Ethical Debate Over Normothermic Regional Perfusion

By Stacey Kusterbeck

Medical Ethics Advisor (MEA) interviewed Adam Omelianchuk, PhD, an assistant professor at Baylor College of Medicine’s Center for Medical Ethics and Health Policy and lead author of a paper on ethical concerns involving normothermic regional perfusion (NRP).¹

MEA: What are the central ethical concerns that you see with NRP?

Omelianchuk: There are three: Legal compliance, which involves liability risks for surgeons, transplant programs, and hospitals; adherence to the dead donor rule, which involves the non-maleficent and trustworthy character of transplant medicine; and adequate disclosure about the protocol to decision-makers and the broader public, which involves respect for persons and their autonomous choices.

MEA: What about concerns involving NRP violating the dead donor rule, an important ethical principle in organ transplantation?

Omelianchuk: There is currently a big debate over this. The Organ Procurement & Transplantation Network’s paper about NRP found that there are “serious ethical concerns that NRP is not consistent with the Dead Donor Rule.”² Usually, the rule is defined in terms of prohibiting causing death via transplant surgery, and requiring procurement to happen only after the patient has been declared dead. That’s mostly right, but I think of it as being a bit broader. Transplant teams ought to avoid involvement with the donor’s death. And waiting for an independent determination of death from the treating team is the best way to avoid this involvement.

The rule is meant to uphold the respect for human life, in the sense that no one’s life is worth less than the organs inside their body, no matter how diminished the quality of life may be, and [to] help maintain the “firewall” between the transplant team and the treating team so as to avoid conflicts of interest. Both respect for life and avoidance of conflict of interest are foundational to public trust.

In donations after circulatory determination of death, the death declaration is valid only if the cessation of circulation is permanent. NRP transplanters may interpret this to mean that only the cessation of circulation to the brain needs to remain permanent, and they take action to make it so. If they don’t cut off flow to the brain, they risk restarting brain functions like breathing reflexes and possibly some level of awareness. They also have to study the efficacy of their occlusion methods to ensure this doesn’t happen. They would be liable for harming the donor if their efforts failed or they made an error.

What this tells us is that determining whether the cessation of circulation to the brain is permanent is a shared activity between the treating and transplant teams — something that clearly breaches the firewall and raises a conflict of interest.

Second, they can believe the donor is dead (or “beyond harm”) only if they have faith in what they have done to the donor, which raises the “respect for life” problem. The truth is that they don’t really know if the donor is dead when they restart ECMO (extracorporeal membrane oxygenation) blood flow in the body, but they operate anyway.

MEA: Since NRP can increase the number of available high-quality organs, is there an argument to be made that it is ethically justified?

Omelianchuk: There is. In my view, the soundness of such an argument depends on the permissibility of mixing transplant surgery with euthanasia, meaning it is OK to take organs from those who fall below a certain “quality of life” threshold and who have consented to donate regardless of whether or not the surgery would cause death.

Some bioethicists think this is what we essentially do now, but we just haven’t been honest about it. I am not one of them. Basically, these bioethicists don’t think death is morally important, and that we should abandon the dead donor rule.

Transplant programs, however, have been very hesitant to affirm this reasoning, even in places where euthanasia is legal. The issue of public trust is important for donation rates, and broad swaths of the population already have trouble trusting that healthcare professionals will adequately care for them if they identify as donors.

So, it isn’t clear that allowing organ donation euthanasia would lead to an overall net increase of organs — which is the whole point of doing NRP.

MEA: What about the alternative approach of normothermic machine perfusion — is that a more ethically acceptable option in your view?

Omelianchuk: In my opinion, yes, it is. It is clearly consistent with all of our accepted ethical frameworks, it takes no special justification, and researchers love it. It is sometimes framed as a competitor to NRP, and objected to as being cost-prohibitive. But it is actually complementary, and, in the future, every organ will probably be “pumped” before being transplanted. The chief disadvantage of it right now is that it produces fewer organs per donor than NRP, and there is little to no technology available for pediatric organs. Give it time and perhaps some congressional funding, though, and I think things could really improve.

MEA: How can ethicists help with these cases at hospitals/health systems?

Omelianchuk: Ethicists are very divided about this practice, and I suspect many more are uncertain about it. Those who are opposed to it need to make sure that they are careful not to unnecessarily impugn the motives of the transplant teams who want to do it. This is part of safeguarding the goods of collegiality and keeping lines of communication open. Those in favor of it need to be actively involved with shaping and influencing the consent process, calling for organizational buy-in, and creating a hospital policy that everyone — including outsiders who come in to do NRP or insiders who conscientiously object to NRP — can abide by and accept.

Regardless of the debate over the dead donor rule, I think everyone agrees that more adequate disclosure to decision-makers is needed if NRP is to be recommended, and more of the government’s healthcare spending should be allocated to transplant programs to fund machine perfusion techniques.

Ethicists who are consulted at their local hospitals should take an advisory role and present the debate over it as neutrally as possible. Then, ethicists should give their informed opinion on it — and, I think, they should disclose their attitude toward the dead donor rule.

REFERENCES

1. Omelianchuk A, Capron AM, Ross LF, et al. Neither ethical nor prudent: Why not to choose normothermic regional perfusion. Hastings Cent Rep 2024;54:14-23.
2. Organ Procurement and Transplantation Network. Ethical analysis of normothermic regional perfusion. https://optn.transplant.hrsa.gov/media/mq2m43uf/20240123-ethics_nrp_wp_final.pdf