On the ethics of NRP and the American College of Physicians NRP statement

Abstract

To the Editor: We commend Parent et al.1Parent B Caplan A Moazami N Montgomery RA. Response to American College of Physician’s statement on the ethics of transplant after normothermic regional perfusion.Am J Transplant. 2022; (10.1111/ajt.16947): 1-4Google Scholar for engaging ethical issues regarding “normothermic regional perfusion” (NRP) heart procurement. They critique a 2021 statement by ACP,2American College of Physicians. 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. https://www.acponline.org/acp_policy/policie/ethics_determination_of_death_and_organ_transplantation_in_nrp_2021.pdf. Published 2021. Accessed February 7, 2022.Google Scholar whose ethics committee we lead and staff. ACP calls for a pause of NRP because the manner and declaration of death involved raise ethical and legal concerns. Parent’s article does not lessen those concerns. NRP restarts donor circulation using the donor’s own blood following declaration of irreversible circulatory death. But this restart invalidates the declaration, reversing what was declared irreversible. And because brain death has not occurred, NRP includes active steps (ligation or balloon occlusion) to prevent circulation to the brain. Asserting repeatedly that the donor is dead by circulatory criteria1Parent B Caplan A Moazami N Montgomery RA. Response to American College of Physician’s statement on the ethics of transplant after normothermic regional perfusion.Am J Transplant. 2022; (10.1111/ajt.16947): 1-4Google Scholar,3Wall AE, Fiedler A, Karp S, Shah A, Testa G. Applying the ethical framework for donation after circulatory death to thoracic normothermic regional perfusion procedures. Am J Transplant. 2022. 10.1111/ajt.16959Google Scholar does not refute this. Rather than follow the legal definition of death, the authors redefine it. They claim circulatory death has occurred because “circulation has stopped on its own and there will be no attempt to restart it.” Yet donor circulation is restarted in NRP. This is resuscitation of the donor, not reperfusion of an organ; if not resuscitation, ligating blood vessels would not be part of the protocol. Notably, the NYU NRP protocol details what occurs, calling the procedure heart DCD to which the standard DCD approach applies; explaining the addition of NRP; noting all blood vessels to the donor’s brain will be ligated “to ensure that blood flow to the brain is not reestablished once circulation… to all organs of the body” is reestablished; and stating “standard DBD procurement will commence.”4US National Library of Medicine. https://clinicaltrials.gov/ct2/show/NCT04284319. Accessed February 7, 2022.Google Scholar That switch from DCD to DBD acknowledges (induced) brain death. Yet the donor was declared dead by circulatory criteria. ACP supports DCD. But NRP is different. “Organ retrieval after cardiopulmonary arrest and the induction of brain death”2American College of Physicians. 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. https://www.acponline.org/acp_policy/policie/ethics_determination_of_death_and_organ_transplantation_in_nrp_2021.pdf. Published 2021. Accessed February 7, 2022.Google Scholar is a more transparent description. Moreover, Parent’s assertions the protocol need not be explained because donors/families have a “right not to know the specific information that would be too clinical or burdensome” and that information need only be given in response to questions,1Parent B Caplan A Moazami N Montgomery RA. Response to American College of Physician’s statement on the ethics of transplant after normothermic regional perfusion.Am J Transplant. 2022; (10.1111/ajt.16947): 1-4Google Scholar undermines informed consent. Arguments that cost-savings justify NRP1Parent B Caplan A Moazami N Montgomery RA. Response to American College of Physician’s statement on the ethics of transplant after normothermic regional perfusion.Am J Transplant. 2022; (10.1111/ajt.16947): 1-4Google Scholar are also ethically problematic. Regarding procedural issues, Parent notes that ACP’s brief statement, published on our website (not in a journal), did not include authorship or COI disclosures. While that is the practice of ACP, AMA, and others, a good point is made; we will review our procedures. ACP disclosure of interests and conflicts policy was followed throughout our process with no relevant disclosures made including about NRP or organ transplantation. Having raised this topic—we note the Parent article says, “BP received a gift from United Therapeutics to provide salary support.” However, NYU’s website more broadly says the “Transplant Ethics and Policy research program is funded by a gift from United Therapeutics” and claims independence,5NYU Transplant Ethics & Policy. https://med.nyu.edu/departments-institutes/population-health/divisions-sections-centers/medical-ethics/research/transplant-ethics-policy. Accessed February 7, 2022.Google Scholar yet transplant physicians are advisory board members and/or ethics statement co-authors. Questions about the ethics program’s objectivity seem to be raised. Together, we must support organ transplantation, expanding access—but without violating ethics, physician responsibilities to patients and society, and US law, and while increasing public understanding of donation and maintaining trust in the health care system. The authors of this manuscript have conflicts of interest to disclose as described by the American Journal of Transplantation. The authors are chair (IOO), co-chair (NND) and staff (LSS) to the Ethics, Professionalism and Human Rights Committee of the American College of Physicians.