Note: The following editorial can be found in the June 2024 issue of the American Journal of Bioethics.
This issue covers a topic widely being discussed at Ethics Committee meetings around the country, namely the line between life and death in organ procurement. While the debate over whether and when patients are “really” dead via neurological criteria has garnered most of the attention of the bioethics community over the past few decades, new developments in procurement of organs from patients declared dead by cardio-respiratory criteria has ignited a controversy within the field (though not in the public sphere).
In cases of organ procurement after death declarations by virtue of permanent cessation of circulation and respiration (cDCD), the typical procedure has involved waiting a short period of time (typically 5 minutes) after arrest and then declaring the patient dead. The organs are removed and cooled and transported in a cooled state to slow anoxic damage. While this procedure has grown in recent years, the number and quality of organs is generally significantly poorer than organs that are procured from patients declared dead by neurological standards.
Two important developments have increased the quality and number of organs available including the ability to procure hearts from cDCD, which the methods described above normally do not make possible. First, Normothermic Machine Profusion (NMP) involves taking some blood from the donor’s body and setting up a circulation system for the organ outside the body. The blood is oxygenated and recirculates, dramatic improvements in organ recovery rates. New developments and improvements in NMP technology and techniques are continuing to show that NMP can produce impressive results, comparable to the gold standard of organ procurement from patients declared dead by neurological criteria. NMP is promising and ethically uncontroversial.
A second method of procurement is gaining even more traction, but it is the source of ethical controversy. In Normothermic Regional Profusion (NRP), 5 minutes after the cessation of circulation, the patient is declared dead. Then efforts are made to occlude or prevent blood flow the brain by clamping the arch vessels, including cerebral arteries, to the brain. At that point, extracorporeal membrane oxygenation (ECMO) is initiated. There are two forms of NRP. Depending on where circulation is cut off, ECMO can be used to restore oxygenated blood flow to the abdominal organs (a-NRP) or the both the thoracic and abdominal organs (TA-NRP). In TA-NRP, one of its chief advantages is the restoration of spontaneous circulation of the heart so that its function can be assessed.
There are at least three controversies about the ethics of TA-NRP. First, there is the question of whether TA-NRP violates the Dead Donor Rule that prohibits procurement of organs necessary for life from patients until after they are dead. The Uniform Determination of Death Act (UDDA) requires that patients who are declared dead have irreversible cessation of cardio-pulmonary function or the loss of the function of the brain. TA-NRP seems to violate the first criteria (which is the criteria used to declare death), since circulation is restored, and the heart typically functions again. Defenders of TA-NRP respond by denying that circulation has been restored. They claim that as long as circulation has been cut off from reaching the brain, any apparent circulation is merely organ perfusion, not resuscitation. There has been some question of whether or not circulation has really been completely cutoff from the brain (leading to a pause in TA-NRP in the UK), but once that question has been adequately addressed positively, TA-NRP would be seen as acceptable to its defenders. This ongoing debate hinges on whether resuscitation with ECMO that is cut off from the brain constitutes a restoration of cardio-pulmonary function or whether somehow circulation doesn’t “count” unless it includes the brain. At times defenders have appealed to the intention behind the act as key (organ procurement vs saving the patient), but as Glazier and Capron have pointed out, there is nothing in UDDA that references intentions. Death is permanent cessation of cardio-pulmonary function. Regardless of why heart function and circulation are restored, their restoration seems to undermine the claim of death.
Even if one were to grant that cutting off circulation to the brain somehow makes the restoration of circulation no longer “count” as restoration of function, a second controversy arises over the proximate cause of that cessation of circulation to the brain. The American College of Physicians, in their critique of NRP state that a better description of the procurement process is that in NRP, they cut off circulation to the brain knowing you they are going to attempt to restore circulation . If it is the act of cutting off circulation to the brain that is the key to making the patient count as dead, then the proximate cause of death is the act of cutting off circulation to the brain. If, as James Bernat suggests in this issue, the cessation of the functioning of the brain is the true standard of death, then it is the cutting of circulation that does all the work in NRP. One wonders why there is the pretense of waiting for cessation of circulation at all. For any patient where there is a plan to withdraw life support and donate organs, why not just cut off circulation to the brain? Ethically, it is difficult to avoid the conclusion that the teams (and not the underlying disease) are the cause of death of the patient.
Finally, even if one accepts that NRP patients are dead and that the occlusion to the brain is not the cause of death, there are real questions about the language used to describe the process and the very complicated issues involved in communicating about NRP with the donor’s family members. One approach is simply not to inform families about the process. For example, in one defense of NRP, the authors claimed “Regarding what authorizing families should be told about NRP—Informed consent is not just dumping all details on grieving traumatized families. It requires giving morally relevant information in a sensitive and respectful manner. The technique details of standard deceased organ recovery are not shared with families. Whether families want to know, or need to know, specific NRP techniques, is not known”. This seems to be a plea not to bother grieving families with information that they may find uncomfortable. Others have argued that the language used to describe NRP should be “circumspect.” They recommend not referring to “ECMO” or “recirculation” (and of course no mention of “resuscitation”. Instead, they insist on calling NRP “organ reperfusion.” The idea seems to be to emphasize the organs without any recognition or reference to the fact that the organs are part of the patient’s body at the time that ECMO is initiated.
It is not hard to see why proponents are NRP are anxious to avoid the risk of clarity. A family has been told that their loved one has a poor prognosis and very little likelihood of surviving. What about options that might rescue them (like ECMO)? They are told their family member is not an ECMO candidate since there is very little chance of the patient recovering while on ECMO. The family is told that the patient is a registered organ donor. Under the terms of First-Person Authorization, organ procurement will move forward. And while they are not an ECMO candidate, they will, in fact, be put on ECMO for organ procurement.
Other families are told that resuscitating a patient will cause harm and recommend making the patient DNR. But the same resuscitation efforts that the family has been persuaded to abandon are then implemented.
Families who are struggling with end-of-life decisions often struggle with the idea that the organs that the teams say don’t work well enough for the patient to recover will actually work for someone else. This is a familiar experience for clinical ethicists and critical care physicians. It is not easy to navigate. NRP is likely to be much more complicated in many cases. What about the patient already on ECMO who is a donor and the decision is made to discontinue ECMO? How will that communication be handled?
A quick rule of thumb in bioethics should be that relying on not telling people what you are doing or attempting to obfuscate with misleading language is a pretty good indication that you are on the wrong track. While some NRP advocates want transparency and complete disclosure, too many leaders and professional organizations have pushed for obfuscation. This is at a minimum a red flag for NRP.
David Magnus, PhD is the Editor in Chief of The American Journal of Bioethics.