作者
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
发表日期
2021/12/1
期刊
Heart Rhythm
卷号
18
期号
12
页码范围
2050-2058
出版商
Elsevier
简介
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 …
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A Gasperetti, M Schiavone, M Ziacchi, J Vogler… - Heart Rhythm, 2021