Non-heartbeating organ donation: clinical process and fundamental issues

M. D. D. Bell

The General Infirmary at Leeds, Great George Street, Leeds LS1 3EX, UK

E-mail: dominic.bell{at}leedsth.nhs.uk

Accepted for publication September 10, 2004.


    Abstract
 Top
 Abstract
 Case presentation
 Discussion
 References
 
This case report outlines the clinical process whereby a patient with severe traumatic brain injury became a non-heartbeating organ donor after a withdrawal-of-care decision. This process raises a series of ethical questions regarding decision-making on grounds of futility, the role of the next of kin, informed consent, the accommodation of manoeuvres directed towards organ retrieval at maximal viability, and the timing and determination of death. Although many aspects of the process can be accommodated within fundamental ethical principles and a broad interpretation of the concept of the ‘best interests’, the variance with established law requires authoritative clarification if a need for transplantable organs is to be responded to without compromising the reputation of practitioners involved in this area of care. Therefore, this recruitment strategy warrants wide public and professional debate to achieve longer-term sustainability and ensure the protection of all parties.

Keywords: complications, death ; organ donation, consent ; organ donation, futility ; organ donation, legal problems


    Case presentation
 Top
 Abstract
 Case presentation
 Discussion
 References
 
A 43-yr-old man was transferred to this institution for neurosurgical intervention after sustaining a severe traumatic brain injury in a road accident. CT scanning at the receiving hospital demonstrated extensive injury with extradural/subdural haematomata, and multiple contusions (Fig. 1). At craniotomy, the brain herniated from the skull and it proved impossible to control the bleeding points. Definitive surgery was abandoned, the scalp sutured without replacing the bone flap, and the patient transferred to the neurosurgical intensive care unit for supportive care only, pending discussion with the next of kin. The one accessible pupil was dilated, irregular and unreactive, this triggering suspension of analgesic and sedative infusions. Over the following 8 h, the patient remained unresponsive, but continued to make some ventilatory effort, requiring mechanical support for satisfactory gas exchange. The picture was complicated by significant neurological disability following removal of a posterior fossa astrocytoma and subsequent radiotherapy at 6 yr of age (Fig. 2). The parents, mindful of this primary deficit, accepted the opinion that this was a non-survivable injury, favoured withdrawal of support, and expressed a wish that the patient become an organ donor after death. In view of the persistent ventilatory effort it did not appear likely that he would fulfil criteria for brainstem death within the foreseeable future, if at all, ongoing bleeding rendering classical cardiorespiratory death more likely.



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Fig 1 CT scan demonstrating extradural/subdural haematoma, effacement of the lateral ventricle and midline shift.

 


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Fig 2 CT scan of posterior fossa demonstrating previous destruction of normal architecture.

 
The key components necessary to achieve viable organ retrieval from a non-heartbeating donor were explained in verbal and written format to the family, who subsequently confirmed their approval. Supportive care was both maintained and escalated, including the administration of blood, whilst the transplant team was mobilized. The coroners in both local and referring jurisdictions were contacted and ‘consent’ granted for removal of any organ or tissue below the level of the neck. The transplant coordinators formally interviewed the family to conduct the screening questionnaire and confirm ‘lack of objection’ to organ retrieval. Blood samples were taken for tissue typing and virological screening, and ceftazidime and methyl prednisolone administered. Heparin, used in this scenario to improve microvascular flow, was withheld on the basis of uncontrolled bleeding with derangement of both platelet numbers and coagulation. The acute theatre was placed on standby with a surgical team in attendance and all perfusion equipment primed. Approximately 2 h after the original parental declaration of ‘assent’, extubation took place with the family present. The patient progressed to asystole within 3 min and after observation over the 2 min that this was sustained, examination for signs of death was conducted. After confirming lack of responsiveness, respiratory effort and cardiac output over the subsequent 3 min, with pupillary findings as before, the patient was certified as dead. Intravenous and monitoring lines were disconnected and the patient, accompanied by his parents, transferred to the operating theatre 5 min after certification. Surgical intervention to initiate cold perfusion before retrieval began 6 min later. Both kidneys were retrieved and transplanted later that day with immediate establishment of primary function. The heart was taken for valves only and documentation was made by the surgical team to the effect that nothing abnormal was detected during the retrieval process, pending the subsequent forensic post-mortem.


