Efficacy and safety of the new TightRail™ mechanical sheath for transvenous lead extraction: Results of a French multicenter study - Université de Bretagne Occidentale Access content directly
Journal Articles Journal of Cardiovascular Electrophysiology Year : 2022

Efficacy and safety of the new TightRail™ mechanical sheath for transvenous lead extraction: Results of a French multicenter study

Abstract

Abstract Introduction The aim of this study was to assess the safety and efficacy of the TightRail™ sheath for pacemaker/defibrillator transvenous lead extraction (TLE). Methods Multicenter observational study including patients who underwent a TLE with the TightRail™ sheath in five French university hospitals from September 2014 to January 2020. Results Two hundred and twenty‐five patients (76% males, 71 ± 12 years) underwent a TLE procedure with the TightRail™. A total of 438 leads were extracted using the TightRail™, and the mean age of the extracted leads was 128 ± 85 months; of these, 344 (79%) were pacing leads and 94 (21%) were implantable cardioverter defibrillator leads. The overall clinical success of the extraction procedures was 93%. Overall, 410 of the 438 leads (95%) were extracted (complete or incomplete removal). After multilevel mixed‐effects logistic regression model, we found that lead age (odds ratio [OR], 95% confidence interval [CI] for a 1 year increase: 1.11 [1.07–1.15], p < .001) and number of leads extracted (OR, 95% CI: 2.09 [1.50–2.96], p < .001) were the two independent factors associated with complete lead removal failure. Finally, there were 7 (3%) cases of major complications but no per‐procedural death. Conclusion This is the first large‐scale survey assessing the efficacy and safety profile of the Tightrail™ mechanical sheath. The clinical success rate was 93%, and the lead removal failure was dependent on the age and number of leads. We show a satisfactory safety profile in this cohort of patients from primarily low‐volume centers with older leads.
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Dates and versions

hal-04244015 , version 1 (16-10-2023)

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Adrien Artus, Jacques Mansourati, Marjaneh Fatemi, Bertrand Pierre, Alexandre Schatz, et al.. Efficacy and safety of the new TightRail™ mechanical sheath for transvenous lead extraction: Results of a French multicenter study. Journal of Cardiovascular Electrophysiology, 2022, 33 (4), pp.731-737. ⟨10.1111/jce.15399⟩. ⟨hal-04244015⟩
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