Sowing "seeds of trust": How trust in normothermic regional perfusion is built in a continuum of care.

Normothermic regional perfusion (NRP) is a promising technology to improve organ transplantation outcomes by reversing ischemic injury caused by controlled donation after circulatory determination of death. However, it has not yet been implemented in Canada due to ethical questions. These issues must be resolved to preserve public trust in organ donation and transplantation. This qualitative, constructivist grounded theory study sought to understand how those most impacted by NRP perceived the ethical implications. We interviewed 29 participants across stakeholder groups of donor families, organ recipients, donation and transplantation system leaders, and care providers. The interview protocol included a short presentation about the purpose of NRP and procedures in abdomen versus chest and abdomen NRP, followed by questions probing potential violations of the dead donor rule and concerns regarding brain reperfusion. The results present a grounded theory placing NRP within a trust-building continuum of care for the donor, their family, and organ recipients. Stakeholders consistently described both forms of NRP as an ethical intervention, but their rationales were predicated on assumptions that neurologic criteria for death had been met following circulatory death determination. Empirical validation of these assumptions will help ground the implementation of NRP in a trust-preserving way.

Cost-effectiveness of a Novel Hypoglycaemia Programme: The 'HARPdoc vs BGAT' RCT.

AIMS: To assess the cost-effectiveness of HARPdoc (Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised care), focussed upon cognitions and motivation, versus BGAT (Blood Glucose Awareness Training), focussed on behaviours and education, as adjunctive treatments for treatment-resistant problematic hypoglycaemia in type 1 diabetes, in a randomised controlled trial. METHODS: Eligible adults were randomised to either intervention. Quality of life (QoL, measured using EQ-5D-5L); cost of utilisation of health services (using the adult services utilization schedule, AD-SUS) and of programme implementation and curriculum delivery were measured. A cost-utility analysis was undertaken using quality-adjusted life years (QALYs) as a measure of trial participant outcome and cost-effectiveness was evaluated with reference to the incremental net benefit (INB) of HARPdoc compared to BGAT. RESULTS: Over 24 months mean total cost per participant was £194 lower for HARPdoc compared to BGAT (95% CI: -£2498 to £1942). HARPdoc was associated with a mean incremental gain of 0.067 QALYs/participant over 24 months post-randomisation: an equivalent gain of 24 days in full health. The mean INB of HARPdoc compared to BGAT over 24 months was positive: £1521/participant, indicating comparative cost-effectiveness, with an 85% probability of correctly inferring an INB > 0. CONCLUSIONS: Addressing health cognitions in people with treatment-resistant hypoglycaemia achieved cost-effectiveness compared to an alternative approach through improved QoL and reduced need for medical services, including hospital admissions. Compared to BGAT, HARPdoc offers a cost-effective adjunct to educational and technological solutions for problematic hypoglycaemia.

Tailored psychological intervention for anxiety or depression in COPD (TANDEM): a randomised controlled trial.

BACKGROUND: The TANDEM multicentre, pragmatic, randomised controlled trial evaluated whether a tailored psychological intervention based on a cognitive behavioural approach for people with COPD and symptoms of anxiety and/or depression improved anxiety or depression compared with usual care (control). METHODS: People with COPD and moderate to very severe airways obstruction and Hospital Anxiety and Depression Scale subscale scores indicating mild to moderate anxiety (HADS-A) and/or depression (HADS-D) were randomised 1.25:1 (242 intervention and 181 control). Respiratory health professionals delivered the intervention face-to-face over 6-8 weeks. Co-primary outcomes were HADS-A and HADS-D measured 6 months post-randomisation. Secondary outcomes at 6 and 12 months included: HADS-A and HADS-D (12 months), Beck Depression Inventory II, Beck Anxiety Inventory, St George's Respiratory Questionnaire, social engagement, the EuroQol instrument five-level version (EQ-5D-5L), smoking status, completion of pulmonary rehabilitation, and health and social care resource use. RESULTS: The intervention did not improve anxiety (HADS-A mean difference -0.60, 95% CI -1.40-0.21) or depression (HADS-D mean difference -0.66, 95% CI -1.39-0.07) at 6 months. The intervention did not improve any secondary outcomes at either time-point, nor did it influence completion of pulmonary rehabilitation or healthcare resource use. Deaths in the intervention arm (13/242; 5%) exceeded those in the control arm (3/181; 2%), but none were associated with the intervention. Health economic analysis found the intervention highly unlikely to be cost-effective. CONCLUSION: This trial has shown, beyond reasonable doubt, that this cognitive behavioural intervention delivered by trained and supervised respiratory health professionals does not improve psychological comorbidity in people with advanced COPD and depression or anxiety.

