Pre-Mortem Interventions for the Purpose of Organ Donation: Legal Approaches to Consent.

The administration of Pre-Mortem Interventions (PMIs) to preserve the opportunity to donate, to assess the eligibility to donate, or to optimize the outcomes of donation and transplantation are controversial as they offer no direct medical benefit and include at least the possibility of harm to the still-living patient. In this article, we describe the legal analysis surrounding consent to PMIs, drawing on existing legal commentary and identifying key legal problems. We provide an overview of the approaches in several jurisdictions that have chosen to explicitly address PMIs within codified law. We then provide, as an example, a detailed exploration of how PMIs are likely to be addressed in one jurisdiction where general medical consent law applies because there is no specific legislation addressing PMIs - the province of Ontario in Canada.

Developing Guidance for Donor Intervention Randomized Controlled Trials: Initial Discussions From the Canada-United Kingdom 2022 Workshop.

BACKGROUND: Donor interventions, including medications, protocols, and medical devices administered to donors, can enhance transplantable organ quality and quantity and maximize transplantation success. However, there is paucity of high-quality evidence about their effectiveness, in part because of ethical, practical, and regulatory challenges, and lack of guidance about conduct of donor intervention randomized controlled trials (RCTs). METHODS: With the vision to develop authoritative guidance for conduct of donor intervention RCTs, we convened a workshop of Canadian-United Kingdom experts in organ donation and transplantation ethics, research, and policy to identify stakeholders, explore unique challenges, and develop research agenda to inform future work in this promising field. RESULTS: Donor intervention trials should consider perspectives of broad group of stakeholders including donors, transplant recipients, and their families; researchers in donation and transplantation; research ethics boards; and healthcare providers and administrators involved in donation and transplantation. Unique challenges include (1) research ethics (living versus deceased status of the donor at the time of intervention, intervention versus outcomes assessment in different individuals, harm-benefit analysis in donors versus recipients, consent, and impact on research bystanders); (2) outcome data standardization and linkage; and (3) regulatory and governance considerations. CONCLUSIONS: Donor intervention RCTs hold potential to benefit organ transplantation outcomes but face unique research ethics, outcome data, and regulatory challenges. By developing research agenda to address these challenges, our workshop was an important first step toward developing Canada-United Kingdom guidance for donor intervention RCTs that are poised to improve the quality and availability of transplantable organs.

Ethical considerations for theatre teams in organ donation after circulatory determination of death.

Transplant surgery is an area that gives rise to a number of ethical considerations. As medicine continues to expand the boundaries of what is technically possible, we must consider the ethical implications of our interventions, not solely on patients and society, but also on those asked to provide that care. Here, we consider physician participation in procedures required to provide patient care in the context of the ethical convictions held by the physician, with an emphasis on organ donation after circulatory determination of death. Strategies that can be used to mitigate any potential negative impact on the psychological well-being of members of the patient care team are considered.

CRITCON-Pandemic levels: A stepwise ethical approach to clinician responsibility.

CRITCON-Pandemic levels with an associated operational responsibility matrix were recently published by the Intensive Care Society as a modification to Winter Flu CRITCON levels, to better account for differences between a winter flu surge in critical care activity and the capacity challenges of the COVID-19 pandemic. In this paper, we propose an expansion and explanation of the operational matrix to suggest a stepwise ethical approach to clinician responsibility. We propose and outline the main ethical risks created at each level and discuss how those risks can be mitigated through a balanced application of the predominant ethical principle which in turn provides practical guidance to clinician responsibility. We thus seek to specify the ethical and legal principles that should be used in applying the operational matrix, and what the practical effects could be.

Ethical considerations in the use of pre-mortem interventions to support deceased organ donation: A scoping review.

