(HealthDay News) – The subcutaneous implantable cardioverter-defibrillator (S-ICD System) is both safe and effective for the treatment of life-threatening ventricular arrhythmias, according to a study published in the Aug. 27 issue of Circulation.
Raul Weiss, MD, from The Ohio State University in Columbus, and colleagues prospectively studied adult patients with a standard indication for an ICD, who neither required pacing nor had documented pace-terminable ventricular tachycardia. The 180-day complication-free rate for the S-ICD System was compared with a pre-specified performance goal of 79% as the primary safety end point. The induced ventricular fibrillation conversion rate was compared with a pre-specified performance goal of 88% to evaluate primary effectiveness. Success was defined as two consecutive ventricular fibrillation conversions out of four attempts.
The researchers found that device implantation was attempted in 321 of 330 enrolled patients (74% male; mean age, 52 years), and was successfully implanted in 314 patients. Over a mean follow-up of 11 months both primary end points were met, with a 180-day system complication-free rate of 99% and an acute ventricular fibrillation conversion rate of over 90% in the entire cohort. In 21 patients there were 38 discrete spontaneous episodes of ventricular tachycardia/ventricular fibrillation recorded, all of which successfully converted. An inappropriate shock was received in 41 patients (13.1%).
“The findings support the efficacy and safety of the S-ICD System for the treatment of life-threatening ventricular arrhythmias,” the authors write.
Several authors disclosed financial ties to Cameron Health, which manufactures the S-ICD System and funded the study.