The S-ICD device is a "leadless" implantable cardioverter defibrillator that, unlike other ICDs, delivers its regulating shock via subcutaneous leads rather than leads threaded through blood vessels to the heart.
The study presented today was a pooled analysis of data from 889 patients enrolled in Boston Scientific’s S-ICD investigational device exemption trial and the Effortless post-market trial. Researchers compared patients with certain kinds of congenital heart defect treated with the S-ICD with patients without CHDs, also S-ICD-treated.
The study found no incidence of appropriate shocks for the CHD cohort for ventricular arrhythmias and a 7.1% rate in the non-CHD group. Overall complication rates were similar in both groups, the researchers said.
The study showed that "the S-ICD is a safe option in CHD patients deemed to be at high risk for [sudden cardiac death] who do not have pacing indications," the researchers said. "Further research to accurately define SCD risk in the diverse anatomic substrates of CHD patients is warranted."
Boston acquired the S-ICD device when it bought Cameron Health for $1.35 billion in 2012.