Ethical Controversies in Normothermic Regional Perfusion: Issues for Intensive Care Unit Nurses

Trinh, a nurse, was caring for Devon, a 20-year-old college student who experienced cardiac arrest in the hot tub while home visiting his family for the holidays. His mother, Catalina, found him partially submerged and not breathing. She pulled him out, called emergency services, and started cardiopulmonary resuscitation. When the paramedics arrived, Devon was in cardiac arrest with ventricular fibrillation. Spontaneous circulation returned after 4 cycles of cardiopulmonary resuscitation, 4 defibrillations, and 2 doses of epinephrine. He did not regain consciousness after the resuscitation. He was transported to the local community hospital for continued care. He was intubated and received targeted temperature management and vasopressor support. He responded to noxious stimuli with decerebrate posturing but had no cough, gag, or corneal reflexes. His toxicology screen result was negative for drugs. Imaging studies on admission and 7 days later confirmed he had experienced severe anoxic brain injury. His neurologic assessment remained unchanged during his hospitalization.Per institution policy and regulatory requirement, the local organ procurement organization (OPO) was notified. Given Devon’s poor prognosis, Catalina decided to withdraw life-sustaining treatments. Once that decision was documented, the OPO representative approached Catalina to discuss options for organ donation after cardiac death (DCD). Thoracoabdominal normothermic regional perfusion (TA-NRP) was proposed as the technique that could yield the most lifesaving organs, including Devon’s heart. During TA-NRP, after death according to cardiopulmonary criteria has been declared and a mandatory waiting period has elapsed, an incision is made into the sternum, the right atrium is cannulated and connected to the venous limb of an extracorporeal membrane oxygenation (ECMO) circuit, cerebral vessels are occluded with cross-clamps to prevent reperfusion of the brain, and the aorta is cannulated and attached to the arterial limb of the ECMO circuit.1 The TA-NRP procedure reduces warm ischemia time, which can damage organs, and allows transplant surgeons to assess organ quality in situ before accepting them for transplant.Devon was not a registered organ donor, so the decision to proceed with donation was contingent on consent from his surrogate decision-maker, Catalina (he was an only child and his father had died 2 years earlier). Although Catalina was devastated by her son’s condition, she was willing to consider donation. Catalina told the OPO representative she had to pray about the decision and asked to speak with the hospital chaplain.Trinh was the night nurse caring for Devon after the OPO representative made the request. That night, sitting by her son’s bedside, Catalina confided to Trinh her distress about the donation process. She told Trinh the OPO representative said they would take her son into the operating room before the ventilator was removed so they could “get to his organs quickly” after he died. Catalina could accompany her son to the operating room but would need to leave immediately after death was pronounced. Catalina told Trinh they were going to check Devon’s heart function with a machine before taking it out. Catalina asked Trinh what that meant since his heart would stop beating when he died. Trinh did not know how to answer, which caused her moral distress because she knew Catalina had confided in her and expected a knowledgeable response that did not add to her suffering. Although she had been a nurse for 2 years, Trinh had never cared for a DCD donor. Trinh had cared for a patient who had been declared dead by neurologic criteria. That patient had undergone antemortem heart catheterization as part of organ suitability testing. Trinh had never heard of TA-NRP and wondered how transplant surgeons could assess heart function after death.Because the OPO representative, Aaron, was on the unit to monitor Devon’s condition, Trinh asked him what Catalina meant by “check the heart function with a machine.” Aaron told Trinh the transplant team had asked to use TA-NRP for organ recovery because they were optimistic that Devon’s heart would be suitable for transplant. He explained that TA-NRP was an exciting advancement in transplant surgery that involves reperfusing the heart and lungs using ECMO after a declaration of death by cardiopulmonary criteria. Since TA-NRP restores cardiac contractile function, surgeons can assess native organ function in situ.2 Aaron assured Trinh that Devon would not regain consciousness or experience pain because surgeons would ligate perfusion to the brain before commencement of ECMO circulation.1 Trinh asked how long TA-NRP had been in practice and wondered why she had never heard about it. Aaron reassured her it had been practiced for more than a decade in parts of Europe and was being used more and more in the United States.Still uncomfortable, Trinh asked her