Exciting times for heart-assisting devices at U-M
Cardiovascular Center becomes one of the first certified centers in U.S., while new device tested at U-M gets FDA approval
ANN ARBOR, Mich – 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 one of the first centers 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.
The U-M Center for Circulatory Support is also working with the Ann Arbor-based Terumo Cardiovascular Systems Corporation. TCVC is a sister company of Terumo Heart Inc., also based in Ann Arbor, which makes an experimental VAD called the DuraHeart. That device will have its first test in a clinical trial that will begin later this year, with Pagani as co-leader.
The HeartMate II is the latest in a string of VADs and other devices to receive approval from the FDA. Smaller and lighter than previous devices, it can be implanted in women, smaller men and adolescents who were previously not able to receive the HeartMate XVE. It connects through the skin to an external system controller that regulates the speed of the rotary pump. A power cable connects the device to a small monitor and power base unit, or patients can roam for hours using a wearable battery pack.
The HeartMate II has allowed 77 percent of patients to survive up to a year while they waited for a transplant, or while they recovered without a transplant. It has also resulted in fewer complications than previous devices, including infections, strokes and surgical bleeding.
U-M also offers heart-assist devices for cardiogenic shock, a severe acute condition that can kill quickly if not treated, and for children whose hearts are failing due to congenital defects or infections of the heart muscle.
One U-M patient, Maddie Shaw, recently celebrated her fourth birthday on the same day that she observed her one-year anniversary of living with an Excor Pediatric device, also called a Berlin Heart. She received the device under an FDA exemption, but more children may now receive it at U-M and a handful of other centers through a new clinical trial.
Maddie has spent more than a year in the Pediatric Cardiothoracic Intensive Care Unit at U-M’s C.S. Mott Children’s Hospital, waiting for a transplant while the device keeps her alive. She holds the American record and is approaching the world record for number of days on the device.
Meanwhile, U-M offers certain adult patients the CardioWest temporary total artificial heart (TAH-t), which completely replaces the lower part of the heart and takes over all pumping function.
U-M is one of only 11 U.S. hospitals that offers this device, and may soon take part in a clinical trial of a portable driver for the TAH-t that will allow patients to leave the hospital while they wait for a heart. U-M’s first two TAH-t patients have both received heart transplants and are doing well.
For more on the U-M Cardiovascular Center’s heart-assist device program, visit www.umcvc.org or call toll-free, 888-287-1082.
About heart failure and heart-assist devices:
* Ventricular assist devices (VADs) and other heart-assisting technologies are used to support the hearts of adults and children with advanced heart failure, and patients in cardiogenic shock.
* More than 5 million Americans have some form of heart failure, with 550,000 more diagnosed every year.
* Each year about 2,200 Americans receive a heart transplant, but many more are too sick to be listed for a transplant, or die while waiting for one.
* More than a dozen devices have been approved to help failing hearts, or are in clinical trials.
* The Joint Commission, which accredits health care organizations such as hospitals, recently launched a program to certify VAD centers that provide a broad range of high-quality care.
Written by: Kara Gavin
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