Last week a team of Colorado doctors reported that between 2004 and 2007, they successfully conducted heart transplants in three infants. While pediatric heart transplants are nothing new, the cases have caused quite a stir because the medical team, in the eyes of some ethicists, crossed the accepted boundary between life and death.
According to the doctors' report, published in the New England Journal of Medicine, the medical team had newborns in their intensive care unit who had suffered birth asphyxia -- basically, around the time they were born, the supply of oxygen to their bodies got cut off. The results were catastrophic -- they had severe and irreversible neurological injuries. At a designated time, the doctors took the babies off life support, removed their hearts and transplanted them into children with severe congenital heart disease, for whom other measures had failed.
Now here's what the doctors did differently: After withdrawing life support, the standard of medical practice is to wait between 2 and 5 minutes before removing a donor's organs. The reason is murky (because, frankly, the science around it is between weak and nonexistent), but experts feel that this amount of time is long enough to prevent "autoresuscitation," when a donor's heart may start beating again, making it premature to declare death and unethical to harvest an individual's organs.
In pediatric medicine, even a wait as short as 2 to 5 minutes can seriously compromise a heart's viability and how well it may work once it's been transplanted. And as the study's authors note, baby hearts are hard to come by -- "one-quarter of all infants waiting for a heart die on the wait list for it -- an order of magnitude higher than adult heart transplant recipients."
The medical team, with the consent of its ethics committee, and more important, of the parents of all of the children involved, decided to push the limits of irreversibility: Instead of waiting 2 to 5 minutes before taking the babies off life support, at which point their hearts stopped beating, they waited just 75 seconds. Technically, they violated the standard of care by removing the hearts without giving the donors enough time to autoresuscitate.
So far the practice has been a success. Researchers compared the three infants' post-transplant lives with a control group of 17 infants who had transplants under the usual rules. Three of the 17 infants in the control group died less than six months after their transplants, while each of the Colorado infants is doing well after six months. That's a 100 percent rate of survival, compared to 84 percent.
Doctors also discovered that the Colorado infants had fewer episodes of organ rejection (when the recipient baby's immune system starts to attack the donated heart because it doesn't recognize it as a native part of its body) than the control group. Further, the Colorado team estimated that their method could increase the pool of donors. That's because the shorter time to harvest the organs makes them more likely to function once they're transplanted. The doctors estimate their protocol could represent a 70 percent increase in organ donation.
So what's the problem? Enter the "dead-donor rule," which literally means that no doctor can take an organ out of someone's body until he or she is declared dead. It's basically the Golden Rule of transplant medicine, and it's what prevents doctors from taking organs from people who might be on the borderline of death or even still alive. It has been around since the dawn of transplant medicine in the late 1960s. The goal of the rule was simple: Keep doctors' consciences clear and prevent them from taking organs preemptively. Back then, it was an easy rule to follow, mainly because ICU medicine hadn't advanced to its state today. A person died when in the words of the doctor "they were cold, stiff, and blue."
But today technology allows us to keep people's hearts beating and their lungs breathing indefinitely. The advent of successful transplants and intensive care medicine has given birth to another definition of death, cardiopulmonary death, declaring someone dead after his or her heart irreversibly stops beating -- that 2 to 5 minute rule.
So the big point that ethicists have been debating (including in an excellent round-table discussion on the New England Journal's Web site moderated by Dr. Atul Gawande) is this: Did the Colorado doctors violate the dead-donor rule? And even if they didn't violate it, how can a heart be dead if you can start it beating in someone else's chest?
The quick answer seems to be that brain death supersedes cardiac death. If that's the case, the dead-donor rule applies to the donor infants. They were declared brain-dead, having suffered irreversible loss of brain function, determined by a doctor's physical exam, and by an absence of electrical activity on computer brain tests. But we haven't resolved the dilemma of determining how long to wait, after a patient's heart has stopped beating, and before the brain has shut off, to declare when he or she is dead.
The truth is, given our medical technology, we (doctors, families and patients via advanced directives) are forced to make a collective decision on when to withdraw life support. This happens every single day in every single hospital in America. In short, when it come to death, we're making a judgment call.
That admission makes some uneasy. In an editorial in the New England Journal, Dr. Robert Veatch, a professor of medical ethics at Georgetown, noted that we could change the dead-donor law so that once we decided there was no hope for a sick or injured organ donor, we could intervene faster. But that's a slippery slope. Take the case of a doctor in California who is accused of prescribing drugs to hasten a man's death so his organs could be harvested more quickly.
Others have suggested that a committee of experts get together and look at the donor rule. Perhaps doctors should redefine death not as the loss of electrical activity in the brain, or the loss of a beating heart, but as the loss of consciousness. According to Veatch, polls show that "many Americans -- perhaps as many as a third of the population -- already support this higher-brain, or consciousness-based definition on religious or philosophical grounds." But, really, how does a slope get more slippery than defining consciousness and when it's gone?
The answer may be simpler than all of these things and lie in the Colorado study itself. The medical team carefully weighed the situation, and consulted with its hospital ethics committee. Most important, they talked with the families and obtained their consent. Like so much in real-time medicine, it was a mix of science, morality, compassion and instinct. Yes, they pushed the envelope, but nobody can argue they did it subversively. Like all good doctors, they made an open and clear judgment in the best interest of their patients. Some will argue they could have and should have waited for some governing body somewhere to decide that death equals 75 seconds of cardiac arrest. But then three children could have died and we wouldn't be here discussing medical progress.