5
Expanding the Population of Potential Donors

Much of this report has focused on increasing the rates of donation by the small and relatively static population of deceased donors for whom there has been neurologic determination of death. Of the more than 2 million deaths that occur each year in the United States, it is estimated that there are only 10,500 to 16,800 eligible donors with neurologic determination of death (Guadagnoli et al., 2003; Sheehy et al., 2003). This chapter focuses on expanding the opportunities for donation to the much larger segment of U.S. deaths, those with circulatory determination of death. Because most Americans support organ donation and many have designated their consent for donation by signing their driver’s license or a donor card or by joining a donor registry, it is important to identify ways in which these individuals can have the opportunity to be organ donors after they die.

This chapter builds on the work of two previous Institute of Medicine (IOM) reports (IOM, 1997, 2000) that emphasized the importance of developing the nation’s capabilities for donation after circulatory determination of death (DCDD). It is not possible for this chapter to provide in-depth coverage of the many issues that must be addressed on this topic; however, the committee urges that its recommendations be actively pursued, as there is an opportunity to significantly expand the number of organ donors and thereby provide improved health and lifelong benefits for transplant recipients.

The chapter begins with an overview of some of the key terminology that is involved and presents a brief synopsis of the clinical issues that present both challenges and opportunities for DCDD. Since DCDD has been a topic of considerable discussion, the chapter presents the highlights



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Organ Donation: Opportunities for Action 5 Expanding the Population of Potential Donors Much of this report has focused on increasing the rates of donation by the small and relatively static population of deceased donors for whom there has been neurologic determination of death. Of the more than 2 million deaths that occur each year in the United States, it is estimated that there are only 10,500 to 16,800 eligible donors with neurologic determination of death (Guadagnoli et al., 2003; Sheehy et al., 2003). This chapter focuses on expanding the opportunities for donation to the much larger segment of U.S. deaths, those with circulatory determination of death. Because most Americans support organ donation and many have designated their consent for donation by signing their driver’s license or a donor card or by joining a donor registry, it is important to identify ways in which these individuals can have the opportunity to be organ donors after they die. This chapter builds on the work of two previous Institute of Medicine (IOM) reports (IOM, 1997, 2000) that emphasized the importance of developing the nation’s capabilities for donation after circulatory determination of death (DCDD). It is not possible for this chapter to provide in-depth coverage of the many issues that must be addressed on this topic; however, the committee urges that its recommendations be actively pursued, as there is an opportunity to significantly expand the number of organ donors and thereby provide improved health and lifelong benefits for transplant recipients. The chapter begins with an overview of some of the key terminology that is involved and presents a brief synopsis of the clinical issues that present both challenges and opportunities for DCDD. Since DCDD has been a topic of considerable discussion, the chapter presents the highlights

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Organ Donation: Opportunities for Action of recent conferences and major reports. It then examines general ethical considerations, before focusing on the ethical issues specific to controlled and to uncontrolled DCDD. Because uncontrolled DCDD has not been fully explored, the chapter provides an estimate of the potential number of donors as well as outlining major challenges in moving forward in this area. An additional group of potential donors are those with age or medical characteristics outside of the standard criteria for organ donation. Issues relevant to expanded criteria donors are discussed. The chapter concludes with the committee’s recommendations on DCDD and expanded criteria donation. BACKGROUND AND ISSUES Determination of Death The fundamental tenet of organ donation is the dead donor rule, that is, that organ donation should not cause or hasten death (Robertson, 1999). As discussed in Chapter 1, the advent of external ventilation technologies and other technological advances led to the development of criteria for neurologic determination of death (based on the irreversible loss of function of the whole brain, including the brain stem) and to clarification of criteria for circulatory determination of death (irreversible cessation of circulatory function) (Report of the Ad Hoc Committee, 1968; President’s Commission, 1981). However, the terminology that has arisen, specifically, the terms brain death and cardiac death, has often been misunderstood and thought to imply only the death of an organ—either the brain or the heart—and not the death of the human being. The committee believes that it is particularly important to clarify the terms that are used so that it is fully understood that death can be declared or determined by a physician either by the use of neurologic criteria or by the use of circulatory criteria. When it is necessary to distinguish between the ways in which death is determined, the committee suggests using the terms neurologic determination of death (NDD) or circulatory determination of death (CDD). In either case, organ donation occurs only after death. Because different kinds of protocols and procedures are used to recover organs from individuals who have died according to these two criteria, it is useful to distinguish between donation in these different contexts. The committee recommends a change in terminology to donation after neurologic determination of death (DNDD) and donation after circulatory determination of death (DCDD).1 The com- 1 Donation after circulatory determination of death was previously termed “non-heart-beating donation” or “donation after cardiac death.”

