Pediatric Heart Donations after Cardiac Death Spur Debate
by Kay M. Perry, JD, Regulatory Analyst for Research Operations, University of Texas Health Science Center San Antonio, San Antonio, TX
Organ transplants have become fairly commonplace; but a controversial study recently reported in the New England Journal of Medicine shows there may be a different approach to pediatric heart transplants. Between May 2004 and May 2007, physicians at Denver Children's Hospital performed the first heart transplants in pediatric patients where the donors died from cardiocirculatory causes. This naturally begs the question whether the donor was truly legally dead if his or her heart could function in another human body, a question that has spurred debate among bioethicists, physicians, and attorneys.
In this study, the three donor infants had irreversible brain damage and their parents consented to removal from life support due to the futility of providing continuing care. The family members were referred to an organ donation organization and, as is standard, the donor patients' physicians were not involved in the recipient patients' treatment (to avoid conflicts of interest). The parents of the children awaiting a donor were given the option of receiving a heart as part of this study or one off-study which would come from a donor who had been pronounced brain dead. The parents choose to participate, presumably due to the long wait times for infant heart donors. In the first transplant case, the heart was removed at three minutes after loss of cardiac function. Subsequently, the hospital ethics committee recommended shortening the waiting time from pronunciation of death to removal of the heart to 75 seconds, which the team did for the second two cases. The shortened timeframe was based on the fact that there has been no reported case of a child or adult spontaneously recovering circulation beyond 60 seconds from loss of cardiac function. All three recipient patients survived to the six month point.
Donation after Cardiac Death (DCD) was the approach used prior to the 1960s, when the concept of brain death was put forth as a substitute for cardiac death. Due to a shortage of available donors who have died from brain death, there has been an revival in the use of DCD in the past 15 years. There has only been one DCD heart transplant in an adult, which was actually the very first successful heart transplant. While it seems illogical to transplant the heart of a person who died due to cardiac reasons, in fact the typical DCD donor has an irreversible brain injury, but does not meet the definition of brain dead, and is being maintained by life support; the donor's heart is a healthy organ in and of itself. DCD is still not as common today due to concerns over whether the organs are as suitable since blood circulation is required to help prevent the organs from deteriorating. Organ donation protocols take this issue into account when establishing waiting times and methods for procurement and transplantation, thus overall outcomes are similar between transplantations after cardiac death and those after brain death.
Many bioethicists challenge this type of donation on the grounds that the donor is not legally dead if the heart can be manually resuscitated in another human being. Others argue it is acceptable because the heart won't be manually resuscitated due to a "do not resuscitate" order, and therefore it is irrelevant whether it could be.
As an example of one state's approach to this issue, Texas law defines death as "when... there is irreversible cessation of the person's spontaneous respiratory and circulatory functions." The statute also provides, however, that if a person's respiratory and circulatory functions cannot spontaneously cease due to artificial means of support, then the person can only be pronounced dead when the person has "irreversible cessation of all spontaneous brain function." Furthermore, "[d]eath must be pronounced before artificial means of supporting a person's respiratory and circulatory functions are terminated." It appears, then, that this study could not have been conducted in the manner in which it was under Texas law since the life support was removed from the donor infants prior to pronouncing death by cessation of cardiocirculatory functions without also waiting for irreversible cessation of brain function.
Of course, the laws of the states vary in how they define death, so there is no one correct answer to the issue of whether a donor in this circumstance is legally dead or not. Presumably given the apparent success of this study, and the fact that DCD has been used increasingly more over the past 15 years, physicians will push for more DCD opportunities for would-be recipients who are on long waiting lists. The ethics of donations in this situation will likely be debated on the floors of many state legislative assemblies in the years to come.
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