Reinforcing Global Oversight of Organ Transplantation: Activity and Outcome Monitoring Through the Development of Registries.

Establishing transparency and oversight of organ transplantation by regulatory agencies is of paramount importance to assure ethical, legal, and clinically robust transplantation practices. Registries reporting activity and outcome data of the donor and recipient, including donor source (living or deceased), must be developed for each transplant and should be a mandatory requirement to achieve accreditation to perform transplant surgeries. Collected data for the living organ donor must include the nationality, the nature of their relationship with the recipient, and the complications encountered by living donors that result in prolonged morbidity or mortality. Long-term patient and graft survival must be reported for the recipient with the underlying reasons for mortality or graft loss. To retain the authorization to perform organ transplantation, a facility must ensure that it reports this required information regarding every organ transplant.

Expanding Opportunities for Living Donation: Recommendations From the 2023 Santander Summit to Ensure Donor Protections, Informed Decision Making, and Equitable Access.

A strategic vision toward global convergence in transplantation must encourage and remove barriers to living organ donation and transplantation. Here, we discuss deliberations of a working group of the 2023 Santander Summit charged with formulating recommendations for the safe expansion of living donor kidney transplantation and living donor liver transplantation worldwide. Living donor kidney transplantation has grown to be the preferred treatment for advanced kidney failure. Living donor liver transplantation emerged more recently as a strategy to reduce waitlist mortality, with adoption influenced by cultural factors, regional policies, clinical team experience, and the maturity of regional deceased donor transplant systems. Barriers to living donor transplantation span domains of education, infrastructure, risk assessment/risk communication, and financial burden to donors. Paired donor exchange is a growing option for overcoming incompatibilities to transplantation but is variably used across and within countries. Effectively expanding access to living donor transplantation requires multifaceted strategies, including improved education and outreach, and measures to enhance efficiency, transparency, and shared decision making in donor candidate evaluation. Efforts toward global dissemination and vigilant oversight of best practices and international standards for the assessment, informed consent, approval, and monitoring of living donors are needed. Fostering greater participation in paired exchange requires eliminating disincentives and logistical obstacles for transplant programs and patients, and establishing an ethical and legal framework grounded in World Health Organization Guiding Principles. Sharing of best practices from successful countries and programs to jurisdictions with emerging practices is vital to safely expand the practice of living donation worldwide and bring the field together globally.

Developing and Expanding Deceased Organ Donation to its Maximum Therapeutic Potential: An Actionable Global Challenge From the 2023 Santander Summit.

On November 9 and 10, 2023, the Organización Nacional de Trasplantes (ONT), under the Spanish Presidency of the Council of the European Union, convened in Santander a Global Summit entitled "Towards Global Convergence in Transplantation: Sufficiency, Transparency and Oversight." This article summarizes two distinct but related challenges elaborated at the Santander Summit by Working Group 2 that must be overcome if we are to develop and expand deceased donation worldwide and achieve the goal of self-sufficiency in organ donation and transplantation. Challenge 1: the need for a unified concept of death based on the permanent cessation of brain function. Working group 2 proposed that challenge 1 requires the global community to work toward a uniform, worldwide definition of human death, conceptually unifying circulatory and neurological criteria of death around the cessation of brain function and accepting that permanent cessation of brain function is a valid criterion to determine death. Challenge 2: reducing disparities in deceased donation and increasing organ utilization through donation after the circulatory determination of death (DCDD). Working group 2 proposed that challenge 2 requires the global community to work toward increasing organ utilization through DCDD, expanding DCDD through in situ normothermic regional perfusion, and expanding DCDD through ex situ machine organ perfusion technology. Recommendations for implementation are described.

When is directed deceased donation justified? Practical, ethical, and legal issues.

This paper explores whether directed deceased organ donation should be permitted, and if so under which conditions. While organ donation and allocation systems must be fair and transparent, might it be "one thought too many" to prevent directed donation within families? We proceed by providing a description of the medical and legal context, followed by identification of the main ethical issues involved in directed donation, and then explore these through a series of hypothetical cases similar to those encountered in practice. Ultimately, we set certain conditions under which directed deceased donation may be ethically acceptable. We restrict our discussion to the allocation of organs to recipients already on the waiting list.

A Single-center Exploration of Attitudes to Deceased Organ Donation Over Time Among Healthcare Staff in Intensive Care.

