Supporting organ donation through end-of-life care: implications for heart-beating donation

The first Organ Donation Taskforce Report recognized the importance of resolving certain ethico-legal controversies and providing clear guidance to practitioners to facilitate various organ donation practices, among which were measures taken to sustain patients and their organs prior to death, with the objective of preserving the capacity for viable organ retrieval and transplantation after the person's demise. ¹ It is not contentious that anxieties regarding preparatory measures pertaining to potential controlled donation after cardiac/cardiopulmonary death (DCD) have impeded the development of such protocols across the UK (and Europe as a whole), albeit that the number of such donors has increased 10-fold over the last decade. ² Indeed, such donors have ceased being marginal contributors to the overall deceased donor rate and now comprise a very substantial, and increasingly indispensable, percentage of all such donors. ³

In the light of these uncertainties, the United Kingdom Donation Ethics Committee (UKDEC) recently issued a consultation paper titled An Ethical Framework for Controlled Donation After Circulatory Death, ⁴ and a Report of a Consensus Meeting has been produced by the British Transplantation Society, the Department of Health and NHS Blood & Transplant, both addressing conflicts of interest and other ethical issues. ⁵ Moreover, legal guidance emanating from the Department of Health and the Welsh Assembly, and the Scottish Executive, has endorsed the notion that certain such measures may potentially be in the person's best interests (or for their ‘benefit’ in Scotland) taking all factors into consideration, where there is evidence that the person wished to be an organ donor after death (e.g. where his or her name is on the Organ Donor Register). ⁶ This advice is entirely consistent with developments in UK law whereby decision-makers must take into account, as far as is reasonably ascertainable, the past wishes and feelings of the individual and the beliefs and values that would be likely to have influenced their decision had they been able to make it (Mental Capacity Act 2005 and the Adults with Incapacity [Scotland] Act 2000). These would of course include their wishes regarding organ donation after death. The best interests determination has become increasingly holistic, so that the decision-maker must consider, and balance, all the patients' interests and not just their clinical interests. These would include their psychological, emotional, altruistic and spiritual interests, etc. ⁷ This is an enormously important principle to establish, as at the point where it is determined that further life-sustaining measures (e.g. artificial ventilation) should be discontinued as they no longer offer any clinical benefit to the patient, to fail to continue such treatment for at least some short period thereafter will inevitably jeopardize the prospect of subsequent donation in most instances. This is principally by virtue of the need for organ retrieval and transplantation teams to be in readiness. This has now led to the typical practice of discovering individuals' organ transplant potential and their organ donation wishes prior to the removal of treatment (e.g. checking the Organ Donor Register) and the death of the patient. UKDEC confirms the absence of any conflict of interest necessarily occurring in connection with such practices and asserts that ‘When planning end of life care for a patient for whom life-sustaining treatment is no longer appropriate, if the patient wished to be an organ donor, then care that facilitates successful donation is likely to be highly compatible with their best interests’. ⁸ Of course, there may be some specific procedures regarded as too extreme or too invasive to satisfy a best interests evaluation (the Department of Health guidance for instance suggested femoral cannulation would be very unlikely to ever be seen as being in a patient's best interests), but these are all situation-specific and not centrally germane to the theme of this paper.

