August 13, 2007
A heart pioneer: Total artificial heart patient nears one-year anniversary of receiving high-tech implant at U-M
First patient treated in Michigan since FDA approval
lived on device for three weeks, until a donated heart became available
ANN ARBOR, MI – A year ago, 42-year-old Phillip Hall was facing near-certain death, perhaps within weeks. But today, he’s about to celebrate his birthday, his tenth wedding anniversary — and the one-year anniversary of the day he was rushed into a University of Michigan operating room and implanted with a temporary total artificial heart that saved his life by replacing his own failing heart.
He and the U-M Cardiovascular Center quietly made a major milestone in Michigan history last fall, when a surgical team led by Francis Pagani, M.D., Ph.D., implanted the high-tech device in his chest.
It was his only hope: No other heart-assisting devices were a good option, because of his complex heart history and the severe failure of both sides of his heart. If he was going to survive long enough to receive a heart transplant, Hall would need to have a machine take over completely for both of his heart’s pumping chambers.
At the time, the U-M’s Center for Circulatory Support team was one of only five American teams certified to treat patients using the CardioWest temporary Total Artificial Heart, or TAH-t. Since then, four more centers have begun offering it; none are in Michigan.
In early September of 2006, Phil Hall agreed to be the U-M’s pioneer patient. And the rest, as they say, is history.
Three weeks to the day after receiving the artificial heart, Hall got the news that a donor heart had become available. He received his transplant on October 4 at U-M, also with Pagani as the lead surgeon and Jonathan Haft, M.D., assisting. A few weeks later he went home to Belleville, Mich. to recover further. Now, he’s well enough that he will soon begin taking classes toward a forensic science degree.
And now, Hall is ready to tell his story. “When told I had a 30 percent chance to live another two months, and no other options for my heart situation, I went through shock, disbelief and denial,” he says. “I learned everything I could about the TAH-t in a day and a half, and told Dr. Pagani, ‘I want to live – let’s do it.’ I thank God, my entire U-M medical team including all the doctors and nurses, and my family and friends. My life is a true gift from God.”
“It’s been quite a roller coaster ride,” his wife Beth Hall adds. “Every morning we open our eyes, we thank God for another day. We are truly blessed.” In addition to her husband’s heart trouble, the couple has been taking care of Phil’s nephew and two nieces for the past four years. And tragically, only 10 days after Phil received his new heart, his mother died. This spring, Beth lost her job.
Pagani, who heads the U-M Center for Circulatory Support and has treated many patients using a broad variety of heart-assisting devices, says he is pleased with his first TAH-t patient’s progress. “Mr. Hall is doing well, and his long term prognosis is very good,” he says. “The TAH-t was the best option by far from a selection of many devices that we offer, because his previous surgery complicated placement of an LVAD device that would have supported his heart’s left ventricle. The whole team, and Mr. Hall himself, deserve credit for the success.”
It all began in May of 2005, when Hall’s heart began to fail, and his heart muscle began to die, for unknown reasons – a condition called idiopathic cardiomyopathy. He had heart-valve surgery to improve his heart function temporarily. But by the time he was sent to U-M in April 2006, his heart was five times normal size – enlarged from trying to compensate for its weakened pumping power.
The U-M team placed him on the transplant list in May, and used medicine to stabilize his condition so he could go home. But by September, his condition had worsened and he’d lost 60 pounds.
In the operation, the lower portion of Hall’s own heart was removed and the TAH-t was connected to the remaining upper chambers and to his circulatory system. That allowed it to take over the heart’s two main jobs: pumping blood to the lungs and then pumping it to the body.
The TAH-t is the only temporary total artificial heart approved by the U.S. Food and Drug Administration, and has been implanted in more than 650 patients, many of whom were treated as part of the clinical trials that led to the FDA approval. It is a much-updated version of the one that was implanted in Barney Clark, who achieved fame in 1982 as the world’s first artificial heart patient. The TAH-t is manufactured by Syncardia Systems, Inc., of Tucson, Arizona.
A different device from a different manufacturer that was approved in fall 2006 serves another purpose: totally implantable and battery-powered, it is meant for patients who are not eligible for a transplant.
The TAH-t implanted in Hall is made up of two pumping chambers, or ventricles, that are connected to the major blood vessels that formerly led to and from the patient’s heart. Each of the ventricles is connected to a console outside the body, via an air hose that passes through the skin. The console pulses pressurized air to drive the pumping chambers, and monitors pump function. The TAH-t pumps 9.5 liters of blood per minute, the best of any heart-assisting device.
Although patients using the TAH-t cannot leave the hospital and must be near the console at all times, the device offers the chance to stay alive and regain function in vital organs until a transplant occurs, for select patients who have no other option. In fact, the one-year survival rate for TAH-t patients was 79 percent in a 2004 study that led to FDA approval of the device, compared with 46 percent for control patients who did not receive the device. One-year and five-year survival rates after heart transplantation among patients who had received a TAH-t as a “bridge” to human heart transplant were 86 and 64 percent. The U-M team will be participating in a trial evaluating a more portable console that will permit patients to be discharged and live at home while awaiting heart transplantation with the TAH-t.
With their TAH-t patient doing well, the U-M team is ready to evaluate other patients for possible use of the TAH-t, as it becomes part of the array of heart-assisting devices offered at U-M. In addition to the TAH-t and heart transplant, the U-M Center for Circulatory Support offers extracorporeal membrane oxygenation (ECMO), the Thoratec and HeartMate ventricular assist devices, the Novacor ventricular assist device, the investigational HeartMate II LVAD, the Orqis and TandemHeart devices that are attached to the circulatory system outside the body, and the Abiomed device.
Soon, they will begin recruiting patients for clinical trials of the Duraheart and Levacor rotary ventricular assist devices, which use a magnetically levitated rotor to pump blood. And earlier this year, the pediatric heart-assist team implanted its first child with the Berlin Heart, after receiving special permission from the FDA. For more information on advanced treatment for heart failure at the U-M Cardiovascular Center, visit www.umcvc.org or call toll-free 1-888-287-1082.
Written by Kara Gavin
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