Eugene F Diamond. The Linacre Quarterly. Volume 69, Issue 1, 2002.
The modern era of allogenic organ transplantation began in the mid 1960s. Then, improvement in surgical techniques, understanding of immunologic tolerance, and the development of drugs to control rejection expanded the technical feasibility of transplantation procedures. To some this represented a “crisis of success” as there was a resultant increase in demand for organs without a parallel increase in supply. According to the United Network for Organ Sharing database there are now 75,000 patients waiting for an organ. Among those waiting for a heart or liver transplant approximately 1/3 will die before an organ becomes available. The primary source of donor organs will be those who have had an irreversible cessation of total brain function and who are being maintained on ventilators in intensive care units. These are commonly called Heart Beating Cadaver Donors and will constitute a pool of 10,000-12,000 potential donors per year. Despite extensive public awareness campaigns, the ratio of actual to potential donors has not increased sufficiently. One response has been to attempt a greater reliance on living donors (kidneys) partial transplants (liver and lungs) and sources of dubious ethical propriety such as anencephalic infants and animals.
Another potential source of transplantable organs is patients who have been declared dead by traditional cardiopulmonary, rather than brain-based criteria. These are referred to as Non-Heart Beating Cadaver Donors. The success of transplants using organs from these sources has been limited by problems with warm ischemia. Two recent strategies to circumvent the problem of warm ischemia are in situ preservation following uncontrolled pulmonary arrest and procurement from patients who have died after choosing to forego life-support treatment. Both of these methods of procuring organs from Non-Heart Beating Cadaver Donors (NHBCD) have posed a new array of ethical problems related to ethical issues related to the definition of death potential conflicts of interest and acceptable behavior in controlling the dying process the consent process for procurement.
The major problem with organs taken from NHBCD is the deterioration of organs from warm ischemia. This is resultant from the prolonged period between the declaration of death following aseptole and the process of removing organs. Two approaches have been suggested:
Uncontrolled Cardiopulmonary Death
These are usually patients who are brought to an emergency room and die as a result of myocardial infarction or multiple traumas. To avoid warm ischemia a balloon catheter is inserted and inflated above and below the renal arteries and the kidneys are cooled by an infusion of cold preservative solution through this catheter and cannulas inserted through the abdominal wall.
Because of difficulty in obtaining consent from families overwhelmed by the circumstances of a sudden unanticipated demise, the Organ Bank of Illinois has proposed that the insertion of cannulas for installation of preservative solutions be carried out prior to asking for family consent. This is based on an experience of greater likelihood of getting consent if catheters are already in place and approaches to families are therefore less urgent.
Despite disclaimers that inserting catheters are non-deforming or non-mutilating, there is a great deal of concern about proceeding without family consent. There is little consensus about the morality of performing invasive procedures on dead patients to benefit others. At a minimum they are disrespectful of the dead, disregard family input and foster unwanted attitudes in medical staff.
Controlled Timing and Place of Death
This method is what has become commonly known as the Pittsburgh Protocol. Under this protocol families who have decided to forego life support may be approached to donate organs. The decision to stop life support should in all instances precede the decision to donate. This allows time for discussion before any invasive procedure and the time and location of death are controlled. Warm ischemia time is minimized by taking the patient to the operating room before organs are removed immediately after pronouncement of death.
For purposes of discussion, it will be assumed that the decision to stop the ventilator is appropriate given the circumstances of patient’s terminal condition. The family must give fully informed consent to 1) placement of a femoral artery catheter to measure pulse pressure, 2) declaration of death following absence of pulse pressure when the ventilator is removed, 3) removal of organs after death is declared 4) If removal of life support does not result in death of the patient “in a very short time”, the procedure will be cancelled and the patient returned to intensive care.
Death is declared after 1) two minutes of ventricular fibrillation 2) two minutes of asystole or 3) two minutes of electromechanical dissociation.
Ethical Issues
A fundamental question is whether increasing the number of transplants deserves to be a priority in a time of scarce resources. To what extent is the attempt to increase the number of donor organs influenced by the increase in the number of surgeons and institutions performing transplantation and the need to increase the funding of centers whose prestige, opportunities for training and funding for research depend on increasing the number of operations done? Public perception of motives other than saving lives might undermine the acceptance of dramatic programs to increase NHBCD.
