Nov. 12, 2001

Landmark Clinical Trial at 22 Medical Centers Finds Implanted Heart Pumps Lengthen and Improve Lives of Terminally Ill Heart Failure Patients Study provides the first proof that machines can offer a long-term treatment for the failing heart

Implanted heart pumps can extend and improve the quality of life of terminally ill heart failure patients, a three-year landmark study of 129 patients at 22 major medical centers has found.

Supervised by investigators at Columbia University's International Center for Health Outcomes and Innovation Research, the multi-center and multi-sponsored REMATCH* trial found that the use of an implanted heart pump with wearable controls more than doubled the likelihood that terminally ill heart failure patients would be alive at the end of one year. These patients were either too sick or too old to be candidates for a heart transplant.

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.

The findings of the approximately $25 million trial are being published in the November 12 early web site edition of the New England Journal of Medicine.Ê The results are being presented the same day at the 2001 American Heart Association scientific sessions in Anaheim, Calif.

*Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure

"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," says Dr. Eric Rose, chairman of surgery at Columbia Presbyterian Medical Center of NewYork-Presbyterian Hospital, the Morris and Rose Milstein/Johnson & Johnson Professor of Surgery at Columbia University College of Physicians & Surgeons, and principal investigator of the study.

Columbia University, the National Heart, Lung and Blood Institute (NHLBI), and Thoratec Corporation, the Pleasanton, Calif.-based manufacturer of the HeartMateâ 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 data 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, College of Physicians and Surgeons, and the department of surgery.

The researchers say the results imply that such devices soon might be routinely employed as another choice in the medical management of terminally ill heart failure patients. 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.

Currently, the Food and Drug Administration allows the use of implanted pump devices only as a bridge to transplantation and after certain types of cardiac surgery. Approximately 4,000 people are on U.S. heart transplant lists, but only 2,733 donor hearts were available worldwide in 1999.

The devices do not offer the same longevity and quality of life as transplants, the researchers say. But more research with next-generation devices and better management of patients with devices could lead to better outcomes.

In the trial, 68 patients whose average age was 66 years old obtained the device, while 61 patients, whose average age was 68 years old, were assigned to the medical management arm of the trial, in which patients received drug therapy and aggressive medical monitoring.

The pump 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.

Besides increasing the life span of the patients, the pump device enhanced quality of life. These patients felt better, were less depressed, and were more mobile. These psychological and physical findings were statistically significant for patients with the device one year after implantation.

Based on the results, the FDA has allowed Thoratec to offer the HeartMateâ 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.

"The REMATCH data proved to be so significant that Thoratec has submitted it to the FDA to seek approval to make the HeartMateâ VE available as soon as possible to congestive heart patients who are not eligible for cardiac transplantation," says D. Keith Grossman, president and CEO of Thoratec. "Thoratec is very appreciative of the collaboration among NHLBI, Columbia University, Dr. Rose and each of the investigators that has resulted in the realization of a goal the entire circulatory support industry has been striving toward for decades."

The researchers chose HeartMateâ VE because it has a textured surface that lowers the probability of clot formation even in the absence of anticoagulant, or clot-preventing, drugs. Thoratec, which provided the devices at no cost and paid for some medical care for the patients, also was willing to put its device through a rigorous randomized trial.Ê

The investigators acknowledge that more research needs to be done to overcome some serious problems with the therapy, including infection and device failure.

"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.