AIM: Pre-mortem interventions (PMIs) are performed on patients before the determination of death in order to preserve or enhance the possibility of organ donation. These interventions can be ethically controversial, and we thus undertook a scoping review of the ethical issues surrounding diverse PMIs. METHODS: Using modified scoping review methods, we executed a search strategy created by an information specialist. Screening and iterative coding of each article was done by two researchers using qualitative thematic analysis, and narrative summaries of coded themes were presented. RESULTS: We identified and screened 5365 references and coded 196 peer-reviewed publications. The most frequently cited issues were related to possible harms to the patient who is a potential donor, and legitimacy of consent. The most controversial issue was that PMIs may place patients at risk for physical harm, yet benefit is accrued mainly to recipients. Some authors argued that lack of direct medical benefit to the still living patient precluded valid consent from surrogate decision makers (SDMs), while many stated that some medical risk could be approved by SDMs if it aligns with non-medical benefits valued by the patient. CONCLUSION: PMIs require consensus that benefit includes concepts beyond medical benefit to the patient who is a potential donor. Informed consent must be confirmed for each PMI and not assumed to be part of general consent for donation. Risk must be proportionate to the potential benefit and newly proposed interventions should be reviewed carefully for medical efficacy and potential risks.

Talking to multi-morbid patients about critical illness: an evolving conversation.

Conversations around critical illness outcomes and benefits from intensive care unit (ICU) treatment have begun to shift away from binary discussions on living versus dying. Increasingly, the reality of survival with functional impairment versus survival with a late death is being recognised as relevant to patients. Most ICU admissions are associated with new functional and cognitive disabilities that are significant and long lasting. When discussing outcomes, clinicians rightly focus on patients' wishes and the quality of life (QoL) that they would find acceptable. However, patients' views may encompass differing views on acceptable QoL post-critical illness, not necessarily reflected in standard conversations. Maintaining independence is a greater priority to patients than simple survival. QoL post-critical illness determines judgments on the benefits of ICU support but translating this into clinical practice risks potential conflation of health outcomes and QoL. This article discusses the concept of response shift and the implication for trade-offs between number/length of invasive treatments and change in physical function or death. Conversations need to delineate how health outcomes (e.g. tracheostomy, muscle wasting, etc.) may affect individual outcomes most relevant to the patient and hence impact overall QoL. The research strategy taken to explore decision-making for critically ill patients might benefit from gathering qualitative data, as a complement to quantitative data. Patients, families and doctors are motivated by far wider considerations, and a consultation process should relate to more than the simple likelihood of mortality in a shared decision-making context.

Resumption of Cardiac Activity after Withdrawal of Life-Sustaining Measures.

BACKGROUND: The minimum duration of pulselessness required before organ donation after circulatory determination of death has not been well studied. METHODS: We conducted a prospective observational study of the incidence and timing of resumption of cardiac electrical and pulsatile activity in adults who died after planned withdrawal of life-sustaining measures in 20 intensive care units in three countries. Patients were intended to be monitored for 30 minutes after determination of death. Clinicians at the bedside reported resumption of cardiac activity prospectively. Continuous blood-pressure and electrocardiographic (ECG) waveforms were recorded and reviewed retrospectively to confirm bedside observations and to determine whether there were additional instances of resumption of cardiac activity. RESULTS: A total of 1999 patients were screened, and 631 were included in the study. Clinically reported resumption of cardiac activity, respiratory movement, or both that was confirmed by waveform analysis occurred in 5 patients (1%). Retrospective analysis of ECG and blood-pressure waveforms from 480 patients identified 67 instances (14%) with resumption of cardiac activity after a period of pulselessness, including the 5 reported by bedside clinicians. The longest duration after pulselessness before resumption of cardiac activity was 4 minutes 20 seconds. The last QRS complex coincided with the last arterial pulse in 19% of the patients. CONCLUSIONS: After withdrawal of life-sustaining measures, transient resumption of at least one cycle of cardiac activity after pulselessness occurred in 14% of patients according to retrospective analysis of waveforms; only 1% of such resumptions were identified at the bedside. These events occurred within 4 minutes 20 seconds after a period of pulselessness. (Funded by the Canadian Institutes for Health Research and others.).

