EUROANESTHESIA 2008 Copenhagen, Denmark, 31 May - 3 June RC1

Transcription

1 ETHICAL AND POLICY IMPLICATIONS OF THE NON-HEART-BEATING CADAVER ORGAN DONOR EUROANESTHESIA 2008 Copenhagen, Denmark, 31 May - 3 June RC1 GAIL A. VAN NORMAN Department of Anaesthesiology University of Washington Seattle, USA Sunday, June 1, :30-11:15 Room B4 There is a rapidly expanding disparity between the number of individuals awaiting organ transplants and the number of organs available for transplantation. Data from the Organ Procurement and Transplantation Network in the United States indicate that although in 2007 approximately 98,000 patients were awaiting organ transplantation, from January through September only 21,400 transplants had taken place [1]. Globally, almost half of countries surveyed experienced only modest increases in organ donation and one-quarter of surveyed countries demonstrated a decreasing growth rate in cadaveric organ donations over the same period [2]. During the length of time it takes to read this review alone, the number of persons listed in the U.S. listed for transplantation will have increased by approximately 15 and the number of both living and dead donors by 1. Insufficient organ donations can no longer be ascribed to lack of public awareness and lack of opportunity to consent to donation. Strategies to improve voluntary donation through public information, required request laws, and public registration of organ donors at driver s licensing bureaus in the U.S. have consistently failed to correct the problem, and it is widely acknowledged that the public is clearly aware of the need [3]. Surveys of patients, physicians, and other healthcare workers demonstrate that significant barriers regarding voluntary organ donation are public and professional ethical concerns about medical definitions of death, mistrust of physician and societal motives regarding organ transplantation, concerns that end-of-life care will suffer, perceived and actual racial disparities in organ distribution, and patients personal, cultural, and ethnic beliefs involving death [3, 4]. DEFINING DEATH Early in the history of transplantation the use of some vital organs, such as the heart and lungs, was a practical impossibility due to damage the organs incurred during the ischaemic time between the time of cardiac arrest and the re-perfusion of the organs in the transplant recipient. Ethical principles precluded using living patients with intact circulations as vital organ donors, since that would require acceptance that actively killing one living patient was justified to save another. In 1968, the Ad Hoc Committee of the Harvard Medical School, lead by Henry Beecher, chairman of anesthesiology at Harvard, attempted to address this problem by redefining death as complete and irreversible cardiovascular arrest, or complete and irreversible cessation of whole brain function [5]. The public only reluctantly accepted this new concept of brain death, in part because it relies on specialized examinations and medical testing, and therefore depends on trust in the physician s competence, veracity and fidelity in establishing and communicating the diagnosis. Misdiagnosis clearly has occurred and has almost certainly resulted in the unintentional killing of donors, some of whom may not have otherwise been at the end-of-life. In one reported near-miss, for example, the putative donor survived to rejoin her family [6]. Despite such problems, brain death is now generally recognized by the public, legal experts, ethicists and theologians, although it has failed to solve the problem of an insufficient supply of organ donors. A recent strategy to expand the donor pool has been to use cadaveric organ donors after controlled cardiac arrest has occurred, so that ultra-short organ ischaemic times are preserved. Cadaveric organ donors fall into four general categories: uncontrolled cardiac arrest and dead on arrival at the hospital (Maastrich category 1), unsuccessful resuscitation in the hospital setting (Maastrich 2), awaiting cardiac arrest, such as in someone for whom life-sustaining therapy will be discontinued (Maastrich 3), and brain dead, but cardiac arrest occurs prior to organ donation (Maastrich 4) [7]. The need for minimal ischaemic time for heart, liver and lung transplants precludes retrieval of these organs from most cadaveric donors, since the timing of cardiac arrest must be predictable, allowing adequate advance preparation so that organ donation can coincide with death. Interest (and controversy) has developed around organ donation from Maastrich 3 patients, who are not brain dead, but in whom a cardiac arrest is both predictable and controllable. In the U.S. these donations are usually referred to as controlled donation after cardiac death, or non-heart beating organ donation (NHBOD) in Europe, to distinguish them from other cadaveric donations in which the circumstances and timing of death are uncontrolled, or even unknown. Usually controlled donation after cardiac death (DCD) occurs when a patient or the family of a patient who is dependent on life-sustaining medical therapy decides to discontinue medical support and donate vital organs after death. To minimize the time between cardiac arrest and organ donation, many institutions plan withdrawal of life-support in an operating room (OR)