charge nurse and the intensivist if they were familiar with TA-NRP. Neither had heard of the practice, and both shared her concerns. It was confusing that Devon would be declared dead but have circulation restored a few minutes later using ECMO. It was even more confusing that before reperfusion, Devon’s cerebral vessels would be clamped to prevent circulation to his brain. They wondered what would happen if the cerebral vessels were not clamped; might he experience pain or consciousness during the organ recovery process? If that was possible, how could he be dead? Wouldn’t that violate the dead donor rule, which is the foundation for ethical organ recovery in the United States? Trinh and her colleagues wondered if the nurse manager, intensive care unit (ICU) medical director, or ethics committee members knew about TA-NRP or had approved its use in their hospital. Since Catalina had not yet given consent for donation, they requested an urgent meeting with ICU leaders and the ethics committee the following morning.After the first heart transplant in 1967, a question arose as to whether the donor was dead at the time of organ recovery.3 This concern led to the adoption of new definitions of death in the United States. In 1981 the National Conference of Commissioners on Uniform State Laws approved the Uniform Determination of Death Act.3 The Uniform Determination of Death Act defines death as irreversible cessation of either circulatory and respiratory functions or of all functions of the entire brain, including the brainstem. The act also states that death must be determined in accordance with accepted medical standards.3 The Uniform Determination of Death Act does not specify the accepted medical standards. The American Academy of Neurology published initial standards for determining brain death in 1995; the most recent guidelines were published in 2023.4 All 50 states and the District of Columbia have adopted the Uniform Determination of Death Act either by case law or by legislation.3 At the time of this writing, only New Jersey allows a religious exemption for accepting a determination of death by neurologic criteria and allows health insurance coverage to continue if such an exemption is invoked.5The dead donor rule, although not enshrined in law, is the foundational ethical principle guiding the transplant enterprise in the United States and around the world.5 According to the dead donor rule, individuals must be declared dead before the removal of any vital organs for transplant.6 Determination of death by neurologic criteria protected transplant surgeons from claims of criminal or civil malpractice because their removal of vital organs was not the cause of death.7 It also created an ethical framework that prioritized a prohibition on actively ending life, establishment of a process to minimize harms, and respect for human dignity. For decades, organs for donation were recovered according to determination of death by neurologic criteria. However, demand for lifesaving organs drove transplant practitioners to seek alternate pathways to deceased organ donation. Donation after cardiac death (using the direct organ recovery and cold storage method) emerged as an alternative.2 With this technique, a ventilator-dependent, critically ill patient, often with severe neurologic injury, is removed from mechanical and circulatory support and allowed to proceed to cardiopulmonary death. After death is declared and the waiting period has elapsed, surgeons recover organs directly from the donor and place them in cold storage for transport. Alternately, some surgeons may choose to assess organ function with either machine perfusion or NRP before accepting a donor organ.8 Machine perfusion restores circulation to a single organ outside the body, whereas NRP restores perfusion in situ to multiple organs in the abdomen only or in the chest and abdomen (as with TA-NRP).9 Although both techniques are effective for preserving organ function, machine perfusion is significantly more expensive than NRP.10As the options for deceased organ donation have expanded, the ethical boundaries for them have become less precise and more contested. The question of whether NRP violates the dead donor rule has generated conflicting opinions. The dead donor rule states that the organ recovery must not cause the death of the donor. Although proponents argue that the intention of NRP is only to perfuse the organs, others argue that NRP nullifies the original death declaration by restoring circulatory function and therefore violates the dead donor rule.2,10Another concern is the ligation of cerebral vessels during TA-NRP. This procedure is intended to prevent the restoration of cerebral circulation and potential sentience during organ recovery, but some argue that it induces the neurologic criteria for determination of death and could even be considered an act of euthanasia.8,11,12 Still others argue that these distinctions are irrelevant and suggest that the intention of the Uniform Determination of