Study explores alternative to

by David Hyland

With four million Americans suffering from terminal heart failure, the outcome of a new national study may be the miracle they’re hoping for.
The study will test the effectiveness of a new mechanical implant, called the HeartMate VE, that takes over the heart’s pumping function. If successful, the device may serve as an alternative to heart transplants.
Later this month, University researchers at Fairview-University Medical Center will begin implanting the device as part of the study.
Leslie Miller, director of the cardiovascular division and the project’s co-investigator said that with 10 percent of people 70 years or older diagnosed with heart failure, the problem may only get worse.
“As our population gets older,” he said, “this disease is only going to be an ever-increasing problem to take care of.”
While the primary cause of heart failure is heart disease, or blockage of arteries, 40 percent of patients may develop it because of a virus, drugs or alcohol abuse.
Lack of available donor organs and the danger of drug treatments for those suffering from the disease’s advanced stages represent some of the key problems in treating heart failure.
While almost 100,000 Americans need heart transplants annually, Miller said only 2,500 donor hearts become available.
“The number of patients who would benefit from some kind of cardiac replacement is huge,” said Soon Park, the project’s co-investigator and assistant professor of surgery.
In these instances, researchers hope the HeartMate can help.
The new device replaces the mechanical function of the heart, pumping blood and restoring regular blood flow to the body.
Though at this stage it is a temporary support mechanism for those awaiting a transplant, researchers hope the device may also serve as an alternative to transplantation.
“One of the issues is to prove that this works,” Miller said. “The hypothesis of this study is that this will be a much more effective and cost effective type of intervention. These patients will survive longer and do better and have a better quality of life than what’s available today.”
To prove its effectiveness, the National Institutes of Health chose 20 institutions, including the University, to test the new device for the next two years.
Critical questions being examined by the tests are survival rates and the patient’s quality of life.
The way the study is being conducted, treatment candidates are randomly chosen. Patients will either receive conventional treatment or get the HeartMate within 24 hours. The surgery, which Park performs, takes between four and eight hours. Miller said patients have a 50/50 chance of receiving the HeartMate.
One of the reasons the University was chosen as a test site was its successful treatment for patients who used the first HeartMate. Since their first implantation of the device three years ago, University researchers enjoyed a 90 percent success rate as opposed to the national average of 70 percent.
Of the University’s 21 patients who received the original HeartMate, 15 later received a heart transplant while four are still waiting.
The University’s heart transplantation program is celebrating its 20th anniversary today, having performed more than 400 heart transplants since 1978.
Miller credits Park’s skill as a surgeon and the group’s approach to treating patients as an important factor in the University’s success.
Sofia Ormaza, coordinator for the study, said their success may stem from the patients’ involvement in the process.
“We all work together as a team and we consider the patient to be the captain of the team,” Ormaza said. “It’s their life.”
Researchers said the new HeartMate is a significant improvement over the first. The original, which was built by Thermo Cardiosystems Inc., was powered by an air compressor and transported on wheels. The new device — smaller and more portable than its predecessor — is fist-sized and runs on an electrical battery-powered motor.
Ormaza said the rechargable batteries are about the size of a cellular phone and must be changed twice a day.
Researchers said the device will help the patients that current treatments allow to slip through the cracks.
“The current medical management has done a lot for these people, but there’s a limit to it,” Park said. “Such a device would be enormously helpful.”
But for Miller, the new HeartMate does more than just buy time for patients.
“It’s not just a survival issue,” Miller said, “it’s to truly return them to a normal, functional capacity.”