Navigating disagreement and conflict in the context of a brain-based definition of death.

In this paper, we discuss situations in which disagreement or conflict arises in the critical care setting in relation to the determination of death by neurologic criteria, including the removal of ventilation and other somatic support. Given the significance of declaring a person dead for all involved, an overarching goal is to resolve disagreement or conflict in ways that are respectful and, if possible, relationship preserving. We describe four different categories of reasons for these disagreements or conflicts: 1) grief, unexpected events, and needing time to process these events; 2) misunderstanding; 3) loss of trust; and 4) religious, spiritual, or philosophical differences. Relevant aspects of the critical care setting are also identified and discussed. We propose several strategies for navigating these situations, appreciating that these may be tailored for a given care context and that multiple strategies may be helpfully used. We recommend that health institutions develop policies that outline the process and steps involved in addressing situations where there is ongoing or escalating conflict. These policies should include input from a broad range of stakeholders, including patients and families, as part of their development and review.

RéSUMé: Dans cet article, nous discutons des situations dans lesquelles un désaccord ou un conflit survient dans le contexte des soins intensifs en ce qui concerne une détermination de décès selon des critères neurologiques, y compris le retrait de la ventilation et d'autres assistances somatiques. Compte tenu de l'importance pour toutes les personnes impliquées de déclarer une personne décédée, un objectif primordial est de résoudre les désaccords ou les conflits de manière respectueuse et, si possible, de préserver les relations. Nous décrivons quatre catégories différentes de raisons causant ces désaccords ou conflits : 1) le chagrin, des événements inattendus et le besoin de temps pour accepter ces événements; 2) les malentendus; 3) la perte de confiance; et 4) les différences religieuses, spirituelles ou philosophiques. Les aspects pertinents du milieu des soins intensifs sont également identifiés et discutés. Nous proposons plusieurs stratégies pour gérer ces situations, en étant conscients que celles-ci peuvent être adaptées à un contexte de soins donné et que plusieurs stratégies peuvent être utiles à appliquer. Nous recommandons que les établissements de santé élaborent des politiques qui décrivent le processus et les étapes nécessaires pour faire face aux situations où il y a un conflit en cours ou qui s'intensifie. Dans le cadre de leur élaboration et de leur examen, ces politiques devraient inclure les commentaires d'un large éventail d'intervenants, y compris les patients et les familles.

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.

Evaluation of the Growth Assessment Protocol (GAP) for antenatal detection of small for gestational age: The DESiGN cluster randomised trial.

BACKGROUND: Antenatal detection and management of small for gestational age (SGA) is a strategy to reduce stillbirth. Large observational studies provide conflicting results on the effect of the Growth Assessment Protocol (GAP) in relation to detection of SGA and reduction of stillbirth; to the best of our knowledge, there are no reported randomised control trials. Our aim was to determine if GAP improves antenatal detection of SGA compared to standard care. METHODS AND FINDINGS: This was a pragmatic, superiority, 2-arm, parallel group, open, cluster randomised control trial. Maternity units in England were eligible to participate in the study, except if they had already implemented GAP. All women who gave birth in participating clusters (maternity units) during the year prior to randomisation and during the trial (November 2016 to February 2019) were included. Multiple pregnancies, fetal abnormalities or births before 24+1 weeks were excluded. Clusters were randomised to immediate implementation of GAP, an antenatal care package aimed at improving detection of SGA as a means to reduce the rate of stillbirth, or to standard care. Randomisation by random permutation was stratified by time of study inclusion and cluster size. Data were obtained from hospital electronic records for 12 months prerandomisation, the washout period (interval between randomisation and data collection of outcomes), and the outcome period (last 6 months of the study). The primary outcome was ultrasound detection of SGA (estimated fetal weight <10th centile using customised centiles (intervention) or Hadlock centiles (standard care)) confirmed at birth (birthweight <10th centile by both customised and population centiles). Secondary outcomes were maternal and neonatal outcomes, including induction of labour, gestational age at delivery, mode of birth, neonatal morbidity, and stillbirth/perinatal mortality. A 2-stage cluster-summary statistical approach calculated the absolute difference (intervention minus standard care arm) adjusted using the prerandomisation estimate, maternal age, ethnicity, parity, and randomisation strata. Intervention arm clusters that made no attempt to implement GAP were excluded in modified intention to treat (mITT) analysis; full ITT was also reported. Process evaluation assessed implementation fidelity, reach, dose, acceptability, and feasibility. Seven clusters were randomised to GAP and 6 to standard care. Following exclusions, there were 11,096 births exposed to the intervention (5 clusters) and 13,810 exposed to standard care (6 clusters) during the outcome period (mITT analysis). Age, height, and weight were broadly similar between arms, but there were fewer women: of white ethnicity (56.2% versus 62.7%), and in the least deprived quintile of the Index of Multiple Deprivation (7.5% versus 16.5%) in the intervention arm during the outcome period. Antenatal detection of SGA was 25.9% in the intervention and 27.7% in the standard care arm (adjusted difference 2.2%, 95% confidence interval (CI) -6.4% to 10.7%; p = 0.62). Findings were consistent in full ITT analysis. Fidelity and dose of GAP implementation were variable, while a high proportion (88.7%) of women were reached. Use of routinely collected data is both a strength (cost-efficient) and a limitation (occurrence of missing data); the modest number of clusters limits our ability to study small effect sizes. CONCLUSIONS: In this study, we observed no effect of GAP on antenatal detection of SGA compared to standard care. Given variable implementation observed, future studies should incorporate standardised implementation outcomes such as those reported here to determine generalisability of our findings. TRIAL REGISTRATION: This trial is registered with the ISRCTN registry, ISRCTN67698474.

