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Postapproval Study of a Subcutaneous Implantable Cardioverter-Defibrillator System
Journal article   Open access   Peer reviewed

Postapproval Study of a Subcutaneous Implantable Cardioverter-Defibrillator System

Michael R. Gold, Mikhael F. El-Chami, Martin C. Burke, Gaurav A. Upadhyay, Mark J. Niebauer, Jordan M. Prutkin, John M. Herre, Steven Kutalek, Jay L. Dinerman, Bradley P. Knight, …
Journal of the American College of Cardiology, v 82(5), pp 383-397
01 Aug 2023
DOI: https://doi.org/10.1016/j.jacc.2023.05.034
Featured in Collection :   UN Sustainable Development Goals @ Drexel
url
https://doi.org/10.1097/01.NPT.0000281274.88195.40View
Published, Version of Record (VoR)CC BY-NC-ND V4.0,  Open
url
https://doi.org/10.1016/j.jacc.2023.05.034View
Published, Version of Record (VoR) Open

Abstract

cardiac arrhythmias heart failure implantable defibrillators ventricular fibrillation ventricular tachycardia
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. 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. 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. 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%. 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) [Display omitted]

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Collaboration types
Industry collaboration
Domestic collaboration
Web of Science research areas
Cardiac & Cardiovascular Systems
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