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Organ Donation: Opportunities for Action mittee believes that current misperceptions justify the shift to a more detailed terminology to clarify important concepts that are particularly relevant to organ donation and transplantation. The change in terminology emphasizes that the starting point for organ donation is death—death that is determined by using one of two sets of criteria. For the most part, it is not necessary to qualify the way in which the determination of death is made, but when the distinction is made, it must be clearly stated. Defining Controlled and Uncontrolled Death The circumstances of death because of cardiac arrest or other causes leading to circulatory determination of death vary widely. Many cardiac arrests occur in the home and at other sites outside of the hospital setting. As a result, a number of factors (such as the duration of time before emergency care is provided and the availability of healthcare professionals and medical equipment) can affect the viability of the organs and the potential that they can be transplanted. In some other circumstances of death, the patient is on ventilatory support and the discussion of donation occurs only after an independent decision to withdraw supportive technologies. In 1995, a categorization schema was developed to address the various circumstances of circulatory determination of death. The Maastricht categories (Box 5-1) outline the circumstances of controlled (or expected) death (Maastricht Category III), in which death is anticipated and occurs after medical supportive therapy is withdrawn, usually in an operating room or hospital intensive care unit, and within a closely monitored time frame. Unexpected or uncontrolled death (Maastricht Categories I, II, and IV) occurs in circumstances in which cardiopulmonary function ceases spontaneously, often with death occurring in an unanticipated fashion, frequently outside the hospital setting or in a situation in which less is known about the viability of the organs; these deaths often involve the loss of circulatory function before the neurologic determination of death (Kootstra et al., 2002; BOX 5-1 Maastricht Categories (as described in Kootstra et al., 1995, p. 2893) Dead on arrival Unsuccessful resuscitation Awaiting cardiac arrest Cardiac arrest while brain dead

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Organ Donation: Opportunities for Action Doig and Rocker, 2003). For Maastricht Categories I, II, and IV, there is a greater likelihood of a long interval between the cessation of circulatory function and the opportunity for the initiation of organ preservation or removal. The terms controlled and uncontrolled are subject to misinterpretation. Donation after either controlled or uncontrolled circumstances of death occurs only after a series of carefully delineated procedures and medical protocols have been followed. Controlled (or expected) circumstances of death typically occur after the family or surrogate has made the decision to withdraw support measures. In uncontrolled (unexpected) circumstances, death occurs after emergency medical procedures and resuscitation measures have been exhausted and are no longer productive. The committee is concerned that the term uncontrolled has been misunderstood on some occasions to imply a lack of procedure or protocols. Other terms, such as unexpected, unanticipated, or unplanned, may be better descriptors of the circumstances of death. Organ donation in cases of expected or controlled death can differ from donation in cases of unanticipated or uncontrolled death in several ways: in the time to initiation of the preservation of the organs to be transplanted, in the psychological preparation of the family, and in the ascertainment by the healthcare team of the potential for organ donation. In controlled-death situations, the family can decide when and where life-sustaining measures will be discontinued (Edwards et al., 1999). In situations involving unanticipated or uncontrolled deaths, there may be many more unknowns; healthcare professionals may arrive after the patient has collapsed and the length of time with hypotension, cardiovascular shock, or cardiac dysrhythmia may be unknown. In general, the kidneys, lungs, liver, and pancreas can be recovered after circumstances of controlled death because the organs can continue to receive oxygenated blood until nearly the time of recovery. Kidneys and lungs are the primary organs recovered after death in uncontrolled situations, since their viability is maintained for longer periods of time (Egan, 2004). Because individuals needing kidney transplants comprise more than 70 percent of the individuals on the transplant waiting list as of March 2006 (OPTN, 2006), it is important to explore the potential of DCDD in both controlled and uncontrolled circumstances as a means to achieve increased donation rates. Controlled DCDD2 is the area that has been the most developed by U.S. programs; uncontrolled DCDD has been utilized primarily in Europe and in 2 As noted above, the terms controlled and uncontrolled describe the circumstances of the death. The phrases controlled DCDD and uncontrolled DCDD are used in this report to describe donation after each of these circumstances of death.

