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Non-Heart-Beating Organ Transplantation: Background and Current Practices

Recommendation 1: All organ procurement organizations (OPOs) should explore the option of non-heart-beating organ transplantation, in cooperation with local hospitals, health care professionals, and communities. A protocol must be in place in order for non-heart-beating donation to proceed. Protocols to cover non-heart-beating donation are needed in order to:

  • make this option available to all patients and families who wish to donate organs and tissues;

  • respond to increased donation referrals generated by HCFA regulations; and

  • contribute to the supply of organs for transplantation.

There are three reasons for recommending that OPOs, together with local hospitals, physicians, and communities, develop the option of non-heart-beating donation.

First, non-heart-beating donation offers an option to patients and families who may wish donation to take place after life-sustaining treatment is withdrawn, and death is determined by cardiopulmonary criteria. Several OPOs report that their non-heart-beating donation protocols were developed in response to urgent family requests. Family requests for non-heart-beating donation have been reported in the literature as well (DeVita et al., 1993). These reports are anecdotal, but they suggest a real interest on the part of families in pursuing the option to donate organs and tissues in this situation. Not all families seek or accept this option. However, research with donor families following death by neurological criteria suggests that families find comfort in salvaging some benefit to



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Non-Heart-Beating Organ Transplantation: Practice and Protocols 1 Non-Heart-Beating Organ Transplantation: Background and Current Practices Recommendation 1: All organ procurement organizations (OPOs) should explore the option of non-heart-beating organ transplantation, in cooperation with local hospitals, health care professionals, and communities. A protocol must be in place in order for non-heart-beating donation to proceed. Protocols to cover non-heart-beating donation are needed in order to: make this option available to all patients and families who wish to donate organs and tissues; respond to increased donation referrals generated by HCFA regulations; and contribute to the supply of organs for transplantation. There are three reasons for recommending that OPOs, together with local hospitals, physicians, and communities, develop the option of non-heart-beating donation. First, non-heart-beating donation offers an option to patients and families who may wish donation to take place after life-sustaining treatment is withdrawn, and death is determined by cardiopulmonary criteria. Several OPOs report that their non-heart-beating donation protocols were developed in response to urgent family requests. Family requests for non-heart-beating donation have been reported in the literature as well (DeVita et al., 1993). These reports are anecdotal, but they suggest a real interest on the part of families in pursuing the option to donate organs and tissues in this situation. Not all families seek or accept this option. However, research with donor families following death by neurological criteria suggests that families find comfort in salvaging some benefit to

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Non-Heart-Beating Organ Transplantation: Practice and Protocols others out of their own loss (Bartucci, 1987; Batten and Prottas, 1987; DeJong et al., 1998; Pearson et al., 1995). Family participants in the workshop confirmed this motivation for organ and tissue donation from their own experiences. Second, recent HCFA regulations require that all deaths and impending deaths be referred to the local organ procurement organization (OPO), and that the option of organ and tissue donation be offered by a trained requester (42 U.S.C. Sect. 482.45). These regulations are in the process of being implemented. As implementation proceeds, these regulations are expected to increase substantially the number of patients that OPOs evaluate as potential donors (Ehrle et al., 1999; McCoy and Argue, 1999; Nathan et al., 1991). Comprehensive evaluation of potential donors should include the option of non-heart-beating donation, and whether the family might wish to consider this option. As is the case with any decision to donate organs and tissues, the decision about non-heart-beating donation rests with the patient and family. Third, non-heart-beating donation has the potential to contribute substantially to the supply of organs and tissues for transplantation. Reports in the literature suggest that non-heart-beating donation might contribute 20% or more to the supply of kidneys (Koostra et al., 1991; Koogler and Costarino, 1998; Lewis and Valerius, 1999), and an undetermined amount to the supply of other solid organs (e.g., the liver and the pancreas) (D’Alessandro et al., 1995; Yersiz et al., 1999). Although this study follows a patient and family-centered approach to donation that emphasizes the needs and wishes of donor patients and families, the needs of critically ill potential recipients are an important social and medical priority as well, and warrant efforts to increase the supply of organs and tissues. The development of non-heart-beating donor protocols is a cooperative effort among OPOs, hospitals, health care professionals, and communities. OPOs act as leaders, intermediaries and facilitators, assisting hospitals with development of protocols or providing OPO protocols to smaller hospitals with limited numbers of referrals and limited resources for protocol and staff development. Hospitals can initiate or facilitate non-heart-beating donation by developing their own non-heart-beating donor protocols. In addition, hospital protocols for the termination of life-sustaining treatment and the provision of palliative care are absolute prerequisites for non-heart-beating donation and for high-quality end-of-life care. NON-HEART-BEATING TRANSPLANTATION: BACKGROUND History The procurement and transplantation of organs from non-heart-beating donors represents both a new practice and a return to a former practice in organ transplantation. During the early years of organ transplantation, all organs for transplantation were obtained from living kidney donors or from patients de-