    Discussion
 Top
 Abstract
 Case presentation
 Discussion
 References
 
The classical cardiorespiratory cadaver, as a source of organs for transplantation, was displaced by the concept of brain/brainstem death,1 which facilitated retrieval of both vital and maximally viable organs from the beating-heart donor. A high relatives' refusal rate2 for this process and an increasing imbalance between supply and demand have, however, forced reconsideration of all donor options. Evidence of viability of organs retrieved from the classically dead,3 including those organs particularly vulnerable to warm ischaemia,4 has resulted in re-evaluation of this broad donor group internationally5 and subsequent promotion within the UK.6 7 Classification of the various subgroups has been undertaken (Table 1),8 with the patient outlined in the above case study falling within the ‘controlled’ category (3).


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Table 1 Maastricht classification of non-heart-beating donor (after Kootstra et al.)8

 
This recruitment process generates a succession of ethical problems and potential legal hurdles,9 10 at least in part due to action previously undertaken to legitimize retrieval from the beating-heart, brainstem-dead donor.11 The issues include decision-making on futility, the role of the next-of-kin, informed consent, manoeuvres directed towards optimal organ viability, the diagnosis of death, and deliberations as to how all these components can be accommodated within ‘best interests’, the principle governing management of the incompetent individual.12

Decision-making on futility
The primary difficulty lies in ensuring that an opinion on futility is robust enough to withstand an allegation of ‘conflict-of-interest’ if it is unit policy to accommodate this donation process, particularly with ‘required request’. The majority of these patients will have sustained a severe brain injury by diverse mechanisms—traumatic, vascular, hypoxic, metabolic or infective—but not be brainstem dead. Although there remains less than universal acceptance of brainstem death as equivalent to death itself,13 the condition has achieved recognition as an objective marker of the futility of ongoing supportive care.14 Lesser degrees of brain injury generate an opinion rather than an unequivocal position, often based not on the likelihood of death, as in the above case, but on the idea that continuation of support would result in survival with a level of neurological disability incompatible with any meaningful existence for that individual. Such prognostic accuracy is very difficult in the early stages after injury and is often only consolidated by continuation of support over time, as evidenced by the guidelines that govern the diagnosis of the persistent vegetative state.15 ‘Quality of life’ in the event of survival is, furthermore, a subjective matter not falling solely within the discretion of the medical profession.16 Even if professional guidelines are followed,17 18 with confirmation by second opinion and multidisciplinary consensus, it is difficult, therefore, to eliminate ‘conflict of interest’, particularly when the variables are not as absolute as in the case under discussion.

Role of the next of kin
The precise role of the next of kin in the health-care management of the incompetent adult is a problem in any jurisdiction. The Mental Health Act 1959 removed any authority under English law and although there is intention to address this under the proposed Mental Incapacity Bill, the current position is that even formalized ‘power of attorney’ is limited to non-medical matters. The Courts have no surrogate authority to consent, being limited to declarations of lawfulness or otherwise on what is proposed, and any authority of the next of kin with regard to donation under the Human Tissue Act 1961 is only activated after death. The responsibility rests therefore with medical staff acting in the ‘best interests’ of the patient,19 but directives from the professional bodies specify the involvement of the next-of-kin in decision-making.20 21 Clearly, if such ‘lack of objection’ to what is proposed is to be valid, this must be based on provision of full information as to process,22 in line with the principles dictated within the proposed Human Tissue Bill23 and time to both consider and reconsider.

Manoeuvres directed towards optimal organ viability
After confirmation of ‘lack of objection’, procedure is inevitably directed towards retrieval at optimal organ viability, which seemingly creates conflict with that primary principle of ‘best interests’. Viability is promoted by minimization of both warm and cold ischaemia time and protective measures, such as the administration of antibiotics, steroids and heparin.