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Organ Donation: Opportunities for Action a few pilot programs in the United States (see below). It is important to note that in the early days of transplantation, DCDD protocols were frequently used, and in some organ procurement organizations (OPOs), it remained a common practice into the 1980s. In recent years, organ recovery from DCDD has again become more commonplace. General Considerations As with many aspects of organ transplantation (Chapter 6), there have been misperceptions about DCDD. In particular, there have been concerns that death is hastened or that the patient’s best chance for survival is compromised in some other way by measures that are used to preserve the viability of the organs for transplantation. Therefore, it is important to clarify the practical aspects of this process. Although it is uncomfortable to discuss the issues around death and, particularly, those that deal with the body after death, openness and clarity about the events that occur in the process of DCDD are very important. Furthermore, healthcare and transplantation professionals must ensure that all aspects of the planning and development of DCDD protocols are transparent and open to a wide range of patient and stakeholder inputs. Successful transplantation of an organ from a deceased donor requires that the organ be viable, a goal that can be met by minimizing the ischemic injury caused by a lack of bloodflow carrying oxygen and other nutrients to the organ(s). The length of time in which the organ can be deprived of oxygen (ischemic) and still be successfully transplanted varies among types of organs. Thus, measures to ensure organ viability for transplantation (and decrease ischemia) must be initiated as rapidly as possible after the patient’s death. In cases of neurologic determination of death, after death is declared—and when there is consent for organ donation—continuous cardiopulmonary function is achieved with artificial assistance until the organs are removed, permitting high-quality circulation of oxygenated blood to maintain organ viability. For individuals who have had cardiac arrest, advanced cardiac life support protocols are followed (Box 5-2) and may be continued as the patient is transported to the hospital. In some cases, all resuscitation measures are administered in the home or other field setting; and if they are found to be nonproductive in regaining heart function, death can be declared in the field by emergency medical personnel, in consultation with a physician. In cases of circulatory determination of death, individuals are generally not on ventilatory support at the time of death, so there is an immediate need to proceed with organ-preserving measures to limit the damage from warm ischemia and improve the viability of the organs for transplantation (Bos, 2005).

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Organ Donation: Opportunities for Action BOX 5-2 Common Criteria for Termination of Advanced Cardiac Life-Support Efforts Termination of advanced cardiac life-support efforts occurs if there is no response after the following interventions have been performed: Acceptable basic cardiopulmonary resuscitation has been provided. Ventricular fibrillation has been eliminated. An advanced airway device has successfully been placed. The operation of the airway device has been confirmed and the device has been secured. Oxygen and end-tidal carbon dioxide levels have been monitored to ensure that proper oxygenation and ventilation have been achieved. The intervention has been maintained for 10 minutes or longer. All rhythm-appropriate drugs have been administered. SOURCE: Kern et al. (2001). For cases of controlled DCDD, measures for preservation and recovery may include the administration of medications to improve organ viability, including heparin, or the use of intravenous cannulation or cardiopulmonary assist devices (bypass procedures). After organ removal, pulsatile perfusion may be used for the kidneys to help determine if the patient’s organs will be eligible for transplantation. For cases of cardiac arrest in uncontrolled circumstances, there is not time to plan in advance to maintain organ viability, but certain organ preservation measures can be implemented after death is declared. The outcomes of controlled DCDD transplantation have been found to be similar to those for DNDD transplantation for most organs. The University of Wisconsin has performed DCDD transplantations since 1974, with DCDD donors making up 10 to 15 percent of the total donations annually (Lewis et al., 2003). Researchers at that university reported on 568 organs transplanted from DCDD donors between 1984 and 2003 and found that the patient and graft survival rates for patients receiving kidney, pancreas, and lung transplants were similar for organs from DCDD and DNDD donors (D’Alessandro et al., 2004). Delayed graft function has been found to be higher in kidneys transplanted from DCDD donors, but long-term graft survival is similar to DNDD organs (Weber et al., 2002; Droupy et al., 2003; Cooper et al., 2004; D’Alessandro et al., 2004). Researchers have found that the liver is more susceptible to warm ischemic injury (Abt et al., 2004; Foley et al., 2005). Much remains to be learned about methods to improve organ viability and to preserve organs recovered through both DCDD and DNDD. Re-

