Mayo receives CMS designation as a Destination Therapy Facility

Friday, November 14, 2003

Mayo Clinic in Jacksonville has been designated Florida's first Destination Therapy Facility by the Centers for Medicare and Medicaid Services (CMS). The designation means that Medicare will reimburse for the surgical implantation of HeartMate Left Ventricular Assist System (LVAS) as a permanent treatment for patients with end-stage heart failure. These people are not candidates for heart transplantation, either because of age or other health issues. The use of LVAS for this purpose is called "destination therapy." The LVAS remains implanted the remainder of the patient's life with no expectation of removing it. The CMS designation came Nov. 6, a year to the day after the Food and Drug Administration (FDA) approved the use of the HeartMate LVAS for destination therapy.

The HeartMate LVAS is a mechanical circulatory assist device. The pump, not much bigger than a hockey puck, is surgically implanted within the abdominal wall. It supports blood circulation by taking the place of the patient's weakened the left ventricle. A tube attached to the left ventricle channels blood from the heart to the pump. The pump then propels blood through another tube attached to the patient's aorta, the body's main artery. A power line comes through the skin connecting the pump to external batteries, which are carried in a vest.

The HeartMate LVAS can dramatically restore a patient's cardiac output. It has been shown to significantly prolong the life of individuals with end-stage heart failure and to greatly improve their quality of life.

Mayo Clinic surgeons have implanted ventricular assist devices since the clinic's heart transplant and mechanical circulatory support programs opened in January 2001.

"Destination therapy is an exciting area that is just beginning to develop," says Dr. Lawrence McBride, surgical director of the heart transplant program. "With FDA approval, destination therapy has become an accepted way of treating patients with very advanced end-stage heart failure."

McBride sees the group of patients eligible for destination therapy expanding, especially since the next generation of ventricular assist devices is now being developed. "The entire system will be implanted within the body," McBride says, "Energy will be transmitted across the skin. Nothing will actually violate the skin barrier itself. So in the continuum of things, it's a progression toward providing more independent living with a better quality of life for the patient."

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