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Columbia University Medical Center Instrumental in Clinical Research Leading to Medicare and Medicaid Approval To Cover Heart Pump

NEW YORK (Oct 3, 2003)

The Centers for Medicare and Medicaid Services (CMS) will provide coverage for the use of Left Ventricular Assist Devices (LVADs), heart pumps for chronic end stage heart failure patients who are ineligible for heart transplant, giving hope to thousands of desperately ill heart patients. Physician-scientists from Columbia University Medical Center's Department of Surgery were instrumental in proving the clinical efficacy of the HeartMate VE LVAD, leading a three-year clinical trial that found the implanted device lengthens and improves the lives of terminally ill heart failure patients.

Results from the nationwide REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Hearth Failure) trial, supervised by investigators at Columbia University's International Center for Health Outcomes and Innovation Research (InCHOIR), found that use of the implanted heart pump with wearable controls more than doubled the likelihood that terminally ill heart failure patients—who were either too sick or too old to get a heart transplant—would be alive at the end of the year. The study, published in the November 2001 New England Journal of Medicine, led to approval by the FDA in November 2002 for use by patients who are ineligible for heart transplant. This marked the first time that a ventricular assist device has been approved to provide permanent support for these patients.

"The REMATCH trial demonstrated that LVAD improves net health outcomes both qualitatively and quantitatively for this group of patients, with significant survival and quality of life benefit," said Dr. Eric Rose, principal investigator for the trial, surgeon-in-chief at Columbia University Medical Center and the Morris and Rose Milstein/Johnson & Johnson Professor of Surgery at Columbia University College of Physicians & Surgeons. "As a result of the REMATCH trial and the decision by CMS, LVAD's will now be available to the sickest of the sick across the country."

Under the new Medicare approval, HeartMate VE can be used to support chronic heart failure patients who have received medical therapy for at least 60 of the last 90 days, have a life expectancy of less than two years and are not candidates for cardiac transplantation. The REMATCH trial compared two groups of patients who did not qualify for heart transplantation. One group received the HeartMate VE and the other group received treatment with medical management involving drug therapy, diet and exercise. The study took place at 21 prestigious transplant centers in the U.S. with 68 patients implanted with the HeartMate VE and 61 treated medically. The study was a collaboration among the National Institutes of Health, Columbia University and Thoratec.

LVAD's are specifically designed to take over the pumping function of the portion of the heart called the left ventricle. The device, which is implanted in the patient's chest, consists of an electric motor and a driveline. Blood fills the pump through a tube placed in the left ventricle. The pump's motion propels blood into the aorta and the rest of the body. When the motor completes each revolution, the diaphragm moves down and blood from the left ventricle again fills the pump. Because the LVAD system is relatively easy to use, patients and their families can maintain it outside the hospital setting.

Manufactured by Thoratec Corporation of Pleasanton, California, the HeartMate is the first and only LVAD approved for long term use.