non-heart-beating organ donation: a two-edged sword

H E C FORUM 1996; 8(3): 168-179.

© 1996 gluwer Academic Publishers~ Printed in the Netherlands.

N O N - H E A R T - B E A T I N G O R G A N D O N A T I O N : A T W O - E D G E D S W O R D

JOS V.M. WELIE, M.Med.S., J.D., Ph.D.

Introduction

Undoubtedly, transplantation medicine is one of the great successes of modem medicine. Although based on a rather elementary mechanical principle -- if it doesn't work, put in a new one -- transplantation of human organs has turned out to be an effective solution for many patients. Unfortunately, many other patients fail to benefit from the achieved know-how because of a severe shortage of donor organs.

Some have sought the solution to this problem by changing organ donation laws. Various European countries have adopted a presumed consent system. As in the explicit consent system, in such a presumed consent system, no person is obligated to donate his or her organs after death. But it is the potential donor, rather than the consenter, who has to make an effort and get him or hers¢~,f registered as a non-donor. Others have rejected this model because it would infringe on individuals' personal freedom. Instead, they have sought the solution in an ardent appeal to the public fo~ more donations, bestowing the genuinely altruistic donor with public honor.

While these politically inflammable debates continue, biomedical scientists and practitioners have not sat still. The techniques for extirpation, conservation, and transplanting continue to be improved, thus increasing the number of transplantable organs and reducing rejections. Nevertheless, the shortage remains.

An innovative solution to the problem of shortage that is currently being tried in a number of hospitals world-wide is Non-Heart-Beating Organ Donation (NHBOD). Some states have embraced this new practice with great zeal. On July 1, 1995, two new paragraphs in Florida's statutes have taken effect facilitating NHBOD (1). However, in most other places the introduction of this practice has evoked considerable ethical "uproar." The articles published in the 1993 special issue of the

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Non-Heart-Beating Organ Donation: A Two-Edged Sword 169

Kennedy Institute of Ethics Journal, and the commentaries in consequent years, underscore the considerable dissensus that exists among those involved in the debates.

As it typically goes with such volatile bioethical issues, they find their way to the Hospital Ethics Committee (HEC). 1 While many HECs may have grown accustomed to the unpopular and ungrateful role of the institution's "watch dog," writing an NHBOD policy is likely to be one of the HEC's most stressful undertakings. NHBOD is a two-edged sword. If the HEC takes seriously the rights and interests of the donors, it is likely to be scorned by the institution's transplantation team. If the HEC joins in the struggle for more transplantable organs, it may become liable to that most serious of medical sins: to sacrifice the weaker, dying patients for the undeniable sake of those who could survive.

Drafting a sound NHBOD policy is difficult not only because of these kinds of moral concerns, but also because of the internal complexity of the matter. NHBOD involves conflicts between the rights of donors and those of organ recipients. It entails questions about the professional responsibilities of healthcare providers to patients and colleagues. It obliges the HEC to reflect on the larger socio-cultural context of medicalized dying. It even forces onto the committee the age-old philosophical question: what constitutes human death? What follows is not primarily aimed at analyzing in detail one or more of these complexities, but rather to provide a systematic review of the primary dilemmas raised by NHBOD, the relevant arguments, and some of my own evaluative conclusions.

The practice of non-heart-beating organ donation

The practice of NHBOD proceeds as follow. Two categories of patients may end up being NHBODonors: (i) patients who have been hospitalized for some time (notably in the Intensive Care Unit) and whose medical treatment has been deemed futile and, hence, is withdrawn; and (ii) patients who unexpectedly suffer a cardiac arrest and cannot be properly resuscitated (notably in the emergency room or during surgery). In either category, upon determining that a patient has suffered from irreversible cardiac arrest, the patient is pronounced dead. To prevent organ damage resulting from warm ischemia, within as short as possible time period cannulas are inserted into the femoral artery and vein to flush the corpse with coolant. How much time may safely pass between the

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cessation of cardiac action and the insertion of the cannulas has yet to be resolved through research. The figures range from two hours to as little as 45 minutes. It should be noted, however, that the Warm Ischemia Time (WIT) also includes any time spent on resuscitation efforts, which may itself range from 5 to 45 minutes. Once the cannulas have been inserted and the corpse is properly cooled, the organs can be preserved for extirpation and transplantation for two to three hours.

