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John J. ParisApril 29, 2002

“We are being pressured to participate in non-heartbeating cadaver organ transplants at our hospital, and we don’t think it is ethical,” commented the I.C.U. director of a major medical center. He and his staff opposed the process that removes life-sustaining ventilation from a terminally ill patient, waits two minutes to declare the patient dead, and then has the surgeons harvest vital organs.

Their perspective conflicts with the 1985 statement of the Pontifical Academy of Science that with patient or family permission, “cadaver transplants deserve the support of the medical profession, of the law and of people in general.” The academy’s position was a restatement of the traditional Catholic teaching on transplantation of cadaver organs summarized in Pope Pius XII’s 1956 allocution to doctors:

A person may will to dispose of his body and to destine it to ends that are useful, morally irreproachable and even noble, among them the desire to aid the sick and suffering. One may make a decision of this nature with respect to his own body with full realization of the reverence which is due it.... This decision should not be condemned but positively justified.

Additional support for that moral standard is found in John Paul II’s encyclical Evangelium Vitae (1995), in which the pope notes that “a particularly praiseworthy example [of self-giving] is the donation of organs performed in an ethically acceptable manner, with a view to offering a chance of health and even life itself to the sick who sometimes have no other hope” (No. 86).

Despite nearly a half-century of moral legitimation and encouragement of organ donation, the United States still falls woefully short of meeting the demand for transplantable organs. In part, the very success of improved transplantation techniques has led to the increased demand: as of February 2002, UNOS (United Network for Organ Sharing) had a waiting list for 79,523 major organs, while in the previous year the total number of transplanted organs was 22,953.

This disparity between the number of transplantable organs and the need for such organs has led transplant programs to seek to expand the sources of transplantable organs. Among the proposed solutions is organ procurement from non-heartbeating cadaver donors (N.H.B.C.D.)—that is, donors who are declared dead by virtue of irreversible cessation of heartbeat and respiration. These potential candidates fall into two groups: 1) uncontrolled: the time and location of death are unexpected. These deaths generally occur in emergency rooms following sudden cardiac arrest and failed resuscitation; 2) controlled: the time and location of death are predetermined. These deaths occur in hospitalized patients for whom there is a planned withdrawal of life support.

Although N.H.B.C.D.’s had been the primary source of transplantable organs prior to the adoption in the 1970’s of neurological criteria for death, the usefulness of such organs was severely limited by what is called warm ischemia time. Death quickly leads to tissue deoxygenation and organic ischemia, which renders the organs nonviable. The continuously profused organs of living donors, or donors meeting the neurological standards for death, do not incur these problems. Consequently, living donors and those who are “brain dead” soon displaced N.H.B.C.D.’s as the preferred source of transplantable organs.

By the 1990’s, however, the inability to acquire an adequate supply of continuously profused organs led to a reconsideration of using N.H.B.C.D. organs. Two proposals for shortening the warm ischemia time were put forth, both of which raise profound ethical and legal difficulties. In the first, the Regional Organ Bank of Illinois sought to recruit donors from those on whom cardiopulmonary resuscitation had proven unsuccessful. That proposal failed when all 35 families approached refused permission to insert vascular catheters into the femoral arteries of the “newly dead” corpses to achieve in situ cold preservation fluid infusion. The Illinois Organ Bank then undertook another approach. Physicians presumed consent to infuse recently deceased patients as a means of preserving the organs until physicians could have a discussion of organ donation with the families. In six of the seven cases in which this was done at Loyola University Medical Center, consent for organ retrieval was granted by the families.

The rationalization for the presumed consent was that medical students and residents regularly practiced intubation techniques without seeking consent on the corpses of patients for whom attempted resuscitation had failed. That policy, however, has come under severe criticism in both the legal and bioethics communities. Nor could it withstand what Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, describes as the outrage that would erupt if the public believed that to retrieve organs, physicians were treating the newly dead in a disrespectful, callous or crude manner.

The University of Pittsburgh transplant center proposed a different protocol to obtain profused organs. Families of dying patients who were on life-sustaining ventilators were asked to authorize the harvesting of organs once the patient was removed from the ventilator, stopped breathing and had been declared dead according to traditional criteria of irreversible cessation of heartbeat and respiration. The Pittsburgh protocol proposed a two-minute waiting period to assure that the patient would not auto-resuscitate. Once the patient was declared dead, the heart would be restarted and the corpse ventilated to support the continued profusion of organs. Renée Fox, a medical sociologist at the University of Pennsylvania, denounced this procedure as bordering on the ghoulish. In her view this “macabre” practice was a little short of “medically rationalized cannibalism.”

Since the University of Pittsburgh was a leading transplant center, the proposal occasioned widespread comment and analysis. How, it was asked, could you declare death by irreversible cessation of heart and respiration when, in fact, you could medically restart the heart and ventilate the lungs? How is the patient dead, if the heart is once again beating? What is the meaning of irreversible cessation? Is it enough that the patient or family authorize withdrawal of mechanical support and that there is no auto-resuscitation for two minutes? Can you then legitimately declare the patient to be dead, even though you will restart the heart to achieve profusion for the organs? As Joanne Lynn, the medical director of the president’s commission’s report Deciding to Forego Life-Sustaining Treatment, put it, “To achieve societal approval for taking organs from non-heartbeating cadaver donors, we must ensure that the bodies are really dead before organ procurement begins.” If the heart can be restarted, the process is not irreversible. If the heart is, in fact, revived, Lynn, like Fox, believes the protocol must be condemned.

