Ethics Perspective on a Controversial Innovation to Recover Donor Hearts for Transplantation

Normothermic Regional Perfusion for controlled Donation after Circulatory Death (NRPcDCD) references various protocols aiming at optimal recovery of organs donated for transplantation following pronouncement of death on circulatory and respiratory criteria. While there are protocols for abdominal (A-NRP) reperfusion only and ex situ reanimation of the heart, I am concerned here with in situ thoracoabdominal NRP (TA-NRP). This is what is most discussed and debated in regard to ethical and legal permissibility of NRP-cDCD.

What Is TA-NRP?

TA-NRP does not commence until pronouncement of death occurring after a typically five-minute stand-off period to preclude spontaneous resumption of circulatory or respiratory functions. Subsequently, the heart is restarted by artificial mechanical means while still in the thoracic cavity (in situ), often with extracorporeal membrane oxygenation (ECMO). Reperfusion enables observation and evaluation of vital organs prior to surgical excision. Organs deemed unsuitable for transplantation need not be removed. Ischemic injury is minimized by reperfusion in those organs that appear sufficiently healthy for use in a recipient, enhancing quality and long-term outcomes.

Reported outcomes of TA-NRP-cDCD thus far indicate potential for significant increases in quality and quantity of transplantable organs, especially hearts. I have been told that approximately 20 transplant programs in the U.S. and several internationally have implemented protocols using TA-NRP. Other programs and jurisdictions either have not done so yet, reportedly have done so but then paused, or have decided for now—presumably on ethical-legal grounds—not to use TA-NRP for organ recovery.

Objections to TA-NRP-cDCD

The primary ethics issue debated by bioethicists is that TA-NRP is perceived by some to violate the meaning of “irreversible” or “permanent” in statutory versions of the Uniform Determination of Death Act (UDDA). If so, this could be perceived also as a violation of the Dead Donor Rule (DDR) requiring that vital organs are recovered only from dead donors and that the recovery process must not be the proximal cause of death. For example, the Kansas “Determination of Death” statute 77-205 states: “An individual who has sustained either (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead. A determination of death must be made in accordance with accepted medical standards.” Missouri’s legal definition of circulatory death, 194.005, is similar: “When respiration and circulation are not artificially maintained, there is an irreversible cessation of spontaneous respiration and circulation.”

Bioethicists objecting to the use of TA-NRP-cDCD believe that reperfusion of the heart in situ constitutes resuscitation of the patient. They claim the prior death pronouncement on criteria of “irreversible cessation of circulatory and respiratory functions” is consequently annulled. If the patient is now alive, they are ineligible for organ recovery on grounds of the DDR. Occlusion of vessels to the brain in the TA-NRP protocol would lead to brain death, but as a causative factor, which would be impermissible also. There is also worry that TA-NRP would violate the public trust. A 2021 statement of the American College of Physicians (citation below) makes these arguments against TA-NRP-cDCD.

Good Outcomes

Other ethicists argue convincingly, I think, in favor of proceeding with this protocol. They interpret determination of death laws as technically compatible with TA-NRP. It is argued that mechanically perfusing an organ or organs while still in the thoracoabdominal region does not constitute resuscitation of a patient, hence there is no violation of either the UDDA or DDR. TA-NRP proponents argue that clamping vessels to the brain is permissible or even obligatory so as to ensure permanent absence of brain function while reperfusing the thoracic-abdominal regions and recovering organs. Ensuring brain death in this manner is not problematic for the DDR because the patient was already legally dead, and that pronouncement is not, or should not be, considered reversible/annullable by means of regional reperfusion.

Proponents point to the good outcomes experienced from TA-NRP protocols, while avoiding the fallacy of an “ends justifies means” argument or even reliance on the ethics principle of “double effect.” They ask, “Who is harmed?” by TA-NRP—given that there was no intent by any stakeholder to continue life supports in violation of an agreed upon DNAR order and no prognosis for meaningful recovery due to a terminal condition. In addition, the decedent and/or their loved ones valued organ donation as something good that could happen in the midst of their tragedy. Instead of harms, it appears that only good can come from innovative and improved protocols optimizing both quality and quantity of organs for transplant. Harms might result instead by failing to utilize an available protocol with real potential for saving the lives of those awaiting transplant.

A 2022 article by Wall et al. in the American Journal of Transplantation (citation below) makes a strong case in favor of TA-NRP-cDCD. I find their ethics arguments to be valid and ultimately more persuasive than those in opposition to this protocol.

Ethics Recommendations

Avoiding real or potential violation of the public trust is a fundamental norm for organ recovery and transplantation. Even ethically worthy innovations, if unable to be communicated adequately to the donor base, might be perceived negatively and result in a net loss of organ donors. Lack of transparency about a new and controversial organ recovery protocol would be ethically problematic, especially for donor authorization or family consent. While it may be challenging to convey to prospective donors the complexities of TA-NRP without confusion and diminished comprehension, I think it is possible. Empirical evidence from peer institutions utilizing TA-NRP validates an optimistic perspective and provides guidance to organ procurement organizations and transplant programs for how to do it well.

Until persuaded otherwise, I conclude that TA-NRP-cDCD seems ethically permissible although not obligatory; and if utilized by OPOs and transplant programs, the following recommendations apply:

1. Deliberate TA-NRP-cDCD with awareness of ethical-legal controversy amongst bioethicists, nationally and internationally.
2. Provide accommodations for individual conscientious objection throughout the process.
3. Perfuse only the thoracoabdominal region, mitigating possibility of any continuation or restoration of brain activity during recovery of organs.
4. Exercise transparency and mitigate potential for violation of public trust.
5. Conduct careful and ongoing risk-benefit analysis.

REFERENCES:

*Ethics, Determination of Death, and Organ Transplantation in Normothermic Regional Perfusion (NRP) with Controlled Donation after Circulatory Determination of Death (cDCD): American College of Physicians Statement of Concern. (2021). American College of Physicians, 1–6.

*Wall, A. & Amy Fiedler, et al. (2022). Applying the ethical framework for donation after circulatory death to thoracic normothermic regional perfusion procedures. Am J Transplant, 22:1311-1315. https://doi.org/10.1111/ajt.16959.

Tarris Rosell, PhD, DMin
Rosemary Flanigan Chair at the Center for Practical Bioethics