◆ The transplantation community endorses non-heart-beating organ donation (NHBD) to increase the supply of transplantable organs.
◆ Controlled NHBD occurs after withdrawal of life-support followed within 1–2 hours by cardiac arrest.
◆ Uncontrolled NHBD occurs after failed cardiopulmonary resuscitation (CPR) in an unexpected cardiac arrest.
◆ Controversial fundamental assumptions in NHBD include: the meaning of the ‘irreversibility’ of death, unacknowledged conflicting interests during EOL decisions, and perimortem donor interventions that may cause harm.
◆ Clinicians must understand NHBD ethical issues in order to obtain informed consent.
The 2 types of non-heart-beating organ donation (NHBD) (controlled and uncontrolled) can increase the supply of transplantable organs at end of life (EOL) . We describe the medical steps and ethical challenges of NHBD in the intensive care unit (ICU).
Several medical conditions qualify for controlled NHBD:
◆ Acute traumatic and non-traumatic brain/spinal cord injuries.
◆ Neuromuscular or pulmonary diseases.
There is no lower or upper age limit, but most donors are <75 years. Donors have transplantable organs (e.g. liver, kidneys, heart, and/or lungs) and are dependent on circulatory and/or ventilatory life-support. There are several steps involved [2,4]. First, a decision is made to discontinue life-support based on either patient’s expressed wishes or the best-interest standard. Secondly, consent is obtained from prior donor registration or surrogates. Thirdly, withdrawal of life-support in the ICU or operating room is co-ordinated with the surgical procurement team. Mechanical asystole determining absent circulation (AC) must ensue within 2 hours from treatment withdrawal to minimize donor warm ischaemia time; otherwise, NHBD is aborted. Fourthly, death is declared after AC and a mandatory ‘no-touch’ period. AC is confirmed electrocardiographically or by absent arterial pulse manually or through indwelling catheters. The no-touch period between the onset of AC and surgical procurement varies from 75 seconds to 10 minutes . Finally, in situ perfusion with cold preservative fluid halts warm ischaemic injury of transplantable organs. This is facilitated through either antemortem cannulation of femoral vessels and administering heparin and phentolamine to enable rapid flushing of blood from organs after AC, or a super-rapid recovery laparotomy/median sternotomy, direct cannulation and perfusion of the abdominal aorta and decompression of the inferior vena cava, followed by en-bloc removal of viscera .
Controlled NHBD is ethically justified by expert-panel opinions [2,4]. First, clinicians decide to withdraw life-support independent of NHBD, thus avoiding conflicting interests in EOL decision-making . Secondly, informed consent is obtained. Third, antemortem interventions are compatible with the double-effect principle because they are intended for preserving organs and the unavoidable risk of donor harm is foreseen but unintended. Fourth, the short no-touch period after AC is compliant with the ‘accepted medical standards’ in the Uniform Determination of Death Act . AC of 65 seconds is postulated as permanent cessation of circulation because autoresuscitation (spontaneous return of circulation) is unlikely without prior cardiopulmonary resuscitation (CPR), and no attempts are made to restart circulation by CPR because of the do-not-resuscitate decision .
Uncontrolled NHBD follows unexpected cardiac arrest: in-hospital, out-of-hospital, and/or after determining brain death [8,9]. Death is declared after 30 minutes of unsuccessful CPR by confirming absent arterial pulse, usually followed by a ‘hands-off period’ of up to 5 minutes. Then CPR is resumed or continued until extracorporeal membrane oxygenation (ECMO) is initiated. ECMO maintains systemic circulation with oxygenated blood and preserves transplantable organs. A balloon catheter may be inflated in the thoracic aorta to prevent perfusing cerebral and coronary circulation and resuscitating donors on ECMO [6,10]. ECMO allows time for consent and coordinating surgical procurement. Uncontrolled NHBD is said to be justified ethically because:
◆ Decisions to stop CPR are independent of NHBD.
◆ AC is permanent when death is pronounced.
◆ ECMO is intended to preserve NHBD opportunity.
◆ Informed consent is obtained before procurement.
Ethical challenges in NHBD
Unresolved ethical challenges threaten the acceptability of NHBD among the general public and medical community. These challenges are not limited to harm from ignoring quality EOL indicators or transplanting marginal quality allografts . The most serious challenges in NHBD originate from controversial fundamental assumptions .
