2
Non-Heart-Beating Donation and End-of-Life Care

Recommendation 2: The decision to withdraw life-sustaining treatment should be made independently of and prior to any staff-initiated discussion of organ and tissue donation. The decision should be based on the gravity of the patient’s condition and on his or her wishes to stop burdensome treatment (or on guidance from a surrogate decision maker who represents or affirms the patient’s wishes). It should follow established hospital protocols for withdrawing support and providing terminal care.

Recommendation 3: As recommended in the 1997 IOM report, statistically valid, observational studies of patients after the cessation of cardiopulmonary function need to be undertaken by appropriate experts. These studies should address the following:

  • conditions under which cardiac autoresuscitation might occur and at what intervals;

  • signs, symptoms, and testing technologies that could guide the determination of death by irreversible cardiopulmonary function, and

  • assessment of various technological and clinical observations of the degree and permanence of loss of brain function in whole or in part following the cessation of cardiopulmonary function.

Such studies are needed in order to develop further consensus on the appropriate interval between the cessation of cardiopulmonary function and the declaration of death.



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Non-Heart-Beating Organ Transplantation: Practice and Protocols 2 Non-Heart-Beating Donation and End-of-Life Care Recommendation 2: The decision to withdraw life-sustaining treatment should be made independently of and prior to any staff-initiated discussion of organ and tissue donation. The decision should be based on the gravity of the patient’s condition and on his or her wishes to stop burdensome treatment (or on guidance from a surrogate decision maker who represents or affirms the patient’s wishes). It should follow established hospital protocols for withdrawing support and providing terminal care. Recommendation 3: As recommended in the 1997 IOM report, statistically valid, observational studies of patients after the cessation of cardiopulmonary function need to be undertaken by appropriate experts. These studies should address the following: conditions under which cardiac autoresuscitation might occur and at what intervals; signs, symptoms, and testing technologies that could guide the determination of death by irreversible cardiopulmonary function, and assessment of various technological and clinical observations of the degree and permanence of loss of brain function in whole or in part following the cessation of cardiopulmonary function. Such studies are needed in order to develop further consensus on the appropriate interval between the cessation of cardiopulmonary function and the declaration of death.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols To maintain the support and trust of care providers, families and the general public, it is essential that the decisions, actions, and personnel involved in the withdrawal of life-sustaining treatment and the declaration of death be kept separate from the decisions, actions and personnel involved in the recovery of organs. Trust depends on the knowledge that the best care will be provided to all patients regardless of decisions about organ and tissue donation. Organ transplantation has gained strong social, medical, and policy support. Public education and public policy measures emphasize the importance of organ donation in providing the life saving benefits of transplantation to organ recipients. The 1997 Institute of Medicine (IOM) report identified the potential for conflict of interest between patient care and organ recovery. One protection against such conflict of interest is the legal mandate of the Uniform Anatomical Gift Act (UAGA) that the person who declares death not be associated in any way with the organ procurement team (IOM, 1997b, pp. 55–57). All organ recovery protocols adhere to this mandate. However, in an environment of support for donation, the potential for actual or perceived conflicts of interest between patient care and organ recovery is more complex. In non-heart-beating donation, medical treatment is modified in order to allow donation to proceed. These modifications include medications and procedures, and the process of withdrawing life-sustaining treatment and declaring death. The 1997 IOM report’s recommendations in these areas are intended to prevent harm or potential harm to the patient while still making it possible for donation to take place, in conformity with patient and family wishes. Empirical research should be undertaken to address concerns about the determination of death. The five-minute time interval between cardiopulmonary arrest and the declaration of death recommended in the 1997 IOM report is a considered judgment based on the available data and on expert interpretation of these data. The 1997 report recommended further study in this area that has not been pursued. Although end-of-life research is an ethically sensitive undertaking, simple, noninvasive observations and data collection can contribute to a greater understanding of terminal events, and greater certainty in the declaration of death. In addition, further research is needed into the psychosocial and ethical impact that non-heart-beating donation may have on families, the community, and health care providers. The level of concern or misunderstanding about the determination of death, or about the possibility that the donor may not expire following the withdrawal of support, are not known. A qualitative study of nurses’ responses to non-heart-beating donation suggests that these concerns need to be better understood (Wolf, 1994). TERMS AND CONCEPTS When death is declared by neurological criteria, the patient commonly is described as “brain dead.” Unfortunately, some confusion persists among the

