(See Corrections & Amplifications item below.)
In a controversial new approach that may reduce the number of babies who die each year awaiting a new heart, doctors in Denver have performed the first transplants of hearts from infants who died a cardiac-related death.
Until now, it was thought that hearts from those donors were too badly damaged to be transplanted successfully. Only hearts from donors who were brain-dead -- and whose hearts were still functioning after they were declared dead -- have been considered suitable for transplant.
To make the donors' hearts more viable, doctors at Children's Hospital in Denver altered the standards for declaring the patients dead -- a move that has provoked serious concern among some medical experts.
The Denver researchers narrowed to as little as 75 seconds the time between when the donor was pronounced dead and when the heart was removed. The Institute of Medicine, a nonprofit advisory organization, outlined the current guidelines, which call for waiting up to five minutes as a way of making certain that the heart does not start beating again on its own. But removing the heart earlier increases the odds of a successful transplant since it limits the damage caused by a lack of oxygen to the organ.
Details on the three cardiac-death transplants at Denver Children's Hospital are reported in Thursday's New England Journal of Medicine.
In an accompanying opinion piece in the medical journal, Georgetown University medical ethicist Robert Veatch questioned whether the procedure was legal when the event is declared a cardiac death.
"If a heart is restarted, the person from whom it was taken cannot have been dead according to cardiac criteria," he wrote. "Removing organs from a patient whose heart not only can be restarted, but also has been or will be restarted in another body, is ending a life by organ removal."
He added that "under current law, it is not possible to procure a transplantable heart after cardiac death."
Still, some experts said other transplant centers are likely to follow the Denver lead.
"It is really amazing," said Jonathan Chen, the director of pediatric cardiac surgery at New York Presbyterian Hospital, of the successful transplants in Denver. He said other major medical centers will "absolutely" try similar approaches, although he said some hospitals may wait for longer-term follow-up data before going ahead.
As many as 50 infants a year die while on a waiting list for a heart transplant. Many more who need a transplant, but who aren't on a wait list, also die. Dr. Chen, whose center is one of the busiest in the country with about two dozen pediatric heart transplants a year, said the demand for the procedure is about double the number of donors.
The new approach by the Denver surgeons, if adopted, would "open up a huge field of donors," said Olaf Reinhartz, the surgical director of the pediatric-transplant program at Lucile Packard Children's Hospital in Palo Alto, Calif.
"If this was to become standard procedure, then it could single-handedly get rid of the problem of death on the waiting list," he said.
Mark Boucek, the surgeon who led the Denver team, said he has already been asked about the procedure by other hospitals and believes it "very likely" similar transplants will be performed by other teams.
"Any program committed to transplantation deals with the tragedy of losing a child waiting for a heart," he said. Dr. Boucek, who is now at the Joe DiMaggio Children's Hospital in Hollywood, Fla., said he expected the procedure to be tried in adults as well.
But adoption of the new transplant procedure may be slowed by ethical worries.
James Bernat, a neurologist at Dartmouth Medical School, said that he expects the transplant community to reject any movement to reduce the waiting time between death and organ harvesting to 75 seconds.
He said current research is insufficient to determine if 75 seconds is long enough to be sure the donor is truly dead and that there is no chance of the heart spontaneously recovering. "There is a primal fear people have of being declared dead wrongly," Dr. Bernat said. "Faced with that kind of issue, I think physicians and transplant enterprises need to be mindful to reassure skeptical people that there will be no instance in which surgeons will procure organs from someone before they are dead."
The three Denver transplants were performed over a three-year period beginning in May 2004. The average age of the donors was just under four days.
In all the cases, a decision was made by the families of the babies to withdraw life support. The three donor babies had severe neurological injuries but were not considered to be brain dead. The average age of the babies receiving a new heart was just over two months. All are alive today.
Write to David Armstrong at email@example.com
Corrections & Amplifications
Jonathan Chen is the surgical director of the Pediatric Cardiac Transplant Program at the Morgan Stanley Children's Hospital of NewYork-Presbyterian. This Personal Journal article incorrectly identified him as the director of pediatric cardiac surgery at NewYork-Presbyterian Hospital.Printed in The Wall Street Journal, page D1