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Non-Heart-Beating Organ Transplantation: Practice and Protocols clared dead following the irreversible cessation of respiratory and cardiac function (DeVita et al., 1993; IOM, 1997b). Organs removed after death suffered considerable ischemic damage that compromised transplantation outcomes. The concept of determining death by neurological criteria was introduced in the late 1960s (Report of the Ad Hoc Committee,1968). These criteria have been incorporated into the Uniform Determination of Death Act (UDDA). According to this act, death can be determined by cardiopulmonary or neurological criteria: the permanent cessation of cardiopulmonary function or the irreversible loss of all brain function. Although challenges and reconsiderations continue to surface, the use of neurological criteria for death has gained wide medical, legal, ethical, and public acceptance in the United States (Bernat, 1998; IOM, 1997b; Olnick, 1991; Veatch, 1993). Since the establishment and acceptance of neurological criteria for death, the majority of organs for transplantation in the United States have been obtained from patients who are declared dead by these criteria. After death has been declared, cardiopulmonary function is sustained artificially until the organs are removed. Mechanical ventilation and other forms of medical support are continued in order to maintain the circulation of oxygenated blood to the organs and to maintain organ viability for transplantation. Because of improved transplant outcomes, organ procurement after death by neurological criteria has virtually replaced organ procurement after death by cardiopulmonary criteria. During the past decade, renewed interest in organ donation following death by cardiopulmonary criteria has developed for two main reasons. The first reason is patient and family interest in organ donation in cases where neurological criteria for death cannot be met, but the decision has been made to withdraw life-sustaining treatment (DeVita et al., 1993). The second reason is the potential for increasing the supply of organs for transplantation. The patient who becomes a non-heart-beating organ donor cannot sustain life without continued medical intervention. When this medical intervention is stopped, cardiac and respiratory functions cease, death is declared, and organs are removed. The process must be carried out rapidly in order to remove organs before they become unsuitable for transplantation. Non-heart-beating donor organ procurement may be controlled or uncontrolled. In uncontrolled non-heart-beating organ procurement, organs are removed after the patient suffers a sudden cardiopulmonary arrest. The patient may arrive at the hospital in arrest, may suffer an unanticipated arrest (Maastricht categories I and II), or may arrest after neurological criteria for death have been established (Maastricht category IV) (IOM, 1997, pp. 25, 42–43; Koostra, 1995). For the patient who arrives in arrest or for whom arrest is unanticipated, death is declared when resuscitation efforts fail to restore heart function. In these cases, issues of consent arise. The patient’s wishes about donation may not be known, and there may be a delay while the family is located and informed of the patient’s condition. Organ viability can be preserved in situ while efforts are

