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Artificial Heart Changed to Address Clotting Fears

January 24, 2002|From Associated Press

WALTHAM, Mass. — The maker of the world's first self-contained artificial heart said Wednesday it has removed a piece of the device because of fears it may cause clotting.

Deposits that can cause clotting were found on a plastic cage in the artificial hearts of two patients who died. So the cage has been removed, said Edward Berger, spokesman for Danvers-based Abiomed.

A majority of recipients of the AbioCor heart have had clots, called hematomas, removed, Berger said. Also, one of the patients who died had suffered a stroke, apparently caused by a blood clot, but doctors attributed his death to other causes.

Doctors are concerned the plastic cage is touching the tissue and restricting the flow of blood, which some doctors fear could lead to clotting, said Dr. David Lederman, Abiomed's chief executive.

"There's no way we can definitively make any conclusion," Lederman said. "Since we don't need it, we removed it."

The plastic cage was created for early devices that were tested on cows. The cage was meant to prevent heart tissue from obstructing blood flow into the replacement heart.

But the cage is not needed on humans because surgeons are attaching the device in a place where there is no concern about blockage, Berger said.

The plastic-and-titanium device has been implanted in six patients who were all dying of heart failure and too sick for heart transplants. Three have died, two of organ failure and one of bleeding during surgery.

The first recipient of the device, Robert Tools, suffered a stroke four months after receiving it. The hospital said Tools' death in November was unrelated to the stroke.

Doctors had said all along that strokes were among the risks for artificial heart patients.

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