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Organ Donation: Opportunities for Action search efforts in these areas continue (see, for example, Magliocca et al., 2005) and need to be bolstered. Prior Reports and Recommendations IOM has released two previous reports on DCDD, formerly known as non-heart-beating organ donation (NHBD) and donation after cardiac death. The first report, Non-Heart-Beating Organ Transplantation: Medical and Ethical Issues in Procurement, undertaken at the request of the U.S. Department of Health and Human Services and published in 1997, noted that organ donations from living donors and DNDD donors would not bridge the widening gap between organ supply and demand in the United States (IOM, 1997). Despite the clear need to increase the rates of organ donation, the report found that the majority of transplantation programs in the United States did not have a mechanism or protocol for organ recovery after DCDD. The small number of programs with active involvement in DCDD concentrated virtually all of their efforts on controlled DCDD (Cooper et al., 2004). Although implementation of uncontrolled DCDD protocols and programs is recognized as an opportunity to greatly increase the number of potential organ donors (especially kidney donors), the need to limit the warm ischemia time by means of early postmortem cannulation and cooling has raised the fundamental ethical issue of initiating organ preservation before informed consent is obtained from family members. At the time that the IOM report was published, enabling legislation existed in several other Western democratic countries and in three jurisdictions in the United States (Washington, D.C., Virginia, and Florida) that allowed this practice while the next of kin were being sought for permission for organ recovery (IOM, 2000). Strong opposition to this position was taken by the American Society of Transplant Physicians (ASTP), who articulated the following reservation: “Uncontrolled NHBDs do not meet the principles of the ASTP, particularly in the area of consent, and therefore, the ASTP does not support the widespread use of this organ source” (IOM, 1997, p. 80). Perhaps in consideration of this testimony, which was concordant with several surveys of public sentiment conducted at the time, the IOM committee concluded: “Cannulation and cooling without consent may be a situation in which a decision based on deference to what the public is prepared to accept may be the wisest policy at the moment” (IOM, 1997, p. 55). Despite this constraint placed on uncontrolled DCDD, the IOM committee concluded that “the recovery of organs from NHBDs is an important, medically effective, and ethically acceptable approach to reducing the gap that exists now and will exist in the future between the demand for and

