Key result
S-ICD achieves ~98% shock efficacy and high complication-free rates over four years.
Why the study?
Previous studies demonstrating S-ICD safety and efficacy included atypical clinical patients or had limited follow-up, leaving long-term outcomes in diverse real-world settings unclear.
Does the subcutaneous implantable cardioverter-defibrillator (S-ICD) system provide long-term safety and efficacy in patients with standard S-ICD indications?
Does the subcutaneous implantable cardioverter-defibrillator (S-ICD) system provide long-term safety and efficacy in patients with standard S-ICD indications?
The S-ICD demonstrates high shock efficacy (98.4%) and low complication rates over a median 4.2 years of follow-up in a real-world U.S. cohort.
Supports S-ICD use in standard indications; extends shorter prior follow-up yet remains observational and hypothesis-generating.
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)
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Gold et al. (2023) studied this question. The subcutaneous implantable cardioverter-defibrillator achieved a shock efficacy rate of 98.4% and a complication-free rate of 93.4% over a median follow-up of 4.2 years.
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