Preliminary ethical analysis

There is nothing radically new about NHBOD, so it seems. It certainly is not as innovative as some of the other proposed solutions to reduce organ shortage, such as cloning IVF embryos and using one of the twins as a spare organ bank. The idea behind NHBOD is actually quite simple: If someone's heart has stopped beating (and cannot be revived), the person is dead; once a person has died, his or her body is no longer an intrinsic part of the living human being but a corpse; and the organs of a human corpse may be extirpated (provided an informed consent has been given).

At first sight, then, NHBOD is without moral problems since it is solely based on long accepted premises. But a more detailed examination of this practice reveals that it could end up being extremely radical indeed. The most pressing moral problems concern the interests of the potential donor (although the interests of the surviving family members should not be ignored). How can we guarantee that the possible NHBODonor, while still alive, is treated as any other live patient? How can we guarantee that the terminally ill patient in the ICU is not already viewed by the healthcare personnel (or perhaps even the donor's family) as a valuable source of organs? How can we guarantee that the patient suffering from a cardiac arrest is resuscitated as long as there is a chance of success, especially if such extended attempts end up disqualifying the patient as an NHBODonor? And finally, what guarantees that the patient is really dead before the cannulas are inserted - for if (s)he was not, flushing the body would be tantamount to murder.

Futility judgments

For everyone involved, the temptation is real to start viewing and, hence, treating an ICU patient as a potential organ donor rather than as


a patient whose intrinsic dignity demands optimal care and respect. After months of ardent yet unsuccessful attempts to reverse the patient's down- hill course, the patient may be abandoned by the ICU team. After months of exhausting daily visits, family members may finally lose hope, and frustration and anger sets in. Other patients have to be turned away from the ICU because a bed has not become available. When, on top of all that, we know that various human lives could be saved with the still healthy organs of this patient, the tiny cross that may be on the patient's driver's license indicating consent to organ donation begins to appear larger . . . . It is perhaps human for the mind to start considering such options - which is exactly why we have to protect ourselves.

But are we able to build-in sufficient safeguards where NHBOD is concerned? Take our ICU patient. Suppose we manage to withstand the temptation to deem a patient's treatment fut/le prematurely; suppose we manage to completely block out the prospect of saving other lives when assessing the ICU patient's own interests; suppose that we nevertheless conclude that continued medical interventions no longer concur with the care and respect that we owe this person. The proper way to go, then, would be to withdraw such medical interventions and to "limit" ourselves to providing comfort care until the patient dies her own death.

However, if we want to preserve the patient's organs, we cannot let her die in this way. Until we are ready with the preparations for cooling the body, we have to stabilize the patient with the same medical interventions that we had just found futile (i.e., not to benefit the patient in any regard). Only then will we withdraw (declare the patient dead, and insert the cannulas). But imposing such futile medical interventions onto a patient, even a patient whom we know to be a voluntary organ donor, is a violation of her intrinsic dignity (irrespective of any brain damage that precludes her from experiencing what is happening to her). We are violating one of the most important moral imperatives: never to treat a fellow human being as a mere means for some other (person's) end, but always as an end in herself. Hence, it is not at all "reasonable" -- as some medical experts apparently believe (2, p. 45) -- to seek an informed consent from the potential donor (let alone the family) for medical interventions (such as heparin "therapy") solely aimed at increasing the chances of successful procurement without benefitting the patient herself.

Futile treatment must always be discontinued, and organism-stabilizing and organ-preserving measures should be (re)started only after the patient has been pronounced dead. This is why in cases of brain death such

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measures do not have to be withdrawn. Brain dead patients are dead. But our ICU organ donor has yet to die. A patient should be treated as a corpse-to-be-harvested only after (s)he has died.

It may well be that the only way to guarantee that any and all ICU patients are granted the personal respect and care they deserve, is simply to leave out ICU (and similar patients) from the NHBOD protocol. It neutralizes the incentive to pass a verdict of futility solely or even partly based on the possibility of saving other lives. In fact, it keeps us from stepping onto the slippery slope of nonvoluntary termination of life. After all, withdrawing life-support that was not really futile from the perspective of the patient's own interests is the same ethically as nonvoluntary termination of life.

For the very same reason, one may consider leaving out of the NHBOD protocol any cases of (assisted) suicide or euthanasia, and even refusal of life-saving treatment cases. Although it seems perfet:tly consistent for a patient refusing treatment and/or seeking death, also to be an organ donor, care providers may be more likely to grant rather than question such patient wishes when they know that the patient's death will save other lives. While a patient's quest for death is not necessarily a hidden cry for compassionate care, in many instances it may well be. A physician's justified eagerness to procure more donor organs may suffice to keep him or her from discerning that hidden cry.