SARS-CoV-2 infection and early mortality of waitlisted and solid organ transplant recipients in England: A national cohort study.

Patients waitlisted for and recipients of solid organ transplants (SOT) are perceived to have a higher risk of contracting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and death; however, definitive epidemiological evidence is lacking. In a comprehensive national cohort study enabled by linkage of the UK transplant registry and Public Health England and NHS Digital Tracing services, we examined the incidence of laboratory-confirmed SARS-CoV-2 infection and subsequent mortality in patients on the active waiting list for a deceased donor SOT and recipients with a functioning SOT as of February 1, 2020 with follow-up to May 20, 2020. Univariate and multivariable techniques were used to compare differences between groups and to control for case-mix. One hundred ninety-seven (3.8%) of the 5184 waitlisted patients and 597 (1.3%) of the 46 789 SOT recipients tested positive for SARS-CoV-2. Mortality after testing positive for SARS-CoV-2 was 10.2% (20/197) for waitlisted patients and 25.8% (154/597) for SOT recipients. Increasing recipient age was the only variable independently associated with death after positive SARS-CoV-2 test. Of the 1004 transplants performed in 2020, 41 (4.1%) recipients have tested positive for SARS-CoV-2 with 8 (0.8%) deaths reported by May 20. These data provide evidence to support decisions on the risks and benefits of SOT during the coronavirus disease 2019 pandemic.

Maintaining the permanence principle for death during in situ normothermic regional perfusion for donation after circulatory death organ recovery: A United Kingdom and Canadian proposal.

There is international variability in the determination of death. Death in donation after circulatory death (DCD) can be defined by the permanent cessation of brain circulation. Post-mortem interventions that restore brain perfusion should be prohibited as they invalidate the diagnosis of death. Retrieval teams should develop protocols that ensure the continued absence of brain perfusion during DCD organ recovery. In situ normothermic regional perfusion (NRP) or restarting the heart in the donor's body may interrupt the permanent cessation of brain perfusion because, theoretically, collateral circulations may restore it. We propose refinements to current protocols to monitor and exclude brain reperfusion during in situ NRP. In abdominal NRP, complete occlusion of the descending aorta prevents brain perfusion in most cases. Inserting a cannula in the ascending aorta identifies inadequate occlusion of the descending aorta or any collateral flow and diverts flow away from the brain. In thoracoabdominal NRP opening the aortic arch vessels to atmosphere allows collateral flow to be diverted away from the brain, maintaining the permanence standard for death and respecting the dead donor rule. We propose that these hypotheses are correct when using techniques that simultaneously occlude the descending aorta and open the aortic arch vessels to atmosphere.

How the mode of organ donation affects family behaviour at the time of organ donation.

INTRODUCTION: End of life and organ donation discussions come at a time of acute emotional unrest for grieving relatives. Their attitudes and eventual decisions regarding consent to organ donation are shaped by multiple factors during these stressful periods. At our tertiary centre intensive care unit, we anecdotally observed that the mode of organ donation affects family behaviour as to whether families stay until transfer to theatre for organ recovery, or leave after consenting for donation. We sought to ascertain if this observation was true and then to hypothesise reasons for why this may be the case. METHODS: Records of patients consented for deceased organ donation between 1 January 2015 and 31 December 2017 at the Nottingham University Hospitals NHS Trust were reviewed and analysed. RESULTS: After exclusion criteria were applied, 91 patient cases were included in the final analysis (donation after brainstem death (DBD), 36; donation after circulatory death (DCD), 55). Thirty-six per cent of DBD families stayed until the point of organ recovery compared to 80% of DCD families (p < 0.00001). DISCUSSION: We hypothesise that this family behaviour may be indicative of an acceptance in DBD of the patient's death, and therefore that the patient has moved beyond further harm. For this reason, the family may feel able to leave after consent for donation. A greater understanding of how family behaviours differ depending on the mode of organ donation may aid how these families are best cared for in the intensive care unit.