2 DCD has been plagued with logistical and policy challenges, ethical controversies, and problems with public and professional acceptance, many of which have been highlighted by successive reports of the Institute of Medicine in the U.S. [8, 9]. Institutions participating in DCD have frequently done so without consistent protocols and policies [10, 11]. There have been worrying conflicts of interest among procurement (transplant) coordinators, who have at times acted on behalf of both the donor and the recipient. There are many ethical concerns about the definition of death and the administration of therapies to the organ donor that may hasten death [10, 11]. Many believe that the care and needs of the dying patient will not be met because of a shift of priorities toward the organ recipient, and this is increased by the sometimes inappropriate assignments of end-of-life care to OR physicians and healthcare workers who do not have adequate knowledge, experience or training in the many complex issues surrounding death, including the relief of physical and psychological suffering. Surveys of OR nurses, anaesthetists, transplant surgeons, critical care staff, organ procurement personnel, medical examiners, and neurologists have found that DCD is associated with personal conflicts regarding utilitarian and altruistic values, confusion regarding the concepts of end-of-life organ donation and active euthanasia, suspicion regarding professional motivations and patient outcomes, emotional ambiguity for the families of loved ones facing withdrawal of life-sustaining care, and uncertainty about the timing of declaration of death. OR personnel decry the transformation of the operating room from a traditional place of healing and hope, to a place of death. Neurologists have raised concerns that DCD may represent an attempt to circumvent brain death criteria for the purpose of organ donation, and may allow or even promote subjectivity in evaluations of prognosis and medical futility in neurologically impaired patients [4]. Education of healthcare providers has been slow, and in many cases absent. SOME OF THE ETHICAL ISSUES DCD donation accomplishes several highly laudable medical and ethical goals. The process of gifting vital organs promotes personal, professional and societal values of community concern and altruism. It can provide meaning for patients and families at a time otherwise filled with grief and loss. It saves lives. Ethical and legal principles supporting the rights of dying patients and their families to forgo burdensome medical interventions, even if they are life-sustaining, has been well established in Western countries [12]. Competent patients and/or their legally designated surrogates clearly also have the right to donate vital organs for transplantation after death [13]. DCD begins with the decision to withdraw life-sustaining medical therapy, progresses through the compassionate care of the dying patient, and ends after the patient s death and subsequent donation of their vital organs. DCD thus combines at least two ethically complex scenarios - the care of a patient at the end of life, and the generous and selfless gift of organ donation. However, it is when these events cross that there is the potential for conflict, confusion, and error, which, without thoughtful planning, can lead to harmful results for patients, families, professionals, and the organ donation system itself. WITHDRAWING LIFE-SUSTAINING TREATMENTS In most cases, the decision to withdraw life-sustaining treatments is an act of respect for patient autonomy. But the act involves much more than simply turning off machines. Patients report that the most feared symptoms associated with the end of life are dyspnoea, pain, and anxiety. Ethical management of these symptoms involves balancing symptomatic relief against administration of drugs that might hasten death. The principle of double effect recognizes that when treatments intended to relieve suffering incidentally hasten death, ethical principles against killing have not been breached [14]. In some countries, intentionally hastening death for the purpose of relieving suffering has come to be ethically and legally acceptable [15]. But hastening death for any other reason remains a violation of crucial ethical principles. Frequently treatments that may not be in the donor s best interests are administered to preserve organ function, such as the placement of invasive haemodynamic monitors and perfusion catheters, or administration of anticoagulants and vasodilators to preserve organ function. Invasive procedures not intended to benefit the dying patient are ethically concerning, and can increase suffering by causing physical discomfort to the patient and emotional distress for their loved ones. Administration of anticoagulants may, depending on the underlying cause of the donor s condition, cause fatal haemorrhage or intracranial bleeding, and vasodilators may lead to detrimental increases in intracranial pressure, all of which can hasten death [16]. Utilitarian-based arguments that the reduction of the donor s life by a few hours or even minutes is justified by the benefits to the recipient could be interpreted as attempts to excuse the killing of an innocent party for the sake of another. Sacrificing one s own life for a worthy cause may be not only ethical, but also heroic. Sacrificing someone else s is neither. The administration of such treatments may be entirely ethically acceptable if their consequences are understood and consented to by the donor or their surrogates. But doing so without the express understanding and permission of the dying patient or their surrogates harms dying patients by placing their needs second to those of the organ recipient. The doctor-patient relationship is harmed through violations

