“With the publication of the ADVANCE trial in Circulation, cardiologists and cardiac surgeons treating advanced heart failure will now have the opportunity to thoroughly review the excellent results our investigators obtained using the HVAD Pump to bridge their patients to transplant,” said co-principal investigator Keith Aaronson, professor in the Division of Cardiovascular Medicine and medical director of the Heart Transplant Program and Center for Circulatory Support at the University of Michigan, USA.
ADVANCE studied 140 patients from 30 US hospitals who received the HeartWare investigational device. The authors noted high rates of 180-day success and survival and improvements in quality of life and functional capacity for patients with end-stage heart failure that were similar to those seen with cardiac transplantation. Success was achieved for the primary endpoint by establishing non-inferiority between the investigational device and comparator arm of the study, which was derived from contemporaneous patients from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) [p<0.0001]. Success on the primary endpoint occurred in 92.0% of the investigational device patients in the per protocol study population, 90.7% of the investigational device patients in the safety study population and 90.1% of INTERMACS control patients.
The most common adverse events were typical of those previously reported for an axial design, continuous-flow pump, and included bleeding, infections, stroke and perioperative right heart failure.
“The high rates of success and survival, as well as improvements in quality of life and functional capacity detailed in the publication, support our belief that, if approved, the HVAD would offer patients with advanced heart failure a valuable new treatment option,” said Doug Godshall, president and CEO, HeartWare. “We are working closely with the FDA as they complete their review of our premarket application application for the HeartWare Ventricular Assist System as a bridge to heart transplant and look forward to their decision.”
“As we showed at our FDA panel meeting last month, some of the more challenging adverse events we observed in this initial study cohort have improved measurably in our continued access cohort by refining post-operative management techniques and by introducing sintered inflow cannulas which appear to be contributing to decreased thromboembolic complications” said Godshall.
The HeartWare Ventricular Assist System is under FDA review for a bridge-to-transplant indication. On 25 April 2012, the FDA’s Circulatory System Devices advisory committee voted nine to two 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. The advisory committee’s recommendation, while not binding, will be considered by the FDA in its review of the premarket approval application submitted for the HeartWare Ventricular Assist System in December 2010.
HeartWare has received CE mark for the HeartWare System in the European Union.