FDA Approves HeartMate as Alternative to Heart Transplant

The U.S. Food and Drug Administration has approved use of the HeartMate assist device, normally used to keep patients alive until a heart transplant, as a permanent alternative to heart transplantation.

The battery-powered heart pump, implanted just above the diaphragm, does not replace a weekened heart but takes over much of the pumping performed by the left ventricle.

A long waiting list for heart transplants and the requirement that transplant patients be in otherwise good health has resulted in a number of patients receiving HeartMates to keep them going, and help them improve their condition, while awaiting a heart transplant.

But the application for permanent use of the device was filed after a study called the Rematch trial found that patients using the HeartMate had half the death rate of heart failure patients treated with medication alone, as well as an improved quality of life.

With the FDA decision, HeartMates now can be implanted in less-healthy patients who are not candidates for a heart transplant.

"I think it's really going to make a fundamental change in how we treat heart failure," said Dr. Robert Kormos of the University of Pittsburgh Medical Center.

LKormos estimated that perhaps 25,000 patients a year might benefit from permanent use of an implantable heart pump -- ten times the number who were able to obtain heart transplants last year.

In addition to the HeartMate, another device, the Novacor, is undergoing evaluation as a permanent alternative to transplant.

The total cost of implanting the pump is estimated to be about $160,000. The federal Centers for Medicare and Medicaid Services covers this cost for pumps used as a bridge to transplant but has not yet established a reimbursement policy for their permanent use.

The HeartMate is about 4 inches in diameter, 2 inches thick, and weighs just over 2 pounds. Batteries for the device remain outside of the patient's body, carried in holster-like garments.

Other sources: FDA, Pittsburgh Post-Gazette