Death Act was permanence, not literal irreversibility as stated in the definition.10 Permanence implies that death will occur because attempts to reverse the underlying cause will not be made, not because they cannot be made. According to this interpretation of the Uniform Determination of Death Act, postmortem donor interventions meant to optimize organ transplant success are consistent with the dead donor rule and respect the autonomous decision of the donor or surrogate decision-maker to donate.13Another ethical issue is the use of first-person authorization versus informed consent. First-person authorization for organ donation does not require a detailed explanation of risks and benefits as with other medical procedures and is granted when individuals indicate their intent by registering online or checking a box on a driver’s license application. The Uniform Anatomical Gift Act was enacted in 1968 and allowed persons to donate organs, eyes, and tissues as gifts to known donees or to any donee in need of an organ for survival.14 In 2006, the Uniform Anatomical Gift Act was updated to include the provision that family members or surrogate decision-makers cannot revoke a person’s intent to donate their organs after death if the person has registered as a donor.14 Although this provision was intended to ensure that a potential donor’s wishes are upheld, the potential donor might or might not have understood that DCD was a route to donation, that DCD might alter the timing or location of their death, or that NRP could be used in the process.6 In these cases, should the potential donor’s right to informed consent override first-person authorization? If the potential donor is not a registered donor, should the surrogate decision-maker be provided enough information to provide informed consent? These are the kinds of questions that remain open regarding the use of NRP in cases of DCD.The Organ Procurement and Transplantation Network Ethics Committee, contracted by the US Department of Health and Human Services to develop policies for the recovery, allocation, and distribution of organs, published in 2023 a white paper that included this statement: “It is unclear whether NRP complies with the Dead Donor Rule. Circulation is restored regionally in the person after circulatory death has been declared, giving rise to questions that are morally meaningful as to whether the person continues to meet criteria required for determination of death.”15 Although a strong utilitarian argument supports the use of TA-NRP to benefit recipients, the Organ Procurement and Transplantation Network Ethics Committee recommended disclosure of NRP and informed decision-making to ensure that donors or their surrogate decision-makers understand that heart recirculation will be part of the recovery technique and that although cerebral vessels will be ligated, residual cerebral circulation cannot be ruled out.Intensive care unit nurses caring for patients who are potential organ donors must be aware of the organ recovery techniques practiced in their facilities. When patients are eligible for DCD, ICU nurses are expected to collaborate with OPOs, support families through the end-of-life process, accompany patients to the operating room for withdrawal of life-sustaining treatments, and provide symptom management as the patient dies. What happens to a donor after declaration of death by cardiopulmonary criteria is not irrelevant, especially if questions remain regarding the irreversibility of that diagnosis and the nurse’s moral and ethical obligations to patients, the newly deceased, and their families. The debate around NRP is unsettled and likely to raise moral and ethical concerns for individual nurses and their clinical teams for some time. The issues related to the recovery of hearts using TA-NRP are particularly complex. As individual hospitals, health systems, and countries develop policies toward TA-NRP and other novel techniques to expand access to lifesaving organs, ICU nurses should participate in that discernment as they play a pivotal role in the process. Nurse participation helps preserve the professional and relational integrity of all stakeholders and trust in the organ donation enterprise.15,16Intensive care unit nurses should also be aware of changes to the OPO certification process implemented by the Centers for Medicare and Medicaid Services in 2020. Organ procurement organizations are ranked into tiers according to combined performance scores based on conversion rates of eligible donors to actual donors and the percentage of organs procured from donors that are actually transplanted. In the 3-tier system, OPOs in the top tier (top 25%) are automatically recertified for another 4 years, those in the middle tier (middle 50%) are recertified pending progress on improvement plans, and those in the bottom tier (bottom 25%) may be decertified.17 The TA-NRP process serves the interests of OPOs by increasing the number of organs available for transplant from a single DCD donor at a much