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Organ Donation: Opportunities for Action the available supply of organs for transplantation” (IOM, 1997, p. 1). That report’s recommendations focused on controlled DCDD and suggested that attention be given to greater consistency in DCDD policies and better support for patients and their families, sustaining the integrity of organ procurement efforts, and maintaining public confidence in the organ transplantation system (Box 5-3) (IOM, 1997). Following publication of the 1997 IOM report, the U.S. Department of Health and Human Services again sought IOM’s assistance in facilitating the adoption of protocols for DCDD, consistent with prior IOM recommendations, by all OPOs in the United States. This resulted in the publication in 2000 of Non-Heart-Beating Organ Transplantation: Practice and Protocols (IOM, 2000) (Box 5-4). The report’s recommendations were congruent with the transplant community’s long-standing orientation toward obtaining organs from DNDD donors in a planned, orderly, and controlled fashion. Subsequently, the addition of DCDD donors to the potential donor pool naturally evolved in a parallel direction that favored an emphasis on controlled DCDD. Many of the same challenges discussed in these two reports still confront the widespread adoption and implementation of DCDD. The present report further expands on those recommendations and emphasizes the need for ongoing efforts to ensure that DCDD is a priority for hospitals and OPOs. A national conference in 2005 examined the essential actions needed to expand the practice of DCDD in the continuum of quality end-of-life care BOX 5-3 Recommendations of Non-Heart-Beating Organ Transplantation: Medical and Ethical Issues in Procurement Written, locally approved non-heart-beating donor protocols; Public openness of non-heart-beating donor protocols; Case-by-case decisions on anticoagulants and vasodilators; Family consent for premortem cannulation; Conflict-of-interest safeguards—separate times and personnel for important decisions; Determination of death (in controlled non-heart-beating donations) by cessation of cardiopulmonary function for at least 5 minutes by electrocardiographic and arterial pressure monitoring; and Family options (e.g., attendance at life-support withdrawal) and financial protection. SOURCE: IOM (1997).

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Organ Donation: Opportunities for Action BOX 5-4 Recommendations of Non-Heart-Beating Organ Transplantation: Practice and Protocols Recommendation 1: All OPOs should explore the option of non-heart-beating organ transplantation, in cooperation with local hospitals, healthcare professionals, and communities. A protocol must be in place in order for non-heart-beating organ and tissue donation to proceed. 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. 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. Recommendation 4: Like all care at the end of life, non-heart-beating organ and tissue donation should focus on the patient and the family. Recommendation 5: Efforts to develop voluntary consensus on non-heart-beating donation practices and protocols should be continued. Recommendation 6: Adequate resources must be provided to sustain non-heart-beating organ and tissue donation. Adequate resources are required to cover (1) the costs of outreach, education and support for OPOs, providers, and the public, and (2) any increased costs associated with non-heart-beating organ and tissue recovery. Recommendation 7: Data collection and research should be undertaken to evaluate the impact of non-heart-beating donation on families, care providers, and the public. SOURCE: IOM (2000). and identified a number of ways to increase opportunities for increasing the opportunities for DCDD (Bernat et al., 2006). As discussed at that conference, there is an ongoing need to ensure that all OPOs and hospitals have policies, organizational structures, and institutional support for DCDD and that there is adequate professional education on organ donation under these circumstances. Furthermore, all DCDD-related efforts must have a strong component of public education, and include measures to strengthen and sustain trust in the medical system. Clear messages and transparent actions are essential for promoting DCDD as an organ donation option. Any episode of inadequate or inappropriate information being conveyed to the public can negatively

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Organ Donation: Opportunities for Action BOX 5-5 National Conference on Donation After Cardiac Death (DCD): Specific Actions Proposed for Agencies and Organizations Association of Organ Procurement Organizations (AOPO) Establish a DCD mentorship in its technical assistance program. Add a DCD component to OPO accreditation standards. U.S. DHHS Advisory Committee on Organ Transplantation Support studies assessing the frequency of autoresuscitation of patients eligible for DCD and other patients who have died after the withdrawal of life-sustaining therapy. Recommend that the Organ Procurement and Transplantation Network (OPTN) modify data submission standards to capture data from Phase I and Phase II clinical trials with the minute-by-minute collection of data to measure systolic and diastolic blood pressure, the level of oxygen saturation, and urine output. Provide guidance on issues of informed consent. OPTN-United Network for Organ Sharing (UNOS) Revise transplant center and OPO membership criteria to require DCD protocols. Establish organ-specific subcommittees on DCD to address organ-specific suitability criteria and allocation policies. affect public perception and damage the understanding and trust of the healthcare system regarding organ donation (Chapter 7). The committee concurs with the actions recommended in earlier IOM reports (Boxes 5-3 and 5-4) and at the National Conference on Donation after Cardiac Death (Box 5-5) and encourages further efforts to overcome the general inertia regarding the full implementation of the policies and practices that will facilitate and expand DCDD. It will be important to focus on the systems changes at the hospital and the OPO levels and will also require that the public and healthcare professionals be engaged in discussions about the complexities of DCDD. Learning from Past Experience and International Models Several European countries have developed and have used the infrastructures of both the emergency medical services and the transplantation services to provide optimal emergency care and to be available as needed to

