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Landmark clinical trial at 22 medical centers finds implanted heart pumps lengthen and improve lives of terminally ill heart failure patients

he trial, collaborated in developing the study's design. The design was novel because it included clinical, regulatory and economic components and established careful data flow and analysis guidelines to prevent bias.

The researchers say the results imply that such devices soon might be routinely employed as another choice in the medical management of terminally ill heart failure patients. This therapeutic option could benefit up to 100,000 people who are terminally ill with end-stage heart failure, for whom transplant is not possible.

Currently, the Food and Drug Administration allows the use of implanted pump devices only as a bridge to transplantation and after certain types of cardiac surgery. Approximately 4,000 people are on U.S. heart transplant lists, but only 2,733 donor hearts were available worldwide in 1999.

The devices do not offer the same longevity and quality of life as transplants, the researchers say. But more research with next-generation devices and better management of patients with devices could lead to better outcomes.

In the trial, 68 patients whose average age was 66 years old obtained the device, while 61 patients, whose average age was 68 years old, were assigned to the medical management arm of the trial, in which patients received drug therapy and aggressive medical monitoring.

The pump device, technically called a left ventricular assist device or LVAD, works by assisting the function of the heart's left ventricle, which becomes weakened in congestive heart failure. The implanted device's pumping mechanism ensures circulation of the blood from the left ventricle to the aorta, the artery that supplies oxygen-rich blood to the brain and the rest of the body.

Besides increasing the life span of the patients, the pump device enhanced quality of life. These patients felt better, were less depressed, and were more mobile. These psychological and physical findings were statistically signif
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Contact: Annie Bayne
as862@columbia.edu
Columbia University Medical Center
15-Nov-2001


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