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Landmark REMATCH Trial Proves Benefits of Heart Pumps for Heart Failure Patients
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The pump device is implanted into the upper part of the abdominal wall.
A tube from the pump fits into the left ventricle, draining blood from the ventricle into the device.
The pump then sends the blood into the aorta, the artery that sends oxygen-rich blood to the brain and the rest of the body.
Another tube extends outside the body and is attached to a small battery pack that is worn on a shoulder holster, and a control system, which can be worn on a belt. |
A three-year landmark multicenter clinical research trial has shown that implanted heart pumps can extend life and improve the quality of life of terminally ill heart failure patients.
Eric A. Rose, MD, Surgeon-in-Chief, Columbia University Medical Center, NewYork-Presbyterian Hospital and Chairman of the Department of Surgery of Columbia University College of Physicians & Surgeons, led the study, known as REMATCH, for Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure.
Investigators at Columbia University's International Center for Health Outcomes and Innovation Research, directed by Annetine C. Gelijns, PhD, supervised data collection and results for REMATCH.
Findings of the approximately $25 million trial were published in November in the New England Journal of Medicine, and results were presented at the 2001 American Heart Association meetings in Anaheim, CA, on November 12.
Media covering REMATCH included the New York Times, Wall Street Journal, NBC Nightly News, USA Today, New York Newsday, and all local New York City network affiliates.
The Thoratec HeartMate™ is roughly the size of a compact disc player. It has a textured surface that lowers the probability of clot formation. |
The researchers 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.
Furthermore, the pump device enhanced quality of life; patients felt better, were less depressed, and more mobile than those in the other group.
The differences were statistically significant for patients with the device one year after implantation.
Patients participating in the REMATCH trial were not eligible for a heart transplant.
"This trial transforms decades of hopeful research into the development of man-made machines to support the failing heart into a successful long-term treatment," Dr. Rose said.
Columbia University, the National Heart, Lung and Blood Institute (NHLBI), and Thoratec Corporation, the Pleasanton, CA-based manufacturer of the HeartMate™ VE device used in the trial, collaborated in developing the study's design.
The design was novel because it included clinical, regulatory, and economic components and established careful date flow and analysis guidelines to prevent bias.
The International Center for Health Outcomes and Innovation Research is a collaboration among Columbia's Mailman School of Public Health, the College of Physicians & Surgeons, and the Department of Surgery.
Based on the results, the FDA has allowed Thoratec to offer the HeartMate™ VE to six surviving patients in the medical management arm of the trial. To date, three of these patients have chosen to have the device implanted. The agency also has allowed the company to include an additional 30 patients in the trial.
"Heart failure affects an estimated 4.7 million Americans, with 550,000 new cases diagnosed each year," says Dr. Claude Lenfant, NHLBI director. "This compelling study shows that even with a high rate of complications, a left ventricular assistance device can provide a significantly longer and better quality of life in extremely ill heart failure patients for whom no other meaningful therapy is available."
With the data from the trial, the investigators are now comparing the cost of implanting the device with the cost of maintaining patients with drugs and medical management. This information could help Medicare and private insurers determine reimbursement policies, if the FDA approves its use.
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