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Organ Donation: Opportunities for Action Conduct financial analysis of the long-term impact of DCD organ use on transplant centers. Use regional meetings as a venue for discussion of and education about DCD. NATCO (The Organization for Transplant Professionals) Expand DCD in all NATCO education programs. American Society of Transplant Surgeons and American Society of Transplantation Establish a joint committee to increase DCD recovery and utilization. Joint Commission on Accreditation of Healthcare Organizations Revise accreditation standards to require hospitals to implement DCD protocols. Provide an annual DCD report that includes regional profiles, new developments, and trends and outcomes. Centers for Medicare & Medicaid Services Revise regulations governing donation, utilization, and reimbursement to reflect the unique characteristics of DCD procurement and transplantation. SOURCE: Bernat et al. (2006). respond to demands for DCDD (Alvarez et al., 2002; Sanchez-Fructuoso et al., 2003; del Rio Gallegos et al., 2004). Furthermore, in the early 1990s efforts were made in Washington, D.C., to develop a program for uncontrolled DCDD. Washington, D.C. In the early 1990s, the Washington Hospital Center in Washington, D.C., developed a rapid organ recovery program that focused on DCDD, particularly organ donation from victims of fatal trauma (Kowalski et al., 1996; Light et al., 1996). The emphasis on DCDD donors (termed “non-heart-beating donors” at the time) included a strong component of community education and input (WHC, 1993). A Community Oversight Committee was formed to provide input into the development of the DCDD protocol (Appendix F) and its implementation. Furthermore, the Office of Decedent

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Organ Donation: Opportunities for Action is especially important to address donor suitability, because only a minority of multiorgan donors are ultimately believed to be suitable lung donors. Recent studies have questioned the relationship between sputum Gram stain results and patient outcomes, now that broad-spectrum prophylactic antibiotic coverage is routinely available. In those studies, no predictive value was found in the numbers or the types of bacteria seen or the presence or absence of white blood cells in donor sputum (Ciulli et al., 1993; Gabbay et al., 1999; Weill et al., 2002). Kawut and colleagues (2005) found that patients receiving expanded-criteria lungs with specific characteristics including age of 55 years or greater, extensive smoking history, or evidence of chest trauma had acceptable rates of survival but tended to spend more time in the intensive care unit, had longer hospitalizations, and had decreased pulmonary function after one year. The use of extended-criteria donor lungs might be acceptable to improve survival because donors are in such short supply and because of the high risk of death for some patients who do not receive lung transplants (Pierre et al., 2002; Kawut et al., 2005). A universally accepted definition of expanded criteria for liver donation has also not yet been established (Busuttil and Tanaka, 2003). Nevertheless, surgeons are beginning to transplant livers that would previously have been considered unacceptable (Fukumori et al., 2003). For example, therapeutic use of inotropic drugs, donor age, and the presence of moderate to severe hepatic steatosis independently influence the severity of liver preservation injury and the duration of stay in the intensive care unit for liver transplant recipients (Briceno et al., 2002). OPTN-UNOS’s organ-sharing liver transplant registry database has been used to identify predictors of death or retransplantation in liver transplant recipients. In a multivariate regression model, donor age, recipient age, recipient creatinine concentration greater than 2 milligrams per deciliter, and ventilator dependency for the recipient were associated with graft failure at 1 year, especially in liver transplant recipients infected with hepatitis C virus (Condron et al., 2005). Various investigators have confirmed that biological factors can be used to predict liver preservation injury, because, as with other organs, ischemia time is an important determinant of organ function and transplant efficacy (He et al., 2004; Cuende et al., 2005). Renz and colleagues (2005) recently evaluated the effect of the use of extended donor liver allografts by comparing extended-criteria donor livers allocated by transplant center instead of by regional waiting list priority. Expanded-criteria liver allografts can be transferred out of the region only if they are declined by all of the transplant centers within reasonable geographic proximity. The expanded criteria used included donor age greater than 65 years, DCDD, positive viral serology, split liver grafts, hypernatremia, or a history of cancer, steatosis, or high-risk behavior in donors. The rate of patient access to liver transplantation increased by 77 percent and the

