Safety and Outcomes of Transvenous Lead Extraction of Advisory ePTFE-Coated Implantable Cardioverter-Defibrillator Leads: A Multicenter Experience With RELIANCE G.
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Gad Mohamed, Hanumanthu Balaram Krishna, Cha Yong-Mei, Qian Zhiyong, Kusumoto Fred M, Kella Danesh, Vardar Ufuk, Mehta Rohit, Misra Satish K, Patel Neel, Beaty Elijah H, Coons Tricia L, Hartge Francis, Birgersdotter-Green Ulrika M, Bender Aron, Patton Kristen K, Goldberg Elliott, Mason Pamela K, Wang Bo, El-Chami Mikhael F, Woollett Malcolm, Kiehl Erich L, Han Paul, Montgomery Jay A, Raymond-Paquin Alexandre, Mondesert Blandine A, Schaerf Raymond H M, Koneru Jayanthi N, Marchlinski Francis E, Kutalek Steven P, Saleh Moussa, Epstein Laurence M, Schaller Robert D
Аннотация
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.