Extravascular ICD Pivotal Study – Clinical Trial Review

Extravascular ICD Pivotal Study- Clinical Trial Review Extravascular implantable cardioverter defibrillator is a novel concept. Lead systems are considered to be the Achilles heel of conventional transvenous ICDs. To overcome this subcutaneous ICDs were developed, to avoid the vascular risks of transvenous ICDs. But they were not capable of overdrive pacing for ventricular tachycardia [1]. The lead of subcutaneous ICD is placed between the sternum and skin so that larger current is needed for pacing and defibrillation. This would mean a larger device with higher battery capacity. The extravascular ICD uses substernal electrodes which avoids the sternal bone between the electrode and the myocardium as in the case of subcutaneous ICD [2]. Extravascular ICD Pivotal Study was a prospective non-randomized premarket global clinical study involving patients with class I or IIa indication for an ICD [2]. The primary efficacy endpoint was successful defibrillation at implantation. Implantation was attempted in 316 patients of which 302 had induction of ventricular arrhythmia and defibrillation testing protocol completed. Success of defibrillation was 98.7%. 299 of the 316 patients were discharged with a working ICD system. Freedom from major system or procedure related complications at 6 months was 92.6%. The success rate of antitachycardia pacing was 50.8%. A total of 29 patients received 118 inappropriate shocks for 81 arrhythmic episodes. Eight systems were explanted without extr...
Source: Cardiophile MD - Category: Cardiology Authors: Tags: General Cardiology Source Type: blogs