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Non-Heart-Beating Organ Transplantation: Practice and Protocols public and among care providers about what constitutes brain death and whether it means that the person is “really” dead (Sullivan et al., 1999; Youngner et al., 1989; DeJong et al., 1998). In addition, the terminology of brain death and cardiac death may suggest that there are two kinds of death, rather than two ways of determining that death has occurred (Menikoff, 1998). The committee was concerned that the terminology of “cardiac death” and “brain death” might contribute to doubts or misunderstandings about whether and when death “really” takes place. This report uses the terms “death established by neurological criteria” and “death established by cardiopulmonary criteria.” It describes the organ and tissue donation process as “non-heart-beating donation,” and the patient as a “non-heart-beating donor.” Although these terms are more familiar to health care professionals than to the general public, the committee judged them to be more accurate than the simpler terminology of “brain death” and “cardiac death” for conveying when and how death is determined. The distinction between death by cardiopulmonary criteria and death by neurological criteria affects the terminology for describing medical interventions to sustain cardiopulmonary functions. The person who is declared dead by neurological criteria prior to donation continues to receive mechanical ventilation, fluids, and medications. These measures do not constitute life support because death has already been established. Instead, these measures are sometimes described as “artificial” or “aggressive” support. In non-heart-beating donation, the patient dies after artificial support measures have been withdrawn and breathing and heart function have ceased. Thus, the measures that maintain circulation and ventilation can appropriately be called “life-sustaining treatment.” This term describes a practice that is not universally accepted, but it conveys the actual sequence of events: life-sustaining treatment is withdrawn, the patient dies, and organs and tissues are removed. The committee recognized that terminology needs to be comprehensible to the general public and to those who are considering this donation option. They chose to use more technical terminology for this report, but recognized that it may be appropriate to modify this terminology according to the situation. WITHDRAWING LIFE-SUSTAINING TREATMENT Decisions to withdraw life-sustaining treatment have received considerable attention in recent decades. Although such decisions are not accepted universally, the mainstream of American ethical, legal, and clinical opinion accepts the withdrawal of life-sustaining treatment based on the patient’s clinical condition and wishes.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols The Decision to Withdraw Treatment In the field of bioethics there is a wide range of opinion about whether and when life-sustaining treatment can be withdrawn. At one end of the spectrum is the opinion that such treatment may never be stopped under any circumstances. Death may intervene but can never be assisted by withdrawing treatment. At the other end of the spectrum is the opinion that intentional killing by such means as lethal injection is justified when requested by the patient (Weir, 1989, pp. 227–278). Mainstream opinion in bioethics falls in the middle ground between these two points. Mainstream opinion endorses the withdrawal of life sustaining treatment, with differences of opinion about what treatments may be discontinued under what conditions. Debates focus on the certainty or reliability of diagnosis and prognosis, the imminence of death, the degree of suffering, the degree of neurological impairment, the burdens and benefits of continued treatment, and the degree of certainty that the patient would not want further treatment. Legally, the right to refuse unwanted medical intervention is based on the common law right to bodily integrity, the constitutional right to privacy, and court opinions upholding the right of competent persons to refuse medical treatment. Recent case decisions involve decisions to withdraw life-sustaining treatment made by third parties on behalf of those who lack decision-making capacity (Beauchamp and Childress, 1994, pp. 170–180; Emanuel, 1988; Weir and Gostin, 1990). In law and bioethics there is general consensus that the absence of capacity does not diminish the right to refuse medical intervention and therefore to have treatment withdrawn under the guidance of a designated decisionmaker. Variations among state laws affect the authority that a surrogate may exercise on the patient’s behalf and the options for family/surrogate decision-making, but not the underlying ethical grounds for refusing treatment on another’s behalf (Brody, 1995; IOM, 1997b). Clinically, the withdrawal of life-sustaining treatment is based on an understanding of the patient’s wishes and on as accurate an assessment as possible of the patient’s condition and prospects for improvement. Treatment that offers diminishing prospects for restoring health or critical bodily functions is described sometimes as “futile” (Beauchamp and Childress, 1994, pp. 212–214). Clinicians seek a degree of certainty about both the burdens and benefits of treatment and the patient’s wishes when the withdrawal of treatment is being considered. Given the uncertainty of “futility” assessments and differences in opinion about the burdens and benefits of treatment, not all clinicians and not all patients or families will make the same decisions. Ultimately, decisions to forgo life-sustaining treatment are judgments that can best be made according to the patient’s own values about the burdens and benefits of treatment and the prospects for an acceptable outcome (Callahan, 1991). They rest on patient wishes, family input, and clinical judgment, independent of organ transplantation needs.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols The decision to withdraw life-sustaining treatment, to allow the heart and breathing to stop, and not to attempt resuscitation, is consistent with end-of-life care, whether or not organ donation follows. The Decision to Donate Organs and Tissues Controlled non-heart-beating donation cannot take place unless life-sustaining treatment is stopped. However, the decision to donate organs and tissues and the action of recovering organs and tissues after death are distinct and separate from the decision to stop life-sustaining treatment and the action of withdrawing such treatment. Two separate and distinct clinical teams are responsible for these two sets of decisions and actions. Conflict of interest prevents the organ donation team from being involved in the decision to stop treatment or in the process of withdrawing treatment. In maintaining this clear distinction, the committee is aware that the roles and responsibilities of each team do, in fact, overlap. Both teams provide the families with information and support; both contribute to patient management decisions prior to donation. Close collaboration between the two teams leads to more consistent care for the patient and family, and to better transplant outcomes—a goal that patients and families share. However, the interests of the organ donation team must not influence the decision to withdraw life sustaining treatment. Due to increasing public awareness of organ donation, families may raise the question of donation before a decision about continuing or withdrawing treatment has been made. Those who are providing care to a patient may need to respond to such inquiries. In these circumstances, the family’s interest can be supported, and arrangements made to discuss donation options as soon as possible after treatment decisions have been made. Withdrawing Life-Sustaining Therapy Non-heart-beating donation has raised concerns that measures taken to maintain organ viability will in some way harm the patient or hasten his or her death (IOM, 1997 p. 51). Such concerns were the basis for the 1997 IOM report’s recommendations that consent be obtained and anesthesia or analgesia administered for procedures such as cannulation, and that medications such as phentolamine (a vasodilator) and heparin (an anticoagulant) not be administered routinely but on a case-by-case basis, based on the patient’s condition. These measures are taken to maintain organ viability, not to benefit the patient; the recommendations ensure that these measures at least cause no harm (p. 52). The process of withdrawing life-sustaining treatment raises similar concerns. Just as there are differences of opinion about withdrawing life sustaining treatment, there are differences of opinion about specific steps in the process of “terminal weaning” from ventilator support (Tasota and Hoffman, 1996). For example, mechanical ventilation may be stopped in order to stop unwanted and

