Approaching the Families of Potential Deceased Organ Donors: An Overview of Regulations and Practices in Council of Europe Member States.

The primary aim of this study was to describe regulations and practices concerning the family approach to discuss donation, specifically after the neurological determination of death, one of the most challenging steps in the donation pathway. A secondary objective was to assess the impact of legislation on consent rates for organ donation. The Council of Europe surveyed 39 member states about national regulations, practices, and consent rates; 34 replied. Opt-out legislation is present in 19, opt-in in 9 and a mixed system in six countries. An opt-out register is kept by 24 countries and an opt-in register by 18 countries, some keeping both. The mean consent rate was 81.2% of all family approaches. Most countries regulate how death using neurological criteria is confirmed (85.3%), while regulation of other aspects of the deceased donation pathway varies: the timing of informing the family about brain death (47.1%) and organ donation (58.8%), the profile of professional who discusses both topics with the family (52.9% and 64.7%, respectively) and the withdrawal of treatment after brain death (47.1%). We also noted a mismatch between what regulations state and what is done in practice in most countries. We suggest possible reasons for this disparity.

A brain-based definition of death and criteria for its determination after arrest of circulation or neurologic function in Canada: a 2023 clinical practice guideline.

This 2023 Clinical Practice Guideline provides the biomedical definition of death based on permanent cessation of brain function that applies to all persons, as well as recommendations for death determination by circulatory criteria for potential organ donors and death determination by neurologic criteria for all mechanically ventilated patients regardless of organ donation potential. This Guideline is endorsed by the Canadian Critical Care Society, the Canadian Medical Association, the Canadian Association of Critical Care Nurses, Canadian Anesthesiologists' Society, the Canadian Neurological Sciences Federation (representing the Canadian Neurological Society, Canadian Neurosurgical Society, Canadian Society of Clinical Neurophysiologists, Canadian Association of Child Neurology, Canadian Society of Neuroradiology, and Canadian Stroke Consortium), Canadian Blood Services, the Canadian Donation and Transplantation Research Program, the Canadian Association of Emergency Physicians, the Nurse Practitioners Association of Canada, and the Canadian Cardiovascular Critical Care Society.

RéSUMé: Ces Lignes directrices de pratique clinique 2023 Lignes directrices de pratique clinique dicale du décès basée sur l'arrêt permanent de la fonction cérébrale qui s'applique à toute personne, ainsi que des recommandations pour la détermination du décès par des critères circulatoires pour des donneurs d'organes potentiels et des recommandations pour la détermination du décès par des critères neurologiques pour tous les patients sous ventilation mécanique, indépendamment de leur potentiel de donneur d'organes. Les présentes Lignes directrices sont approuvées par la Société canadienne de soins intensifs, l'Association médicale canadienne, l'Association canadienne des infirmiers/infirmières en soins intensifs, la Société canadienne des anesthésiologistes, la Fédération des sciences neurologiques du Canada (représentant la Société canadienne de neurologie, la Société canadienne de neurochirurgie, la Société canadienne de neurophysiologie clinique, l'Association canadienne de neurologie pédiatrique, la Société canadienne de neuroradiologie et le Consortium neurovasculaire canadien), la Société canadienne du sang, le Programme de recherche en don et transplantation du Canada, l'Association canadienne des médecins d'urgence, l'Association des infirmières et infirmiers praticiens du Canada, et la Société canadienne de soins intensifs cardiovasculaires (CANCARE) et la Société canadienne de pédiatrie.

Comparing Deceased Organ Donation Performance in Two Countries that Use Different Metrics: Comparing Apples With Apples.

