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Media Inquiries: 434-924-5679 U.Va. HEALTH SYSTEM WINS MEDICARE APPROVAL FOR MECHANICAL HEART FAILURE TREATMENT |
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There’s a new option for seriously ill heart failure patients in Virginia and the mid-Atlantic who are not eligible for a heart transplant – a mechanical heart. The Centers for Medicare and Medicaid Services (CMS) has named the University of Virginia Health System the fifty-eighth medical center in the nation to be able to use the mechanical, implanted left ventricular assist device (LVAD) as a final or “destination” treatment for end-stage heart failure. Previously, the device was only used to keep transplant patients alive while they waited for a donor heart. U.Va. and Sentara Norfolk are the only hospitals in Virginia approved to use LVAD’s as a long-term, destination treatment for heart failure. To win approval by CMS, medical centers need to have performed at least sixteen LVAD procedures in the last three years. The decision means that U.Va. can now use LVAD’s as destination treatment and be reimbursed by CMS. Until recently, medication was the only option for heart failure patients ineligible for a transplant, usually because of age or chronic diseases in other organs. “There were groups of heart failure patients on whom we could not use the left ventricular assist device simply because they were not transplant candidates,” said Dr. James D. Bergin, associate professor of internal medicine and medical director of the heart failure and cardiac transplantation program at U.Va. “We can use LVAD’s on selected individuals who have failed all previous therapies for heart failure. It’s not going to make them live forever, but we can help patients we could not help before. This also allows us to cover the commonwealth with two major medical centers, so no one has to travel too far if an LVAD is an appropriate therapy for them,” Bergin said. An LVAD is a small mechanical pump, powered by an external plug or by wearable batteries, which is surgically implanted in a heart patient. U.Va. uses a third generation version of the HeartMate device manufactured by Thoratec, Inc. of California. It was approved for destination therapy for heart failure by the Food and Drug Administration (FDA) in 2002. The left ventricle performs about 80 percent of the heart’s work, supplying oxygenated blood to the body. When the ventricle becomes weak in heart failure, the HeartMate device takes over. Implanted in the abdomen below the diaphragm, the device collects blood from the ventricle through a conduit attached to the lower tip of the heart. Blood is then propelled by a special pump to the aorta, which carries it to the rest of the body, nourishing the brain, liver, kidneys and other vital organs. “This is a very portable device,” Bergin said, “and allows patients to live as normal a life as possible with heart failure. Patients can wear a battery pack to get around or they can plug in and do their work at an office. When it works well, the HeartMate works nicely.” The main downside to the device, Bergin said, is that it requires a large open-chest operation, usually bigger than bypass surgery. Infection can also be a serious risk since the device must be attached to a power source through the skin. According to Bergin, investigators in clinical trials reported last year that the two-year survival rate for end-stage heart failure patients using an LVAD was 29 percent, compared to eight percent for patients taking medication alone. February 10, 2004 |