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Non-Heart-Beating Organ Transplantation: Practice and Protocols made to contact the family, but in order to do this, certain invasive procedures (e.g., the insertion of cannulae) must be performed without consent. As far as this study was able to determine, only one center in the United States preserves organs in situ in this situation, although it is more common in Europe (Alvarez et al., 1997, 1999; Ward et al., 1997). Under a program based on extensive community outreach and local legislation, this medical center takes measures to preserve organs in situ pending family contact and consent (Washington Hospital Center, Appendix F). The situation is simpler for the patient who arrests unexpectedly after death has been declared by neurological criteria and cardiac function cannot be sustained. In this situation, organs are removed rapidly following an unanticipated arrest—thus, the term “uncontrolled”—but the issues of consent are less complex. The option of donation may have been considered; consent may have already been given, or consent can be obtained readily in order for donation to proceed on short notice. In controlled non-heart-beating donation, a decision is made to discontinue life-sustaining medical intervention. This decision is made when treatment offers little if any prospect for recovery or the patient’s wishes to forgo such treatment are known (Beauchamp and Childress, 1994, pp. 196–234; President’s Commission, 1983; Weir, 1989). A separate decision is made to donate organs after death. Life-sustaining treatment is discontinued, although measures to maintain the quality of the organs (e.g., the placement of cannulae and the administration of fluids and medications) may be undertaken. Death is declared when cardiopulmonary function ceases. Organs are removed after death has been declared. Non-heart-beating organ donation has been undertaken in Japan, where the concept of neurological death remains controversial, and in parts of Europe, as an additional source of organs for transplantation (Hoshinga et al., 1995; Koostra, 1995; Yong et al., 1998 ). At this time, less than 3% of organ donors in the United States are non-heart-beating donors (Yong et al., 1998). The number of OPOs that engage in non-heart-beating organ procurement is also quite small. Although half of the OPOs in the country have non-heart-beating donation protocols, the majority of non-heart-beating organ procurement in the United States is conducted by no more than a dozen active programs. These programs report that non-heart-beating donors account for anywhere from 6% to 30% of their total donors (Table 4-1). The Institute of Medicine Report: 1997 In 1997, the Department of Health and Human Services (DHHS) asked the IOM to conduct a study of non-heart-beating organ transplantation. DHHS requested a thorough study of the medical and ethical issues involved in this ap-

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Non-Heart-Beating Organ Transplantation: Practice and Protocols proach to organ donation, with particular attention to the rights and welfare of donors (IOM, 1997b, p. 73). The IOM study concluded that “the recovery of organs from NHBDs [non-heart-beating donors] is an important, medically effective, and ethically acceptable approach to reducing the gap … between the demand for and the available supply of organs for transplantation” (IOM, 1997b, p. 1). The report made specific recommendations for non-heart-beating organ procurement: written, locally approved non-heart-beating donor protocols; public openness of non-heart-beating donor protocols; case by case decisions about the use of anticoagulants and vasodilators; family consent for premortem cannulation; safeguards against conflict of interest between patient care and organ procurement; determination of death (for controlled non-heart-beating donors) by cessation of cardiopulmonary function for at least five minutes by electrocardiographic and arterial pressure monitoring; and donation arrangements that honor family wishes (e.g., to remain with the dying patient), and protect the family from financial liability for donation. The 1997 report based these recommendations on underlying ethical considerations (pp. 50–64): avoiding harm or potential harm to the donor patient, supporting donor and family choice and consent (autonomy), and avoiding conflicts of interest between organ procurement and donor patient care. According to the 1997 report, non-heart-beating organ procurement protocols may vary in ways that reflect local variations in population, custom, and medical practice. However, consistency with underlying scientific and ethical standards for patient care is essential to sustain ethical practice and public trust (pp. 47–50). NON-HEART-BEATING DONOR PROTOCOLS: 1997–1999 The 1997 IOM study on non-heart-beating organ transplantation found considerable variation in the recovery of organs from non-heart-beating donors by different OPOs and medical centers. It found considerable variation among OPOs in the level of interest and involvement in non-heart-beating organ transplantation. Based on these findings, the 1997 report made specific recommendations for the development and content of non-heart-beating donor protocols. Following the release of the 1997 IOM report, the Department of Health and Human Services (DHHS) requested that the IOM undertake a follow-up study designed to facilitate the development of OPO non-heart-beating donor protocols. This 1999 report covers the findings and recommendations of the follow-up study.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols TABLE 1-1 Organ Procurement Organization Protocols   1997 1998 Changes, 1997–1998 Approved protocols 27 28 1997:2 protocols approved but on hold 1998:19 protocols not revised (includes 1 reactivated without revision); 9 protocols revised (includes 1 revised and reactivated, and 1 new) Draft protocols 7 7 3 drafts unchanged, 2 drafts revised, 2 drafts introduced, 2 drafts canceled No protocols 29 28 1 new protocol approved TOTAL 63 63   In preparing for the follow-up study, IOM staff assessed changes in non-heart-beating organ protocol development and content following the release of the 1997 IOM report. Tables 1-1 and 1-2 summarize their findings. Table 1-1 summarizes changes in the number of OPOs with non-heart-beating donor protocols between 1997 and 1998. Table 1-2 summarizes changes in protocol content between 1997 and 1998. Both tables are based on informal telephone contacts with OPOs in which they were asked for (1) a brief account of their involvement in non-heart-beating donation, and (2) a copy of their protocol. Protocol Development: 1997–1998 Between 1997 and 1998, the number of OPOs with approved non-heart-beating donor protocols increased from 25 to 28, the number of OPOs engaged in drafting or revising protocols decreased from 9 to 7, and the number of OPOs that did not engage in non-heart-beating donation, and did not have protocols, decreased from 29 to 28 (see Table 1-1). Of 29 OPOs without protocols in 1997, 26 remained without protocols in 1998. Two drafts were initiated, but two others were dropped. Only one OPO developed an approved protocol between 1997 and 1998. The majority of OPOs that had no protocols in 1997 reported no protocols and no plans to develop them in 1998. In addition, the level of non-heart-beating procurement activity changed little between 1997 and 1998. The OPOs most active in non-heart-beating organ procurement in 1997 continued to be most active in 1998. The remaining OPOs reported using their non-heart-beating donor protocols seldom or not at all during 1998. The possibility of an association between non-heart-beating organ procurement activity and protocol revision was considered but not found. Among nine