Resuscitation

If patients in the ICU run the risk of being overtreated, patients in the Emergency Room (and Operating Room) run the risk of being undertreated. The WIT, the time period between cardio-pulmonary arrest and the insertion of femoral catheters, has to be as short as possible. As mentioned above, the maximum WIT is still an object of scientific research. One Japanese study reports that the WIT does not influence renal function, if it does not exceed 60 minutes, but no maximum WIT is mentioned (3). The NHBOD protocol of the University of Pittsburgh Medical Center does not set an absolute limit either, but speculates that a WIT of more than two hours may be too long (4, p. A-6) However, the protocol of the Catholic University of Nijmegen Hospital (Netherlands) requires that the WIT not exceed 45 minutes (5, p. 3).

An hour (or less) is very short given that resuscitation may last 30 minutes or more. It is generally assumed that the brain is only completely


dead (and hence the patient is dead) after some 10 minutes of complete cardiopulmonary arrest (i.e., after cessation of resuscitation). One then has to go and talk to the family, explain that their beloved has died, discuss organ donation, and ask for permission to start preservative measures. In some instances legal authorities have to consent to organ extirpation as well. Clearly, then, time is a precious commodity in NHBOD.

Normally, resuscitation may last 30 minutes or longer. In fact, the resuscitating team may, when nothing seems to work, continue against the odds for another five minutes or so just to be sure. Unlike protracted ventilation of ICU patients (notwithstanding the futility of such treatment), extended ER resuscitation against the odds of success does not violate a patient's human dignity, because it is intended to save the patient rather than to use him for someone else's benefit. However, when it is known that the patient is a possible donor -- and every ER/OR physician does know or should know that -- under severe pressure of time, the team may be less eager to risk "ruining" a good donor. Imagine a senior surgeon reprimanding a young medical resident that she just lost both her own patient and three more patients who could have been saved with that patient's organs. The next time around that young resident may not go those extra five minutes.

It is not easy to prevent undertreatment of ER/OR patients. First, a hospital may want to specify as many as possible objective criteria to determine whether to (dis)continue resuscitation. Such objective criteria can help the unexperienced physician in deciding whether or not to go the extra five minutes and, if necessary, to defend his or her decision to peers and seniors in the medical hierarchy. The availability of such objective criteria will also instill trust in the hospital's "clientele" -- that they will always be treated as patients rather than as mere organ donors.

The second approach would be to separate as much as possible the team involved in resuscitation from the team involved in organ procurement. As mentioned, it is beyond reality to assume that those involved in resuscitation can simply 'qalock out" the thought of organ donation. Every properly trained physician knows -- or should know -- about that possibility if we are going to reduce the shortage of donor organs. Rather, the separation of teams enables a separation of responsibilities. It is the duty and responsibility of the organ procurement team to decide whether or not to proceed with organ procurement and to justify such decisions. It is the duty and responsibility of the resuscitation

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team to decide about (dis)continuing resuscitation and to justify such decisions in light of the patients's own interests. At least formally, no individual care provider should ever be caught in the double bind of having to save one patient's life while securing organs and potentially saving various lives. 2

Dead or alive?

The issue that is probably least considered among practitioners but philosophically most troublesome is the criterion for diagnosing death. After many years of fierce debates that were originally initiated by the possibility of organ transplantation and the demand for more organs, a consensus has emerged that (at least for transplantation purposes) whole- brain death not only is a necessary but also a sufficient criterion of death. This new criterion replaced the traditional criterion of cardiac death that had been current for hundreds, if not thousands of years. Although death is never easy to accept and ever more difficult if one's beloved is still 'q~reathing," we have learned to accept that the brain, rather than the heart, is the physiological unifying center of the body. With the brain having died, the body is but a collection of dying organs that can be temporarily sustained by man-made machinery.

While brain death implies (impending) cardiac death, the reverse obviously is not true. Although it is still a topic of medical scientific debate as to how many minutes of ischemia it takes for the whole brain to have died, it is generally assumed that a period of some 10 minutes of complete cardiopulmonary arrest (that is, after all resuscitation attempts have ended) is required to diagnose a patient as dead.

