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FDA Approves Implanted Heart Pumps That Lengthen and Improve Lives of Terminally Ill Heart Failure Patients

Landmark Study Led By Columbia University Medical Center Researchers Leads To FDA Approval

NEW YORK (Nov 7, 2002)

Almost one year after Columbia University Medical Center researchers completed a three-year landmark clinical trial that found implanted heart pumps lengthen and improve the lives of terminally ill heart failure patients, the Food and Drug Administration has approved the pump for use by patients who are ineligible for transplant.

The pump, known as the HeartMate VE, is manufactured by the Pleasanton, Calif.-based Thoratec Corp. Previously the FDA would allow the use of implanted pump devices only as a bridge to transplantation and after certain types of cardiac surgery. The pump will be implanted in patients at Columbia University Medical Center.

Results from the nationwide trial, supervised by investigators at Columbia University's International Center for Health Outcomes and Innovation Research, 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 one year.

The team found that patients with the implanted device had a 52.1 percent chance of surviving a year, compared with a 24.7 percent survival rate for patients who took drugs and were medically monitored. The likelihood of survival for two years in patients with the device was 22.9 percent vs. 8.1 percent in the other group.

The findings of the so-called REMATCH, or the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure, were published in the Nov. 12, 2001, New England Journal of Medicine and presented at the 2001 American Heart Association scientific sessions in Anaheim, Calif.

The device, technically called a left ventricular assist device or LVAD, works by assisting the function of the heart's left ventricle, which becomes weakened in congestive heart failure. The implanted device's pumping mechanism ensures circulation of the blood from the left ventricle to the aorta, the artery that supplies oxygen-rich blood to the brain and the rest of the body.

"Our team is thrilled that the FDA recognizes the need to transform medical care for people with end-stage heart failure," says Dr. Eric Rose, chairman of surgery at Columbia University Medical Center and Morris and Rose Milstein/Johnson & Johnson Professor of Surgery at Columbia University College of Physicians & Surgeons. Dr. Rose, also principal investigator of the study, adds, "This therapeutic option could benefit up to 100,000 people who are terminally ill with end-stage heart failure for whom transplant is not possible."

Under the direction of Dr. Annetine C. Gelijns and Dr. Alan J. Moskowitz, both associate professors at Columbia University College of Physicians & Surgeons, researchers at the International Center for Health Outcomes and Innovation are currently analyzing the costs associated with LVAD therapy and medical management of patients with end-stage heart failure. These data will be used to calculate the cost-effectiveness of using LVAD therapy compared to state-of-the-art medical therapy, which will be critical to establishing the societal value of mechanical circulatory assist devices for treating this growing population of patients.