Changing the Conversation From Should to How: It Is Time to Implement Normothermic Regional Perfusion as the Standard Procurement Procedure for Donation After Circulatory Death in the United States

In the United States, the utilization of liver grafts from donation after circulatory death donors (DCD) has increased dramatically during the past 5 y, driven by improved outcomes with the application of machine perfusion technologies.1,2 Although DCD liver grafts were historically considered to be inferior to donation after brain death (DBD) liver grafts, as noted by Croome et al,3 outcomes of DCD liver transplantation using sequential normothermic regional perfusion (NRP) and normothermic machine perfusion (NMP) or NRP alone versus static cold storage should no longer be the case.3 DCD grafts are not inferior to DBD grafts, but, as this study clearly demonstrates, there are suboptimal procurement and preservation strategies that are often applied to DCD. This study adds to the existing literature on NRP, once again demonstrating its superiority compared with super rapid recovery (SRR) as a procurement technique for DCD. What is notably missing is a comparison group of SRR followed by NMP, a cohort that these centers should have been able to provide. Because of this limitation, the value of NMP in the absence of NRP for DCD liver grafts remains unclear, and this commentary will focus specifically on the value of NRP with and without NMP. What is clear is that we, as a liver transplant community, can no longer consider SRR with static cold storage a reasonable standard for DCD and transplantation. We previously argued that if NRP meets the ethical standards of DCD donation and is shown to increase organ utilization and improve recipient outcomes, the procedure is not only ethically acceptable but also ethically obligatory.4 NRP is uniquely beneficial for DCD because it is a single intervention that perfuses all of the organs intended for transplantation, providing a global benefit rather than the singular organ benefit provided by ex situ machine perfusion. Given the mass of data on NRP superiority in terms of both utilization and recipient outcomes across multiple organs, we believe that the conversation in the United States about whether we should make NRP the standard of care for DCD organ procurement should be replaced with a conversation about how we can make NRP the standard of care for DCD organ procurement. Beyond the benefits that NRP provides to multiple organs, there are other unique benefits that NRP provides that are lost when SRR is used for procurement. First, it allows for extended warm ischemic time thresholds because of early reperfusion and baseline laboratory analysis, which provides insight into the extent of the ischemic injury sustained during the dying process. Second, NRP allows for a detailed functional assessment of grafts in situ allowing teams to make utilization decisions early in the donation process. Moreover, NRP can improve late reallocation rates when intraoperative declines occur because perfusion can be continued while transplant centers are being contacted and while assessing the organs. It also allows time to determine an optimal preservation strategy, which may be NMP if there are logistical reasons for needing to extend the preservation time beyond what would be acceptable for static cold storage. Although NRP adds cost compared with SRR, it is substantially less than ex situ machine perfusion, especially considering that each organ has a separate ex situ machine perfusion cost.5 With the expansion of the donor pool for all organs using NRP, the costs are offset by the increase in transplantable organs. Finally, the universal application of NRP has the potential to improve equitable access to DCD liver grafts because all transplant centers would have access to high-quality DCD organs, rather than only those that can afford, or have access to, NMP. The first step to making NRP the standard of care is to gain broad support from professional and governmental organizations. This part of the playbook is not unique to NRP. In the 1990s, when DCD donation was making a resurgence in the United States, the Institute of Medicine published a report entitled “Non-Heart-Beating Organ Transplantation: Medical and Ethical Issues in Procurement.”6 This report unequivocally supported the ethical and medical acceptability of DCD donation, emphasized the value of expanding the opportunity for patients and families to donate organs at the end of life, and made recommendations for the standardization of practice to maintain public trust in organ donation. Encouraging organizations such as the National Academies of Medicine, the Organ Procurement and Transplantation Network, and those representing critical care, transplantation, organ donation, and palliative care to support NRP has the potential to increase knowledge and acceptance of NRP within the medical community and the public at large. The second step toward the universal application of NRP is standardization of the procedure. The American Society of Transplant Surgeons developed 3 consensus statements on standardization of NRP, addressing thoracoabdominal NRP, abdominal NRP, and ethical and legal conformance.7–9 These consensus statements should serve as a template for developing national standards for the conduct of NRP donation. Standardization should include not only technical aspects but also information disclosure to families, conduct of end-of-life care for donors, and laboratory testing parameters and reporting, including a single, standard flowsheet, photo documentation, and biopsy slide pictures. Moreover, standardized data collection is essential for high-quality research on utilization, optimization, and quality of organs exposed to NRP. Finally, moving toward an NRP as a universal standard for DCD donation requires broad buy-in from transplant centers, Organ Procurement Organizations (OPOs), donor hospitals, and the public. Qualitative and survey-based research studies on how different stakeholders have experienced NRP, information needs of these stakeholders, and their perceptions of the procedure are needed to determine how best to build consensus around the acceptability and value of NRP. We foresee one of the main barriers to implementation being the development of widespread expertise in both the technical aspects of the procedure and the provision of high-quality perfusion to the organs. Our center has offered training and proctoring in NRP, with national workshops as well as individual and team-based, hands-on workshops. There are also international master classes. Some OPO-based NRP programs are offering hands-on training. Moreover, US donor surgeon credentialing now includes NRP. The American Society of Transplant Surgeons recommends a minimum of 5 successful cases to demonstrate technical competence in the NRP procedure for procurement surgeons, which is a reasonable requirement, but surgeons may need additional proctoring for complex cases (eg, abdominal NRP with thoracic SRR). Although the development of expertise will be an investment for transplant programs and OPOs, it will be well worth the time and effort to develop a high-quality nationwide NRP program. Universal adoption of NRP has the potential to skyrocket access to transplantation in an ethical, equitable, and high-quality manner. We are at the cusp of transforming organ donation and transplantation in the United States through the widespread adoption of the disruptive technology of NRP, and if we do it well, we stand the chance of ushering in a new era in transplantation that aligns the interests of all parties, including donors, recipients, transplant centers, and OPOs.