hospital mortality rate was 2.5%, with septic shock identified as the primary cause of mortality. Multivariable analysis revealed CKD (OR: 19.0; 95% CI: 1.84-194.9; p = 0.018) and systemic infection (OR: 12.7; 95% CI: 1.14-142.8; p = 0.039) as independent predictor for all-cause mortality. Lead age ≥ 10 years (OR: 14.58, 95% CI: 1.36-156.2; p = 0.027) was identified as sole independent risk factor for procedural complication. Conclusion: TLE in young patients is safe and effective with a procedure-related mortality rate of 0.0%. CKD and systemic infection are predictors for all-cause mortality, whereas lead age ≥ 10 years was identified as independent risk factor for procedural complications in young patients undergoing TLE.

Safety of same-day discharge after lead extraction procedures.

BACKGROUND: Same-day discharge (SDD) after cardiovascular procedures is rapidly gaining ground. OBJECTIVE: We sought to evaluate the safety of SDD after transvenous lead extraction (TLE). METHODS: We performed a retrospective chart review of patients who underwent elective TLE between January 2020 and October 2021 at our institution. The primary outcome was SDD, and major procedural complications and readmissions within 30 days of the procedure were secondary outcomes. RESULTS: In this analysis of 111 patients who underwent elective TLE, 80 patients (72%) were discharged on the same day (SDD group) while 31 patients (28%) stayed overnight (overnight group). Lead malfunction was the most common indication for TLE in both groups. Patients in the overnight group were more likely to have a lead dwell time of ≤10 years than those in the SDD group (38.7% vs 20% of all leads in each group; P = .042), have laser sheaths used for extraction and a higher number of leads extracted. No major complications were reported in both groups. In a multivariate analysis, lower body mass index and the use of laser sheath during TLE were predictors of overnight stay. Patients who underwent a procedure using advanced extraction techniques were 3.5 times more likely to stay overnight (95% confidence interval 1.27-9.78; P = .016). CONCLUSION: In appropriately selected patients undergoing elective lead extraction, SDD is feasible and safe. Higher body mass index, fewer extracted leads, shorter lead dwell times (<10 years), and less frequent use of laser-powered extraction sheaths were associated with an increased likelihood of SDD.

Transvenous lead extraction of implantable cardioverter-defibrillators: A comprehensive outcome-and risk factor analysis.

BACKGROUND: Device complications, such as infection or lead dysfunction necessitating transvenous lead extraction (TLE) are continuously rising amongst patients with transvenous implantable-cardioverter-defibrillator (ICD). OBJECTIVES: Aim of this study was to characterize the procedural outcome and risk-factors of patients with indwelling 1- and 2-chamber ICD undergoing TLE. METHODS: We conducted a subgroup analysis of all ICD patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) database. Predictors for procedural failure and all-cause mortality were assessed. RESULTS: We identified 842 patients with an ICD undergoing TLE with the mean age of 62.8 ± 13.8 years. A total number of 1610 leads were treated with lead dysfunction (48.5%) as leading indication for extraction, followed by device-related infection (45.4%). Lead-per-patient ratio was 1.91 ± 0.88 and 60.0% of patients had dual-coil defibrillator leads. Additional extraction tools, such as mechanical rotating dilator sheaths and snares were utilized in 6.5% of cases. Overall procedural complications occurred in 4.3% with 2.0% major complications and a procedure-related mortality of 0.8%. Clinical success rate was 97.9%. All-cause in-hospital mortality was 3.4%, with sepsis being the leading cause for mortality. Multivariate analysis revealed lead-age ≥10 years (OR:5.82, 95%CI:2.1-16.6; p = .001) as independent predictor for procedural failure. Systemic infection (OR:9.57, 95%CI:2.2-42.4; p < .001) and procedural complications (OR:8.0, 95%CI:2.8-23.3; p < .001) were identified as risk factors for all-cause mortality. CONCLUSIONS: TLE is safe and efficacious in patients with 1- and 2-chamber ICD. Although lead dysfunction is the leading indication for extraction, systemic device-related infection is the main driver of all-cause mortality for ICD patients undergoing TLE.

Lead Sequestration in Perovskite Photovoltaic Device Encapsulated with Water-Proof and Adhesive Poly(ionic liquid).