Issues regarding Defining and/or Hastening Death
Criteria for death using brain-based standards have constantly and incontrovertibly focused on irreversibility both in statutory and clinical definitions. Irreversibility confirms death to reinforce certainly that death is final with no hope of recovery. The Uniform Determination of Death Act states “An individual who has sustained either 1) irreversible cessation of respiratory and circulatory functions or 2) irreversible cessation of all functions of the entire brain including the brain stem is dead. A determination of death must be made in accordance with accepted medical standards.” This standard has been enacted into statutes in most states.
The concept of irreversibility has been defined as “a lost function cannot be restored by anyone, under any circumstances at any time now or in the future.” A less categorical definition states “the loss of function cannot be reversed by those present at this time.”
Under the Pittsburgh Protocol, death is declared after two minutes when the failure to restore cardiac function will result not from a lack of present means, but from a decision not to use them. The patient who has qualified as NHBCD may be in a state when organs are removed where it might be possible to restore function, but a decision has been made not to attempt to do so. This raises questions as to whether the Pittsburgh protocol fulfills the criterion of irreversibility. Defenders of the protocol argue that irreversibility should be determined by an inability to autoresuscitate. It is customary to declare those patients dead who have Do Not Resuscitate Orders and who arrest when we have no plans to resuscitate them. There are no data to confirm that autoresuscitate is impossible after the two minutes allowed in the Pittsburgh Protocol. Shewmon has suggested a longer period of 20 minutes but he also lacks data to confirm a more prolonged period of observation precluding autoresuscitation.
How does adding the goal of procuring organs affect the morality of the situation? Is it possible to be confident that the goal of acquiring viable organs does not affect decisions made in the best interest of the dying patient?
Will the use of narcotics to control pain be altered when organ harvesting is anticipated? Will the decision to discontinue life support be derivative of the anticipated organ donation despite scrupulous attempts to separate the decision to stop the respirator from the decision to donate organs? Is it possible, in other words, to be sure that the decision to shorten life will not be influenced by the reality that death is to occur in a fashion that produces viable organs?
It will be difficult for families and health care personnel to avoid the impression that the death is staged or even ceremonial. There will be emotional consequences for those who must say their farewells to a conscious or unconscious patient who is then wheeled to the operating room to die among strangers who have heretofore not participated in his care. It would be possible to insert femoral catheters in the intensive care unit and then remove life support prior to taking the patient to the operating room. It is questionable whether this would ameliorate emotional reactions or actually aggravate them by mixing patient care and transplant procedures inseparably.
The Consent Process
When the strategy of the health care team is directed toward increasing the number of transplantable organs, the consent process may be altered. It is usually assumed that both the donor and the next of kin would agree to the donation. In practice, different organ procurement organizations proceed differently. 19% follow the deceased’s wishes, 19% follow the next of kin’s wishes, 10% proceed if neither party objects and 8% proceed if either party consents or neither objects. The availability of a Durable Power of Attorney or a Living Will could strongly affect the decision. There is seemingly no national consensus as to what constitutes valid consent. Clear direction from an advanced directive or a unanimous agreement between patient and family would seem to constitute a minimum requirement for most hospital settings in contrast with Organ Procurement Organizations’ policies.
Public Policy Considerations
While a heroic attempt has been made in the Pittsburgh Protocol to protect the best interests of donors and to separate caregivers and transplant teams rigorously, the pervasive atmosphere, rightly or wrongly, is to guarantee an increase in available donor organs. In an institution that identifies itself as a “transplantation center” and in which the salutary goal of saving lives of critically ill patients pervades the environment, strict standards will be vulnerable to “end justifies the means” rationales. Although under the common law, no one has a property interest in a dead body, a limited interest in a corpse resides with the next of kin who are expected to arrange for the disposition of the remains. A pre-mortem decision to donate one’s organs is not binding on next of kin. The Uniform Anatomical Gift Act adopted in all states, made it possible for an individual to make an anatomic gift, which would take effect upon death. This was followed by the Uniform Determination of Death Act to clarify the dead donor rule, now operative in 47 states. The National Organ Transplant Act in 1984 established a mechanism for finding donors and prioritizing recipients. This system, not surprisingly, has not achieved the goal of matching organ supply with demand. The shortfall using brain-based criteria to qualify heart beating cadaver donors (HBCD) has further encouraged the development of protocols for non-heart beating cadaver donors (NHBCD).
The very sensitive background to these strategies is the public’s confidence in the process. If the public perceives that the motivation is self-interest rather than life saving, the end result might be a decrease rather than an increase in the availability of transplantable organs.