Postapproval Study of a Subcutaneous Implantable Cardioverter-Defibrillator System (JACC August 2023-1)-Article: Postapproval Study of a Subcutaneous Implantable Cardioverter-Defibrillator System

Article: Postapproval Study of a Subcutaneous Implantable Cardioverter-Defibrillator System

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The Subcutaneous Implantable Cardioverter-Defibrillator (S-ICD) system has been shown to be safe and effective in a large, diverse cohort of patients in the S-ICD PAS (Subcutaneous Implantable Cardioverter-Defibrillator System Post Approval Study). The study achieved all prespecified safety and efficacy endpoints, with shock efficacy rates of 98.4% for converting ventricular tachycardia or ventricular fibrillation episodes. Complication rates were low, with a complication-free rate of 93.4% and an electrode-related complication-free rate of 99.3% at 5 years. Only 1.6% of patients required replacement of the S-ICD with a transvenous ICD for pacing needs. The cumulative all-cause mortality rate was 21.7%. The study also evaluated the impact of defibrillation testing on outcomes and found that it did not affect shock efficacy or the frequency of appropriate or inappropriate shocks. Overall, the study demonstrates the long-term safety and efficacy of the S-ICD in a diverse patient population and supports its use as an alternative to transvenous ICDs in eligible patients. Further research is needed to evaluate hybrid modular systems that combine a leadless pacemaker for bradycardia with an S-ICD.

Keywords

Subcutaneous Implantable Cardioverter-Defibrillator

S-ICD

Safety

Efficacy

Shock efficacy

Complication rates

Electrode-related complications

Transvenous ICD

Mortality rate

Defibrillation testing