The crucial issue raised here is what ramifications this new frame of reference, and clinical pathway, for DCDs have for donors after brain(stem) death (DBDs)? In particular, what legally and ethically justifies continuing to treat an individual to the stage of development and confirmation of brainstem death after it has been agreed that there is no further prospect of clinical benefit? These include patients brought into an emergency department, who are not transferred to intensive care (there is a new initiative to promote donation in stroke patients in accident and emergency departments), ⁹ and patients already in ICUs. The latter will include those who are already believed to be brainstem dead but who are yet to be tested and those who are believed to be likely to go on to develop brainstem death in the foreseeable future. While DBD has been in general decline, ¹⁰ and the percentage of patients who may go on to develop brainstem death may be reducing – due for instance to changes to clinical practice in the treatment of stroke (the more regular use of cerebral compression has apparently reduced the number of patients with cerebral infarction who go on to develop brainstem death) ¹¹ – these potential donors are crucial to the overall transplant effort and for heart and liver transplantation in particular. ¹² However, the Potential Donor Audit for the period 2003–2006 revealed that 400 to 600 patients died annually in ICUs but for whom no brainstem death tests were conducted, despite such tests being likely to prove positive. ¹³ These figures are diminishing but remain substantial. ¹⁴ While there are undoubtedly sound clinical reasons why organ donation in some cases would not have been feasible, the Organ Donation Taskforce Report stated that ‘there is a prima facie case that BSD [brainstem death] tests are not undertaken in all suitable situations’. ¹⁵

There is, though, no major ethico-legal dilemma attaching to the maintenance of artificial ventilation of such patients during the time necessary to confirm brainstem death which is already suspected, whether the person wished to be an organ donor or not. In its response to the House of Lords European Union Committee Report, the Government stated that ‘A key step is the performance of brain stem tests in all appropriate patients – not just because they may become organ donors – but because professional guidelines identify it as the most appropriate course of action for both the patient and their family’. ¹⁶ Guidelines issued in 2005 by the Intensive Care Society state that certification of death by brainstem testing is important in its own right and ‘independent of any subsequent consideration of organ donation’. ¹⁷ To establish death by measures designed to directly test brain activity seems to be a practice which serves patients' interests. Reasons given by clinicians for not proceeding with neurological testing in such scenarios include cardiovascular instability, prior intimation from the family that they would not agree to donation and anxieties over the applicability of brainstem testing by virtue of residual sedation or biochemical abnormalities. ¹⁸ It appears that in many of the cases where such tests are not undertaken, these could nonetheless have been legitimately carried out.

But what of patients who need continued support but for whom brainstem death is likely or possible but not anticipated to occur imminently? I leave for the present the inevitable conflicts which may arise in terms of intensive care bed allocation in such cases. What justifies continued treatment of a patient now deemed ‘clinically futile’? ¹⁹ The following rationales are typically offered. It was stated in evidence to the House of Lords Committee that ‘The Intensive Care Society has issued a statement in a more recent publication that to diagnose brain-stem death should be pursued wherever possible, because it is the diagnosis of death rather than the diagnosis of futility that requires the withdrawal of care’. ²⁰ Bell ²¹ has also remarked that brainstem death has ‘achieved recognition as an objective marker of the futility of ongoing supportive care’. But this potential rationale is problematic in relation to the present class of patients. The continuation of treatment which is not in the best interests of the patient is a civil, and perhaps criminal, battery. ²² If further treatment is pointless and there are no factors, clinical or otherwise, pointing to a reason for further treatment, then it should be withdrawn as it is no longer in the patient's best interests. Whether rightly or wrongly, common law systems have required a justification for supporting (extending) life by means of medical interventions, not invariably for failing to do so, i.e. a reason to as opposed to not to. Dame Elizabeth Butler-Sloss stated in Re L (Medical Treatment: Benefit) that ‘There is a strong presumption in favour of preserving life, but not where treatment would be futile, and there is no obligation on the medical profession to give treatment which would be futile’. ²³ This is a stance which is mirrored in the ancient and hallowed Hippocratic principles of medicine. ²⁴

The Intensive Care Society guidelines allude to the notion that relatives will more easily accept the withdrawal of mechanical ventilation in such patients, and remove any doubt regarding the patient's ability to recover. However, this does not necessarily speak to a legal or moral imperative, merely a desire to assuage and palliate the concerns and anxieties of loved ones. The notion that this is in the patient's best interests presumably requires an interest being ascribed to the patient that his/her relatives should avoid any avoidable suffering. But of course the patient may have no relatives alive or present, or they may be perfectly content for treatment to be withdrawn at that stage anyhow. Indeed, in some instances a protracted determination of death may itself produce suffering in relatives. Generalizations are inappropriate.

