Post-Approval Study of Subcutaneous ICD Supports a Benefit

In an FDA-mandated study, the rate of successful termination of ventricular tachycardia and ventricular fibrillation was high.

Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have been around for about 10 years. There have been three randomized trials of S-ICDs. The FDA approved the first S-ICD in 2012 but mandated a study of these devices in clinical practice. In this manufacturer-sponsored prospective registry analysis, 1643 patients were enrolled and had a median follow-up of 4.2 years.

There were 446 discrete arrhythmic episodes treated with appropriate shocks in 209 patients. First-shock efficacy was 92% and did not differ significantly between those with monomorphic ventricular tachycardia (VT) and polymorphic VT/ventricular fibrillation (VF). Overall shock efficacy was 98.4%, with no significant difference between monomorphic VT and polymorphic …

Reviewing Author

Mark S. Link, MD

Disclosures

Editorial BoardsCirculation; UpToDate

Mark S. Link, MD

Disclosures

Editorial BoardsCirculation; UpToDate

Post-Approval Study of Subcutaneous ICD Supports a Benefit

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Reviewing Author