New Hope for Heart Failure Patients
A Columbia study shows that patients with heart failure can live longer and better lives with an implanted mechanical device that assists the heartinstead of replacing it.
The study, published last November 15 in The New England Journal of Medicine, shows that end-stage heart failure patients who received an implantable left ventricular assist device (LVAD) lived significantly longer than patients who received medical therapy only. The majority of terminal heart failure patients receiving the HeartMate LVAD lived for over a year, half of those lived for two years or more, and eighteen patients receiving the HeartMate are still alive today, nearly five years later. Compare this to end-stage heart failure patients receiving medical therapy only: Only a quarter of that group in the trials lived for a year, and only 8 percent made it to the two-year mark.
In fact, the study was the first of its kind to show a substantial improvement in quality of life for patients who received mechanical devices. Each patient was monitored for pain, energy level, mental outlook, and ability to perform routine activities; while a five-point increase is considered meaningful, patients receiving the implant showed a seventeen-point increase.
This makes the findings of the study all the more astounding. If patients about to die could be given an extra year, let alone three or more, with improved function and quality to boot, implantable LVADs may well prove a viable alternative to heart transplants.
As medical technology has advanced, more patients survive heart attacks to live longer lives, which means that more of them eventually suffer heart failure. In the last two decades, the number of people dying of heart failure has more than doubled. So implantable LVADs could have a potentially enormous impact. I foresee that it will become like hemodialysis is to kidney disease, says Rose. Currently 300,000 patients receive hemodialysis. Thats larger than the population of Kansas City.
Roses study is called REMATCHfor Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure. The trials were designed by Columbias International Center for Health Outcomes and Innovation Researcha collaboration between the College of Physicians and Surgeons and the Mailman School of Public Healthwhich coordinated the trials at twenty different transplant centers around the country. Rose, chairman of Columbias Department of Surgery, was the principal investigator for the entire study and lead author of the article.
Its not the first breakthrough in pioneering surgical interventions for Rose, who celebrated his twentieth anniversary at Columbia last fall. In 1984, he performed the worlds first cardiac transplant on a child. (That patient graduated from college this year.) Since then, Rose has built Columbias cardiac transplant center into the worlds largest while shifting the focus of his own research toward mechanical cardiac assist devices.
LVADs are smaller and simpler than the artificial hearts designed to replace the heart altogether, and the study results lead Rose and others to question the hype surrounding artificial hearts. The role for artificial hearts is going to be relatively small, says Rose. Most of these patients with end-stage heart failure dont need total heart replacementplus, the remaining heart serves as backup for the mechanical device. Indeed, after REMATCH, it may be unethical to offer a patient an artificial heart that may only prolong their life by sixty days or so.
Rose and his colleagues at Columbia are also working on combining LVAD implantation with promising experimental therapies. Its possible that LVADs may someday offer us a bridge to recovery while new stem cells injected into the heart muscle replace damaged heart muscle, he predicts.
Based on the results of REMATCH, the HeartMate is expected to win FDA approval soon for primary treatment of end-stage heart failure in patients not qualifying for heart transplant. For Rose, REMATCH represents a point of inflection in the development of mechanical devices to support the heart. For the first time, he says, we have rigorous evidence that using machines to keep heart failure patients alive is no longer a dream; its a reality.
Elliot Stern, D.O.
Photos: Rose: Rene Perez. LVAD image: Courtesy of Thoratec Corporation.