Safety and Outcomes of Transvenous Lead Extraction of Advisory ePTFE-Coated Implantable Cardioverter-Defibrillator Leads

BACKGROUND: Expanded polytetrafluoroethylene (ePTFE)-coated implantable cardioverter-defibrillator (ICD) leads are associated with progressive coil calcification and rising shock impedance, prompting a recent safety advisory. However, data regarding the safety and efficacy of transvenous lead extraction (TLE) for these chronic leads remain limited. OBJECTIVES: To evaluate the safety, efficacy, and procedural outcomes of TLE in patients with advisory ePTFE-coated ICD leads. METHODS: We performed a retrospective multicenter study at 13 centers of patients undergoing TLE of ePTFE-coated ICD leads. Primary endpoints included procedural success, complications, and short-term mortality. Multivariable analyses identified predictors of outcomes. RESULTS: Among 423 patients undergoing extraction of advisory RELIANCE ICD leads (Boston Scientific), mean lead dwell time was 7.5 ± 5.3 years, and impedance-defined coil calcification was present in 15.1%. Laser sheaths were used in 63.8% of procedures and multiple extraction tools in 21.7%. Complete lead removal was achieved in 95.5%, clinical success in 98.8%, and extraction failed occurred in 1.2%. Major complications occurred in 0.9% of patients, with no procedural deaths. Calcified leads were associated with longer dwell times but not higher rates of major complications. Thirty-day mortality was 2.8%, primarily among patients undergoing extraction for infection. CONCLUSIONS: In this large multicenter cohort, TLE of advisory ePTFE-coated ICD leads was associated with high procedural success and low major complication rates despite long lead dwell times. Outcomes were consistent with contemporary TLE experience and do not suggest increased procedural risk attributable to this lead model. The presence of impedance-defined coil calcification did not adversely affect procedural outcomes, supporting TLE at experienced centers when clinically indicated.