Again, time is precious in NHBOD. Every minute counts. Some advocates of NHBOD have even tried to save time by reverting back to the old criterion of cardiac death. A notable example is the University of Pittsburgh Medical Center's NHBOD-protocol. It suggests that if a patient has become totally unconscious and unresponsive to noxious or painful stimuli, and if there is no spontaneous breathing and no palpable pulse in a large artery, the patient may be declared dead if one of the following three cardiographic conditions has been met as well: Two minutes of ventricular fibrillation, or two minutes of electrical asystole, or two minutes of electrical dissociation. Either of these three two-minute periods should rule out the possibility of spontaneous autoresuscitation and, in that sense, guarantee that the cardiac arrest is irreversible. But it


is not at all clear that these two minutes also guarantee the occurrence of the death of the entire brain, including the brain stem.

While the debate about cardiac death is by no means settled, one should not dismiss the recent convention lightly. Switching between criteria (using whole-brain death to extirpation of brain dead patients, and cardiac death to justify NHBOD) is likely to diminish the public's precarious willingness to donate organs. One does not want to impart the impression that death is defined by the patient's suitability as an organ donor. Yet some authors have come very close to such a position: "From January 1993 through May 1994, 130 organ donors were referred to our procurement organization (OPO). Of these, 114 donors met standard criteria for brain death and were treated as heart-beating donors (HBDs). 3 However, 16 patients with severe neurologic injury did not meet these criteria, due to preservation of brain stem reflexes, and were considered for NHB donation." In fact, one of these 16 patients "continued to have spontaneous respirations" (resulting in extensive warm ischemia and precluding organ recovery) (6, p. 707).

Moreover, switching between criteria is ethically unwarranted. Under the new convention, not only is brain death a sufficient criterion of death (allowing organ extirpation from "breathing" patients), it is a necessary criterion as well. It is only when the entire brain has died that the patient's body has become a mere collection of dying organs, signifying the patient's personal death. Advocates of two sufficient criteria of death (neither of which can be a necessary criterion) have to explain how irreversible cardiac death not only implies impending personal death, but ontologically constitutes personal death at present. This may be rather difficult given the successful practice of replacing irreversibly arrested hearts by new donor hearts without the recipient-persons dying in- between.

If the criterion of brain death (as both sufficient and necessary) prevails, it is advised explicitly to make mention of this 10-minute period as well. As Lynn has pointed out, "the proposed Pittsburgh protocol might allow taking organs from persons not yet known to be dead. In fact, it might allow taking organs from persons who are not dead, depending upon some specifications of that definition. This is imprudent, to say the least" (7, p. 177). To the least, indeed: if the surgeon inserts preservation fluids prior to the patient's death, these fluids will kill the patient and the surgeon will be liable to allegations of murder.

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Family member5

Although the interests of the potential donor are most important, one should not underestimate the possible harm of NHBOD to surviving family members. Such harm may occur if too much pressure is placed on the family to agree to organ donation. For example, if the patient is in the ICU and continued life support is deemed ineffective (i.e., futile), it should be discontinued irrespective of the family's wishes (which is not to say that family members should be barred from being present at the time of withdrawal). Even if the family is not told that the team is considering organ extirpation, imagine how the family will feel if they afterwards find out that the physicians, at the time of the DNR debate, already knew about the planned organ donation, but did not tell them! They will feel betrayed, as well as feel guilty for making a decision (i.e., that medical treatment had become futile) in matters in which they are (largely) incompetent, but resulting in their family member's (premature) death.

Of course, in certain cases a futility judgment requires the input of family members in order to establish the patient's personal interests. 4 To prevent family guilt and anxiety, one may decide simply to leave all ICU patients out of the NHBOD protocol, or at any rate those patients whose treatment is not deemed ineffective and, hence, futile on purely medical grounds.

When family members are confronted in the ER or OR with the death of their beloved, there is the risk of emotional harm if they are pressured into agreeing to organ extirpation. And pressure there will be, because the clock is ticking. If the family wants to say a final goodbye prior to the femoral cannulation, there will be even less time. Yet the family members' right to mourn should take precedence over the healthcare providers' duty to save life through rapid organ extirpation and transplantation.

