Ethical Decisions in Transplantation

Deceased Donor Organs

The United Network for Organ Sharing (UNOS), the organization that administers the U.S. Organ Procurement and Transplantation Network (OPTN), reported that as of January 6, 2012, more than 16,000 people (adults and children) on its national patient list were waiting for a liver, and that a total of 6341 liver transplants were performed at 131 U.S. liver transplant programs during 2011. The total number of transplants performed annually has gradually decreased since 2006, in which 6651 liver transplants took place.

Many end-stage liver disease patients die each year waiting for a transplant, and their numbers appear to be increasing each year. Based on the latest data available, of those liver patients registered on the UNOS/OPTN Transplant Waiting List, 1791 died in 2000, 1894 in 2005, and 1468 in 2010, before a liver could be obtained. These deaths occurred despite the generally increasing number of deceased donor livers obtained from 2000 to 2010: 4595 in 2000, and 6009 in 2010. However, many families decline the option to donate their loved one’s organs because of cultural, religious, and other factors, as well as a lack of public education. The number of livers procured each year therefore cannot meet the current or future needs in the United States. Because donor livers are a scarce resource, questions of fairness in their procurement and distribution are inevitable.

Definition of Death

Acceptance of organ procurement and transplantation depends, in large part, on public confidence that deceased donor organs are procured only when people are actually dead, according to the public understanding of that term. Although the determination of death constitutes a medical decision, the concept of death depends on social, legal, and medical conventions. Fundamentally, transplantation must contend with the fact that the concept of death is culturally constructed, informed by religious beliefs, and situated within a historical context.

The medical criteria for whole-brain death in the United States were authoritatively defined by a U.S. presidential commission in 1981. The major principles are as follows:

• Both cerebral and brainstem functions must be absent.

• The cause or causes of this total lack of brain functioning should have been identified and determined to be irreversible. However, in actuality the cause of death may be unknown. In such cases the procedures for determining death by neurological criteria typically involve both a longer period of observation after the first examinations compatible with brain death before confirming the diagnosis, and greater use of confirmatory tests, such as cerebral blood flow studies, than would occur when the nature of the brain injury is clearly identified.

• The absence of all brain function must have persisted during a period of treatment and observation.

The Uniform Determination of Death Act (UDDA) (1981) provided the legal framework by stating that “an individual is dead if there is irreversible cessation of circulatory and respiratory functions or if there is irreversible cessation of all functions of the entire brain, including the brain stem.” This means that function will not reverse, and “irreversible” means that function cannot reverse. These two criteria evoke much controversy, as described later. The UDDA statutory definition has been adopted by most U.S. state legislatures; New York and North Carolina have adopted substantially similar versions. In other states, courts have upheld these brain death criteria in judicial rulings.

Despite the UDDA definition, confusion about the concept of death has persisted. The phrase brain death connotes to some the existence of two types of death, “regular” death and brain death . This distinction is reinforced by the perception that the death of patients who lose circulatory and respiratory functions and who are not on ventilator support is different from the death of patients supported by ventilators who have circulatory activity and appear to breathe. In brain death neurological (brain) control of breathing and regulation of circulation have been replaced by external mechanisms—the ventilator and often medications—to support an adequate flow of blood to maintain the function of vital organs, including the heart, lungs, kidneys, liver, pancreas, intestines, and so forth.

Two streams of thought object to the current definition of death for transplant procurement purposes:

• Some advocate narrowing the current whole-brain death criteria to require stricter criteria with prolonged observation and mandatory neurological testing.

• Others contend that the criteria should be widened to include patients who have been declared dead by traditional cardiopulmonary criteria (i.e., the regular dead as contrasted with the brain dead , often referred to as the cardiac dead ) or who are alive by current criteria but have been diagnosed with “permanent loss of consciousness” (i.e., the “higher brain” versus “whole brain” standard). In these situations, organ procurement would occur after the declaration of death by circulatory criteria or with the use of "rapid organ recovery" techniques.