Since the process of dying cannot legitimately be actively foreshortened, warm ischaemia time is mainly minimized by rapid access to a surgical retrieval team immediately after death. The time taken to mobilize such a team usually dictates that supportive care be continued despite the prior declaration that this could no longer be considered in the patient's ‘best interests’ on the grounds of futility. This process, amplified by any escalation of care pending the readiness of the retrieval team, is seemingly at variance with the law.24

Post-retrieval cold ischaemia time is minimized by ensuring that a suitable recipient is identified early by taking blood for tissue typing, and transplanted early by determining via virology screening that there is no contraindication to utilization of the organ. This process too is at variance with the dictates of the UK Code of Practice—‘any tests or treatment carried out on a patient before he dies must be for his benefit and not solely to preserve his organs’25—a position which also generates difficulties in administering the above therapies directed towards organ viability.

Process of dying
The process of dying comes under scrutiny since the time scale dictates the warm ischaemia time. Relief of pain and distress is a basic medical duty and the potential for this process to shorten life is accommodated under the doctrine of ‘double effect’.26 27 This latter principle, which has already been challenged,28 becomes more vulnerable, however, when there is prior knowledge that such shortening will benefit a third party. Since it can be argued that patients with significant neurological disability should be beyond pain and distress, there is a distinct possibility that those individuals that warrant comfort care may inappropriately be denied this to avoid any such accusations.

Timing of death
Timing of death is problematic within the UK and most jurisdictions, there being no professional guidelines or definition at law other than for brainstem death, leaving uncertainty as to when death can be certified and when the process is sufficiently established to permit organ retrieval. The declaration that brainstem death constitutes the only true death29 does not assist certification by cardiac criteria: ‘A person is not dead unless his brain is dead. Arrest of the heart and circulation indicate death only when they persist long enough for the brain to die’.30 Clinical examination for absence of responsiveness, respiratory effort, cardiac output and pupillary response should not be undertaken within 2 min of the onset of asystole, since autoresuscitation is theoretically possible within this time scale. The Pittsburgh approach31 of surgical intervention 2 min after asystole is unlikely, therefore, to be accommodated within UK practice and a more pragmatic position of only initiating perfusion/retrieval at 10 min after certification should be capable of reassuring all parties that death has become sufficiently established at that stage, given the primary neurological insult and likely progression of this during the process of dying.

Defining and ratifying defensible practice
‘Best interests’
With such conflict across multiple fields, how can the process of controlled non-heartbeating donation be accommodated defensibly? The most fundamental consideration relates to the ethical and legal interpretation of ‘best interests’, the principle defining care of the incompetent adult. In relation to other aspects of health-care, this is not limited to ‘best medical interests’, but incorporates ‘the patient's wishes and beliefs when competent, their general well-being and their spiritual and religious welfare’.32 33 It appears essential to consult the next of kin, despite their position at law, to determine their interpretation of these factors. On this basis, once the family understand the nature and severity of the condition and have accepted the futility of ongoing active support, they can legitimately be asked to consider, in the absence of a donor card, whether the patient had either expressed a view with regard to donation or would have been likely to accommodate this altruistic act. Having been given all information about the process involved, if it is their belief that the patient would have wished this to happen, it is reasonable to assume that that individual would wish the organs to be donated at maximal viability, thereby avoiding recipient hazard. It follows that as long as the manoeuvres to promote this end-point are not associated with harm to the individual, they can be accommodated under the term ‘best interests’ and thereby comply with both ethical principles and the law.