The inevitable usage of toxic lead impedes the commercialization of lead halide perovskite solar cells, especially considering lead ions potentially unseals from the discarded and damaged devices and consequently contaminates the environment. In this work, we proposed a poly(ionic liquid) (PIL) cohered sandwich structure (PCSS) to realize lead sequestration in perovskite solar cells by a water-proof and adhesive poly([1-(3-propionic acid)-3-vinylimidazolium] bis(trifluoromethanesulphonyl)imide (PPVI-TFSI). A transparent ambidextrous protective shield manufactured from PPVI-TFSI was achieved and applied in lead sequestration for perovskite solar cells. PCSS provides robustness and water-resistance, which improves device stability toward water erosion and extreme situations (such as acid, base, salty water, and hot water). PPVI-TFSI exhibited excellent affinity toward lead with adsorption capacity of 516 mg·g-1, which assisted to prevent lead leakage in abandoned devices as proved in the test of wheat germination vividly. PCSS provides a promising solution for complex lead sequestration and management issues, which contribute to the commercialization of perovskite solar cells.

Transvenous lead extraction in patients with systemic cardiac device-related infection-Procedural outcome and risk prediction: A GALLERY subgroup analysis.

BACKGROUND: Transvenous lead extraction (TLE) has evolved as one of the most crucial treatment options for patients with cardiac device-related systemic infection (CDRSI). OBJECTIVE: The aim of this study was to characterize the procedural outcome and risk factors of patients with CDRSI undergoing TLE. METHODS: A subgroup analysis of patients with CDRSI of the GALLERY (GermAn Laser Lead Extraction RegistrY) database was performed. Predictors for complications, procedural failure, and all-cause mortality were evaluated. RESULTS: A total of 722 patients (28.6%) in the GALLERY had "systemic infection" as extraction indication. Patients with CDRSI were older (70.1 ± 12.2 years vs 67.3 ± 14.3 years; P < .001) and had more comorbidities than patients with local infections or noninfectious extraction indications. There were no differences in complete procedural success (90.6% vs 91.7%; P = .328) or major complications (2.5% vs 1.9%; P = .416) but increased procedure-related (1.4% vs 0.3%; P = .003) and all-cause in-hospital mortality (11.1% vs 0.6%; P < .001) for patients with CDRSI. Multivariate analyses revealed lead age ≥10 years as a predictor for procedural complications (odds ratio [OR] 3.23; 95% confidence interval [CI] 1.58-6.60; P = .001). Lead age ≥10 years (OR 2.57; 95% CI 1.03-6.46; P = .04) was also a predictor for procedural failure. We identified left ventricular ejection fraction <30% (OR 1.70; 95% CI 1.00-2.99; P = .049), age ≥75 years (OR 2.1; 95% CI 1.27-3.48; P = .004), chronic kidney disease (OR 1.92; 95% CI 1.17-3.14; P = .01), and overall procedural complications (OR 5.15; 95% CI 2.44-10.84; P < .001) as predictors for all-cause mortality. CONCLUSION: Patients with CDRSI undergoing TLE demonstrate an increased rate of all-cause in-hospital, as well as procedure-related mortality, despite having comparable procedural success rates. Given these data, it seems paramount to develop preventive strategies to detect and treat CDRSI in its earliest stages.

Atrial Fibrillation and Transvenous Lead Extraction-A Comprehensive Subgroup Analysis of the GermAn Laser Lead Extraction RegistrY (GALLERY).

