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| Vol. 22, No. 8 |
| May 1, 2000 |
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Small Pump Makes Big Stride
Doctors at the Texas Heart Institute and St. Luke's Episcopal Hospital reached a milestone in the field of mechanical circulatory support recently when they began clinical trials of the Jarvik 2000 heart assist device. The first patient to receive the device in the clinical investigation, a woman suffering from cardiomyopathy, or an enlarged heart, is recovering well since undergoing the procedure on Monday, April 10, say doctors. "The patient has made an excellent and rapid recovery. Before her surgery two weeks ago, she couldn't even get out of bed. Now she is feeling well and is walking again," says Dr. O.H. Frazier, chief of cardiopulmonary transplantation and director of surgical research at the Texas Heart Institute. "She has made great improvement medically, especially considering the severity of her illness. There were no complications during or after the procedure, and the device is performing extremely well." The Food and Drug Administration (FDA) granted Texas Heart Institute and St. Luke's Episcopal Hospital an initial investigational device exemption for the implantation of the Jarvik 2000. This is the only site in the country conducting clinical trials with this pump. The device, about the size of a "C" battery, is a valveless, electrically powered miniature axial flow pump that fits directly into the left ventricle. This pump takes over the function of the left ventricle by pumping oxygenated blood throughout the body when the heart is no longer able to do so on its own.
The tiny mechanism was implanted as a "bridge to transplant," which means the device will keep the patient's heart functioning temporarily while the person awaits a heart transplant. The American Heart Association estimates that each year between 20,000 and 40,000 Americans could use a heart transplant. In 1998, 2,340 heart transplants were performed in the United States. "This clinical evaluation is critical to understanding the benefits of this technology and in securing FDA approval for this device beyond the investigational phase," says Dr. Frazier, chief of transplant service at St. Luke's. "The Jarvik 2000 could, in the future, provide a much-needed treatment option for patients waiting for a heart transplant, and ultimately be widely used as a permanent support device much like a pacemaker." Baylor College of Medicine's Dr. Michael E. DeBakey has also developed a heart assist device with the help of NASA engineers. The DeBakey/NASA Axial Flow Ventricular Assist Device has been placed in several patients in Europe, the first of which occurred in November 1998. Jarvik Heart, Inc. and the Texas Heart Institute have been developing the Jarvik 2000 for more than 10 years. Dr. Robert Jarvik developed the Jarvik-7 total artificial heart, which was implanted in Dr. Barney Clark at the University of Utah in 1982. Five patients received the Jarvik-7 over the next three years; the patient that survived the longest was supported by the device for almost two years. The Jarvik-7 is still implanted in patients as a bridge to transplant. The results from the implantation of the Jarvik 2000 in the current study group will be published at a later date in a scientific journal. - KRISTINA VAN ARSDEL
©2006 Texas Medical Center E-Mail: tmcinfo@texmedctr.tmc.edu URL: http://www.tmc.edu/tmcnews/05_01_00/page_02.html |