Still others have proposed the elimination of the dead donor rule (DDR) altogether, permitting organ recovery before the declaration of death. The DDR provides the moral framework guiding organ procurement from deceased donors, such that vital organs may be removed only after clinicians confirm the patient’s death. The DDR aims to ensure public trust in organ procurement by preventing premature removal of organs. However, controversy remains over whether donation after circulatory determination of death does and should conform to the DDR. For some, the circulatory determination of death does not conform to the DDR because cardiopulmonary resuscitation could be (re)instituted, meaning that organs could technically be procured before the individual’s death. According to Truog and Miller, those advocating the DDR confuse the dying process with death. Donation after cardiac death is a rapidly expanding component of the donor pool that has received increased emphasis.

Recently OPTN has proposed revisions to the language describing procurement. To date, organ removal following death caused by the permanent and irreversible loss of circulatory and respiratory function has been referred to as donation after cardiac death or DCD . However, OPTN has proposed the term donation after circulatory death , to accurately reflect the definition of death determined by cardiopulmonary criteria used in the medical community. The UNOS/OPTN Proposal for Public Comment rationalized the new term as follows: “This change is particularly important because the heart is not dead (nor are other organs) when the heart stops, but when circulation and oxygenation to the tissues are irreversibly stopped,” and “the proposed changes will help to maximize the number of donors and transplants by identifying the currently unrealized donor potential through the clarification and updating of language.”

Public opinion surveys reveal that the public would not welcome a violation of the DDR. However, most of those surveyed poorly understood current definitions of brain death. For many laypeople, doubts still remain in light of physical evidence of skin warm to the touch, a heartbeat, and the breathing process—although they are machine generated—which to all appearances seem to confirm signs of life. To address public misunderstandings of brain death, Truog contends that either the definition of death must change or the DDR must not be requisite. Although the latter option seems ethically defensible, it is not likely to find widespread support. It appears that as the organ demand continues to rise, challenges to the DDR will continue to be made. The window of time between when clinicians declare death and when organ procurement begins appears to be narrowing, coinciding with efforts to embrace novel and broader interpretations of the concepts of irreversibility and cessation. Indeed, when one center began to remove infant hearts for transplantation after short periods (75 to 90 seconds) from the declaration of death, much outrage appeared, despite the resultant increase in available organs. Given the lack of public comfort with and understanding of the definitions of death and the process of organ procurement, distrust will likely accompany proposed changes to the DDR by professionals, especially those associated with the transplantation enterprise.

Family Veto of Organ Donor Cards

Organ donor cards and designation of willingness to donate on drivers’ licenses constitute a means for would-be donors to express their consent for donation, thereby increasing donation rates. Although signed donor cards indicate the donor’s intention to donate organs, historically organ procurement organizations (OPOs) also sought consent from next of kin. This practice stemmed from potential publicity and legal challenges that could arise if family members objected to donation. This de facto family veto stood in contrast to the provisions of the 1968 Uniform Anatomical Gift Act, which authorized gifts by any person older than 18 years of age with decision-making capacity.

In 2006 the Revised Uniform Anatomical Gift Act (currently adopted by 45 states) strengthened the language that bars any individual from “making, amending, or revoking” the donation of an anatomical gift for an individual who previously documented (e.g., via donor card) his or her consent to donate. This revision makes it unlawful for an OPO to allow the family members to veto donation in the presence of a signed donor card, as long as the donor did not revoke the gift before death. However, it also granted OPOs the authority to require life-sustaining interventions to preserve organs in individuals with signed donor cards, regardless of the donor’s preference for end-of-life care communicated by advance directives or surrogates. This raises two ethical concerns related to informed consent using donor cards. First, individuals signing donor cards may not understand that agreeing to donate permits premortem interventions to ensure medical suitability of the organs. In addition, the provisions of the 2006 law raise questions regarding autonomy, by limiting donors’ ability to use designated surrogates to communicate preferences related to life-prolonging interventions.

Given the potential conflict between patient preferences regarding life-sustaining interventions and consent to organ donation, a 2007 amendment to section 21(b) of the 2006 law now requires the attending physician to resolve any potential conflict with the prospective donor or his or her health care surrogate. However, the amendment still mandates the provision of life-sustaining intervention to ensure medical suitability of the organs while the conflict is being resolved. Education during advance health care planning and offering the option for would-be donors to document their specific preferences for premortem OPO procedures at the time of consent may mitigate these concerns.

