Postapproval Study of a Subcutaneous Implantable Cardioverter-Defibrillator System.

BACKGROUND

The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to avoid complications related to transvenous implantable cardioverter-defibrillator (TV-ICD) leads. Device safety and efficacy were demonstrated previously with atypical clinical patients or limited follow-up.

OBJECTIVES

The S-ICD PAS (Subcutaneous Implantable Cardioverter-Defibrillator System Post Approval Study) is a real-world, multicenter, registry of U.S. centers that was designed to assess long-term S-ICD safety and efficacy in a diverse group of patients and implantation centers.

METHODS

Patients were enrolled in 86 U.S. centers with standard S-ICD indications and were observed for up to 5 years. Efficacy endpoints were first and final shock efficacy. Safety endpoints were complications directly related to the S-ICD system or implantation procedure. Endpoints were assessed using prespecified performance goals.

RESULTS

A total of 1,643 patients were prospectively enrolled, with a median follow-up of 4.2 years. All prespecified safety and efficacy endpoint goals were met. Shock efficacy rates for discrete episodes of ventricular tachycardia or ventricular fibrillation were 98.4%, and they did not differ significantly across follow-up years (P = 0.68). S-ICD-related and electrode-related complication-free rates were 93.4% and 99.3%, respectively. Only 1.6% of patients had their devices replaced by a TV-ICD for a pacing need. Cumulative all-cause mortality was 21.7%.

CONCLUSIONS

In the largest prospective study of the S-ICD to date, all study endpoints were met, despite a cohort with more comorbidities than in most previous trials. Complication rates were low and shock efficacy was high. These results demonstrate the 5-year S-ICD safety and efficacy for a large, diverse cohort of S-ICD recipients. (Subcutaneous Implantable Cardioverter-Defibrillator [S-ICD] System Post Approval Study [PAS]; NCT01736618).

Informations de copyright

Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures This study was sponsored by Boston Scientific. Dr Gold has received consulting fees from Boston Scientific and Medtronic; and has participated in clinical trials with Boston Scientific, Medtronic, and Abbott. Dr El-Chami has received compensation for services from Boston Scientific and Medtronic. Dr Burke has received honoraria and research grants from AtaCor Medical, Biosense Webster, and Boston Scientific; and has held equity in AtaCor Medical. Dr Upadhyay has served on advisory boards at Abbott, BioTel, Biotronik, and Medtronic; and has served a speaker for Zoll Medical. Dr Herre has received research support from Analytics 4 Life, Boston Scientific, and EBR Systems; has received consulting fees from Medtronic; and has served as the Board Chair for LifeNet Health. Dr Kutalek has received consulting fees and compensation for services from Boston Scientific. Dr Knight has received consulting and speaker fees and investigator and/or fellowship support from Abbott, Atricure, Boston Scientific, Biosense Webster, Biotronik, CVRx, and Medtronic. Ms Leigh is a full-time employee of Boston Scientific. Ms Lucas is a full-time employee of NAMSA. Mr Carter is a full-time employee of Boston Scientific. Dr Brisben is a full-time employee of Boston Scientific. Dr Aasbo has received consulting fees from Boston Scientific and Biotronik. Dr Weiss has received compensation for services from Abbott, Boston Scientific, Biosense, Biotronik, S4, and Sanofi; has received research grants from Abbott, Boston Scientific, Biosense, and Medtronic; and has received fellowship support from Abbott, Boston Scientific, Biosense Webster, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.