FDA perspective on assessing the clinical benefit of cardiac resynchronization and implantable cardioverter-defibrillator devices

Over the past couple of decades, the clinical benefit of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices has been shown in several large randomized controlled trials [1 –5]. ICDs have been shown to reduce the risk of sudden cardiac death and ventricular fibrillation, and CRTs have been shown to benefit patients with heart failure in terms of improvements in cardiac function, with a reduction in mortality and heart failure hospitalizations. Given the rapid pace of technological advances in electrophysiology devices over the last decade and the widespread use of these devices, it seems a distant memory when the risks and benefits of ICDs and CRTs were being evaluated as a new emerging technology.

Source: Journal of Electrocardiology - August 18, 2018 Category: Cardiology Authors: Kimberly A. Selzman Source Type: research