Reversibility of death in NHBD
Death is an irreversible biological/ontological state and separates the dying process from the disintegration process. The dying process may be interrupted or reversed by resuscitation; however, death cannot be reversed and is irreversible . Death is defined philosophically as an ‘irreversible state of loss of the integrative unity of the organism as a whole’; the organism cannot resist the disintegration entailed by entropy . If NHBD is non-compliant with the irreversibility of death, then donating organs is the proximate cause of death. A weak construal of ‘irreversible’ is invoked in donors, i.e. the state of AC will not be reversed, and therefore is ‘permanent’ . Replacing the objective standard of irreversibility (cannot be reversed) with a subjective notion of permanence (will not be reversed) is incompatible with the death concept . As Marquis explains:
‘Suppose that Joe has a heart attack and his circulatory function stops. Fred, a physician standing next to Joe, refuses to perform CPR on Joe because Joe is a rival . . . Suppose that CPR would have been successful, but because it was not performed, cessation of Joe’s circulatory function was permanent. Was Fred’s refusal to act wrong? Not if we understand the irreversible cessation of circulatory function as equivalent to the permanent cessation of circulatory function . . . On that understanding, Joe was dead as soon as he collapsed, and Fred’s failure to perform resuscitation was not wrong, for he had no obligation to resuscitate a corpse’.
Another implication of the ‘permanence’ construal of ‘irreversible’ is that ‘two patients in exactly the same physiologic state would be considered dead or alive depending on whether resuscitation will be attempted’ , even though ‘death is a state of a body’.
Acceptable medical standards
There is only one state of death, with 2 proposed diagnostic tests: confirming irreversible cessation of either whole brain (including brainstem) functions, or circulatory and respiratory functions . Irreversible cessation of whole brain function has not occurred in NHBD, since CPR survivors can regain critical brain functions after 10 minutes of AC. Historical reports claim that no-touch periods >2 minutes after AC are unnecessary (Table 390.1) [1,14,15]. However, autoresuscitation is reported from a few seconds to 33 minutes after terminating CPR, including after monitored electrical asystole for 3–7 minutes with (n = 3) or without (n = 6) an arterial line . Some early autoresuscitation cases are explained by discontinuing positive pressure ventilation and relieving dynamic lung hyperinflation, and/or delayed cardiac delivery of vasoactive drugs. However, most cases of autoresuscitation are late (after several minutes) and unexplained . Physicians declare death in practice by confirming AC without a waiting period. The declaration is validated retrospectively after passage of time confirming the ‘irreversibility’ . This retrospective validation is impossible in NHBD, making it imperative to define the no-touch period after AC with scientific certainty.
Table 390.1 Clarification of the controversies surrounding the interpretation of ‘the irreversibility of death’ in non-heart-beating donors
Absent circulation is irreversible at 2–10 minutes
Absent circulation is not irreversible at 2–10 minutes
Permanent is a reasonable ‘construal’ of irreversible
The ordinary meaning of irreversible is ‘not capable of being reversed.’ Permanent is not a ‘construal’ of irreversible at all
There is a moral/legal obligation not to resuscitate
Irreversible is not a moral/legal concept. The obligation not to resuscitate is due to the patient being alive. Death is a state of a body, and those in exact states cannot be both dead and alive
There is no difference in outcome by waiting for irreversibility
This admits that permanence is a prognosis of death, not a diagnosis of death. The donor is dying
Autoresuscitation does not occur after 65 seconds of absent circulation
This is based on inadequate data (n = 5), and tries to explain away the Lazarus phenomenon*
The studies report historical cases of successful NHBD donors with short observation timelines and small sample sizes. The effects of antemortem interventions and surgical procurement influence the scientific reliability and are susceptible to the confounding effect of ‘self-fulfilling prophecy’
Permanence accords with accepted medical standards
This mischaracterizes accepted medical standards. In the usual circumstances, the consequence of a mistaken diagnosis of death does not result in immediate organ removal
Brain death is not required to diagnose death
The intent of the law is that there is only one death per person. Donors are not brain dead
* Five studies published between 1912 and 1970 that reported on 108 heterogeneous patients aged 9 months to 87 years with incomplete definition or standardization of selection criteria, monitoring methods, or observation timelines. Only five cases had electrocardiogram monitoring continued >2 minutes after loss of cardiac activity.
