Other Highlights Of The Rematch Trial

· How does the pump device work? Doctors implant the pump, which is the size of a compact disc player, into the upper part of the abdominal wall or in the peritoneal lining. The device has a tube entering the left ventricle that drains blood from the ventricle into the device. The pump then sends the blood to the aorta, the artery that supplies oxygen-rich blood to the brain and the rest of the body. Another tube attached to the pump extends outside the body and is attached to a videotape-sized battery pack, which is worn on a shoulder holster, and a beeper-sized control system, worn on a belt.

· The trial was a unique collaboration: Under the collaborative agreement among the university, government, and industry, doctors at 22 cardiac transplant centers in the United States enrolled 129 patients into REMATCH between May 15, 1998, and July 27, 2001. Institutional review boards, or committees that oversee human research, at each of the 22 centers approved the protocol.

· How sick were the patients who were enrolled? End-stage heart failure patients enrolled in the trial were severely debilitated, having a 75 percent likelihood of dying within one year. All were short of breath at rest and approximately 70 percent needed intravenous drugs to support their blood pressure. Many needed to be in the intensive care unit.

· Considerations in selecting patient population: The investigators chose to use only patients ineligible for transplantation because they wanted to test the device’s utility for a two-year period. Patients were deemed ineligible for transplant for at least one of the following reasons: they were older than 65; they had insulin-dependent diabetes mellitus with organ damage; or they had chronic kidney dysfunction. Had the investigators included patients who could get transplants, they would have been ethically obligated to give such individuals transplants rather than the device within the two-year period if hearts became available. Also, a study design that included patients eligible for transplantation would have required many more patients to be able to prove the device’s ability to extend lives.

· Preventing bias among investigators during the trial: Once selected, the patients were randomly assigned to one of the two treatment groups: medical management, which included intensive drug therapy and continued monitoring, or device implantation. Investigators caring for the patients on a monthly basis knew which patients received the device, but to prevent bias, center investigators were unaware of data collected from the other centers.

· Patient protection during the trial: To ensure patients were not being exposed to any undue risk throughout the course of the trial, statisticians at Columbia, the National Heart, Lung, and Blood Institute (NHLBI), and the Food and Drug Administration kept track of the results. The progress and patient risk of the trial were accessed periodically by an independent NHLBI-appointed Data and Safety Monitoring Board.

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Tags

Drug Administration, National Heart, NHLBI, REMATCH