Artificial heart implanted in patient at Jewish Hospital

Thursday, May 6th 2004, 10:56 am

By: News On 6

LOUISVILLE, Ky. (AP) _ An AbioCor artificial heart was implanted in a critically ill patient this week at Jewish Hospital, ending more than a year's lapse in the experimental surgeries at the hospital.

The seven-hour surgery was performed Monday by Drs. Laman Gray and Rob Dowling, a hospital spokeswoman said Wednesday. The patient, who was not identified, was in critical but stable condition.

The patient is the 13th recipient of the experimental pump in an ongoing clinical trial by the device's maker, Abiomed Inc. of Danvers, Mass.

It was the sixth implant performed at Jewish by Gray and Dowling and the first since January 2003.

The latest recipient is one of two AbioCor patients currently living with the pump. The other underwent surgery on Feb. 20 at the Texas Heart Institute at St. Luke's Episcopal Hospital in Houston. The Texas patient is off the ventilator and in stable condition, according to that hospital.

The softball-sized AbioCor is powered by batteries and made of plastic and titanium. It has no wires or tubes sticking through the skin, unlike earlier mechanical hearts that were attached to machinery outside the body.

The Food and Drug Administration approved 15 AbioCor implants as part of the initial clinical trial, Abiomed vice president Ed Berger said.

The company's goal is for the two other surgeries to be done in the first half of this year, Berger said Wednesday.

The clinical trial has targeted patients with end-stage heart failure who have a high probability of dying within a month.

The company plans to seek FDA approval later this year for initial commercial sales of the device, Berger said. Under the request, sales would be limited to patients facing imminent death from heart failure and for whom there is no alternative therapy available, he said.

``The company is very pleased that this implant has been performed and we look forward to continued progress along our plan toward initial commercial introduction,'' Berger said.

Robert Tools of Franklin, the first AbioCor recipient in July 2001, lived five months before dying from a stroke. The second recipient, Tom Christerson of Central City, lived 17 months and was able to move back home.

The third AbioCor patient at Jewish bled to death hours after his implant operation in April 2002. The fourth patient at Jewish died 101 days after the implant. The fifth recipient underwent the surgery on Jan. 22, 2003, and died 54 days later.