The medical community must decide whether a patient needs to be brain dead before doctors can remove his heart and other organs, James Bernat, professor of medicine at Dartmouth Medical School, said in his Aug. 14 article in the New England Journal of Medicine. Bernat's article responds to a case study, also featured in the journal, that documents three recent cases of heart transplantation from infants who had serious brain injuries but were not brain dead. Two of the infants were pronounced dead 75 seconds after circulation had ceased in the patients' bodies, a shorter than average wait time.
This was the first time surgeons removed hearts from patients who were not brain dead, Bernat said. He contended that this practice may be unethical because the cessation of circulation can be reversible in some situations.
"In normal donors, the baby is brain dead and declared dead, but on a ventilator, and [the surgeons] take out the heart," Bernat said. "This was a very different protocol ... The babies are not brain dead, but their brains are severely damaged."
Bernat was one of three experts whose commentary was featured in the journal. He said he believed that the journal's editors wanted readers to know they were aware of the experiment's controversial nature.
Robert Veatch, a professor of medical ethics at the Kennedy Institute of Ethics at Georgetown University, argued in his commentary that the surgeons committed a crime. They pronounced the infants dead by a definition of cardiac criteria that he disagreed with.
"In order to be dead by cardiac criteria, the loss of function has to be irreversible," Veatch said. "They also claim in the article that they reversed the heart function -- that it started again successfully -- which means the infants weren't dead, which means the physicians are responsible for the death of the patients."
In addition to arguing against the study's definition of death, Veatch said he was surprised by the decision to shorten the wait time between cessation of circulation and organ removal. Removing organs soon after death increases the likelihood of a successful transplantation.
Veatch agreed with Bernat that the medical community must come to a consensus on this issue before implementing shortened wait times.
"If they were going to pronounce the patients dead by heart criteria and take other organs, it's still a problem of changing the length of the wait time in order to establish irreversibility," Veatch said. "These doctors more or less changed the time on their own without developing any kind of peer consensus, and 75 seconds seems like a very short time period."
While he believes state legislatures could consider revising definitions of death, Veatch said doctors lack the legal authority to change this definition on their own. The dead donor rule, which currently governs transplantation procedures, states that patients must be declared dead before organ removal.
Unlike Veatch, Bernat believes it may be ethical in some circumstances to remove hearts from patients declared dead by the cardiac definition when patients' hearts have "irreversibly" stopped beating. Because of its faulty definition of death, the dead donor rule has halted progress in transplantation procedures, Bernat said.
"By requiring organ donors to meet flawed definitions of death before organ procurement, we deny patients and their families the opportunity to donate organs if the patients have devastating, irreversible neurologic injuries that do not meet the technical requirements of brain death," he wrote in his commentary. "It appears that reliance on the dead donor rule has greater potential to undermine trust in the transplantation enterprise than to preserve it."
The Health Resources and Service Administration, part of the U.S. Department of Health and Human Services, funded the case study. HRSA is also planning a meeting of leaders of the medical community to discuss appropriate wait times and whether complete brain death is a pre-requisite for organ removal.
"There was enough that was unusual or questionable about this experimental protocol that, before it graduates into standard clinical practice, it should be subjected to appropriate scrutiny by experts," Bernat said.