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Non-Heart-Beating Organ Transplantation: Practice and Protocols OPOs that described themselves as “active” or “experienced” in non-heart-beating organ procurement, three revised their protocols between 1997 and 1998, and six did not. Protocol Content In 1997, 25 OPOs provided approved non-heart-beating donor protocols for the IOM study, which found that these protocols varied greatly (IOM, 1997b). The protocols were found to be consistent in two main areas: (1) requiring an independent decision to withdraw life support prior to any discussion of organ donation and (2) requiring an independent declaration of death by a physician not associated with the OPO, procurement team, or transplant team. The protocols varied on criteria for declaring death, the administration and timing of medications and medical procedures, and management of the withdrawal of life support (p. 44). Following the publication of the IOM report in 1997, a limited number of OPOs revised their non-heart-beating organ procurement protocols or developed new draft protocols. Nine OPOs revised their protocols in accordance with the report’s recommendations (see Table 1-2). Although they represent too small a number for meaningful tabulation, two OPOs made similar revisions in draft protocols. These findings suggest that the influence of the 1997 IOM report was limited primarily to OPOs that are already interested or involved in non-heart-beating organ donation. For these OPOs, the report provided a resource for protocol development and revision. The variations that the IOM study found problematic in 1997 persist in the unrevised protocols, and the OPOs without protocols in 1997 have not developed them. Revisions in protocol content between 1997 and 1998 reflect the recommendations of the 1997 IOM report in two main areas: (1) clinical guidelines and (2) family provisions. Clinical Guidelines Clinical guidelines include the five-minute interval between the cessation of cardiopulmonary function and the declaration of death, and guidelines for administering medications and placing cannulae. Revised protocols are far more likely to follow the recommendations of the 1997 IOM report (Table 1-2). Revisions in these areas suggest that OPOs are interested in greater clarity and consistency in the clinical management of non-heart-beating organ donors. The 1997 IOM report provided a set of specific recommendations for accomplishing this. The degree of consensus in these areas is discussed in Chapter 4. Family Provisions The 1997 IOM report recommended that family opportunities for visiting and remaining with the patient be limited as little as possible by the donation

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Non-Heart-Beating Organ Transplantation: Practice and Protocols TABLE 1-2 Non-Heart-Beating Donor Protocols: Consistency with Institute of Medicine Recommendations: 1997–1998   All Approved Protocols Revised Protocols 1998 (n = 9)a Unrevised Protocols 1998 (n = 19)b   1997 (n = 25) 1998 (n = 28) Medications handled case by case 0 6 (21%) 6 (66%) 0 Consent for cannulation 8 (32%) 13 (46%) 6 (66%) 7 (37%) More rigorous criteria for determination of death 2 (8%) 13 (36%) 8 (88%) 2 (10%) Separate discussions (e.g., life support, donation) 20 (80%) 23 (82%) 9 (100%) 14 (74%) Independent declaration of death 25 (100%) 28 (100%) 9 (100%) 19 (100%) Family options 13 (52%) 15 (54%) 4 (44%) 11 (58%) Financial protection 8 (32%) 10 (36%) 3 (33%) 7 (37%) aIncludes one new protocol; one revised and reactivated. bIncludes one protocol reactivated without revisions.

