Long term safety of S-ICD System defibrillatior published in Jo.American College of Cardiology-Boston Scientific

The Journal of the American College of Cardiology published data confirming the long-term safety and efficacy of the Boston Scientific Corporation S-ICD System (subcutaneous implantable defibrillator) for patients at risk of sudden cardiac arrest. The study, Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry was led by Dr. Martin Burke, professor of medicine at the University of Chicago. The analysis combined data from two large S-ICD studies to provide the most comprehensive look at S-ICD System patient outcomes to date. The S-ICD System – which was approved by the FDA in 2012 and which gained Category 1 CPT Codes in January – was shown to be highly effective, converting more than 98 percent of heart arrhythmias that can lead to sudden death. These data are comparable to efficacy outcomes found in transvenous ICD (TV-ICD) clinical trials (95-99%).

When assessing 889 patients with a total of 1,571 patient-years of follow-up, there were no lead failures and no systemic infections associated with the S-ICD System. The total rate of complications observed in this analysis was low relative to rates found in comparable TV-ICD studies. The rate of cumulative complications increased by just one percentage point annually after the first year (9% at one year; 10% at two years; 11% at three years). Major acute complications related to the operation were lower than observed in studies with TV-ICD (2% versus 3-5%).The all-cause mortality rate for the S-ICD patients was 1.6 percent per year, comparing favorably to observed mortality rates in similar TV-ICD studies (2.5-5.5% per year).