Organ donation networks audit and report on national or regional organ donation performance, however there are inconsistencies in the metrics and definitions used, rendering comparisons difficult or inappropriate. This is despite multiple attempts exploring the possibility for convergently evolving audits so that collectives of donation networks might transparently share data and practice and then target system interventions. This paper represents a collaboration between the United Kingdom and Australian organ donation organisations which aimed to understand the intricacies of our respective auditing systems, compare the metrics and definitions they employ and ultimately assess their level of comparability. This point of view outlines the historical context underlying the development of the auditing tools, demonstrates their differences to the Critical Pathway proposed as a common tool a decade ago and presents a side-by-side comparison of donation definitions, metrics and data for the 2019 calendar year. There were significant differences in donation definition terminology, metrics and overall structure of the audits. Fitting the audits to a tiered scaffold allowed for reasonable comparisons however this required substantial effort and understanding of nuance. Direct comparison of international and inter-regional donation performance is challenging and would benefit from consistent auditing processes across organisations.

The ethics of semantics in medicine.

In this paper, we discuss the largely neglected topic of semantics in medicine and the associated ethical issues. We analyse several key medical terms from the informed perspective of the healthcare professional, the lay perspective of the patient and the patient's family, and the descriptive perspective of what the term actually signifies objectively. The choice of a particular medical term may deliver different meanings when viewed from these differing perspectives. Consequently, several ethical issues may arise. Technical terms that are not commonly understood by lay people may be used by physicians, consciously or not, and may obscure the understanding of the situation by lay people. The choice of particular medical terms may be accidental use of jargon, an attempt to ease the communication of psychologically difficult information, or an attempt to justify a preferred course of action and/or to manipulate the decision-making process.

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.

Impact of a Devastating Brain Injury Pathway on Outcomes, Resources, and Organ Donation: 3 Years' Experience in a Regional Neurosciences ICU.

OBJECTIVE: To assess the impact of introducing a devastating brain injury (DBI) pathway on patient outcome, intensive care unit (ICU) resources, and organ donation practice in the first 3 years of implementation in a regional neurosciences ICU in the South West of England. METHODS: Patients with DBI admitted to our ICU between 2015 and 2018 were identified from our ICU database and their outcomes compared to those of non-DBI patients. Data were also obtained from the national potential donor audit to compare organ donation metrics before and after the introduction of the DBI pathway. Organ donation metrics in DBI patients and non-DBI patients were compared once the pathway had been implemented. RESULTS: We admitted 85 DBI patients (1.3% of all admissions), with a significantly shorter median length of ICU stay than in non-DBI patients, 1.14 versus 2.93 days (p < 0.001). Decisions for withdraw life-sustaining treatments (WLST) were made significantly earlier in DBI patients, median 26.2 versus 84.8 h (p < 0.001). Over 8% of DBI patients survived, while 31% progressed to brain death compared to 7.1% in the general population (p < 0.001), and 25% become solid organ donors compared to 1.3% of the general population (p < 0.001). There was an increase in the proportion of donors after brain death (DBD) to donors after circulatory death (DCD) in the 3 years following the introduction of the DBI pathway (p = 0.024). There was also an increased proportion of DBD donors to DCD donors of 76% versus 24% in the DBI group compared to 62% versus 38% (p = 0,002) in the non-DBI population. Prognostic scoring systems do not provide accurate estimates of survival rate in this population. CONCLUSIONS: Admitting patients with perceived DBI to ICU and avoiding the early WLST allows identification of unexpected survivors and gives families more time in decision making at the end of life. The DBI pathway increases the potential for organ donation and increases the proportion of DBD donors. These benefits outweigh the small impact of a DBI pathway on ICU resources.

Determination of Brain Death/Death by Neurologic Criteria: The World Brain Death Project.

