ABIOCOR SURGERY PERFORMED, PATIENT DOES NOT
(Louisville, Ky.) - University of Louisville
surgeons Laman Gray, M.D., and Rob Dowling, M.D., performed surgery
Wednesday, April 10, 2002 at Jewish Hospital to implant the seventh
AbioCorä Implantable Replacement Heart, manufactured by ABIOMED,
Inc., of Danvers, Mass. While the AbioCor functioned as expected,
the patient died post operatively. The AbioCor multidisciplinary
team is actively reviewing all details of the case.
Out of respect for the patient and
family, interviews and additional details, including the name
of the patient, will not be available.
The patient was in a severely debilitating preoperative condition.
The patient had a history of heart problems, was on multiple medications
to maintain a stable blood pressure, had an intra-aortic balloon
pump and was on a ventilator prior to surgery, according to the
"The clinical trial was the only
option left for this patient," said Dr. Gray. "Like
all of our AbiCor patients, the patient was a hero, and has our
utmost respect. We are truly saddened by this death."
"We extend our deepest sympathy
to the patient's family and friends," said Dr. Dowling.
To be accepted into the AbioCor clinical
trial, the FDA requires that patients have a high probability
of dying within 30 days. The patients and their families receive
extensive education about the technology and the risks involved
in participating in the studies. In addition, they meet with an
independent patient advocate throughout the process.
Wednesday's surgery was the third procedure
performed at Jewish Hospital, which also implanted the world's
first and second replacement heart. The world's first recipient,
Robert Tools, died 151 days after his surgery on July 2, 2001.
Tom Christerson, the longest living recipient, received his heart
September 13, 2001. He was discharged to The Inn at Jewish Hospital
on March 20, 2002.
Jewish Hospital is among the
top ten cardiac centers in the United States and, along with the
University of Louisville, is dedicated to excellence, research