While the goal of an increased number of transplantable organs is laudable, the prevention of death does not justify the dehumanization of the dying process. In the case of NHBOD, "the dying of a patient is so closely connected with the procedure to remove organs that focus on the patient's dying can easily be subordinated to the transplant procedure" (8, p. 39). Many family members may find relief in the prospect of human life going on through the organs of their beloved parent, spouse, or child. They will agree to organ donation even under the pressure of time. Life goes on; but a life also ended, and the value of mourning should not be


forgotten in the rush to save life. It is not possible to safeguard and foster such awareness by means of

a protocol. In fact, it is because death has been protocolized in every detail and to the minute, that Fox has characterized NHBOD (as practiced in Pittsburgh) as "an ignoble form of cannibalism" (9, p. 238). It is, however, possible to prevent NHBOD protocols from turning dying patients into spare parts and degrading their family members into mere signatories of legal consent.

NOTES

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The arguments presented here reflect in part the deliberations of the HEC at Catholic University of Nijmegen, St. Radboud Hospital (the Netherlands),. on which I served as scientific secretary at the time NHBOD was being discussed. However, the Hospital's nephrologists and surgeons had opted for a rather limited NHBOD practice, excluding intensive care and OR patients. The Committee, however, never addressed the ethical issues involved in the more inclusive NHBOD practice.

I should also emphasize t h e fact that many of the arguments presented here were developed by the Nijmegen HEC. However, my reflections should not be considered to reflect the position of either the Nijmegen St. Radboud Hospital nor its HEC. It is therefore rather unfortunate that the changes in the Florida Statutes concerning organ donation and transplantation include a paragraph allowing the physician who attends the donor at his or her death to participate in interventions aimed at preserving the organs, without there being any clause relieving this physician of the responsibility for the decision to initiate such interventions by explicitly transferring that responsibility to another physician. The authors are confusing the criterion for determining a patient's death with the empirical tests for determining whether this criterion has been met. Apparently, 114 donors, when tested for brain activity (e.g., by means of an EEG) were found to have no detectable activity and, hence, met the criterion for whole-brain death. Medical treatment is futile if'such treatment is unable effectively to foster the patient's interests. Hence, there could be two reasons

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J.V.M. Welie

underlying a particular futility judgment: [1] medical treatment can still effectuate many interests commonly valued by patients (such as extending life or improving function), but a particular patient is not interested in these treatment objectives (e.g., because she fears the severe suffering that the treatment will cause, or the blood transfusion that is a necessary part of treatment); [2] none of the patient's (particular) interests can be effectuated via the treatment available (e.g., the chemotherapy has been found not to have any effect whatsoever on the patient's cancer, precluding either an extension of life or palliation).

REFERENCF_S

Act relating to organ and tissue donation (Enacted by the Legislature of the State of Florida, to take effect on July 1, 1995), HB 2445, 1995 Legislature. State of Florida. DeVita MA, Vukmir R, Snyder JV, Graziano C. Non-heart- beating organ donation: A reply to Campbell and Weber. Kennedy Institute of Ethics Journal. 1995; 5(1):43-49. Hoshinaga K, et al. Early prognosis of 263 renal allografts from non-heart-beating cadavers using an in situ cooling technique. Transplantation Proceedings. 1995; 27(1):703-706. University of Pittsburgh Medical Center Policy and Procedure Manual: Management of Terminally Ill Patients Who May Become Organ Donors After Death (May 1992). Reprinted in Kennedy Institute of Ethics Journal. 1993; 3(4):A1-A15. Academisch Ziekenhuis Nijmegen St Radboud: Non-Heart-Beating Donatieprocedure (revised version). Nijmegen, The Netherlands; October, 1994. Available (in Dutch) from the University Hospital Nijmegen, Hospital Ethics Committee, Department of Ethics, Philosophy and History of Medicine, PO Box 9101, 6500 HB Nijmegen, The Netherlands. D'AUessandro AM, et al. Controlled non-heart-beating donors: A potential source of extrarenal organs. Transplantation Proceedings. 1995; 27(1):707-709. Lynn J. Are patients who become organ donors under the Pittsburgh protocol for "non-heart-beating donors" really dead? Kennedy Institute of Ethics Journal. 1993; 3(2):167-78. Campbell ML, Weber LJ. Procuring organs from a non-heart-


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beating cadaver: Commentary on a case report. Kennedy Institute of Ethics Journal. 1995; 5(1):35-42. Fox RC. An ignoble form of cannibalism: Reflections on the Pittsburgh protocol for procuring organs from non-heart-beating cadavers. Kennedy Institute of Ethics Journal. 1993; 3(2):231-39.

non-heart-beating organ donation: a two-edged sword

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