IMPORTANCE: There are inconsistencies in concept, criteria, practice, and documentation of brain death/death by neurologic criteria (BD/DNC) both internationally and within countries. OBJECTIVE: To formulate a consensus statement of recommendations on determination of BD/DNC based on review of the literature and expert opinion of a large multidisciplinary, international panel. PROCESS: Relevant international professional societies were recruited to develop recommendations regarding determination of BD/DNC. Literature searches of the Cochrane, Embase, and MEDLINE databases included January 1, 1992, through April 2020 identified pertinent articles for review. Because of the lack of high-quality data from randomized clinical trials or large observational studies, recommendations were formulated based on consensus of contributors and medical societies that represented relevant disciplines, including critical care, neurology, and neurosurgery. EVIDENCE SYNTHESIS: Based on review of the literature and consensus from a large multidisciplinary, international panel, minimum clinical criteria needed to determine BD/DNC in various circumstances were developed. RECOMMENDATIONS: Prior to evaluating a patient for BD/DNC, the patient should have an established neurologic diagnosis that can lead to the complete and irreversible loss of all brain function, and conditions that may confound the clinical examination and diseases that may mimic BD/DNC should be excluded. Determination of BD/DNC can be done with a clinical examination that demonstrates coma, brainstem areflexia, and apnea. This is seen when (1) there is no evidence of arousal or awareness to maximal external stimulation, including noxious visual, auditory, and tactile stimulation; (2) pupils are fixed in a midsize or dilated position and are nonreactive to light; (3) corneal, oculocephalic, and oculovestibular reflexes are absent; (4) there is no facial movement to noxious stimulation; (5) the gag reflex is absent to bilateral posterior pharyngeal stimulation; (6) the cough reflex is absent to deep tracheal suctioning; (7) there is no brain-mediated motor response to noxious stimulation of the limbs; and (8) spontaneous respirations are not observed when apnea test targets reach pH <7.30 and Paco2 ≥60 mm Hg. If the clinical examination cannot be completed, ancillary testing may be considered with blood flow studies or electrophysiologic testing. Special consideration is needed for children, for persons receiving extracorporeal membrane oxygenation, and for those receiving therapeutic hypothermia, as well as for factors such as religious, societal, and cultural perspectives; legal requirements; and resource availability. CONCLUSIONS AND RELEVANCE: This report provides recommendations for the minimum clinical standards for determination of brain death/death by neurologic criteria in adults and children with clear guidance for various clinical circumstances. The recommendations have widespread international society endorsement and can serve to guide professional societies and countries in the revision or development of protocols and procedures for determination of brain death/death by neurologic criteria, leading to greater consistency within and between countries.

Cortrak feeding tube placement: accuracy of the 'GI flexure system' versus manufacturer guidance.

Electromagnetic (EM) guided enteral tube placement may reduce lung misplacement to almost zero in expert centres, but more than 60 undetected misplacements had occurred by 2016 resulting in major morbidity or death. AIM: Determine the accuracy of manufacturer guidance in trace interpretation against what is referred to as the 'GI flexure system'. METHODS: The authors prospectively observed the accuracy of the 'GI flexure system' of trace interpretation against manufacturer guidance in primary nasointestinal (NI) tube placements. FINDINGS: Contrary to manufacturer guidance, 33% of traces deviated >5 cm from the sagittal midline and 26.5% were oesophageal when entering the lower left quadrant, incorrectly indicating lung and gastric placement, respectively. Conversely, the GI flexure system identified ≥99.4% of GI traces when they reached the gastric body flexure; 100% at the superior duodenal flexure. All lung misplacements were identified by the absence of GI flexures. CONCLUSION: Current manufacturer guidance should be updated to the GI flexure system of interpretation.

Cortrak feeding tube placement: interpretation agreement of the 'GI flexure' system versus X-ray.

