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Artificial heart operation fails

Thursday, November 29, 2001

HOUSTON -- A man suffering from chronic heart failure died from severe bleeding during surgery to become the sixth person with a self-contained mechanical heart, doctors said Wednesday.

The surgical team performing the procedure at St. Luke's Episcopal Hospital on Tuesday spent 20 hours trying to control the bleeding.

The heart device performed well during the surgery, officials said.

Dr. O.H. Frazier, who led the team, said the bleeding was related to the patient's previous cardiac surgery and heart failure, which required blood thinning treatment and other medications.

The patient was not a candidate for a heart transplant, said Frazier, the chief of cardiopulmonary transplantation at the Texas Heart Institute.

"He was a man of courage, well-liked and committed to participating in this clinical trial," Frazier said. "Those of us who have come to know this person are truly saddened by this loss."

Five patients across the country have received the AbioCor, a battery-run, plastic-and-titanium device the size of a softball. All have done well, though the first recipient suffered a stroke earlier this month.

The man who died Tuesday was the first of a second group of five patients who will be implanted with the artificial heart during a clinical trial of the device by its manufacturer, Abiomed.

The death was "an unavoidable aspect of trying to test a therapy on such a sick and fragile population," said Edward Berger, vice president for strategic policy and planning with Abiomed.

He said the plan is to implant the device in 15 patients by June. If testing goes well, the device could be on the market in 2003.


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