Data from a long-term post-approval registry study of the S-ICD subcutaneous pacemaker made by Boston Scientific (NYSE:BSX) showed high successful implantation rates and “acceptable” short-term complication rates, researchers said today at the annual Heart Rhythm Society conference in Chicago.
The study looked at data from 1,637 S-ICD patients who met the criteria for implantable cardioverter defibrillator implantation, passed at least 1 electrocardiogram screening vector and had a life expectancy of more than 1 year. The mean follow-up time was 2 years and the study plans to follow patients out to 5 years.
Conversion of induced ventricular tachycardia/ventricular fibrillation was successful in 98.7% of patients, with 1st shock conversion achieved in 95.6%. The 30-day complication rate was 3.8% including an infection rate of 1.2%; women and patients with diabetes were more likely to experience complications.
“Contemporary U.S. patients implanted with an S-ICD are younger with more end state renal failure but otherwise have similar co-morbidities and clinical characteristics as transvenous ICD patients. Implantation success is high and short term complication rates are acceptable. At the time of presentation, mean follow-up will be 2 years; follow-up will continue to 5 years for all patients,” according to the study.