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Non-Heart-Beating Organ Transplantation: Practice and Protocols burdensome treatment; sedatives and narcotics may be administered in order to provide palliative care at the end of life. Both of these have been questioned as measures that may unduly hasten the dying process, and they generated considerable discussion at the workshop. This study finds the withdrawal of life support, including terminal weaning and palliative care, to be (1) an area in which opinions and practices reasonably may differ, as long as they support patient choice and comfort, and (2) an area that is managed by the patient care team, rather than the organ donation team. The separation between the patient care team and the organ donation team should be maintained as much as possible during the process of withdrawing life-sustaining treatment, as well as during the decision making process. Extensive work on withdrawing treatment has been done in bioethics and in end-of-life care (Hastings Center, 1987; Weir, 1989; Emanuel, 1995; Lo, 1995; Moskowitz and Nelson, 1995; Solomon, 1995; Tasota and Hoffman, 1996; IOM, 1997b; Singer et al., 1999). This work provides the basis for excellent guidelines for withdrawing life-sustaining treatment, support for patient and family choices, psychosocial and spiritual support, bereavement support, palliative care and the relief of pain and suffering, respect for patient and family choices, assistance with financial needs, and help with caregiving. Hospital policies and protocols should guide the withdrawal of life-sustaining treatment whether or not organ and tissue donation is to follow. Such policies and protocols provide a standard for end-of-life care that applies to donors and nondonors alike, and provide a mechanism for ensuring that the standard of care is maintained for both. DETERMINING DEATH Controlled non-heart-beating donation takes place after life-sustaining treatment has been withdrawn, cardiopulmonary function has ceased, and death has been declared. The time between the withdrawal of treatment and cardiopulmonary arrest varies according to the patient’s condition. During this time, breathing and circulation continue, but both oxygenation and perfusion of organs and tissues are diminished (warm ischemia). Occasionally, a patient does not expire after life sustaining treatment has been withdrawn. If death does not occur within a limited time, organ viability suffers. Most non-heart-beating donation protocols stipulate that if death does not occur within one hour organ recovery will not be carried out. Instead, the patient will remain in a patient care unit and will continue to receive palliative care until death occurs. In most cases, cardiopulmonary function ceases and death is declared shortly after support has been withdrawn. The 1997 IOM study found that non-heart-beating donation protocols varied in their criteria for declaring death after the cessation of cardiopulmonary function. The report found that some protocols allowed the removal of organs immediately following cardiopulmonary arrest;