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Organ Donation: Opportunities for Action pretransplantation mortality rate was reduced by 50 percent compared with the rates obtained by the traditional allograft allocation system. The waiting times, complications, and lengths of hospitalization were similar; and there were no significant differences in patient or graft survival, although the causes of death were different. This study confirms the need to establish and update guidelines to include all current and prospective variables that might influence donor selection, graft function, and patient and graft survival. Ethical Considerations for Expanded-Criteria Organ Donation The use of expanded-criteria organs raises a number of ethical issues. On the one hand, their use has the potential to save or significantly improve lives. As noted already, many expanded-criteria organs have been used and the outcomes achieved have been good; they have shortened waiting times, enabled patients to move off of dialysis, and have enabled some people who might have died waiting for an organ to live. On the other hand, because the use of some expanded-criteria organs is associated with greater risks of morbidity and mortality, there is a risk that some patients will be harmed. Moreover, given these risks, many patients will view expanded-criteria organs as less desirable, thus generating questions of the fair allocation of standard-criteria versus expanded-criteria organs. Without attempting a complete ethical analysis of the use of expanded-criteria organs, the committee offers the following guidance: Because expanded-criteria organ donation has the potential of increasing the number of donated organs and thereby saving and improving lives, the use of expanded-criteria organs should be further explored. Consent for the use of expanded-criteria organs should be obtained from transplant candidates. The consent information should distinguish between expanded-criteria organs with known heightened associated risks and expanded-criteria organs with unknown heightened associated risks. So-called expanded-criteria organs that are known to function as well as standard organs (as is the case with some categories of DCDD organs) should not be labeled or treated as expanded-criteria organs. Practices associated with the use of expanded-criteria organs must be evidence based. Accordingly, ongoing collaborative research is needed. Expanded-criteria organs should be allocated in ways that minimize potential harms, for example, by matching organs infected with a particular agent with patients infected with the same agent. Cost-effectiveness should be considered in the development of practice guidelines.

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Organ Donation: Opportunities for Action Next Steps for Expanded Criteria The potential exists to expand the pool of potential donors while also maximizing the quality of the transplanted organ and protecting the safety of the recipient. The development of nomenclature that denotes different categories of organ quality is important to clinical practice. Terminology that can provide separate designations for organ quality and organ screening for disease status is needed. Less precise terms such as “expanded criteria” or “marginal” should be replaced with terms or categories of terms that convey information about the organ’s quality or laboratory screening results. These categories of organ quality and designations for organ screening will evolve with new knowledge about graft survival. Organ Quality Much remains to be learned about the spectrum of organ variability, particularly for organs other than kidneys, and there is a need to develop the quantitative measures that can inform patients and clinicians. Although there have been age restrictions in the past, it is apparent that there is wide variability in the suitability of organs obtained from donors of all ages. It is important to develop an evidence-based approach to the characterization of the quality of organs. Ensuring the accuracy and integrity of registry data is fundamental in this process; and a uniformly accepted, scientific method-quality, multicenter database should be supported. Such an effort would likely accelerate the development of guidelines that define acceptable outcomes after expanded-criteria organ donation and may help refine competency standards and qualifications for transplant surgeons. In addition, such an effort, in which OPOs, donor service areas, and transplant centers are more closely linked around data collection and reporting standards, will provide a unique opportunity for OPOs and transplant centers to interface with other national programs investigating the relationships between clinical effectiveness, quality, and safety. Evaluations of cost-effectiveness should be included as new practice guidelines are developed; and such evaluations are likely to be more rigorous as all data elements (e.g., age, disease state, resuscitation status, and waiting time) that could potentially influence outcome are considered. Targeted Research Needs The cellular changes that correlate with or predict graft function and survival are not well described. Efforts to further the understanding of warm and cold ischemia and reperfusion injury at the cellular level are needed. Such research will likely identify important molecular determinants