Background: Atrial fibrillation is the most common arrhythmia and has been described as driver of cardiovascular morbidity and risk factor for cardiac device-related complications, as well as in transvenous lead extraction (TLE). Objectives: Aim of this study was to characterize the procedural outcome and risk-factors of patients with atrial fibrillation (AF) undergoing TLE. Methods: We performed a subgroup analysis of all AF patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) database. Predictors for all-cause mortality were assessed. Results: A total number of 510 patients with AF were identified with a mean age of 74.0 ± 10.3 years. Systemic infection (38.4%) was the leading cause for TLE, followed by local infection (37.5%) and lead dysfunction (20.4%). Most of the patients (45.9%) presented with pacemaker systems to be extracted. The total number of leads was 1181 with a 2.3 ± 0.96 leads/patient. Clinical procedural success was achieved in 97.1%. Occurrence of major complications was 1.8% with a procedure-related mortality of 1.0%. All-cause mortality was high with 5.9% and septic shock being the most common cause. Systemic device infection (OR: 49.73; 95% CI: 6.56−377.09, p < 0.001), chronic kidney disease (CKD; OR: 2.67; 95% CI: 1.01−7.03, p = 0.048) and a body mass index < 21 kg/m2 (OR: 6.6; 95% CI: 1.68−25.87, p = 0.007) were identified as independent predictors for all-cause mortality. Conclusions: TLE in AF patients is effective and safe, but in patients with systemic infection the mortality due to septic shock is high. Systemic infection, CKD and body mass index <21 kg/m2 are risk factors for death in patient with AF undergoing TLE.

Full Life-Cycle Lead Management and Recycling Transparent Conductors for Low-Cost Perovskite Solar Cell.

Realizing a full life-cycle management for toxic lead (Pb) and reducing material/manufacture cost are the key steps in determining the commercialization process of perovskite photovoltaics. In this work, we develop full lifecycle material management for a carbon-based perovskite solar cell (C-PSC) to immobilize and recover Pb against environmental pollution, followed by refabrication of C-PSC based on recovered materials and recycled transparent conductors from obsolete devices. Pb immobilization is first achieved by a strong coordination interaction between undercoordinated Pb ions from perovskite and a C═O bond from green pseudohalide ions (pseudo-X), and the resulting C-PSC with the structure of ITO/SnO2/pseudo-X-perovskite/carbon yields an efficiency of 16.63%. Pb from an end-of-life C-PSC is then recovered by dissolving the obsolete perovskite layer into DMF/DMSO precursor solvent, followed by replenishing a certain amount of MAI to guarantee new perovskite layer formation. The refabricated C-PSC based on recovered perovskite and a recycled transparent conductor displays comparable efficiency (15.30%) to that of C-PSC with commercial raw materials, also exceeding the previous efficiency record for C-PSCs based on recycled materials. Such refabricated C-PSC is relatively low-cost.

Patient related outcomes of mechanical lead extraction techniques (PROMET) study: A comparison of two professions.

BACKGROUND: With an increasing number of cardiac implantable electronic devices (CIEDs), there has been a paralleled increase in demand for transvenous lead extraction (TLE). Cardiac surgeons (CS) and cardiologists perform TLE; however, data comparing the two groups of operators is scarce. OBJECTIVE: We compared the outcomes of TLE performed by cardiologists and CS from six European lead extraction units. METHOD: Data was collected retrospectively of 2205 patients who had 3849 leads extracted (PROMET) between 2005 and 2018. Patient demographics and procedural outcomes were compared between the CS and cardiologist groups, using propensity score matching. A multivariate regression analysis was also performed for variables associated with 30-day mortality. RESULTS: CS performed the majority of extractions (59.8%), of leads with longer dwell times (90 [57-129 interquartile range (IQR)] vs. 62 [31-102 IQR] months, CS vs. cardiologists, p < .001) and with pre-dominantly non-infectious indications (57.4% vs. 50.2%, CS vs. cardiologists, p < .001). CS achieved a higher complete success per lead than the cardiologists (98.1% vs. 95.7%, respectively, p < .01), with a higher number of minor complications (5.51% vs. 2.1%, p < .01) and similar number of major complications (0.47% vs. 1.3%, p = .12). Thirty-day mortality was similarly low in the CS and cardiologist groups (1.76% vs. 0.94%, p = .21). Unmatched data multivariate analysis revealed infection indication (OR 6.12 [1.9-20.3], p < .01), procedure duration (OR 1.01 [1.01-1.02], p < .01) and CS operator (OR 2.67, [1.12-6.37], p = .027) were associated with 30-day mortality. CONCLUSION: TLE by CS was performed with similar safety and higher efficacy compared to cardiologists in high and medium-volume lead extraction centers.

Cases of Azygous Coil Extraction.