Adapted with permission from Joffe A et al., ‘Donation after cardiocirculatory death: a call for a moratorium pending full public disclosure and fully informed consent’, Philosophy, Ethics, and Humanities in Medicine, 6, 17, Copyright © 2011 Joffe et al. http://www.peh-med.com/content/6/1/17. Licensed under the terms of the Creative Commons Attribution License 2.0 http://creativecommons.org/licenses/by/2.0/.
Prognostication in uncontrolled NHBD
Reinstituting CPR and/or ECMO after declaring death ‘retroactively negates’ the death diagnosis in uncontrolled NHBD . The concern is: the patient is dead using a weak ‘construal’ of ‘irreversible’; however, the dead donor is resuscitated with CPR (and/or ECMO), the exact intervention that was ethically disallowed to justify the weak construal of ‘irreversible’. Initiating ECMO after >1 hour of CPR can resuscitate >40% of cardiac arrest patients with good neurological outcomes . Similarly, some NHBD donors are resuscitated and organ procurement is aborted .
NHBD should be independent of EOL decisions . EOL decisions can be subjective because of inaccurate prognostication of survival and future quality-of-life [18,19]. Subconscious biases can have potent and pervasive influence on the complex psychology of medical decision-making . Unrecognized conflicting interests can exist if clinicians know of the NHBD option in advance of EOL decision-making. Clinicians are aware of transplantation benefit in end-organ failures, patients on transplant waiting lists, and the institutional academic/financial prestige from transplantation . Conflicting interests may have consequences including premature withdrawal of medical care in salvageable patients.
Clinicians associated with transplantation should not obtain NHBD consent . Some Spanish clinicians assume two conflicting roles: intensivists caring for critically-ill patients and procurement coordinators consenting for donation . Many institutions permit clinicians to have simultaneous conflicting roles: caring for the terminally ill, discussing EOL and life-support withdrawal, managing donors, and caring for critically ill recipients before and/or after transplantation .
The US team-huddle programmes embed procurement coordinators with hospital staff [1,10]. Team-huddle programs enable surveillance for donors, early antemortem interventions for optimizing organ perfusion and protection, and overcoming familial barriers to donation consent . Team-huddling of intensivists with procurement professionals can create conflicting interests .
Antemortem interventions and the double-effect principle
Antemortem interventions benefit the recipient and not the donor. It is arguable whether a donor can consent to non-beneficial interventions that are potentially hastening/causing death . Administering heparin and phentolamine can be harmful because of haemorrhage and hypotension. Vascular cannulation is an invasive procedure requiring anaesthesia. With heparin, four factors should be fulfilled to apply the double-effect principle:
[the] action (giving heparin) must be intrinsically good (done to obtain functional organs); the bad effect (death) may be foreseen but the agent must only intend the good effect; the bad effect must not be a means to the good effect; and the good effect must be proportional to (compensate for, or outweigh) the bad effect. [One must consider] whether the bad effect (death) is not intended, whether the bad effect (death) is not a means to the good effect (obtaining functional organs), and whether the good effect (obtaining functional organs) is proportional to the bad effect (death) .
Potential NHBD donors that survive >2 hours can suffer additional EOL distress from antemortem interventions and failed NHBD.
NHBD can increase the supply of transplantable organs at the EOL. Unresolved ethical challenges threaten the acceptability of NHBD. Intensivists should be familiar with the ethical challenges in order to make an informed decision on their participation and to obtain informed consent from donors.
Text credit for “Suppose that Joe has a heart attack and his circulatory function stops…”: Reproduced from Marquis D, ‘Are DCD Donors Dead?’, Hastings Center Report, 40, pp. 24–31, Copyright 2010, with permission from Wiley and the Hastings Center.
Text credit for “[the] action (giving heparin) must be intrinsically good (done to obtain…”: Reproduced from Joffe A et al., ‘Donation after cardiocirculatory death: a call for a moratorium pending full public disclosure and fully informed consent’, Philosophy, Ethics, and Humanities in Medicine, 6, 17, Copyright © 2011 Joffe et al. http://www.peh-med.com/content/6/1/17. Licensed under the terms of the Creative Commons Attribution License 2.0 http://creativecommons.org/licenses/by/2.0/.
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