Long-term complications in patients implanted with subcutaneous implantable cardioverter-defibrillators: Real-world data from the extended ELISIR experience
Alessio Gasperetti, Marco Schiavone, Matteo Ziacchi, Julia Vogler, Alexander Breitenstein, Mikael Laredo, Pietro Palmisano, Danilo Ricciardi, Gianfranco Mitacchione, Paolo Compagnucci, Antonio Bisignani, Andrea Angeletti, Michela Casella, Francesco Picarelli, Thomas Fink, Lukas Kaiser, Samer Hakmi, Leonardò Calò, Carlo Pignalberi, Luca Santini, Carlo Lavalle, Ennio Pisanò, Iacopo Olivotto, Claudio Tondo, Antonio Curnis, Antonio Dello Russo, Nicolas Badenco, Jan Steffel, Charles J Love, Roland Tilz, Giovanni Forleo, Mauro Biffi, Alessio Gasperetti, Marco Schiavone, Matteo Ziacchi, Julia Vogler, Alexander Breitenstein, Mikael Laredo, Pietro Palmisano, Danilo Ricciardi, Gianfranco Mitacchione, Paolo Compagnucci, Antonio Bisignani, Andrea Angeletti, Michela Casella, Francesco Picarelli, Thomas Fink, Lukas Kaiser, Samer Hakmi, Leonardò Calò, Carlo Pignalberi, Luca Santini, Carlo Lavalle, Ennio Pisanò, Iacopo Olivotto, Claudio Tondo, Antonio Curnis, Antonio Dello Russo, Nicolas Badenco, Jan Steffel, Charles J Love, Roland Tilz, Giovanni Forleo, Mauro Biffi
Abstract
Background: Recently, the Food and Drug Administration issued a recall for the subcutaneous implantable cardioverter-defibrillator (S-ICD) because of the possibility of lead ruptures and accelerated battery depletion.
Objective: The aim of this study was to evaluate device-related complications over time in a large real-world multicenter S-ICD cohort.
Methods: Patients implanted with an S-ICD from January 2015 to June 2020 were enrolled from a 19-institution European registry (Experience from the Long-term Italian S-ICD registry [ELISIR]; ClinicalTrials.gov identifier NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue.
Results: A total of 1254 patients (median age 52.0 [interquartile range 41.0-62.2] years; 973 (77.6%) men; 387 (30.9%) ischemic) was enrolled. Over a follow-up of 23.2 (12.8-37.8) months, complications were observed in 117 patients (9.3%) for a total of 127 device-related complications (23.6% managed conservatively and 76.4% required reintervention). Twenty-seven patients (2.2%) had unanticipated generator replacement after 3.6 (3.3-3.9) years, while 4 (0.3%) had lead rupture. Body mass index (hazard ratio [HR] 1.063 [95% confidence interval 1.028-1.100]; P < .001), chronic kidney disease (HR 1.960 [1.191-3.225]; P = .008), and oral anticoagulation (HR 1.437 [1.010-2.045]; P = .043) were associated with an increase in overall complications, whereas older age (HR 0.980 [0.967-0.994]; P = .007) and procedure performed in high-volume centers (HR 0.463 [0.300-0.715]; P = .001) were protective factors.
Conclusion: The overall complication rate over 23.2 months of follow-up in a multicenter S-ICD cohort was 9.3%. Early unanticipated device battery depletions occurred in 2.2% of patients, while lead fracture was observed in 0.3%, which is in line with the expected rates reported by Boston Scientific.
Trial registration: ClinicalTrials.gov NCT00473876.
Keywords: ICD complications; Lead complications; S-ICD; S-ICD recall; Subcutaneous implantable cardioverter-defibrillator.
Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.
Source: PubMed