BACKGROUND: Blind (unguided) feeding tube placement results in 0.5% of patients suffering major complications mainly due to lung misplacement detected prior to feeding. Electromagnet-guided (Cortrak) tube placement could pre-empt such complications but undetected misplacements still occur due to incorrect trace interpretation. By identifying gastrointestinal (GI) flexures from the trace, 'the GI flexure system', it has been proposed that tube position can be interpreted. AIMS: To audit agreement between standards of interpreting tube position: the Cortrak 'GI flexure' system versus X-ray. METHODS: In 185 primary nasointestinal tube placements tube position determined by Cortrak trace interpretation (GI flexure) was retrospectively compared with radiological position in a blinded study. FINDINGS: Radiological and Cortrak interpretation agreed in 92.2-98.3% of placements at different GI flexures. Discrepancy mainly occurred because some radiological images were unclear or did not cover all anatomical points. CONCLUSION: The GI flexure method of Cortrak interpretation appears safe but would necessitate prospective radiological investigation to definitively test equivalence.

A Donation After Circulatory Death Program Has the Potential to Increase the Number of Donors After Brain Death.

OBJECTIVES: Donation after circulatory death has been responsible for 75% of the increase in the numbers of deceased organ donors in the United Kingdom. There has been concern that the success of the donation after circulatory death program has been at the expense of donation after brain death. The objective of the study was to ascertain the impact of the donation after circulatory death program on donation after brain death in the United Kingdom. DESIGN: Retrospective cohort study. SETTING: A national organ procurement organization. PATIENTS: Patients referred and assessed as donation after circulatory death donors in the United Kingdom between October and December 2013. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A total of 257 patients were assessed for donation after circulatory death. Of these, 193 were eligible donors. Three patients were deemed medically unsuitable following surgical inspection, 56 patients did not proceed due to asystole, and 134 proceeded to donation. Four donors had insufficient data available for analysis. Therefore, 186 cases were analyzed in total. Organ donation would not have been possible in 79 of the 130 actual donors if donation after circulatory death was not available. Thirty-six donation after circulatory death donors (28% of actual donors) were judged to have the potential to progress to brain death if withdrawal of life-sustaining treatment had been delayed by up to a further 36 hours. A further 15 donation after circulatory death donors had brain death confirmed or had clinical indications of brain death with clear mitigating circumstances in all but three cases. We determined that the maximum potential donation after brain death to donation after circulatory death substitution rate observed was 8%; however due to mitigating circumstances, only three patients (2%) could have undergone brain death testing. CONCLUSIONS: The development of a national donation after circulatory death program has had minimal impact on the number of donation after brain death donors. The number of donation after brain death donors could increase with changes in end-of-life care practices to allow the evolution of brain death and increasing the availability of ancillary testing.

In-hospital logistics: what are the key aspects for succeeding in each of the steps of the process of controlled donation after circulatory death?

Donation after circulatory death (DCD) donors are becoming an increasingly important population of organ donors in Europe and worldwide. We report the state of the art regarding controlled DCD donation describing the organizational and technical aspects of establishing a controlled DCD programme and provide recommendations regarding the introduction and development of this type of programme.

Confirming nasogastric tube position with electromagnetic tracking versus pH or X-ray and tube radio-opacity.

Recent evidence suggests official statistics greatly underestimate the occurrence of complications from misplaced nasogastric (NG) tubes, even when detected. Current methods of confirming tube position do not provide adequate protection from misplacement. In addition, some tubes are inadequately radio-opaque. We prospectively audited placement of Cortrak polyurethane tubes (PUTs) to determine: accuracy of the electromagnetic (EM) trace in confirming tube position, radio-opacity of PUTs compared with previously placed polyvinylchloride (PVC) Ryles tubes and whether 12 French PUTs can be used to aspirate gastric residual volumes (GRVs). A total of 127 PUTs were placed in 113 patients. EM traces accurately confirmed tube position compared with X-ray (100% agreement). A 'gastric' EM trace has been defined for future use by other operators. PUTs were adequately radio-opaque with good agreement between interpreters (>98%) whereas PVC Ryles tubes were insufficiently radio-opaque (57-73%), invisible in 23% of cases and with poor agreement between interpreters leaving risk of error. The alternative of using pH confirmation was not possible in 44%. In these cases subsequent X-ray incurred a 2-hour delay to feed and medicines. In addition, neither post-placement pH testing nor X-ray warn of lung placement and potential trauma, whereas the EM trace warned of lung placement prior to damage in 7% of placements. 12 French, single-port PUTs appear adequate to aspirate large GRVs. EM tracing may be considered a standalone method of confirming NG tube position. Corflo (Cortrak) PUTs are adequately radio-opaque. Use of PVC Ryles and other inadequately radio-opaque tubes should stop.