Required Request and Presumed Consent Laws

Since the mid-1980s a series of required request laws were enacted to require hospitals to implement policies ensuring that the families of all eligible donors receive the opportunity to donate. Required request laws were followed by routine notification laws, which mandated that all hospitals receiving Medicare or Medicaid funds notify the local OPO of all individuals whose death is imminent or who have died in the hospital. Routine notification laws were designed to increase OPO involvement in the organ request process, with the underlying assumption that health care providers communicated ineffectively with families about donation. However, research findings suggest that a substantially greater percentage of patients’ families prefer that the treating physician make the initial request for organ donation, given that the physician knows the patient’s condition best and has spent the most time with the family. Nevertheless, both of these policies rest on the assumption that increasing the number of eligible donors’ families approached for consent would increase organ donation. Although the number of deceased donor livers has increased nationally from 2000 (N = 5199) through 2011 (N = 6685), the failure to increase donation sufficient to meet the growing demand for livers and other organs has prompted discussion about whether eliminating decision making at the time of death may result in greater increases in organ donation rates.

The U.S. Department of Health and Human Services established the Organ Donation Breakthrough Collaborative, a quality improvement initiative designed to “encourage adoption of ‘best practices’ for identifying potential donors and obtaining consent for deceased organ donation.” The collaborative set a national goal of a 75% conversion rate (“the number of actual donors divided by the number of potentially medical suitable donors”). Preliminary evidence of the initiative’s effectiveness was documented when the conversion rate for all organs increased from 52% in March 2004 to 60% in August 2004, before and after implementing the initiative, compared to a control group, which remained at 51%. The conversion rate for all organs has continued to grow, reaching 72.6% in 2011, although the liver recovery rate was 65.1% in the same year ( Table 29-1 ). Although well intentioned to help patients in need of lifesaving organs, such efforts presume that prospective donors’ deep-seated values and beliefs are “convertible” and that the decision not to consent is “preventable.” This disposition seems to disregard individuals’ cultural and religious attitudes or preferences against donating.

A number of other strategies have been considered to increase deceased donation. For example, presumed consent is an “opt-out” model in which a would-be donor is presumed to consent to organ donation unless he or she had documented an objection to donation before death. The rationale for presumed consent includes the supposition that the majority of individuals favor donation but never document their consent to donate, as well as the notion that one should minimize the decision-making burden on families at the time of a loved one’s death. Several European countries have adopted presumed consent laws, and a systematic review reported a 20% to 30% increase in organ donation with presumed consent. However, in their analyses of presumed consent, Rithalia et al and Healy independently concluded that presumed consent alone did not likely explain the increases in donation rates; rather, the resources that such countries invest in organ donation organization, infrastructure, education, and procurement staff contributed to the improved donation rates. In addition, a recent qualitative study of transplant physicians from 13 European countries that adopted presumed consent revealed that in all countries donation was always discussed with the family at the time of death, and that donation did not proceed if the family objected. In light of these findings, it remains unclear whether presumed consent laws would in fact increase organ donation. Moreover, concern arises regarding a potential negative impact of presumed consent on organ donation rates in places, like the United States, that value patient or family autonomy.

Mandated choice constitutes another strategy for increasing organ donation. Working within the constructs of an “opt-in” model, mandated choice requires that individuals explicitly decide “yes” or “no” regarding whether to be an organ donor, typically as part of a requirement for obtaining a driver’s license. Proponents of mandated choice argue that it preserves autonomy relative to presumed consent and also minimizes families’ decision-making burden at the time of death. However, questions remain regarding the effectiveness of mandated choice policies in increasing organ donation. For example, a mandated choice law was repealed in Texas after the majority of individuals refused to designate themselves as organ donors, resulting in an adverse impact on organ procurement efforts overall. Moreover, this approach also raises questions about populations in which few people obtain drivers’ licenses. Although there is a strong need to identify strategies to ameliorate the current organ donation shortage, it remains to be seen whether such policies will be implemented in the future.