Background: Changes to deceased organ donation in the United Kingdom, including establishment of the specialist nurse for organ donation (SNOD) role, have resulted in increased numbers of donations. Have increasing numbers of donations altered attitudes among intensive care unit (ICU) healthcare professionals (ICU staff) to organ donation over time? Methods: A written survey of ICU staff at Nottingham University Hospitals National Health Service Trust was conducted across 2 wk in 2015, 2018, and 2020 (pre-COVID-19). Participants were asked to submit descriptors (words/phrases) they associated with 3 aspects of donation: donation after brain death (DBD), donation after circulatory death (DCD), and SNOD role. Three independent and blinded assessors categorized the descriptors as positive or negative in favorability. Thematic analysis was used to identify trends within each group of descriptors. Results: Across the 3 surveys, 281 responses were returned, containing a total of 2095 descriptors. Positive descriptors were found in 65% of DBD responses, 46% of DCD responses, and 92% of SNOD role. Over time, there was some evidence of increased polarization of opinion for DCD and to a smaller degree DBD. Attitude toward the SNOD role remained consistently highly favorable over time. Thematic analysis was correlated with the assessor favorability ratings to identify specific factors for positive or negative attitudes; this demonstrated the themes that were the most common causes of positive or negative attributions for each aspect of organ donation. Conclusions: ICU staff were found to be highly favorably positive toward the SNOD role, positive toward DBD, and negative toward DCD. Although we found broadly positive perceptions of the benefits of deceased organ donation, negative attitudes toward DCD centered on timescale and complexity of the donation process. Measurement of staff attitudes to organ donation may allow targeted interventions that support staff and improve patient and family care through the organ donation process.

The British transplantation society guidelines on organ donation from deceased donors after circulatory death.

Recipient outcomes after transplantation with organs from donation after circulatory death (DCD) donors can compare favourably and even match recipient outcomes after transplantation with organs from donation after brain death donors. Success is dependent upon establishing common practices and accepted protocols that allow the safe sharing of DCD organs and maximise the use of the DCD donor pool. The British Transplantation Society 'Guideline on transplantation from deceased donors after circulatory death' has recently been updated. This manuscript summarises the relevant recommendations from chapters specifically related to organ donation.

Baseline Ethical Principles and a Framework for Evaluation of Policies: Recommendations From an International Consensus Forum.

To maintain public trust and integrity in organ and tissue donation and transplantation (OTDT), policymakers, governments, clinical leaders, and decision-makers must ensure that policies proposed to increase donation and transplant activity satisfy baseline ethical principles established by international agreement, declaration, and resolution. This article describes the output of the Baseline Ethical Domain group of an international forum designed to guide stakeholders in considering these aspects of their system. Methods: This Forum was initiated by Transplant Québec and co-hosted by the Canadian Donation and Transplantation Program partnered with multiple national and international donation and transplantation organizations. The domain working group members included administrative, clinical, and academic experts in deceased and living donation ethics and 2 Patient, Family, and Donor partners. Identification of internationally accepted baseline ethical principles was done after literature reviews performed by working group members, and a framework for consideration of existing or novel policies was completed over a series of virtual meetings from March to September 2021. Consensus on the framework was achieved by applying the nominal group technique. Recommendations: We used the 30 baseline ethical principles described in World Health Organization Guiding Principles, Declaration of Istanbul, and Barcelona Principles to generate an ethical framework-presented graphically as a spiral series of considerations-designed to assist decision makers in incorporating these ethical principles into practice and policy. We did not seek to determine what is ethical but instead described a method of evaluation for policy decisions. Conclusions: The proposed framework could be applied to new or existing OTDT policy decisions to facilitate the transformation of widely accepted ethical principles into practical evaluations. The framework includes adaptation for local contexts and could be applied broadly internationally.

Digitally-enabled remote critical care: the challenges of geography and history?

The COVID-19 pandemic has rejuvenated interest in the possibility of using telemedicine as an approach to providing critical care services to patients in remote areas. Conceptual and governance considerations remain unaddressed. We summarise the first steps in a recent collaborative effort between key organisations in Australia, India, New Zealand, and the UK, and call for an international consensus on standards with due considerations to governance and regulation of this emerging clinical practice.

A national pilot of donation after circulatory death (DCD) heart transplantation within the United Kingdom.