3 of trust and broken promises of fidelity; patients expect their doctor to act in the best interests of themselves and none other. Transplant programs will suffer if such actions substantiate public fears that the needs of dying patients will be given secondary importance to the economic and professional pressures on physicians and hospitals to perform transplants. Care of dying patients involves sensitivity to the cultural, religious and spiritual needs and beliefs of patients and their families. Death rites for many people include a gathering of the patient s family and spiritual community at the bedside during death. When patients are transferred to an OR for DCD, they may be separated from their loved ones, spiritual supporters, and trusted physicians during one of life s most sacred moments, and at a time when the presence of these supporters is most needed and appropriate. Most major religions have affirmed support for organ donation in general, but they do not necessarily also accept DCD. A regional conference of the United Methodist Church in the US in 2007, for example, issued a statement that the moment of death is not when the heart stops beating, but when all brain wave activity has ceased [17]. Organ donation prior to that moment, as may occur in some cases of DCD, would be opposed by the church. Physicians involved in care of the donor for DCD must be prepared to respond when a death that is expected does not occur immediately following withdrawal of life-sustaining interventions, and when manifestations of the dying process (such as agonal respirations) lead to distress and suffering among witnesses to the process. Not all medical specialists may have the special training, experience and expertise required to provide competent and compassionate end-of-life care. Protocols calling for the transfer of such patients to the care of an OR anesthesiologist with no specialty training in management of end-of-life care are both ethically and medically wrong. Addressing concerns and needs of the dying patient, even if it results in the loss of some transplantable organs, is an ethical requirement in the care and respect of the donor. DECLARING DEATH One of the most controversial aspects of DCD is the question of when organ donation can ethically begin [18]. The DCD donor presents the dilemma of requiring the earliest declaration of death after circulatory arrest that is both medically supportable and ethically acceptable, while avoiding situations in which the donor is intentionally or unintentionally killed to obtain organs. Optimal preservation of organ function requires that the time interval between death and beginning of organ donation be as short as possible - but there is widespread disagreement about what the shortest acceptable time interval actually is. In some protocols in the US the interval is as short as 75 s, and in others it is as long as 10 min. In Sweden the interval is 20 min, while in Canada it is 5 min [19]. How should this interval be determined? At the University of Pittsburgh in the US the interval is 2 min, based on the assertion that spontaneous resumption of circulation (auto-resuscitation) does not occur after 2 min of asystole. However, subsequent reports in the literature reveal that auto-resuscitation without brain death has been observed in both animals and humans after min, and survival after min of absent circulation has been reported [19]. Auto-resuscitation is a poorly understood phenomenon that has not been rigorously studied, and at this time it is, at best, a weak basis on which to decide that death can be defined at any specific interval. Before the development of cardiopulmonary resuscitation (CPR) techniques, asystole was considered a reliable indicator of imminent death. CPR demonstrates that at least two assumptions about asystole were wrong: it turns out that cardiac arrest is not necessarily an irreversible event, and although unconsciousness occurs rapidly after circulatory arrest, irreversible loss of brain function only occurs after a prolonged period of time. Complete neurological recovery has been reported 30 min after documented asystole, and partial neurological recovery is possible after prolonged interruptions of circulation [19]. Yet irreversibility is the very essence of death itself. If an individual can be revived, they may have been near death but physicians would not describe them as actually being resurrected from the dead. With neither cardiac nor neurologic function being irretrievably lost until after many minutes of asystole, it appears that many, if not all cases of DCD may involve organ donation from patients who are not yet biologically dead. Some authors propose a weak argument to diffuse concerns that patients are not dead when organ donation begins, by pointing out that no efforts will be made to treat asystole, and the arrest will not be reversed even if it can be reversed. They propose that will not be reversed is ethically equivalent to being irreversible b e c a u s e the outcome (death of the donor) is the same [20]. However, these situations are clearly not ethically equivalent. The morality of an action is dependent on the intent of the actor, as well as, and in many cases even more, than the outcome itself. Inability to reverse a cardiac arrest although you intend to do so is not morally the same as never intending and not even attempting to reverse a cardiac arrest even though you might be able to do so if you tried. A potential rescuer who fails in their efforts to save a drowning person is not in a morally equivalent situation to someone who might be able to save the victim if they try, but intentionally stands by and watches them drown. Moreover, a drowning person who is still struggling in the water but who will not be rescued is not actually dead yet, but rather is going to die. A prediction of death must not be confused with a diagnosis of death

