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Updated 10:00 AM September 10, 2007
 

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  Research
Device helps heart transplant candidates while they wait

A new generation of implanted heart-assisting pump does very well at helping severely ill heart-failure patients survive, and thrive, until they receive a transplant, a new national study shows.

In addition to helping 75 percent of patients stay alive for at least six months or until a donor heart became available, the device also helped patients' original hearts regain function and allowed their other organs to heal by restoring blood flow. One patient recovered so fully that a transplant no longer was needed. Patients' quality of life also improved significantly.

"As a bridge to transplant, the HeartMate II is showing excellent survival, good recovery potential for the heart, kidneys and liver, and a favorable impact on quality of life," says Dr. Francis Pagani, co-lead author of the new paper and the director of the Center for Circulatory Support. "These results suggest it would be a very good addition to the options that physicians have for treating patients who require ventricular assistance while they wait for a new heart, and that it has the potential to last years rather than months."

The study results were published in the Aug. 30 issue of the New England Journal of Medicine by a team co-led by a Cardiovascular Center surgeon and a Washington Hospital Center cardiologist.

The experimental device is called the HeartMate II left ventricular assist device or LVAD. It is one of four in a new generation of heart-assisting implants that push the blood out of the heart in a continuous flow, rather than a pulsing flow approach used in older devices already on the market.

It also is much smaller than the older devices — about the size of a D-cell battery — giving it the potential to help more women, teenagers and smaller men with end-stage heart failure whose bodies aren't big enough for other devices. It's quieter and has a smaller tube leading into the implanted device from the controller and battery pack that are worn outside the body.

The study was designed and funded by Thoratec Corp., which makes the HeartMate II and a larger HeartMate LVAD that is already on the market, but the study's authors had independent access to the study data to prepare their analysis.

Although the study did not directly compare the HeartMate II with any other device, the results give further evidence that the new device is more reliable than previous heart-assisting implants. In fact, 68 percent of the 133 patients in the study still were relying on the device after one year while remaining on the heart transplant list. The same clinical trial also includes patients who aren't eligible to receive a heart transplant, and received the devices as a long-term destination therapy.

Pagani is an associate professor of cardiac surgery at the Medical School. He has led U-M's participation in numerous clinical trials of heart-assisting devices, including those of the original HeartMate device and the pilot HeartMate II that preceded the large study whose results are reported today. Dr. Keith Aaronson, medical director of U-M's heart failure program, is a co-author of the new paper.

The co-lead author on the paper is Dr. Leslie Miller, a noted cardiologist formerly at the University of Minnesota who is now the director of cardiology programs at Washington Hospital Center.

Currently adults who need a heart transplant wait an average of 170 days, but nearly 30 percent are still waiting even after two years on the transplant list, according to the United Network for Organ Sharing. As of late August, 2,640 Americans of all ages are waiting for a heart transplant.

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