A report on three heart transplants involving babies is focusing attention on a touchy issue in the organ donation field: When and how can someone be declared dead?
For decades, organs have typically been removed only after doctors determine that a donor's brain has completely stopped working. In the case of the infants, all three were on life support and showed little brain function, but they didn't meet the criteria for brain death.
With their families' consent, the newborns were taken off ventilators and surgeons in Denver removed their hearts minutes after they stopped beating. The hearts were successfully transplanted, and the babies who got the hearts survived.
The procedure – called donation after cardiac death – is being encouraged by the federal government, organ banks and others as a way to make more organs available and give more families the option to donate.
But the approach raises legal and ethical issues because it involves children and because, according to critics, it violates laws governing when organs may be removed.
As the method has gained acceptance, the number of cardiac-death donations has increased. Last year, there were 793 cardiac-death donors, about 10 percent of all deceased donors, according to United Network for Organ Sharing. Most of those were adults donating kidneys or livers.
The heart is rarely removed after cardiac death because of worries it could be damaged from lack of oxygen.
The Denver cases are detailed in today's New England Journal of Medicine. The report also includes three commentaries and a panel discussion with doctors and ethicists. Many of the remarks related to the widely accepted “dead donor rule” and the waiting time between when the heart stops and when it is removed to make sure that it doesn't start again on its own.
In two of the Denver cases, doctors waited 75 seconds; the Institute of Medicine has suggested five minutes, and other surgeons use two minutes.
State laws stipulate that donors must be declared dead before donation, based on either total loss of brain function or heart function that is irreversible. Some commentators contended the Denver cases didn't meet the rule since it was possible to restart the transplanted hearts in the recipients.
But others argue the definition of death is flawed, and that more emphasis should be on informed consent and the chances of survival in cases of severe brain damage.
In the Denver transplants, the three donor infants suffered brain damage from lack of oxygen at birth.
In the first case, doctors waited for three minutes after the heart stopped before death was declared. Then the waiting time was reduced to 75 seconds to reduce the chances of damage to the heart.