AbioCor Patient Dies During Implantation Surgery
A sixth patient to be implanted with an AbioCor artificial heart died during surgery Tuesday at St. Luke’s Episcopal Hospital in Houston, device maker ABIOMED (Danvers, MA) announced Wednesday.
The patient, identified only as a male, died from uncontrolled bleeding due to a failure of his blood to clot, which was related to the patient’s longstanding heart failure and a previous cardiac surgery that required anticoagulation treatment, Dr. O.H. Frazier said in an Abiomed statement.
Frazier is chief of cardiopulmonary transplantation and director of surgical research at the Texas Heart Institute and chief of transplantation service at St. Luke’s. Frazier said he and his team spent 20 hours in the operating room attempting to control the severe bleeding problem.
“This patient knew he had no other hope than this clinical trial and he was determined to take this chance,” Frazier said. “He showed tremendous courage by choosing to participate in this procedure, and those of us who have come to know this person are truly saddened by this loss.”
FDA requirements of the clinical study mandate that the patients have a high probability of dying within 30 days to be accepted into the clinical trial. As part of the established preparation for the procedure, the patient and family received education from the medical team about the technology and the risks involved in participating in the clinical trial, according to Abiomed.
The AbioCor mechanical heart weighs about three pounds and is the first artificial heart to be free of wires connecting the device to the outside. About the size of a large grapefruit, the device consists of a motor and two blood-pumping chambers. Oxygen-depleted blood enters the AbioCor and is hydraulically pumped to the lungs, while the other chamber receives the oxygenated blood and pumps it to the body. It is powered by in internal battery, which is continually recharged transcutaneously by an external battery worn by the patient.
Implantation of the AbioCor involves the total removal of the patient’s own heart.
Five other people have already been implanted with AbioCor artificial hearts. The AbioCor clinical trial began on July 2 when Robert Tools, 59, of Franklin, Ky., received the first AbioCor implant at Jewish Hospital in Louisville, Kentucky. Subsequent implants were performed at Jewish Hospital on Sept. 13; at the Texas Heart Institute, Houston, Texas on Sept. 26; at UCLA Medical Center, Los Angeles, Calif. on Oct. 17; and at Hahnemann University Hospital, Philadelphia, Penn., on Nov. 5. The five patients are in varying stages of rehabilitation and the clinical teams report that the AbioCor hearts have functioned flawlessly in each case, according to Abiomed.
Abiomed announced just earlier this week that it had received FDA permission to enroll an additional five patients in the initial U.S. clinical trial of the AbioCor artificial heart, as reported by Medical Industry Today. Under terms of the company’s investigational device exemption (IDE), the initial AbioCor trial consists of a total of 15 patients divided into three groups of five each.
The AbioCor is seen as a possible treatment for patients with terminal heart failure who do not qualify for a human organ transplant. About 4,000 Americans await heart transplants, far outnumbering the number of organs that are donated.
Abiomed Inc. is a developer, manufacturer and marketer of medical products designed to assist or replace the pumping function of the failing heart. Shares of Abiomed trade on the Nasdaq under the symbol ABMD.
