The Pooled Analysis combines the IDE Study and the EFFORTLESS Registry to evaluate complications and clinical outcomes. This analysis demonstrates worldwide experience for the safety and efficacy of the S-ICD System over a longer follow-up period and in a larger diverse population by pooling the databases.1
The Pooled Analysis, published in the Journal of the American College of Cardiology, supports the long term safety and efficacy of the S-ICD System in a broad range of patients. 43% of the patients in this analysis were primary prevention patients with reduced ejection fraction who were at high risk of sudden cardiac death. The analysis followed 882 patients enrolled for an average of nearly 2 years.1
1) No systemic infections, endocardities, cardiac injuries and electrode failures in this analysis.1
2) Lower acute major complication rate (Hematoma, lead or device mal-position or displacement, pneumothorax) when compared to studies with TV-ICD, likely because S-ICD doesn't require vascular access.1
3) 98.2% spontaneous shock efficacy was similar to results found in TV-ICD studies in treating spontaneous arrhythmias.
4) Appropriate patient identification, operator experience and adoption of Dual Zone Programming demonstrated a trend of 34% reduction in Inappropriate Shock over time to a 4.5% incidence rate at 6 months.1
5) Advances in operator experience associated with patient identification, prep and implant technique have further reduced infections and implant complications for S-ICD System.1