VAD for Permanent Treatment of CHF

A left ventricular assist device (VAD) can now be used permanently to treat patients with end-stage congestive heart failure who do not qualify for a heart transplant and have a life expectancy of less than two years, according to the US Food and Drug Administration (FDA), which has cleared the device for this use.

The VAD, called HeartMate, is implanted alongside the natural heart and takes over the pumping function of the left ventricle for patients whose hearts are too damaged or diseased to produce adequate blood flow. Since 1998, the device has been used as a bridge-to-transplant. The new treatment protocol, known as destination therapy, expands the way mechanical-assist devices can be used, states Thoratec Corporation (Pleasanton, CA), which developed HeartMate. To date, the company says that HeartMate assist devices have been implanted in more than 3,400 patients in 22 countries.

The FDA's decision was based on data from a large clinical trial in which 129 CHF patients participated, all of whom were not eligible for a heart transplant. Of these, 68 were implanted with the HeartMate, and 61 were treated medically. The results of the trial showed that HeartMate nearly doubled and tripled survival over the drug therapy group at one and two years, respectively. Median length of survival for VAD patients was 408 days compared with 150 days for patients in the drug therapy group, with the longest-living VAD patient still alive at over three years.

"In the last few years device therapy, while initially invasive, has demonstrated much better patient tolerance and effectiveness than drug therapy,” said Dr. Leslie W. Miller, chief of cardiology at the University of Minnesota (Minneapolis, USA) and one of the investigators. "This means that device therapy may soon surpass the efficacy of medical therapy and become the treatment of choice in treating selected patients with end-stage heart failure.”




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U. of Minnesota