Outcomes of lung transplantation from organ donation after medical assistance in dying: First North American experience.

Over 2.5% of deaths in Canada occur as a result from medical assisting in dying (MAID), and a subset of these deaths result in organ donation. However, detailed outcomes of lung transplant recipients using these donors is lacking. This is a retrospective single center cohort study comparing lung transplantation outcomes after donation using MAID donors compared to neurologically determined death and controlled donation after circulatory death (NDD/cDCD) donors from February 2018 to July 2021. Thirty-three patients received lungs from MAID donors, and 560 patients received lungs from NDD/cDCD donors. The donor diagnoses leading to MAID provision were degenerative neurological diseases (n = 33) and end stage organ failure (n = 5). MAID donors were significantly older than NDD/cDCD donors (56 [IQR 49-64] years vs. 48 [32-59]; p = .0009). Median ventilation period and 30 day mortality were not significantly different between MAID and NDD/cDCD lungs recipients (ventilation: 1 day [1-3] vs 2 days [1-3]; p = .37, deaths 0% [0/33] vs. 2% [11/560], p = .99 respectively). Intermediate-term outcomes were also similar. In summary, for lung transplantation using donors after MAID, recipient outcomes were excellent. Therefore, where this practice is permitted, donation after MAID should be strongly considered for lung transplantation as a way to respect donor wishes while substantially improving outcomes for recipients with end-stage lung disease.

Practice and challenges for organ donation after medical assistance in dying: A scoping review including the results of the first international roundtable in 2021.

The procedure combining medical assistance in dying (MAiD) with donations after circulatory determination of death (DCDD) is known as organ donation after euthanasia (ODE). The first international roundtable on ODE was held during the 2021 WONCA family medicine conference as part of a scoping review. It aimed to document practice and related issues to advise patients, professionals, and policymakers, aiding the development of responsible guidelines and helping to navigate the issues. This was achieved through literature searches and national and international stakeholder meetings. Up to 2021, ODE was performed 286 times in Canada, the Netherlands, Spain, and Belgium, including eight cases of ODE from home (ODEH). MAiD was provided 17,217 times (2020) in the eight countries where ODE is permitted. As of 2021, 837 patients (up to 14% of recipients of DCDD donors) had received organs from ODE. ODE raises some important ethical concerns involving patient autonomy, the link between the request for MAiD and the request to donate organs and the increased burden placed on seriously ill MAiD patients.

Lung donation after medical assistance in dying at home.

Organ donation after medical assistance in dying (MAID) has only been possible for patients having the MAID procedure performed at a hospital facility due to prohibitive warm ischemic times. Herein, we describe a protocol for lung donation following MAID at home and demonstrate excellent postoperative outcomes. Lung donation following MAID at home is possible and should be considered by transplant programs.

Preoperative comprehensive geriatric assessment and optimisation prior to elective arterial vascular surgery: a health economic analysis.

BACKGROUND: increasing numbers of older people are undergoing vascular surgery. Preoperative comprehensive geriatric assessment and optimisation (CGA) reduces postoperative complications and length of hospital stay. Establishing CGA-based perioperative services requires health economic evaluation prior to implementation. Through a modelling-based economic evaluation, using data from a single site clinical trial, this study evaluates whether CGA is a cost-effective alternative to standard preoperative assessment for older patients undergoing elective arterial surgery. METHODS: an economic evaluation, using decision-analytic modelling, comparing preoperative CGA and optimisation with standard preoperative care, was undertaken in older patients undergoing elective arterial surgery. The incremental net health benefit of CGA, expressed in terms of quality-adjusted life-years (QALYs), was used to evaluate cost-effectiveness. RESULTS: CGA is a cost-effective substitute for standard preoperative care in elective arterial surgery across a range of cost-effectiveness threshold values. An incremental net benefit of 0.58 QALYs at a cost-effectiveness threshold of £30k, 0.60 QALYs at a threshold of £20k and 0.63 QALYs at a threshold of £13k was observed. Mean total pre- and postoperative health care utilisation costs were estimated to be £1,165 lower for CGA patients largely accounted for by reduced postoperative bed day utilisation. CONCLUSION: this study demonstrates a likely health economic benefit in addition to the previously described clinical benefit of employing CGA methodology in the preoperative setting in older patients undergoing arterial surgery. Further evaluation should examine whether CGA-based perioperative services can be effectively implemented and achieve the same clinical and health economic outcomes at scale.