But there may be reasons based on the individual's wishes or values which justify continued life-supporting treatment in particular circumstances. If a comatose and moribund pregnant woman carrying a fetus near viability is admitted to an ICU, an assessment of her wishes and circumstances would routinely be conducted in order to determine whether further supportive treatment was justified as being in her best interests. Similarly, if a patient believed to be imminently developing brainstem death had relatives who needed time to attend the patient's bedside, it would often be deemed to be in the patient's own best interests for treatment to be continued to allow the relatives to be with the patient at the time of death. These are examples of ‘non-medical’ interests which would tip the balance in favour of continuing support based on inferences as to the wishes of the patient. Another interest of the patient which may only be fulfilled – albeit after death – if life-sustaining treatment is continued is the wish to be an organ donor. Such a wish may be gleaned either from an entry on the organ donor registry, possession of a signed organ donor card or discussion with relatives about the specific wishes of the individual.

If organ donation is to become a ‘usual event’, it is essential that the wishes of individuals regarding donation are made available at the time that crucial decisions about care and treatment are being made. Thus, it is necessary for contact to be made with senior nurses for organ donation or transplant coordinators before decisions about life-sustaining treatment are irreversibly implemented but after the initial clinical assessment of benefit has been made, as recommended by the UKDEC vis-à-vis potential DCDs. ²⁵ There is a danger of a lack of joined-up thinking here, with new protocols for DCD operating independently and not informing practice in relation to potential DBD donors. We should arguably be more proactive in discovering the wishes of patients regarding organ donation once the point of ‘clinical futility’ (the moment when no medical benefit can be obtained by the patient from further treatment) has been reached in all instances, whether the person will be a donor or not and regardless of what type of donor they might become. While it has been conventional wisdom that the family should not be approached until at least one set of brainstem death tests have been performed, ²⁶ practice is now apparently much more variable, ²⁷ which is unsurprising as families of potential DCD donors are now regularly approached relatively early in the process.

If treatment such as artificial ventilation (and correction of instabilities arising during this time) may be continued for some limited period of time in the context of controlled donation after circulatory death where the person had a wish to be an organ donor after death, why not in the context of heart-beating/DBD donation also? The patient's best interests may be no different in this regard. Indeed, such a practice leading to the determination of death by neurological criteria may better give effect to a patient's wishes by enabling him/her to donate a wider range of organs. The second guiding principle underlying the work of the UKDEC is that once it has been agreed that organ donation is in the patient's best interests, the ethical imperative is to enable the most successful outcome to that donation. ²⁸ Half of all non-heart-beating donors are ‘kidney only’, and the average yield from such donors is 2.1 organs per donor compared with 3.4 organs per donor for heart-beating donation. ¹¹ Multiorgan donation may indeed contribute to the ‘success’ of the donation from the patient's standpoint.

Apparently only around a quarter of DBDs have been in ICU for more than a couple of days, suggesting that in very many instances the patient's bleak prognosis and eventual condition have become clear pretty soon after entering a high-dependency environment. Longer-term treatment support potentially leading to brainstem death may perhaps be avoided either on account of the patient's obviously hopeless clinical prognosis or because the patient is clinically unstable. As has been noted, treatment/support is sometimes withheld or withdrawn where there would otherwise be a need for the correction of physiological instability. Of course, in some of these instances it is possible that life-sustaining treatment is withdrawn and the patient then becomes a DCD donor instead. There has, for instance, been a significant shift away from heart-beating donation and towards non-heart-beating donation in stroke patients. ¹¹ Indeed, it is conceivable that the growing phenomenon of DCD donation is undermining DBD. ²⁹ It has recently been asserted that ‘there is a feeling within the transplant community that patients are being considered for cardiac-death donation at an early stage rather than waiting for them to fulfil criteria for brainstem death’. ³⁰