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Non-Heart-Beating Organ Transplantation: Practice and Protocols others stipulated waiting periods varying from two to ten minutes; others did not specify a precise time interval (IOM, 1997b, p. 58). Once cardiopulmonary function has ceased, the internal organs are no longer perfused with oxygenated blood and begin to deteriorate rapidly. Optimum organ viability can be achieved by removing the organs rapidly or by preserving them in situ with cold preservative solutions. The need to maintain organ viability creates a strong incentive for an early determination of death. This incentive for the early determination of death places one of the greatest demands on non-heart-beating practice and protocols—the demand for clear and credible standards for determining death prior to organ recovery. The state of consensus on the determination of death prior to non-heart-beating donation is discussed in detail in Chapter 4. Here, the empirical and conceptual issues involved in determining death by cardiopulmonary criteria are reviewed. This review is based on a commissioned paper prepared for the committee and presented for discussion at the workshop (Youngner, DeVita, and Arnold, in press). This paper, and the work of the committee on the issue of determining death, focus on the issues involved, and the work that remains to be done to resolve them. In concurrence with the 1997 IOM, the committee found that the interval of five minutes between the cessation of cardiopulmonary function and the declaration of death provided adequate assurance of the irreversible cessation of cardiopulmonary function, and satisfied the requirements of the Universal Determination of Death Act (UDDA). They reiterated the recommendation of the 1997 report that further study of this interval be undertaken to provide more clarity and certainty in this area. Empirical Grounds for Determining Death Based on a review of the available data and expertise, the 1997 IOM study recommended that in controlled non-heart-beating organ donation (1) an interval of at least five minutes be allowed to elapse between cardiopulmonary arrest and the declaration of death and (2) this period of cardiopulmonary arrest be verified by electrocardiographic and arterial pressure monitoring. In the absence of empirical certainty that cardiopulmonary function ceases irreversibly within five minutes of arrest, the IOM report based this recommendation on expert judgment about the terminal physiology of the brain and the circulatory system (IOM, 1997b, p. 59). It recommended further study to evaluate the validity of the five-minute interval as an indication of irreversible cessation of cardiopulmonary function. The empirical data available indicate that cardiopulmonary arrest becomes irreversible within a shorter time interval—60 seconds or less. However, these data are quite limited (Table 2-1). Further, these were studies of terminal cardiac electrical activity, not autoresuscitation. Thus, existing empirical data cannot confirm or disprove a specific interval at which the cessation of cardiopulmonary function becomes irreversible. The recommendation of a five-minute inter-