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.

Getting out of the box: the future of the UK donation after circulatory determination of death heart programme.

Heart failure imposes a significant burden on all health care systems and has a 5-year mortality of 50%. Heart transplantation and ventricular assist device (VAD) implantation are the definitive therapies for end stage heart disease, although transplantation appears to offer superior long-term survival and quality of life over VAD implantation. Transplantation is limited by a shortage in donor hearts, resulting in considerable waiting list mortality. Donation after circulatory determination of death (DCD) offers a significant uplift in the number of donors for heart transplantation. The outcomes both from the UK and internationally have been exciting, with outcomes at least as good as conventional donation after brain death (DBD) transplantation. Currently, DCD hearts are reperfused using ex-situ machine perfusion (ESMP). Whilst ESMP has enabled the development of DCD transplantation, it comes at significant cost, with the per run cost of approximately GBP £90,000. In-situ perfusion of the heart, otherwise known as thoraco-abdominal normothermic regional perfusion (taNRP) is cheaper, but there are ethical concerns regarding the potential to restore cerebral perfusion in the donor. We must determine whether there is any cerebral circulation during in-situ perfusion of the heart to ensure that it does not invalidate the diagnosis of death and potentially violate the dead donor rule. Besides this, there is a need for a randomised controlled trial to definitively determine whether taNRP offers any clinical advantages over ex-situ machine perfusion. This viewpoint article explores these issues in more detail.

The international experience of in-situ recovery of the DCD heart: a multicentre retrospective observational study.

Background: Heart transplantation is an effective treatment offering the best recovery in both quality and quantity of life in those affected by refractory, severe heart failure. However, transplantation is limited by donor organ availability. The reintroduction of heart donation after the circulatory determination of death (DCD) in 2014 offered an uplift in transplant activity by 30%. Thoraco-abdominal normothermic regional perfusion (taNRP) enables in-situ reperfusion of the DCD heart. The objective of this paper is to assess the clinical outcomes of DCD donor hearts recovered and transplanted from donors undergoing taNRP. Method: This was a multicentre retrospective observational study. Outcomes included functional warm ischaemic time, use of mechanical support immediately following transplantation, perioperative and long-term actuarial survival and incidence of acute rejection requiring treatment. 157 taNRP DCD heart transplants, performed between February 2, 2015, and July 29, 2022, have been included from 15 major transplant centres worldwide including the UK, Spain, the USA and Belgium. 673 donations after the neurological determination of death (DBD) heart transplantations from the same centres were used as a comparison group for survival. Findings: taNRP resulted in a 23% increase in heart transplantation activity. Survival was similar in the taNRP group when compared to DBD. 30-day survival was 96.8% ([92.5%-98.6%] 95% CI, n = 156), 1-year survival was 93.2% ([87.7%-96.3%] 95% CI, n = 72) and 5-year survival was 84.3% ([69.6%-92.2%] 95% CI, n = 13). Interpretation: Our study suggests that taNRP provides a significant boost to heart transplantation activity. The survival rates of taNRP are comparable to those obtained for DBD transplantation in this study. The similar survival may in part be related to a short warm ischaemic time or through a possible selection bias of younger donors, this being an uncontrolled observational study. Therefore, our study suggests that taNRP offers an effective method of organ preservation and procurement. This early success of the technique warrants further investigation and use. Funding: None of the authors have a financial relationship with a commercial entity that has an interest in the subject.