Abroad

Some societies may be comfortable with a (utilitarian) policy of supporting patients entirely for the potential benefit of others and the community as a whole. This appears to be the scheme which is presently being put forward, for instance, at a national and state level across the USA. The 2006 version of the Uniform Anatomical Gift Act (amended in 2007) ³¹ states that measures necessary to ensure the medical suitability of a part (including an organ) of a hospitalized patient referred to an organ procurement organization (OPO), which might be used for transplantation, shall not be withdrawn unless it is known that the patient had expressed a contrary intent. ³² Moreover, any reasonable examination necessary to ensure the medical suitability of the part concerned may be carried out. ³³ This provision applies to any patient on life-support systems who has been referred to an OPO for evaluation as a prospective donor (as is required by federal regulations). This generates the presumption that such a procedure is warranted unless rebutted by evidence of the contrary wishes of the individual. It is designed to place the onus on the individual to justify non-intervention rather than upon the state to justify such measures.

It is, however, unlikely that we would in the UK support such a (utilitarian or communitarian) rationale for continued support of potential deceased organ donors per se. There is, however, no need to do so where there is clear evidence that the person wished to be an organ donor and there are no significant harms attaching to the procedure concerned. This debate is dogged in the context of heart-beating donation by the historical spectre of the elective ventilation saga of the 1990s. But that protocol was evaluated in the context of the fairly limited ethical and legal framing of the time, which failed to recognize that overall patient benefit is a holistic concept involving the weighing and balancing of a variety of factors of both a clinical and non-clinical nature. The Organ Donation Register was also in its embryonic developmental stages and thus evidence of the patient's real wishes regarding donation was very often shrouded in unreliability and mystery. In the light of convincing evidence of the patient's wishes, we can now make a reasoned and reasonable assessment of the overall benefit of measures necessary to facilitate such ends. Of course, not only can such life-sustaining treatment be justifiably continued for only a limited period of time but one would need to consider the precise risks and circumstances in each case, including any particular risks or harms attaching to certain interventions, e.g. the risks of inducing a permanent vegetative state and the indignity attaching to any substantial invasive procedure. But merely continuing an existing treatment regimen for a lengthier period and maintaining physiological stability in the interim period leading to the expected death of the brainstem seems invariably of benefit to a patient who wished to donate organs after death, in the light of their permanently insensate, moribund and unconscious state. At this point, such individuals are beyond experiential, physical or psychological injury and thus have very narrowly delimited welfare interests and potential for (ethical) harm. Indeed, to refuse to preserve the potential for donation after death has the ability to thwart and defeat such patients' interests. The UKDEC stated in its Consultation that ‘Interventions to maintain cardiorespiratory stability and critical organ perfusion are appropriate, until such time as withdrawal of life-sustaining treatment is instigated’. ³⁴ Specifically it ethically endorsed the use of inotropes to maintain blood pressure at an appropriate level while arrangements for organ retrieval are put in place and after the decision to withdraw treatment has been made. ³⁵ This mirrors the legal guidance issued by the Department of Health and the Welsh Assembly in 2009, which stated that ‘Maintenance of life-sustaining treatment may be considered to be in the best interests of someone who wanted to be a donor if it facilitates donation and does not cause them harm or distress, or place them at significant risk of experiencing harm or distress’. ³⁶ Why should this be any different for potential DBD donors?

Conclusion

DBD donation is under extreme pressure in the UK at the present time. Not only does it appear that there are fewer patients likely to go on to develop brainstem death than previously, but also a reluctance to maintain a significant number of patients for a sufficient period to allow for brainstem testing or for progression to possible brainstem death to occur. The very proper perspective that in general, once treatment has been found to be clinically hopeless or futile it should be discontinued forthwith, has seemingly metamorphosed into an immediate imperative to invariably do so, despite the fact that the patient's broader interests may sometimes be served by continuing treatment for some modest period of additional time to the particular end of organ donation. Flexibility is needed in this sphere to avoid frequently defeating the altruistic wishes of patients who are beyond harm of any material kind.