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; Jill Leigh; Lindsay Lucas; Nathan Carter; Amy J Brisben; Johan D Aasbo; Raul Weiss; S-ICD System Post Approval Study Investigators

doi:10.1016/j.jacc.2023.05.034

Postapproval Study of a Subcutaneous Implantable Cardioverter-Defibrillator System

J Am Coll Cardiol. 2023 Aug 1;82(5):383-397. doi: 10.1016/j.jacc.2023.05.034.

Authors

Michael R Gold¹, Mikhael F El-Chami², Martin C Burke³, Gaurav A Upadhyay⁴, Mark J Niebauer⁵, Jordan M Prutkin⁶, John M Herre⁷, Steven Kutalek⁸, Jay L Dinerman⁹, Bradley P Knight¹⁰, Jill Leigh¹¹, Lindsay Lucas¹², Nathan Carter¹¹, Amy J Brisben¹¹, Johan D Aasbo¹³, Raul Weiss¹⁴; S-ICD System Post Approval Study Investigators

Affiliations

¹ Medical University of South Carolina, Charleston, South Carolina, USA. Electronic address: goldmr@musc.edu.
² Emory University School of Medicine, Atlanta, Georgia, USA.
³ CorVita Science Foundation, Chicago, Illinois, USA.
⁴ Center for Arrhythmia Care, Heart and Vascular Center, The University of Chicago Medicine, Chicago, Illinois, USA.
⁵ Cleveland Clinic Foundation, Cleveland, Ohio, USA.
⁶ University of Washington, Seattle, Washington, USA.
⁷ Sentara Cardiovascular Research Institute, Norfolk, Virginia, USA.
⁸ Saint Mary Medical Center, Langhorne, Pennsylvania, USA.
⁹ The Heart Center, Huntsville, Alabama, USA.
¹⁰ Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
¹¹ Boston Scientific, Saint Paul, Minnesota, USA.
¹² NAMSA, Minneapolis, Minnesota, USA.
¹³ Department of Cardiac Electrophysiology, Lexington Cardiology/Baptist Health Medical Group, Lexington, Kentucky, USA.
¹⁴ Mount Sinai Medical Center, Miami Beach, Florida, USA.

PMID: 37495274
DOI: 10.1016/j.jacc.2023.05.034

Abstract

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).

Keywords: cardiac arrhythmias; heart failure; implantable defibrillators; ventricular fibrillation; ventricular tachycardia.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Arrhythmias, Cardiac / therapy
Death, Sudden, Cardiac / epidemiology
Death, Sudden, Cardiac / prevention & control
Defibrillators, Implantable*
Humans
Prospective Studies
Tachycardia, Ventricular* / therapy
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT01736618