Harm
Harm is, however, likely to be interpreted differently by lay and professional groups and to rest on a spectrum of opinion even within each cohort. Maintenance of support prior to mobilization of the retrieval team, if complemented by analgesic and sedative therapy where required, is likely to be acceptable to most. Escalation of support is more controversial since this could encompass a range of procedures, from modification of ventilatory mode to volume therapy, initiation of inotropes or vasopressors, or peripheral or central venous cannulation. Intubation or the siting of femoral catheters to facilitate cold perfusion is likely to cross an arbitrary divide on a spectrum of tolerability, with cardiopulmonary resuscitation predictably deemed unacceptable. Sampling blood for tissue typing and virology is difficult to construe as harm, and if a contraindication to donation is identified early by this process, the process of organ retrieval can be aborted. The administration of antibiotics, methylprednisolone and heparin to improve organ viability is based on established practice within the brainstem-dead donor group, and although the evidence base is not established for the non-heartbeating population it is difficult to construe administration as harmful if a thorough drug history and clinical assessment is conducted to reduce the likelihood of an adverse drug reaction.

Ratification
Most aspects of this procurement strategy can therefore be accommodated within the primary ethical principles of respect for autonomy (albeit by proxy) and non-maleficence,34 coupled with a broad interpretation of ‘best interests’. A formal declaration of the lawfulness of this approach is, however, required to avoid compromising the reputation of practitioners and a repetition of the debacle of ‘elective ventilation’,35 which was eventually declared unlawful.36 The difficulties in certifying death by cardiovascular criteria and declaring a time at which death is sufficiently established for organ retrieval warrant urgent attention. Any work in this direction will inevitably be influenced by transatlantic proposals for the ‘dead-donor rule’ to be abandoned,37 which circumvents difficulties in the diagnosis of death but creates a raft of new ethical and legal problems.38 In defining standards, it will be interesting to observe how the legislature and professional bodies accommodate an inevitable range of opinion on each of the key considerations. It can be argued that, rather than process being defined to accommodate the lowest threshold of the most sensitive, acceptable practice should be determined by the above fundamental ethical principles and declared lawful if criteria such as consent are met. Members of staff holding a more conservative view should then simply hand over care to a practitioner capable of following these principles, thereby paralleling the incorporation of conscientious objection in fields such as termination of pregnancy or end-of-life scenarios where the wishes of the patient are in conflict with the beliefs of the attendant practitioner.39

The ultimate goal to avoid disquiet by truly promoting autonomy would be a more comprehensive advance directive than the current donor card or register,40 one that subscribes to or declines the different organ donation scenarios and the component processes. Patient care would thereby be directed by the wishes of the patient rather than the particular beliefs of individual practitioners. This clearly demands more active engagement of the general public than is currently undertaken and it is uncertain how the public would respond, one possibility being a reluctance to subscribe for fear that such a specific directive may skew the process of care towards organ retrieval rather than treatment of the primary brain injury.

Although a perception of ‘conflict of interest’ cannot ever be eliminated from this activity, therefore, much can be done from many directions to meet the recognized need for transplantable organs, fulfil the altruistic wishes of patients and next of kin, and simultaneously protect both patients and practitioners and the reputation of relevant professional bodies.


    References
 Top
 Abstract
 Case presentation
 Discussion
 References
 
1 Harvard Medical School. A definition of irreversible coma. Report of the ad hoc Committee of the Harvard Medical School to examine the definition of brain death. J Am Med Assoc 1968; 205: 337[CrossRef][Medline]

2 UK Transplant. Potential donor audit Q&A. London: National Heath Service, 2003

3 Weber M, Dindo D, Demartines N, et al. Kidney transplantation from donors without a heartbeat. N Engl J Med 2002; 347: 248–55[Abstract/Free Full Text]

4 Steen S, Sjoberg T, Pierre L, et al. Transplantation of lungs from a non-heart-beating donor. Lancet 2001; 357: 825–9[CrossRef][ISI][Medline]

5 Ruers TJM, Vroeman JPAM, Kootstra G. Non heart beating donors: a successful contribution to organ procurement. Transplantation Proc 1986; 18: 408–10[ISI]

6 National Health Service. More transplants, new lives. London: National Health Service, UK Transplant, 2001

7 Department of Health. Saving lives, valuing donors. A transplant framework for England. London: Department of Health, 2003

