Outcomes in Patients With Congenital Heart Disease Receiving the Subcutaneous Implantable-Cardioverter Defibrillator: Results From a Pooled Analysis From the IDE Study and the EFFORTLESS S-ICD Registry.
Abstract
This study was conceived to determine the safety and efficacy of the subcutaneous implantable cardioverter-defibrillator (S-ICD) in patients with congenital heart disease (CHD). The S-ICD is a treatment option for patients with CHD in which a transvenous device is contraindicated due to anatomic considerations. However, efficacy in this group has not been determined. A pooled analysis of 865 patients in the EFFORTLESS (Evaluation of Factors Affecting the Clinical Outcome and Cost-Effectiveness) registry (an international observational database) and a U.S. Investigational Device Exemption study were reviewed. Nineteen CHD patients versus 846 non-CHD patients with a median follow-up of 567 days and 639 days, respectively, were included. There were no deaths and no appropriate shocks for ventricular tachycardia/ventricular fibrillation in the CHD cohort, versus 26 deaths (3.1%, p = 0.42) and 111 appropriate shocks in 59 patients (7.1%) in the non-CHD cohort (p = 0.23). There were similar complication rates for the CHD versus non-CHD groups (10.5 vs. 9.6% [p = 0.89]), with inappropriate shocks for T-wave oversensing as the only complication in the CHD group (n = 2). The rate of inappropriate shocks was similar for both groups (10.5...Continue Reading
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