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December 3, 2003

UPMC approved for use of heart device

UPMC is among the first centers to receive approval from the Centers for Medicare & Medicaid Services (CMS) to implant left ventricular assist systems (LVAS) approved by the U.S. Food and Drug Administration (FDA) as destination therapy for heart failure patients who do not qualify for transplantation.

Currently, the only FDA-approved device for destination therapy, or permanent support, is Thoratec Corp.’s HeartMate XVE LVAS.

Assist devices are used most often as a bridge to transplantation. In some cases, the devices allow the heart to heal and heart transplantation is avoided. Until FDA and CMS granted approval of the HeartMate system, patients not considered candidates for transplantation did not have the option of being supported with current devices.

“We are pleased to be able to offer this treatment, which marks a new era for the use of ventricular assist devices,” stated Robert L. Kormos, professor of surgery at Pitt’s medical school and director of UPMC’s artificial heart and cardiothoracic transplant programs.

“For more than 15 years, our artificial heart program, in conjunction with UPMC’s congestive heart failure program, has been a key player in the evolving use of mechanical support. We have always kept in focus the ultimate use of these devices as replacement or destination therapy for those who do not qualify for heart transplantation,” Kormos added.

Destination therapy is for patients who require permanent mechanical heart support. Specifically, Medicare approval covers those patients with chronic end-stage heart failure who have a life expectancy of less than two years and who do not qualify for transplantation. Patients must meet additional medical criteria.

In order to qualify for Medicare approval, centers must have performed at least 15 bridge-to-transplant or destination-therapy ventricular assist device (VAD) implants through the National Institutes of Health- and Thoratec-sponsored Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial.

Since its inception in 1985, UPMC’s artificial heart program has supported nearly 250 patients on assist devices for a period of time that equates to more than 50 years.

UPMC was the first center to discharge a patient still on a device to await a human donor. Based on UPMC’s experience, the FDA later allowed patients implanted with the Novacor to be discharged to await heart transplant.

Filed under: Feature,Volume 36 Issue 8

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