By Rob Stein
Washington Post Staff Writer
Thursday, August 14, 2008; A01
Surgeons in Denver are publishing their first account of a procedure in which they remove the hearts of severely brain-damaged newborns less than two minutes after the babies are disconnected from life support, and their hearts stop beating, so the organs can be transplanted into infants who would otherwise die.
A detailed description of the transplants in today's issue of the New England Journal of Medicine has ignited an intense debate about whether the first-of-their-kind procedures are pushing an already controversial organ-retrieval strategy beyond acceptable legal, moral and ethical bounds.
The doctors who performed the operations as part of a federally funded research project defended the practice, and some advocates for organ donation praised the operations as offering the first clear evidence that the procedures could provide desperately needed hearts for terminally ill babies.
Critics, however, are questioning the propriety of removing hearts from patients, especially babies, who are not brain-dead and are asking whether the Denver doctors wait long enough to make sure the infants met either of the long-accepted definitions of death -- complete, irreversible cessation of brain function or of heart and lung function. Some even said the operations are tantamount to murder.
"This bold experiment is pushing the boundaries and raising many questions," said James L. Bernat, a Dartmouth medical professor who wrote one of four commentaries that the journal published with the report -- an unusual step that anticipated the firestorm of reaction the procedures would cause. The journal posted them on its Web site with a videotaped debate among three prominent bioethicists.
"This clearly shows the feasibility of doing this," Bernat said. "The question is: Should this be done?"
The operations are occurring as transplant advocates have become increasingly aggressive in trying to bridge the gap between the number of available livers, kidneys, hearts and other organs and the number of Americans on the waiting list for transplants.
Since the 1970s, most organs have been removed only after doctors declared a patient brain-dead. But in the hopes of obtaining more organs, federal health officials, transplant surgeons and organ banks have been intensely promoting "donation after cardiac death," or DCD. DCD usually involves patients who have devastating and irreversible brain damage but are not actually brain-dead. Their families consent to removing life support, and their organs are removed minutes after the patients' hearts stop beating.
While DCD has become increasingly common, it remains highly controversial. Critics say it endangers the care of dying patients -- a California surgeon is facing criminal charges that he tried to hasten the death of a potential DCD donor in 2006 -- and has raised questions about whether the donors are truly dead.
To address such concerns, hospitals follow strict guidelines, including requiring a clear division between doctors caring for the patients and those removing and transplanting the organs. Most also require surgeons to wait at least two minutes -- and usually five -- after a heart stops to make sure it does not spontaneously start beating again on its own, which has occurred in rare cases.
The Washington Post reported last year that doctors at the Denver Children's Hospital had started removing hearts from babies, sometimes waiting only 75 seconds to increase the chances that the organs would be viable. The new report marks the first time the doctors have described their efforts in a medical journal.
The report details three cases between 2004 and 2007 involving babies who experienced severe brain damage from oxygen deprivation during birth. Their parents decided to discontinue life support several days following their birth after doctors told them there was no hope. The surgeons waited three minutes before removing the first baby's heart, but just 75 seconds for the second and third after an ethics panel monitoring the research decided that would be sufficient.
Surgeons transplanted the hearts into three babies 1 to 4 months old who were dying of heart problems. Six months later, all three recipients were alive, compared with 84 percent of 17 babies who received hearts retrieved through standard organ-donation protocols.
"We're very pleased with the lives we saved," said Mark M. Boucek, who led the team before moving to the Joe DiMaggio Children's Hospital in Hollywood, Fla. "We're trying to deal with a very difficult situation where children die waiting for transplant and parents of other children want to donate."
James Burdick of the Department of Health and Human Services, which funded the study, agreed.
"In a very important way, it's a wonderful story. You had three situations with hopeless medical problems who would have otherwise died but got this gift of life," he said. "It's an important demonstration of what is possible."
But critics questioned whether the donor babies were truly dead when their hearts were removed. In those cases, the hearts were restarted in another child's body, meaning cessation was not irreversible, they argued.
"This practice cannot be ethically justified," said George J. Annas, a Boston University bioethicist. "The donors are not dead. I understand that they would like us to change the definition of death, but they can't do that by themselves. It's very problematic to start treating a baby as an organ donor before it's dead."
Robert M. Veatch, a Georgetown University bioethicist, went further, saying the deaths were equivalent to murder.
"The whole issue is whether the infants from whom the hearts were taken were dead. It seems very clear to me that they were not," he said. "I think it's illegal, and if it's illegal, what we're talking about is the physicians causing the death of the three patients, and that would be homicide. It's immoral. I think it should be stopped."
Boucek, the cardiologist, argued that the hearts were incapable of functioning in the newborns from whom they were removed, satisfying any question about pronouncing the babies dead.
"At the end of the day, we feel we are on very firm ground," he said. "There is no question these all met the criteria that one would establish for death."
Burdick called assertions that the babies were not dead "fussy semantics" that do not "really make common sense."
Because the procedures reopened so many contentious fault lines, two other ethicists proposed scrapping the fundamental ethical tenet that has guided organ transplantation for decades: the "dead donor rule," which states that organs should never be removed from a patient who is not dead. Robert D. Truog of Harvard Medical School and Franklin G. Miller of the National Institutes of Health argued that people with devastating brain injuries or terminal illness, or their family members, should be allowed to decide whether to consent to donate an organ, without needing to adhere to any specific method for declaring death.
"It's a much cleaner way to go, and avoids all of the crazy stuff that we're talking about here, in terms of how do we diagnose death," Truog said during the taped debate.
But a surgeon speaking on behalf of the United Network for Organ Sharing, which oversees the nation's organ-transplant system, rejected that approach, as did several bioethicists. Several experts worry that the Denver cases and such proposals will undermine public confidence in organ donation. They called for a national conference to establish a consensus before more procedures are done.
"The whole area of organ donation relies on the public trusting physicians, in that they believe they won't murder them or commit homicide. They won't hasten their deaths," said Arthur L. Caplan, a University of Pennsylvania bioethicist. "We ought not underestimate public unease."
Boucek welcomed such debate, but said that in the meantime, Denver Children's Hospital plans to continue the procedures and that other hospitals have begun seeking guidance about how to do them as well.
"It would be unfair to parents who are interested in donating and to the patients who would otherwise die if we stopped," he said.