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Non-Heart-Beating Organ Transplantation: Practice and Protocols TABLE 2-1 Autoresuscitation Following Cardiopulmonary Arrest Author Year No. in Study Age Time of Longest Asystole Preceding Recovery (seconds) Comments Robinson 1912 7 9–37 30 Electrical activity after death certified in all Willius 1924 4 29–58 11.4 No autoresuscitation. No certification of death standard or time reported. Only four of six patients studied reported Stroud 1948 23 10–87 No recovery after asystole 20 had electrical activity by EKG after death was determined Enselberg 1952 43 8–80 65 22 had resuscitative measures (i.e., medications and a “thump” to chest [not CPR]) Rodstein 1970 31 ≥73 60 Mean duration of coordinated EKG activity after death; 4.8 minutes; maximum, 17 minutes NOTE: CPR = cardiopulmonary resuscitation; EKG = electrocardiograph.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols val between cardiopulmonary arrest and the declaration of death is based on the acknowledged limitations of these data. However, this recommendation has been criticized as not conservative enough. One critic argues that there is only one standard of death—the permanent loss of all brain function—with two methods for determining that this has occurred. Death can be established by neurological testing or by cardiopulmonary arrest of sufficient duration to bring about the death of the brain. According to this critic, the interval between cardiopulmonary arrest and the declaration of death should be seven minutes or longer (Menikoff, 1998). However, there is no legal or historical basis for such a rigid requirement for declaring death by cardiopulmonary criteria. The UDDA specifies the irreversible loss of all brain function or the irreversible cessation of cardiopulmonary function, not both. The issue of declaring death by cardiopulmonary criteria involves empirical and conceptual clarity on the definitions of irreversibility (Potts et al., 1998). Lack of certainty about the determination of death is a potential obstacle to non-heart-beating donation. However, no studies have been done to determine how significant a concern it may be and for whom: care providers, families and the general public, and/or ethicists. At this time, the five-minute interval has gained acceptance among some, but not all, OPOs. Further study of the validity of this time interval, as recommended in the 1997 IOM report, has not been undertaken. Such study is needed to evaluate the level of uncertainty about the five-minute interval and its relevance for support of non-heart-beating donation (see Chapter 6). Conceptual Issues in Determining Death In their commissioned paper and during the workshop discussion, Youngner, DeVita and Arnold identified the concept of irreversibility as a major conceptual issue in the determination of death by cardiopulmonary criteria. Conceptually, “irreversible” cessation of cardiopulmonary function can be interpreted to mean several things: (1) will not resume spontaneously; (2) cannot be restarted with resuscitation measures; (3) will not be restarted on morally justifiable grounds. Because non-heart-beating donation involves those who elect not to continue life sustaining treatment, the 1997 IOM study accepted that death occurs when cardiopulmonary function will not resume spontaneously, and will not be restarted artificially. Critics have suggested that cardiopulmonary function is not irreversibly lost as long as it could conceivably be restored by vigorous resuscitation efforts (Menikoff, 1998). However, there are no legal or moral grounds for attempting to resuscitate someone who has elected to discontinue life-sustaining treatment. When life sustaining treatment has been withdrawn, when the heart and breathing have stopped, and when the passage of time has rendered the possibility of

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Non-Heart-Beating Organ Transplantation: Practice and Protocols autoresuscitation vanishingly small, there are strong ethical, legal and clinical grounds for concluding that death has occurred. This was the conclusion reached in the 1997 IOM report (pp. 58–59). Further assessment of the irreversible loss of cardiopulmonary function is recommended at the beginning of this chapter. The committee concluded that simple, noninvasive observation following the withdrawal of life sustaining treatment from both donor and nondonor patients would provide valuable information about the cessation of cardiopulmonary function, and that such observation could be done (with consent) without intruding upon the dying person or the family. Similar observational assessment was recommended in the 1997 IOM report, but has not yet been done. In addition, more complex technological and clinical observations need to be conducted by the appropriate experts, in ways that protect patient and family welfare and privacy. In arriving at these recommendations, the committee considered the work that has been done to set the standards for determining death by neurological criteria. The definition of the irreversible cessation of all brain function and its acceptance as a standard for determining death have been developed through extensive study and debate in medicine, ethics and law (Ad Hoc Committee of the Harvard Medical School, 1968). Debates, misunderstandings, and revisions continue to surface (Youngner et al., 1989; Olick, 1991; Veatch, 1993; Bernat, 1998), but the determination of death by neurological criteria has been widely accepted. The determination of death by cardiopulmonary criteria has not been subjected to the same kind of scrutiny as the determination of death by neurological criteria. The vast majority of all deaths are declared in this manner, according to established medical practice and judgment. The committee determined that a reassessment or redefinition of death by cardiopulmonary criteria, on the scale of the work that has been done on death by neurological criteria, was beyond the scope and expertise of this study. The committee addressed the determination of death prior to non-heart-beating donation as a dissemination issue, and suggested following: Consistency in the determination of death by cardiopulmonary criteria should remain a goal for non-heart-beating donation protocols. As suggested during the workshop, uncertainty and controversy may undermine family, provider, and public confidence in non-heart-beating donation. Empirical observations as recommended at the beginning of this chapter are needed to establish the empirical grounds for such consistency. Tests to determine that brain function is entirely absent vary somewhat in timing, extent, and technological complexity. Assessments of the irreversible cessation of cardiopulmonary function vary somewhat as well. However, both methods for determining death are consistent with the Universal Determination

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Non-Heart-Beating Organ Transplantation: Practice and Protocols of Death Act (UDDA) and provide legal, clinical, and ethical grounds for determining that death has taken place before organ recovery begins. The issue at stake in the determination of death is one of trust that the health care system will provide optimum end-of-life care regardless of the demands of organ procurement. Trust is a matter not only of facts and data, but also of attitudes and commitments. Trust depends on optimum end-of-life care for patients and families, donor and nondonor alike, as discussed in the following chapter.