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Organ Donation: Opportunities for Action of viability before the organs are collected and transplanted and may identify better methods of storing and maintaining recovered organs. Organ Screening It is important that, in addition to and separately from organ quality, organs should be denoted as positive or negative for diseases, disorders, and infectious disease agents for which they are screened, such as hepatitis viruses and human immunodeficiency virus. This designation should affect clinical practice, including consent procedures and allocation criteria. Organs should be allocated to minimize harm, e.g., by matching infected organs with similarly infected patients, and detailed, specific informed consent should be obtained when organs are expected to perform below “gold standard” quality. SUMMARY AND RECOMMENDATIONS In 2004, approximately 95 percent of deceased donors were individuals declared dead by neurologic criteria (Table 5-2). However, because deaths determined by neurologic criteria constitute only a small percentage of total deaths in the United States, there is the potential to significantly increase organ donation rates by carefully reexamining and expanding the nation’s ability and infrastructure to transplant organs from deceased individuals with circulatory determination of death, deaths that occur in both anticipated and unanticipated (controlled and uncontrolled) conditions. Research is needed to more fully explore the graft survival rates of other organs and to develop optimum methods for organ preservation and for categorizing the viability of organs. It is acknowledged that DCDD can be a more complex and less facile process than DNDD. Expansion of the nation’s capabilities, particularly in large urban areas with excellent emergency medical care, could provide the opportunity for donation to larger numbers of individuals and families. One set of conservative estimates suggests that at least 22,000 of out-of-hospital cardiac arrest deaths annually in the United States would meet Modified Madrid Criteria for unanticipated DCDD if important ethical and practical matters could be resolved. Before proceeding further, demonstration projects to assess the feasibility of undertaking such a strategy within a defined community should be considered. This activity should complement current ongoing efforts to expand the number of controlled DCDD and DNDD donors and should be accompanied by thorough research on the nature and extent of impediments to the implementation of DCDD protocols and on the effects of efforts to remove them.

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Organ Donation: Opportunities for Action Recommendation 5.1 Implement Initiatives to Increase Rates of Donation after Circulatory Determination of Death. HRSA, the National Institutes of Health (NIH), OPTN, OPOs, donor hospitals, transplant centers, and professional societies should implement initiatives to increase rates of DCDD. Particular emphasis should be given to funding of interdisciplinary research by NIH and HRSA to understand and remove institutional, professional, and community barriers and resistance to DCDD; enhancing public and professional education, disseminating best practices, and monitoring and evaluating DCDD efforts; clarifying required referral regulations to ensure that all potential donors are considered; and adding preparation for organ donation to the end of standard resuscitation protocols. Recommendation 5.2 Encourage and Fund DCDD Demonstration Projects. The U.S. Department of Health and Human Services, states, and local entities should encourage and fund demonstration projects to determine the feasibility of increasing the rates of uncontrolled DCDD in cities with established and extensive trauma centers and emergency response systems. Such demonstration projects should include extensive public and professional education, including an emphasis on donor registry efforts, and participation by all relevant stakeholders in the development of protocols and processes. Recommendation 5.3 Maintain Opportunities for Organ Donation. OPOs should work with relevant stakeholders to obtain community authorization for the use of postmortem organ preservation techniques during the time needed to seek family consent for donation when the deceased person’s donation intention is unknown. Recommendation 5.4 Increase Research on Organ Quality and Enhanced Organ Viability. NIH should request and allocate funds for the purpose of determining the characteristics that modify and define organ quality. NIH should fund further research on enhancing the viability of organs for transplantation, including improved methods of organ preservation and improved criteria (with appropriate point-of-care testing) for determining the viability of organs.

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