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Non-Heart-Beating Organ Transplantation: Practice and Protocols process (IOM, 1997b, pp. 62–63). Revised and unrevised protocols show similar variation in their provisions for family involvement. Customarily, families visit in the intensive care unit (ICU) but not in the operating room (OR). Thus, the location in which life-sustaining treatment is withdrawn affects the family’s option to be present. Non-heart-beating organ donation requires a balance between the needs of families to remain with the patient and the demands of rapid organ recovery. Clearly, organ donation itself is an important family option and requires some adjustment in family contact at the end of life. However, there is room for two-way accommodation: accommodation by the family to the needs of organ procurement and accommodation of the organ procurement process to the needs of families. Factors that influence family options for visiting, leave-taking, and attendance during death include hospital policies and procedures, family and staff preferences, and the demands of the organ procurement process, including the transfer of the patient from a patient care unit to the operating room and the pressure for rapid organ recovery. Priorities for patient and family care during donation are discussed in Chapter 3. Impediments to Non-Heart-Beating Donation In addition to asking about changes in protocols between 1997 and 1998, IOM staff asked OPO contacts about perceived impediments to the development of non-heart-beating donor protocols in their organizations. Table 1-3 summarizes this information. The impediments mentioned are quite similar to the impediments or potential impediments identified in the 1997 IOM report (p. 35). These impediments represent local conditions and concerns that limit OPO involvement in non-heart-beating donation. Factors that affect local acceptance of and participation in non-heart-beating donation are discussed in Chapters 2 and 3. These factors include the following: hospitals: lack of protocols, lack of “interest,” physician and staff resistance; OPOs: limited financial and staff resources for training and outreach, limited technology and expertise; organs: concerns about organ quality, adequate organ supply without non-heart-beating donors, and ethics: medical interventions, termination of life-sustaining treatment, determination of death. Conclusion Based on the information gathered by staff and summarized above, the current study was designed as a dissemination, communication and consensus ef-

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Non-Heart-Beating Organ Transplantation: Practice and Protocols fort, and as a contribution to further non-heart-beating donor protocol development. Clinical innovation involves a message to be disseminated, a target audience, and the translation of the message into changes in practice (Lomas, 1993). Each of these factors must be identified and addressed in order for change to take place; each of them was considered in the design of this study and in the conclusions and recommendations of this report. In this report, the message to be disseminated includes the need for non-heart-beating donor protocols, the emphasis on patient and family choices and concerns, and specific recommendations for protocol content. The target audience includes the OPOs, health care professionals, hospitals, and communities whose cooperation and participation are essential to non-heart-beating donation. The translation of the message into practice requires sufficient research, education, training, financing and follow-up to sustain the development and implementation of protocols. The following chapters report on the committees findings and recommendations for non-heart-beating donation practice and protocols. TABLE 1-3 Issues in Non-Heart-Beating Donor Organ Procurement: 1998 (n = 63) Issues No. of Responses Specific Responses Hospital factors 19 “Lack of interest” (not specified) (10)* Resistance (not specified) (5) Failure to approve protocols (3) Rapid decisions to terminate life support (preceding discussions of organ donation) (1) OPO factors 14 Limited resources (5) Low priority (3) Efforts directed toward required referral (4) Organs 10 Adequate supply without non-heart-beating donors (2) Poor organ quality (8) Adverse publicity 9 Media and public misunderstandings and anxiety (9) Ethics 6 Resistance to discontinuing life support (1) Perceived association with physician aid-in-dying (1) Medical interventions or determinations of death (3) Ethics (not specified) (1) NOTE: OPO = organ procurement organization. *“Lack of interest” (10) or “failure to approve protocols” may indicate “resistance.”