A third patient has received the AbioCor total artificial heart, which is made by the Massachusetts-based corporation Abiomed, this time at the Texas Heart Institute in Houston. In this instance, the patient, who was hospitalized at St. Luke’s Episcopal Hospital, was in the last stages of heart failure, unable to walk, and barely able to speak. Like the first 2 patients, he was not considered a candidate for a heart transplantation. Like the other patients, he received the implant as a permanent replacement for his natural heart.
Two days after the surgery, which was performed September 26, 2001, the man was reported to be breathing on his own, and the heart seemed to have relieved the pulmonary hypertension caused by the chronic heart failure. During a press conference at the institute, O.H. Frazier, MD, the surgeon who implanted the device, said, “This technology seems to work very well, but we have to go patient by patient.” Dr Frazier spent more than a decade helping to develop the implant in the research laboratories of the Texas Heart Institute. However, he was delayed in implanting the artificial device in the required number of animals by the devastation wreaked by Tropical Storm Allison in the Texas Medical Center in early June. That set back his qualification for the human studies. Because of the delay, surgeons at the University of Louisville Health Science Center in Kentucky performed the first and second implants.
A 59-year-old man with diabetes and congestive heart failure was the first patient to receive the artificial heart. He underwent a 7-hour procedure in Louisville on July 2, 2001. The 2 surgeons involved in the procedure, Laman Gray, Jr, MD, and Robert Dowling, MD, had also worked with Abiomed to help develop the device. The thoracic unit of the first generation AbioCor, which weighs ≈2 pounds, includes 2 artificial ventricles with their corresponding valves and a motor-driven hydraulic pumping system. The truly revolutionary portion of the AbioCor, however, is its power system, which allows the machine to be totally implanted, avoiding the risks that occur when lines extend from inside the body to the outside air. The mechanical heart functions on both internal and external lithium batteries. The internal battery is continually recharged from an external console or a basic patient-carried external battery pack by an energy transfer device called a TET (transcutaneous energy transmission) system, which has two sets of coils, internal and external, that transmit power across the skin without piercing the surface.
The second patient received the AbioCor transplant in Louisville on September 13, 2001. The 70-year-old man suffered from impaired kidney function as well as heart failure. Both men were described as doing well in a press conference held in Louisville on September 25, 2001.
The US Food and Drug Administration has approved the implantation of 5 AbioCor devices during these early phases. Continuation of the studies is contingent on frequent reviews of patient progress and study data. Five sites have been selected for the study: Brigham and Women’s Hospital teamed with Massachusetts General Hospital in Boston; Hahnemann University Hospital in Philadelphia; Jewish Hospital Heart and Lung Institute, Louisville, Kentucky; Texas Heart Institute at St. Luke’s Episcopal Hospital in Houston; and the University of California at Los Angeles Medical Center.
Food and Drug Administration and Office of Women’s Health Sponsor Research on Hypertension Medications Used by Pregnant Women
Two contracts awarded by the US Food and Drug Administration (FDA) in cooperation with the Office of Women’s Health will fund studies of 2 drugs, labetalol and atenolol, which are used to treat hypertension in pregnant women. The 2 research contracts, which were awarded to the University of Illinois at Chicago and the University of Washington, are the first in a series that is planned to assess medications commonly used by pregnant women.
The University of Illinois researchers will attempt to determine the doses of labetalol that will have the greatest effect on the mother’s hypertension and pose the least risk to the fetus. The University of Washington study will attempt the same evaluations of atenolol. The FDA is funding the studies because pregnant women commonly use the 2 drugs, even though there are little data available on the effects of these drugs in pregnant women. Few drugs have been studied in pregnant women.
On average, pregnant women receive 3 prescriptions during their pregnancies (excluding prenatal vitamins, iron, and medicine used during delivery). Both centers chosen for the studies are members of the US Department of Health and Human Services National Centers for Excellence in Women’s Health.
Heart Disease Prevention Project Finds High Rate of Undiagnosed Hypertension and/or Diabetes
In preliminary results from the Dallas Heart Disease Prevention Project being performed by the University of Texas Southwestern Medical Center, researchers said, in a released statement, that they have identified a large number of subjects who have undiagnosed high blood pressure or diabetes.
Of the 4000 Dallas County participants identified thus far, 417 were identified as having previously undiagnosed high blood pressure. Another 73 were given a preliminary diagnosis of diabetes—a problem of which they were unaware. “It is essential to make people aware of these conditions, which are risk factors for cardiovascular disease,” said Ronald Victor, MD, scientific director of the project. Researchers hope to sign up 6000 Dallas residents as participants in the study, which is designed to reduce death and disability from coronary heart disease in Dallas County. The area has a rate of heart disease that exceeds that of the rest of the nation.