Positive data from ADVANCE trial of Ventricular Assist Device (HeartWare) for Heart Failure patients

Updated results from the ADVANCE trial evaluating the use of the Ventricular Assist Device, from HeartWare, as a bridge to heart transplantation demonstrate the potential utility of the pump to improve treatment outcomes for end-stage Heart Failure patients. Success for the primary endpoint was judged by establishing non-inferiority between the HeartWare device and data derived from contemporaneous patients from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). Success on the primary endpoint occurred in 92.0% of the investigational device patients, 90.7% of the investigational device patients in the safety study population and 90.1% of INTERMACS control patients. The most common adverse events included bleeding, infections, stroke and perioperative right heart failure. The company says that some of the adverse events observed in the initial study cohort has been improved. The HeartWare Ventricular Assist System is under FDA review for a Bridge-to-Transplant indication. On April 25, 2012, the FDA's Circulatory System Devices Advisory Committee voted 9 to 2 that the benefits outweigh the risks for the use of the HeartWare Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure. See:"Use of an Intrapericardial, Continuous Flow, Centrifugal Pump in Patients Awaiting Heart Transplantation." Circulation, May 22, 2012 DOI: 10.1161/CIRCULATIONAHA.111.058412