Only if the patient is truly dead can N.H.B.C.D.’s be a legitimate source of vital organs. To meet that dead-donor rule, a Michigan State University ethicist, Tom Tomlinson, offered a way to understand the concept of irreversible that did not exclude the logical possibility of the heart’s being mechanically restarted. “Irreversible,” he argued, means only that “the possibility of reversal is not ethically significant.” This would occur whenever the patient or family has refused the use of life-sustaining medical interventions. The irreversibility of heart function is thus a moral, not a metaphysical reality. Death, according to this understanding, is determined not by the failure of medical interventions to achieve heartbeat, but by the decision of the patient or family not to attempt such measures.

The determination of death is not the only ethical concern with regard to taking organs from non-heartbeating cadavers. There is also the need to ensure that the potential donor has not been harmed, wronged or killed in order to obtain the desired organs. To do so would not only be utterly repugnant; it would violate the treating physician’s fiduciary commitment to serve the dying patient’s best interests. Both the patient and family must be convinced that the care of the dying patient is not being compromised.

To protect the dying patient’s interests, and to preclude the potential conflict of interests between the donor and recipient, the decision to withdraw life support should be guided by the patient’s treating physician. To alleviate any concern about social pressure on families to end life support, transplant and organ procurement personnel ought not to be involved until after the decision to terminate respiratory support has been made. An additional concern with regard to families is that the Pittsburgh protocol—to guarantee that minimum time is lost between the determination of death and the transplant teams’ efforts to harvest the organs—exclude the family from being present at the moment of death. The removal of the ventilator and the two-minute waiting period before death is declared are to occur in the operating room, a place from which the family is excluded. They are therefore not present when the patient dies.

Arthur Caplan’s critique of the Pittsburgh protocol highlights the danger of a single-minded focus on expanding the pool of cadaver organ donors: it threatens to undermine public trust in doctors. It also increases stress and burdens on families. Further, the abrupt shift in care of critically ill I.C.U. patients can prove disquieting to health care providers. As Caplan observed, these professionals “do not want to be made party to hastening death in the name of organ procurement.” Caplan concludes his critique with the observation that “no change in organ donor eligibility can be instituted without the enthusiastic support of health care professionals who care for the terminally ill and dying.”

It has taken nearly a decade for that support to materialize. In September 2001 the ethics committee of the American College of Critical Care Medicine and the Society of Critical Care Medicine (S.C.C.M.) issued a position paper titled “Recommendations for Nonheartbeating Organ Donation.” The S.C.C.M. committee supported the proposition that it is ethically and medically acceptable to participate in the procurement of organs from non-heartbeating cadaver donors. In the course of the paper, the committee addressed the major concerns about non-heartbeating cadaver donors—whether these patients are truly dead, whether the practice constitutes active euthanasia, whether there is a prohibitive conflict of interest for professionals and institutions and whether there is adequate social support for dying patients and their families.

The S.C.C.M. committee adopted the position that since no cases of auto-resuscitation have been reported after more than one minute of asystole, apnea and unresponsiveness, two minutes of unresponsiveness, apnea and loss of circulation is an acceptable standard for death in those situations in which no resuscitative attempts will be made. There is, of course, no rationale for attempting resuscitation on a dying patient who has requested the cessation of life-sustaining technologies. Such a refusal, in the words of the Vatican’s 1980 Declaration on Euthanasia, is not suicide (or euthanasia) but the “acceptance of the human condition.”

The care of the dying patient who has been designated an organ donor is a special concern for the critical care staff. Attention must be paid to ensure that such patients are treated with the same degree of comfort and dignity as all other I.C.U. patients. Particular attention is also to be paid to pain control, relief of anxiety and continuity of care throughout the process of preparation for donation.

Crucial in all this activity is that whatever procedures are undergone, they be done with the fully informed consent of the patient and/or family. If the patient is transferred from the I.C.U. to the operating room to facilitate the retrieval of organs, the S.C.C.M. committee believes that, contrary to general practice, the family should be given the opportunity to remain with the patient until the moment of death. Accompanying the patient through the journey of life to its very end, instead of what looks like abandoning the patient to a technological demise, may be of crucial importance to the family. The family must be apprised of the environment, of what will occur and of the need for them to take their leave very shortly after death is pronounced. They should also be provided with social and pastoral support throughout the entire process.

With a continuing shortfall of desperately needed human organs, the non-heartbeating cadaver is a valuable alternative source of organs. The S.C.C.M. committee estimates that as many as 20 percent of potential donors are now in this category. And a study at Children’s Hospital of Philadelphia by Tracy Koogler and colleagues indicates that within that institution, the routine use of N.H.B.C.D.’s could increase organ donation in the pediatric population by as much as 42 percent.

Given the critical need for transplantable organs and the potential for successful transplants from non-heartbeating cadaver donors, the careful circumscribing of the ethical and legal parameters of procurement from non-heartbeating cadaver donors by the critical care medical community should significantly advance the acceptance of organ donation from such patients. The task now, as earlier with regard to harvesting organs from those who met neurological criteria for death, is to educate physicians and the public alike of the truth that even in the face of one’s own death, the gift of life can be given—by what Pope John Paul II describes as the “particularly praiseworthy” act of organ donation.

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