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| Vol. 22, No. 9 |
| May 15, 2000 |
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Doctors Testing Heart Pump as Bridge to Transplant by KRISTINA VAN ARSDEL Texas Medical Center News
The first patient in the Jarvik 2000 clinical trials at the Texas Heart Institute and St. Luke's Episcopal Hospital told those gathered at a press conference on May 3 that she was feeling good and was ready to go home. Lois Spiller, 52, who has cardiomyopathy, or an enlarged heart, received the device on Monday, April 10, after approval was granted from the Food and Drug Administration (FDA) for an initial investigational device exemption. This is the only site in the country conducting clinical trials of the miniature pump, which was implanted as a "bridge to transplant," meaning the device will assist the heart's function while Spiller awaits a transplant. "I was very, very ill before, but now I feel like I have a new life," said Spiller, a retired financial analyst. "I want to let others be aware of the miracle the Lord has created." Under the FDA guidelines, Spiller will remain in the hospital until a donor heart becomes available for transplant. Spiller has lived with heart failure since 1987, and her condition has progressively worsened over the years. According to Dr. Reynolds M. Delgado, III, a heart failure and transplantation cardiologist at St. Luke's and the Texas Heart Institute, Spiller was admitted to the hospital in March with severe heart failure. She was unable to walk and became so sick that she could barely complete a sentence due to her shortness of breath. The device implanted in Spiller is a valveless, electrically powered miniature axial flow pump about the size of a "C" battery. The pump fits directly into the left ventricle and takes over the function of pushing oxygenated blood throughout the body when the heart is unable to do so on its own. Spiller wears the two-pound external battery in a pouch.
Dr. Robert Jarvik, president of Jarvik Heart, Inc., said that the goal for decades has been to create a device that would allow a patient to return to a normal lifestyle. "We want to make a device that's small, that's simple, that's silent and that's safe," he said. "The importance of Mrs. Spiller's experience here will be that this is the first time we have had the opportunity under the FDA investigational protocol to utilize this technology and to show any example of what this work is all about." To be eligible under the protocol, a patient must have end-stage heart failure, be on the transplant waiting list and meet certain size requirements. Dr. O.H. Frazier, chief of cardiopulmonary transplantation and director of surgical research at the Texas Heart Institute and chief of transplant service at St. Luke's, said five patients will receive the device as part of the study. If the clinical trials prove successful, the pump could be used in the future as a treatment option for the approximately 4,500 people on the heart transplant waiting list in the United States. 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 U.S. Currently, the pump has only been approved for clinical trials as a bridge to transplant, but it is designed as a long-term pump that could, in the future, be implanted as a bridge to recovery. Dr. Jarvik indicated that the pump would be tested in a larger group following the initial clinical trials and later the technology would be considered as a permanent solution to heart failure.
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