BACKGROUND: Procedural and clinical outcomes of patients undergoing extraction or removal of azygous coils are not well characterized. OBJECTIVE: Evaluate outcomes in patients who undergo device extraction with an azygous coil in situ. METHODS: Patients undergoing extraction with an azygous coil in situ between May 2015 and January 2021 were included in this retrospective single-center analysis. Outcomes included procedural success, use of laser and mechanical cutting tools during the procedure, procedural complications, and mortality. RESULTS: We identified 2 patients undergoing device extraction with an azygous coil in situ with a dwell time greater than 12 months. The patients were male, aged 73 and 83 years. Both had a history of hypertension, atrial fibrillation, heart failure (ejection fractions <15% and 20%), and cardiomyopathy (nonischemic and ischemic), and presented with an infection (case 1 with a single-chamber ICD and Staphylococcus aureus bacteremia, case 2 with a cardiac resynchronization therapy defibrillator pocket infection). The mean dwell time of all 6 leads extracted was 6.43 years (range 1.33-12.63 years), and the 2 azygous coils had dwell times of 1.33 and 6.04 years. In case 1, the azygous coil was inferior to the cardiac silhouette, while in case 2 it was superior. A 14F laser sheath was employed to remove both azygous coils. Both extractions were a complete procedural success in which all leads were removed completely without intraoperative complications. CONCLUSION: These cases demonstrate the variable courses of azygous coils, provide proof of concept that they can be removed safely, and illustrate that azygous coils can be removed with the same techniques that are commonly used to remove other types of leads.

Feasibility and safety of a transvenous lead extraction program implementation in South America: Challenges, early outcomes, and global collaboration-A single-center experience.

Background: Transvenous lead extraction is the standard of care for cardiac implantable electronic device (CIED) malfunction/infection-related removal. However, data on its performance and results in underdeveloped countries are limited. Objective: The purpose of this study was to report the feasibility and efficacy of a lead extraction program in a tertiary hospital in Chile, South America. Methods: Patients requiring CIED removal at the Electrophysiology Division of the Hospital las Higuera's were retrospectively analyzed. Outcomes including procedure-related mortality, procedural success and failure, and cardiac and vascular complications were reported. Results: A total of 15 patients were analyzed (median age 68 [interquartile range 52-75] years; 80% male). Patients with lead extraction difficulty index >10 represented 33% of patients. Infection was the indication for removal in all patients, with pocket infection (80%). Mechanical rotational tools were used in 66% of cases, and a total of 29 leads were removed. Procedural success was accomplished in 93% of cases. There was 1 (7%) intraprocedural complication and no procedure-related mortality. Conclusions: The development of a lead management program is feasible, safe, and effective in underdeveloped countries.

Outcomes of transvenous lead extraction using the TightRail™ mechanical rotating dilator sheath and excimer laser sheath.

BACKGROUND: Transvenous lead extraction (TLE) is an important part of comprehensive lead management. The selection of tools available has expanded in recent years but data on their efficacy is limited. OBJECTIVE: To evaluate outcomes using the TightRail™ mechanical rotating mechanical dilator sheath in comparison to excimer laser sheaths and describe factors predictive of successful extraction. METHODS: Patients undergoing TLE at a single tertiary center (2013-2019) were included in a prospective registry. Leads targeted for extraction with either an SLS II/Glidelight™ or TightRail™ sheath were included. Outcomes were analyzed on a per-lead basis. Generalized estimating equation (GEE) models were used to assess differences in lead extraction success by extraction tool used while adjusting for nonindependence of multiple leads extracted from the same patient. Covariates included patient comorbidities, lead characteristics, and sheath size. RESULTS: A total of 575 leads extracted from 372 patients were included. Overall success rate was 97%. TightRail™ was the first tool used in 180 (31.3%) leads with success rate of 61.7%; laser sheaths were the first tool in 395 leads (68.7%) with success rate of 67.8%. Predictors of successful extraction included lead age, lead type, and sheath sizing. Extraction success did not differ based on whether a laser or TightRail™ sheath was used (adjusted odds ratio = 0.94; 95% confidence interval = 0.59-1.50). CONCLUSION: The TightRail™ sheath is an effective tool for TLE. Lead age, lead type, and sheath sizing were predictive of successful extraction but sheath type was not. These findings are hypothesis generating and warrant further investigation in a prospective, randomized study.