Exciting Times for Heart-assisting Devices

Once upon a time, people whose hearts were failing had two choices: hope that their own heart kept pumping until they could receive a transplant, or face a certain death, which they might fend off for a while using medicines.

But the last decade has brought incredible advances in technologies that help a failing heart keep pumping. New devices – including one approved by the U.S. Food and Drug Administration on April 21 – are giving patients a better chance at receiving a transplant, or even helping them survive without getting a new heart.

Now, the University of Michigan Cardiovascular Center has become only the third center in the country to be certified independently for its heart-device program.

The certification recognizes the broad range of services and high quality of care for advanced heart failure patients at U-M, which offers adults and children access to nearly a dozen heart-assist devices and a full range of medical and surgical care.

U-M is one of the nation’s most experienced programs offering such devices.

The certification comes from the Joint Commission, which accredits health care organizations and recently began certifying centers that offer ventricular assist devices, or VADs – the umbrella term for devices that help the heart pump blood.

Also this week, U-M’s heart team is celebrating the FDA approval of the HeartMate II, an implanted device about the size of a D-cell battery that promises to help even more patients survive the wait for a transplant.

U-M cardiac surgeon Francis Pagani, M.D., Ph.D., helped lead the national clinical trial that tested HeartMate II in hundreds of patients at 44 hospitals nationwide – including U-M, where 57 patients received the device between 2004 and early 2008.

The results of that trial were published in August 2007 in a paper in the New England Journal of Medicine, and were used in the FDA application by Thoratec, Inc., which makes the HeartMate II as well as its predecessor the HeartMate XVE.

Pagani welcomes both the FDA approval and the new certification program as signs that heart-assist devices have come into their own as an option in heart care.

“When we first began implanting early long-term devices in 1996, we dreamed of a time when we could have a technology to suit every patient, no matter what their condition,” he says. “With HeartMate II, and other devices now in clinical trials or already in use, we are much closer to that dream. And the new certification program can give patients and their families confidence that they will get the best possible care from an experienced team before, during and after their device implantation.”

Pagani, associate professor of cardiac surgery at the U-M Medical School, heads the U-M Center for Circulatory Support, which includes surgeons, cardiologists, intensive care specialists and nurses who focus on patient care, research and education in mechanical circulatory support.