BACKGROUND: The United Kingdom (UK) was one of the first countries to pioneer heart transplantation from donation after circulatory death (DCD) donors. To facilitate equity of access to DCD hearts by all UK heart transplant centers and expand the retrieval zone nationwide, a Joint Innovation Fund (JIF) pilot was provided by NHS Blood and Transplant (NHSBT) and NHS England (NHSE). The activity and outcomes of this national DCD heart pilot program are reported. METHODS: This is a national multi-center, retrospective cohort study examining early outcomes of DCD heart transplants performed across 7 heart transplant centers, adult and pediatric, throughout the UK. Hearts were retrieved using the direct procurement and perfusion (DPP) technique by 3 specialist retrieval teams trained in ex-situ normothermic machine perfusion. Outcomes were compared against DCD heart transplants before the national pilot era and against contemporaneous donation after brain death (DBD) heart transplants, and analyzed using Kaplan-Meier analysis, chi-square test, and Wilcoxon's rank-sum. RESULTS: From September 7, 2020 to February 28, 2022, 215 potential DCD hearts were offered of which 98 (46%) were accepted and attended. There were 77 potential donors (36%) which proceeded to death within 2 hours, with 57 (27%) donor hearts successfully retrieved and perfused ex situ and 50 (23%) DCD hearts going on to be transplanted. During this same period, 179 DBD hearts were transplanted. Overall, there was no difference in the 30-day survival rate between DCD and DBD (94% vs 93%) or 90 day survival (90% vs 90%) respectively. There was a higher rate of ECMO use post-DCD heart transplants compared to DBD (40% vs 16%, p = 0.0006), and DCD hearts in the pre pilot era, (17%, p = 0.002). There was no difference in length of ICU stay (9 DCD vs 8 days DBD, p = 0.13) nor hospital stay (28 DCD vs 27 DBD days, p = 0.46). CONCLUSION: During this pilot study, 3 specialist retrieval teams were able to retrieve DCD hearts nationally for all 7 UK heart transplant centers. DCD donors increased overall heart transplantation in the UK by 28% with equivalent early posttransplant survival compared with DBD donors.

Decision-making About Premortem Interventions for Donation: Navigating Legal and Ethical Complexities.

Premortem interventions (PMIs) for organ donation play a vital role in preserving opportunities for deceased donation or increasing the chances of successful transplantation of donor organs. Although ethical considerations relating to use of particular PMIs have been well explored, the ethical and legal aspects of decision-making about the use of PMIs have received comparatively little attention. In many countries, there is significant uncertainty regarding whether PMIs are lawful or, if they are, who can authorize them. Furthermore, emphasis on consideration of therapeutic goals in substitute decision-making frameworks may discourage consideration of donation goals. In this article, we examine the fundamental questions of who should have the authority to make decisions about the use of PMIs on behalf of a potential donor and how such decisions should be made. We draw on international examples of legal reform that have sought to clarify the legal position in relation to administering PMIs and identify potential elements of an effective regulatory model for PMIs. In doing so, we argue that reforms are needed in many countries to provide legal certainty for clinicians who are responsible for supporting decision-making about PMIs and to ensure that the goals and preferences of potential donors are accorded due consideration in the decision-making process.

Vaccine Effectiveness Against the SARS-CoV-2 B.1.1.529 Omicron Variant in Solid Organ and Islet Transplant Recipients in England: A National Retrospective Cohort Study.

BACKGROUND: The effectiveness of vaccines against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) B.1.1.529 Omicron variant in immunosuppressed solid organ and islet transplant (SOT) recipients is unclear. METHODS: National registries in England were linked to identify SARS-CoV-2 positive tests, noninjury hospitalization within 14 d, and deaths within 28 d between December 7, 2020, and March 31, 2022 in adult SOT recipients. Incidence rate ratios (IRRs) for infection, and hospitalization or death, were adjusted for recipient demographics and calendar month for the Omicron-dominant period (December 20, 2021, to March 31, 2022). Mortality risk following SARS-CoV-2 infection was adjusted for recipient demographics and dominant variant using a Cox proportional-hazards model for the entire time period. RESULTS: During the Omicron-dominant period, infection IRRs (95% confidence intervals) were higher in those receiving 2, 3, and 4 vaccine doses than in unvaccinated patients (1.25 [1.08-1.45], 1.46 [1.28-1.67], and 1.79 [1.54-2.06], respectively). However, hospitalization or death IRRs during this period were lower in those receiving 3 or 4 vaccine doses than in unvaccinated patients (0.62 [0.45-0.86] and 0.39 [0.26-0.58], respectively). Risk-adjusted analyses for deaths after SARS-CoV-2 infection between December 7, 2020, and March 31, 2022, found hazard ratios (95% confidence intervals) of 0.67 (0.46-0.98), 0.46 (0.30-0.69), and 0.18 (0.09-0.35) for those with 2, 3, and 4 vaccine doses, respectively, when compared with the unvaccinated group. CONCLUSIONS: In immunosuppressed SOT recipients, vaccination is associated with incremental, dose-dependent protection against hospitalization or death after SARS-CoV-2 infection, including against the Omicron variant.

A New Defense of Brain Death as the Death of the Human Organism.

This paper provides a new rationale for equating brain death with the death of the human organism, in light of well-known criticisms made by Alan D Shewmon, Franklin Miller and Robert Truog and a number of other writers. We claim that these criticisms can be answered, but only if we accept that we have slightly redefined the concept of death when equating brain death with death simpliciter. Accordingly, much of the paper defends the legitimacy of redefining death against objections, before turning to the specific task of defending a new rationale for equating brain death with death as slightly redefined.