FDA approves HeartMate II mechanical heart pump for heart-failure patients

Heart failure patients at NewYork-Presbyterian Hospital/Columbia University Medical Center were among the first to be implanted with the HeartMate® II LVAS (Left Ventricular Assist System) -- a miniature mechanical pump that helps weak hearts pump blood -- that has now received approval by the FDA as of April 21 for broad use as bridge to transplantation. As part of clinical trials leading to approval, 22 patients received the new device at NewYork-Presbyterian/Columbia -- more than any other hospital in the New York area.

Clinical research studies at medical centers, including NewYork-Presbyterian/Columbia, showed the HeartMate II to be safe and effective, with improved quality of life and survival compared with historical norms for heart-failure patients. In addition, the device is designed to be quieter and more durable than other FDA approved devices.

One-eighth the size of the original HeartMate LVAS, the HeartMate II provides continuous blood flow through the circulatory system using only one moving part -- a rotary pumping mechanism.

"For patients whose hearts are unable to effectively pump blood due to severe heart failure, this remarkable device can help them have active lives as they await a heart transplant," says Dr. Yoshifumi Naka, principal investigator of the clinical research studies and director of cardiac transplantation at NewYork-Presbyterian Hospital/Columbia University Medical Center and associate professor of surgery at Columbia University College of Physicians and Surgeons.

With around 2,200 donor hearts available annually, there are large numbers of patients with end-stage heart failure placed on heart transplant waiting lists. These patients would be candidates to receive the HeartMate II LVAS as a therapeutic option to sustain them until transplant.

FDA approval was based on one-year follow-up data from the first 194 HeartMate II patients enrolled in the trial. Highlights included:

• Survival to cardiac transplantation, recovery or ongoing on HeartMate II support was 80 percent at six months and 77 percent at one year.

• Eighty-four percent of the patients survived to hospital discharge or transplantation.

• The incidence of major adverse events with comparable definitions -- including infections, strokes and bleeding requiring surgery -- was significantly lower than what was clinically observed in the previous bridge-to-transplantation study of the HeartMate VE LVAS (HeartMate II’s predecessor).

Currently, NewYork-Presbyterian Hospital/Columbia University Medical Center is participating in a clinical trial of HeartMate II as a long-term therapy (also known as destination therapy) that could potentially also serve as a permanent support option for these patients.

Source : New York- Presbyterian Hospital/Columbia University Medical Center