lower cost than the alternative, machine perfusion. The new plan was intended to increase the supply of organs available for transplant, but it threatens the viability of OPOs. Although nurses may not be aware of these changes, they have likely noticed increased pressure from their OPO partners to convert potential donors into actual donors and to override family members’ resistance to donation for registered donors in DCD cases.18 Ongoing documentation of the impact of these changes on patients, family members, and clinicians will be vital.Nurses should actively engage in the ethical discourse regarding NRP because institutional decisions to allow or disallow the technique may have significant implications for clinicians, donors, donor families, and recipients.15,16 Nurses unfamiliar with NRP may benefit from reviewing current literature on the topic because NRP is not settled practice and consensus for or against the use of NRP in the United States has not been reached. In 2024, Dudzinski et al16 published recommendations for transplant programs considering TA-NRP for procurement of hearts. The recommendations include seeking guidance from local ethics committees, developing policy statements, ensuring that consent for NRP is secured from surrogates (even when first-person authorization for organ donation has been verified), providing education for health care workers, and permitting clinical staff members to register conscientious objection to participating in NRP.16Provisions 1 through 3 of the Code of Ethics for Nurses state that a nurse’s primary obligation is to advocate for the patient and to respect the inherent dignity of every individual.19 These commitments extend throughout a patient’s life and include respect for the newly deceased body. As nurses encounter ethical issues like NRP in clinical practice, they must respond using established ethical frameworks that express their professional nursing values and moral obligations. It is tempting to rely on others’ ethical analysis to determine ethical boundaries for nursing practice. However, doing so may overlook the ethical concerns that are unique to the nursing role. Sometimes voicing concerns is difficult for nurses if they lack the confidence and support needed to do so. Authentic nurse leaders can create safe spaces for nurses to raise concerns. Creating forums like nursing ethics rounds to apply ethical frameworks to ethically complex cases or topics can help nurses build the confidence needed to constructively speak up about concerns.20–22Moral efficacy, a component of moral resilience, is the nurse’s ability to navigate moral conflict and respond to ethical challenges effectively.23 Trinh demonstrated moral efficacy by embodying the values of respect for autonomy, beneficence, and nonmaleficence when she asked Aaron, the OPO representative, to explain the proposed TA-NRP technique for organ recovery. Trinh then embodied the value of fidelity when she escalated her concerns to the night shift clinical leaders, who agreed that further ethical discernment was urgent. Although TA-NRP was developed to increase the supply of viable lifesaving organs for transplant, it is not without controversy. Trinh was not familiar with that controversy, but Aaron’s description of TA-NRP, Catalina’s bewilderment about what would occur in the operating room, and her team’s lack of knowledge about the technique evoked feelings of moral uncertainty and distress.24 Trinh turned her moral distress into action by escalating her concerns and requesting input from ethics experts.The following morning, Trinh spoke with her nurse manager about Devon’s case and the OPO’s proposal to use TA-NRP. An urgent ethics committee meeting was convened that afternoon. Trinh was invited to participate along with her nurse manager and the ICU medical director. The ethics committee determined they would need more time to thoroughly explore the issue before moving forward with TA-NRP in Devon’s case. Because the institution had no policy regarding the use of NRP for DCD cases, the OPO offered Devon’s mother the opportunity to proceed with DCD using machine perfusion the following night, and she agreed to donation. Trinh was his nurse and accompanied him to the operating room for symptom management after withdrawal of life-sustaining treatments. Catalina was present in the operating room with her son for withdrawal of life-sustaining treatments and was able to hold her son’s hand as he died 15 minutes later. His heart and other organs were successfully recovered for donation.Intensive care unit nurses regularly care for patients undergoing testing for death by neurologic criteria and evaluation for DCD. Provision 4 of the Code of Ethics states that the nurse is accountable and for nursing This the care of potential and actual her act of and moral resilience, Trinh an moral and ethical issue to the of her ICU issues related to NRP remain ICU nurses must with these issues by ethics and on their individual and moral obligations as to for on this