July 21, 2004 PITTSBURGH, July 20 – The University of Pittsburgh Medical Center (UPMC) today is discharging its first patient who was successfully implanted, on July 2, with the Heartmate XVE™ Left Ventricular Assist System (LVAS). It was implanted as a permanent implant in lieu of a heart transplant, as opposed to the traditional use for this type of device.
The patient, 58-year-old John Didion, has recovered well enough to be discharged to his home in Allison Park, Pa.
The Heartmate XVE (LVAS) is a long-term permanent assist device approved by the U.S. Food and Drug Administration (FDA) for this so-called destination therapy in patients with end-stage heart failure who, despite receiving optimal treatment, have a life expectancy of less than two years and are not viable candidates for heart transplantation.
"I never thought this day would be possible," said Mr. Didion. "I am so grateful to the dedicated staff at UPMC. If it weren't for them, I wouldn't be here today. I am living proof that this works."
Last fall, UPMC was among the first centers to receive approval from the Centers for Medicare & Medicaid Services (CMS) to implant left ventricular assist systems approved by the FDA, and UPMC is only one of two approved centers in western Pennsylvania to implant the Heartmate XVE.
"We are pleased to be able to bring this new technology and therapeutic approach to our patients," said Robert L. Kormos, M.D., professor of surgery at the University of Pittsburgh School of Medicine and director of UPMC's Artificial Heart and Heart Transplant programs. "Heart transplantation is still the best option for long-term survival, but unfortunately, is not feasible for everyone. This new therapy allows us to return people to productive lives at home as an alternative to dying from end-stage congestive heart failure."
"The Heartmate XVE has been developed to be a viable therapy and is giving new hope to people," said Dennis McNamara, M.D., associate professor of medicine at the University of Pittsburgh School of Medicine and director of the Heart Failure/Transplantation Program at the UPMC Cardiovascular Institute. "As the technology improves, this may someday, in conjunction with heart transplantation and other new therapies, help us to provide a full spectrum of choices for heart failure therapy."
UPMC also is part of an elite 21-member national cardiac center consortium, known as Heart Hope, and among the first to implement advance practice guidelines for the permanent implantation of heart pumps as destination therapy. With nearly five million Americans living with heart failure, it is estimated that as many as 100,000 patients a year in the United States could benefit from destination therapy, bringing them new hope for increased survival and quality of life.
These new guidelines, which were created by a subset of the Heart Hope Centers, will help improve patient outcomes with life-saving benefits. Their experience has enabled them to identify and address even the smallest nuances in care that can make a significant improvement in patient's survival and hospital discharge rates. There are an estimated 550,000 new cases of heart failure diagnosed each year. This number continues to increase, emphasizing the importance of facilitating these guidelines to support the continued improvement of patient outcomes.
As the use of destination therapy expands, the long-term vision for mechanical support is to assist the heart while it repairs itself using novel new cellular therapies. These goals include promoting recovery from the mechanical effects of heart failure and availability as a viable replacement option when all other choices fail. These goals encompass the broader mission of the McGowan Institute for Regenerative Medicine and are a result of the collaboration among scientists, engineers and clinicians.
UPMC's Artificial Heart Program, in collaboration with UPMC's Congestive Heart Failure Program, is one of the most experienced and active in the United States. The program was established in 1985 and has supported nearly 300 patients on various assist devices for a period of time that equates to more than 65 patient-years. It often serves as both a proving ground for manufacturers and a training center for surgeons from around the world. Devices that UPMC has used over the years include the Jarvik/Cardiowest Total Artificial Heart, Novacor Left Ventricular Assist Device (LVAD), Thoratec VAD and HeartMate I and recently the new miniaturized rotary blood pump, the Heartmate II.
Known also for its aggressive work to enable patients on devices to be discharged to the home setting, UPMC was the first center to discharge a patient still on a device to await a human donor outside the hospital. Based on UPMC's experience, the FDA later allowed patients implanted with the Novacor to be discharged to their homes to await heart transplant. It was the first in the country to develop an experienced bioengineering team, called Vital Engineering, which provides local and national support for patients on these types of devices.
For more information about the cardiac programs at UPMC, the HeartMate or destination therapy, visit http://newsbureau.upmc.com/MediaKits/McGowanMain.htm. For a complete list of Medicare approved facilities, go to http://www.cms.hhs.gov/coverage/lvadfacility.asp.
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