8 Kootstra G, Daemon JHC, Oomen APA. Categories of non-heart-beating donors. Transplantation Proc 1995; 27: 2893–4.[ISI][Medline]

9 Bell MDD. Non heart beating organ donation: old procurement strategy—new ethical problems. J Med Ethics 2003; 29: 176–81[Abstract/Free Full Text]

10 Bell MDD. Non-heart-beating organ donation within intensive care; are the ethical and legal considerations surmountable? J Intensive Care Soc 2003; 4: 76–7

11 Bell MDD, Bodenham AR. Non-heartbeating organ donation—can we balance duty of care, the law and recipient need? Care Crit Ill 2004; 20: 1–2

12 Re F (Mental Patient: Sterilisation) [1990] 2 AC 1 (HL)

13 McConnell JR. The ambiguity about death in Japan: an ethical implication for organ procurement. J Med Ethics 1999; 25: 322–4[Abstract]

14 Williams M, Bell MDD, Moss E. Brainstem death. BJA CEPD Rev 2003; 3: 163–7

15 British Medical Association. Guidelines relating to the persistent vegetative state. Bull Med Ethics 1993; 3: 8

16 R (Burke) v The General Medical Council [2004] EWHC 1879

17 British Medical Association. Withholding and withdrawing life-prolonging medical treatment. London: British Medical Association, 1999

18 General Medical Council. Withholding and withdrawing life-prolonging treatment; good practice in decision-making. London: General Medical Council, 2002

19 Re F (Mental Patient: Sterilisation) [1990] 2 AC 1 (HL)

20 General Medical Council. Seeking patients' consent: the ethical considerations. London: General Medical Council, 1998

21 Department of Health. Good practice in consent. HSC 2001/023. London: Department of Health

22 Department of Health. Isaacs report. London: Department of Health, 2003

23 United Kingdom Parliament. Human Tissue Bill. http://www.parliament.the-stationery-office.co.uk/pa/cm200304/cmbills/009/2004009.htm.

24 Airedale NHS Trust v Bland [1993] A.C. 789 per Lord Browne Wilkinson

25 Departments of Health of Great Britain and Northern Ireland. Cadaveric organs for transplantation: A code of practice including the diagnosis of brain death. London: HMSO, 1983

26 R v Bodkin Adams [1957] CLR 365

27 House of Lords Select Committee on Medical Ethics (1993–94) HL 21-1

28 R v Woollin [1998] 4 All ER 103 (HL)

29 Kennedy I, Grubb A. Medical Law, 3rd edn. London: Butterworths, 2000

30 Pallis C. Reappraising death. Br Med J 1982; 285: 1409–12[ISI][Medline]

31 DeVita MA, Snyder JV. Development of the University of Pittsburgh Medical Center policy for the care of terminally ill patients who may become organ donors after death following the removal of life support. Kennedy Inst Ethics J 1993; 3: 113–43[Medline]

32 General Medical Council. Seeking patients' consent: the ethical considerations. London: General Medical Council, 1998

33 Department of Health. Good Practice in Consent. HSC 2001/023. London: Department of Health, 2001

34 Beauchamp TL, Childress JF. Principles of Biomedical Ethics, 4th edn. Oxford: Oxford University Press, 1994

35 Feest TG, Riad HN, Collins CH, et al. Protocol for increasing organ donation after cerebrovascular deaths in a district general hospital. Lancet 1990; 335: 1133–5[ISI][Medline]

36 National Health Service, Acute Services Policy Unit. Identification of potential donors of organs for transplantation. NHS Executive HSG(94)41. London: National Health Service, 1994

37 Truog RD, Robinson WM. Role of brain death and the dead-donor rule in the ethics of organ transplantation. Crit Care Med 2003; 31: 2391–6[CrossRef][ISI][Medline]

38 Bell MDD. Redefining the ethical and legal foundations of organ procurement. Crit Care Med 2004; 32: 1241

39 Ms B v An NHS Hospital Trust [2002] EWHC 429 (Fam)

40 National Health Service, UK Transplant. http://www.uktransplant.org.uk





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