FDA Approves Heart Pump as Permanent Implant
Benefits Heart Failure Patients Ineligible for Transplant

End-stage congestive heart failure patients who do not qualify for heart transplantation due to age or other health circumstances now have a new treatment option.

On Nov. 6, the Food and Drug Administration approved the Thoratec HeartMate SNAP-VE left ventricular assist system as a permanent implant, called destination therapy. The agency’s approval is based on results of the landmark Randomized Evaluation of Mechanical Assistance in Congestive Heart Failure, or REMATCH, clinical trial that demonstrated the device nearly doubled and tripled survival at one and two years respectively, and improved patients’ quality of life.

The Texas Heart Institute at St. Luke’s Episcopal Hospital is one of the nation’s first cardiovascular centers to offer the HeartMate for use in destination therapy. Since 1986, physicians at the heart institute and St. Luke’s have implanted 178 HeartMate devices in patients waiting for transplants.

“There are more than 4 million people being treated for heart failure in the United States each year who are dying prematurely, for whom a transplant will never be an option. Only about 2,000 donor hearts become available each year. This is the first truly acceptable solution for long-term support of these patients because it allows them to leave the hospital and return to active, productive lives,” says O.H. “Bud” Frazier, M.D., chief of cardiopulmonary transplantation and director of surgical research at the Texas Heart Institute and chief of transplant service at St. Luke’s Episcopal Hospital. The cardiovascular surgeon and his research team have been involved in the development and testing of the HeartMate for more than 25 years.

The Texas Heart Institute at St. Luke’s originated the laboratory and clinical research of the device, and implanted the first 20 HeartMates in the world. Frazier and his team initiated the research which led to the REMATCH study and have implanted more of the devices than any other heart center worldwide.

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©2006 Texas Medical Center

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