Live Liver Donation

Prompted by the increasing organ scarcity, live liver donors have emerged as an important source of organs, constituting 4% of all liver transplants in 2011. Advances in surgical technique within the last decade have demonstrated that living donor liver transplantation (LDLT) confers better graft and patient survival compared to deceased donor liver transplantation for both adult and pediatric recipients. In addition, LDLT is often the only promising source of organs when patients become too sick to await a deceased donor organ. Thus clinical and ethical decisions must be made as to whether such patients should be offered a deceased donor organ. Although this situation justifies some use of living donors, it may also place undue pressure on potential donors (discussed later).

The use of live donors for liver transplantation remains highly controversial (see Chapter 60 ). Briefly, live liver donation violates the ethical principal of nonmaleficence: do no harm. LDLT involves placing living donors at risk for considerable harm with no direct medical benefit to themselves. Although these ethical considerations apply to all living donors, the use of live liver donors raises a host of concerns about donor safety, given the magnitude of risks to both the donor and recipient from the procedure. In the National Institutes of Health–Sponsored Adult-to-Adult Live Donor Liver Transplant Cohort Study (A2ALL) recent report of the first 6-year longitudinal study of live donor complications, 40% of live donors experienced a complication (e.g., bile leak, surgical hernia, infection). As a result, the risks and benefits, the adequacy of informed consent procedures, and the selection of recipients and donors remain under careful scrutiny. Informed consent for live liver donors will remain suboptimal until information on their long-term outcomes becomes available.

The type of living donor raises other ethical concerns. There are three categories of living donors: (1) living related donors (such as parents, siblings, or adult children) who are genetically related to the recipient; (2) living emotionally related donors (such as spouses, significant others, and close friends) who are genetically unrelated; and (3) living unrelated donors who are strangers to the recipient or nondirected donors. This last category has also been referred to altruistic or Good Samaritan donors. To date there have been only 41 nondirected live liver donor transplants, compared to 1092 nondirected live kidney transplants.

Among all categories of donors, living donation raises ethical concerns pertaining to voluntariness and its converse—the potential for coercion or undue pressure. Because of the pressures on potential donors to save a loved one’s life, many donors in the first two categories feel internal or self-generated pressures to donate, whereas others feel pressures from others, albeit less commonly, to donate. Liver transplant teams must evaluate the motives, capacities, and emotions of prospective donors in a variety of factual contexts, while at the same time seeking to respect the decisions of prospective donors with decision-making capacity, valuing the lifesaving potential of this gift to the recipients and the satisfaction of donors. Clinicians have also struggled with how to effectively communicate risks to potential donors to ensure, if possible, an adequate level of informed consent in such situations.

For these reasons, various national and international guidelines have emphasized limiting living donation to those persons who are either genetically or emotionally related to the recipient. Compared to living related donors, whose motives seem largely altruistic, living unrelated donors raise concerns among transplant providers about the possibility of financial compensation for donation and whether nondirected donors can make informed decisions with a clear understanding of the risks and benefits involved. Guidelines typically require that potential donors not receive any economic reward other than payment of reasonable medical expenses and lost income. Many acknowledge, however, that transplant centers have no systematic, reliable means to ensure the “donations” remain uncompensated.

The third category of donors—unrelated or Good Samaritan donors—raises other ethical issues. The key question is whether it is ever ethically acceptable to allow unrelated donors to donate to liver transplant candidates because the risk-benefit ratio differs from directed donation. Ethical concerns remain about justifying live liver donation to strangers because nondirected donors do not benefit from helping a known recipient. In other words, the kinds of psychological benefits obtained by donating to a loved one have traditionally been sufficient to justify the harms incurred by directed donation. But it is less clear whether the psychological benefits obtained by nondirected donors of having done a good deed sufficiently outweigh the harms. However, there is a growing acceptance of nondirected donation as long as the psychosocial benefits can outweigh the risks incurred to donors. Because the risk-benefit considerations differ for nondirected donors, some organ procurement organizations have developed programs specifically tailored to evaluating altruistic donors in an effort to support procurement from these donors. Otherwise, guidelines generally exclude almost all living unrelated donors (in contrast to living emotionally related donors).