Artificial Heart Patient Dies Soon After Surgery

The seventh patient to receive Abiomed Inc.’s self-contained artificial heart died shortly after surgery to implant the heart, the company said on Thursday.

The operation, which has only been approved in a trial setting for patients with a life expectancy of less than 30 days, was performed on Wednesday at the Jewish Hospital in Louisville, Kentucky.

The name of the seventh patient was not given, but physicians said the patient had a long history of heart problems, was on multiple medications to maintain a stable blood pressure and was on a ventilator prior to surgery.

“The clinical trial was the only option left for this patient,” Dr. Laman Gray, one of the surgeons, said.

The AbioCor Implantable Replacement Heart functioned as expected but the patient died after the surgery, the hospital and the company said in separate statements.

All but two of the seven patients who received the implant, which is still in clinical trials, have died: one during surgery and three from later complications. The world’s first recipient, Robert Tools, died 151 days after his surgery.

The US Food and Drug Administration has authorized 15 implants for the initial AbioCor clinical trial and the company said it would continue testing the device.

“We look forward eagerly and optimistically to completing all of the implants that have been authorized by the FDA consistent with our clinical trial plan,” Abiomed Chief Executive Dr. David M. Lederman said in a statement.

The company expects clinical data to be presented to the FDA by the end of 2003, spokeswoman Sara Goldstein said. The AbioCor multidisciplinary team is currently reviewing all details of the current case.

Ultimately, if the replacement heart receives FDA approval, the device would be implanted in patients who are not as severely ill as those in the clinical trial, Goldstein said.