4 By such flawed reasoning, anyone who is ever going to die would have to be defined as already dead. This modified definition of irreversibility creates an irresolvable paradox, because death actually describes a biological state. Under this new definition, an individual is at once both living (as an integrated organism) and dead (because they will not be rescued) immediately preceding and immediately following a cardiac arrest, even though they can only occupy one physical stage or the other at a given time. When the definition of death is dependent on the intentions and motives of a third party and not the physical condition of the person whose heart has stopped, the diagnosis of death is exposed as merely a pronouncement of social convenience, in this case to facilitate organ donation, and not the identification of a biological state. Because irreversibility is an essential characteristic of death, it appears that two aspects of DCD require reconsideration. Either further work must be done to determine when a scientifically based, reproducible and consistent point at which irreversibility of cardiovascular arrest or total cessation of brain function occurs following asystole, or the transplant community may have to examine whether they have already abandoned the dead donor rule. SUMMARY DCD has been developed as a response to a global, widening disparity in the supply and demand for transplantable organs, although its potential to address this disparity is limited. While patients have the right to forgo life-sustaining procedures and then to donate vital organs after death, co-ordinating these events produces the potential for conflicts of interest and violation of ethical principles. In order to address concerns among healthcare workers and members of the public regarding organ donation in general and DCD in particular, policies regarding DCD must assure that practices are morally acceptable, ethically consistent, and are committed to the highest standards of medical care of the dying patient. Policies and practices regarding DCD must address and avoid conflicts of interest, require compassionate and competent care of the dying patient, prioritize the care of the donor over the interests of others until after death, must ensure that treatments that hasten death without benefiting the donor are avoided unless specifically agreed to by the donor, and must ensure that definitions of death are not manipulated for the purpose of facilitating organ donation. KEY LEARNING POINTS Donation after cardiac death (DCD) has been developed in response to a globally widening disparity between the supply of transplantable organs and growing demand. The juxtaposition of two ethically rich events during DCD: the compassionate care of patients during the dying process, and the selfless gift of organ donation after death, carries the potential for conflicts of interest and violation of ethical principles that may result in harm to patients, to physicians and to the organ transplant process. Policies regarding DCD must place adherence to the highest standards of medical care of the dying patient ahead of the interests of potential recipients, and must assure that practices are morally acceptable and ethically consistent. Two significant controversies in DCD are the administration of agents to the dying patient for the purpose of organ preservation that might hasten death, and the timing of the declaration of death. While it is tempting to resolve these controversies in a manner to facilitate organ recovery, ethical principles require us to resolve them in a manner that adheres to critical ethical principles that value the life of the donor as much as that of the recipient, and that does not encourage or permit the systematic sacrificing of dying patients for the purpose of increasing the supply of transplantable organs

5 REFERENCES 1. United Network for Organ Sharing. (accessed ) 2. Sanz A, Boni RC, GhirardiniA, Cost AN, Manyalich M. IRODaT: comparison of worldwide growth rates from 2000 to Organs and Tissue 2005; 3: The American public s attitudes toward organ donation and transplantation. Boston: The Partnership for Organ Donation, Mandell MS, Zamudio S, Seem D, McGaw L, Wood G, Liehr P, et al. National evaluation of healthcare provider attitudes toward organ donation after cardiac death. Crit Care Med 2006; 34: A definition of irreversible coma. Report of the Ad Hoc Committee of the Harvard Medical School to examine the definition of brain death. JAMA 1968; 205: Van Norman G. A matter of life and death: what every anesthesiologist should know about the medical, legal and ethical aspects of declaring brain death. Anesthesiology 1999; 91: Koostra G, Daemen JH, Oomen AP. Categories of non-heart-beating donors. Transplant Proc 1995; 27: Institute of Medicine. Non-heart-beating organ transplantation. Medical and ethical issues in procurement. Washington DC: National Academy Press; Non-heart-beating organ transplantation: practices and protocols. Washington: Institute of Medicine National Academy Press, Speilman B, McCarthy CS. Beyond Pittsburgh: protocols for controlled non-heart-beating cadaver organ recovery. Kennedy Inst Ethics J 1995; 5: Doig CJ, Rocker G. Retrieving organs from non-heart-beating organ donors: a review of medical and ethical issues. Can J Anesth 2003; 50: Deciding to forgo life-sustaining treatment: ethical, medical, and legal issues in treatment decisions. In: Source book in bioethics. Jonsen AR, Veatch RM, Walters L, eds. Washington: Georgetown University Press, 1998: Sadler AM, Sadler BL, Stason EB. The uniform anatomic gift act. JAMA 1968; 206: Hawryluck LA, Harvey WR. Analgesia, virtue, and the principle of double effect. J Pall Care 2000; 16(Suppl): S Van der Heide A, Onwuteaka-Phillipsen BD, Rurup ML, Buiting HM, van Delden JJ, Hanssen-deWolf JE, et al. Endof-life practices in the Netherlands under the Euthanasia Act. N Engl J Med 2007; 356: Koostra G. The asystolic, or non-heart-beating, donor. Transplantation 1997; 63: A United Methodist definition of death for use by organ procurement organizations. Journal of the Pacific Northwest Annual Conference of the United Methodist Church, 134th Annual Session, Tacoma, WA. (15/ ). 18. Menikoff J. The importance of being dead: non-heart-beating organ donation. Issues Law Med 2002; 18: Joffe AR. The ethics of donation and transplantation: are definitions of death being distorted for organ transplantation? Philos Ethics Humanit Med 2007; 2: Youngner S, Arnold R., DeVita M. When is dead? Hastings Ctr Rep 1999; 29: