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1-Year Subcutaneous ICD Post Approval Study Results
Quick Takes
- S-ICD is safe and effective for the prevention of sudden cardiac death due to ventricular tachyarrhythmias in patients with ischemic heart disease and heart failure.
- S-ICD should no longer be considered primarily for patients with niche indications, which should expand the groups of patients who should be considered for this device.
Study Questions:
What were the spontaneous arrhythmias and clinical outcomes in the S-ICD System PAS (Subcutaneous Implantable Cardioverter-Defibrillator Post Approval Study) cohort?
Methods:
The S-ICD PAS prospective registry included 1,637 de novo patients from 86 US centers. Descriptive statistics, Kaplan-Meier time to event, and multivariate logistic regression were performed using data out to 365 days.
Results:
Patients (mean ejection fraction of 32%; 43% ischemic) underwent implantation for primary (76.6%) or secondary prevention indication. The complication-free rate was 92%. The appropriate shock (AS) rate was 5.3%. A total of 395 ventricular tachycardia (VT) or fibrillation (VF) episodes were appropriately sensed, with 131 (33.2%) self-terminating. First and final shock efficacy for the 127 discrete AS episodes were 91% and 100%, respectively. Discrete AS episodes included 67 monomorphic VT (MVT) and 60 polymorphic VT (PVT)/VF, with first shock efficacy of 96% and 87%, respectively. There were 19 storm events in 18 subjects, with 84% conversion success.
Conclusions:
In the first year after implantation, a predominantly primary prevention population with low ejection fraction demonstrated a high complication-free rate and spontaneous event shock efficacy for MVT and PVT/VF.
Perspective:
The present study builds on the prior data regarding the safety and efficacy of S-ICD in a broader cohort of patients. Along with the recently released results of PRAETORIAN and UNTOUCHED trials, the study shows low complication rates and high success rate of ICD therapy in patients with no pacing indication. The utility of the S-ICD will be further enhanced by the development of S-ICD systems with leadless pacing.
Clinical Topics: Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Acute Heart Failure
Keywords: Arrhythmias, Cardiac, Death, Sudden, Cardiac, Defibrillators, Implantable, Defibrillators, Implantable, Heart Failure, Myocardial Ischemia, Primary Prevention, Secondary Prevention, Shock, Stroke Volume, Tachycardia, Ventricular
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