The variable impact of the overdose crisis on organ donation among five Canadian provinces: a retrospective study.

BACKGROUND: While most overdose deaths in Canada occur in the community, some patients are resuscitated, admitted to intensive care units having sustained severe anoxic brain injury, and have the potential to be organ donors. The purpose of this study was to determine the impact of the overdose crisis on organ donation in selected Canadian provinces. METHODS: We obtained data on the total number of organ donors and those dying because of overdose in five Canadian provinces from 2014 to 2018. We also obtained data for January-June 2019 for four of five provinces (Quebec excepted). We accessed federal and provincial data on the number of overdose deaths and compared the proportion of organ donors who died of an overdose both over time and between provinces. The number of organ transplants resulting from donors dying of an overdose from three provinces was also determined. RESULTS: From 2014 to 2017, there was a 35% increase (554 to 747) in total deceased organ donors but a 294% increase (31 to 122) in organ donors dying of an overdose. While the proportion of organ donors dying from an overdose increased overall, this varied from 35% (42 of 121) in British Columbia to < 5% in both Quebec (9 of 182) and Nova Scotia (< 2 of 16). There were 1,043 organ transplants resulting from organ donors dying of overdose in BC, Ontario and Alberta although only 2.5-3.5% (297 of 10,858) of those dying of an overdose became organ donors. CONCLUSIONS: There has been an increase in organ donors dying from drug overdose in Canada. Regional variation mirrors differences in total opiate-related death.

RéSUMé: CONTEXTE: Bien que la plupart des décès par surdose au Canada surviennent dans la collectivité, certains patients sont réanimés et admis dans des unités de soins intensifs après avoir subi de graves lésions cérébrales anoxiques, et peuvent devenir des donneurs d'organes. L'objectif de cette étude était de déterminer l'impact de la crise des surdoses sur le don d'organes dans certaines provinces canadiennes. MéTHODE: Nous avons obtenu des données concernant le nombre total de donneurs d'organes et de personnes décédées d'une surdose dans cinq provinces canadiennes de 2014 à 2018. Nous avons également obtenu des données pour la période de janvier à juin 2019 pour quatre des cinq provinces (à l'exception du Québec). Nous avons consulté les données fédérales et provinciales sur le nombre de décès par surdose et comparé la proportion de donneurs d'organes décédés d'une surdose au fil du temps et entre les provinces. Le nombre de greffes d'organes provenant de donneurs décédés par surdose dans trois provinces a également été déterminé. RéSULTATS: Entre 2014 et 2017, il y a eu une augmentation de 35 % (de 554 à 747) du nombre total de donneurs d'organes décédés, mais une augmentation de 294 % (de 31 à 122) du nombre de donneurs d'organes décédés d'une surdose. Bien que la proportion de donneurs d'organes décédés d'une surdose ait augmenté dans l'ensemble, cette proportion variait de 35 % (42 sur 121) en Colombie-Britannique à < 5 % au Québec (9 sur 182) et en Nouvelle-Écosse (< 2 sur 16). Il y a eu 1043 greffes d'organes provenant de donneurs décédés par surdose en Colombie-Britannique, en Ontario et en Alberta, bien que seulement 2,5 à 3,5 % (297 sur 10 858) des personnes décédées d'une surdose soient devenues donneurs d'organes. CONCLUSION: Il y a eu une augmentation du nombre de donneurs d'organes décédés d'une surdose de drogue au Canada. La variation régionale reflète les différences dans le nombre total de décès liés aux opiacés.

Requests for somatic support after neurologic death determination: Canadian physician experiences.

PURPOSE: Neurologic determination of death (NDD) is legally accepted as death in Canada but remains susceptible to misunderstandings. In some cases, families request continued organ support after NDD. Conflicts can escalate to formal legal challenges, causing emotional, financial, and moral distress for all involved. We describe prevalence, characteristics, and common experiences with requests for continued organ support following NDD in Canada. METHODS: Mixed-methods design combining anonymous online survey with semi-structured interviews of Canadian critical care physicians (448 practitioners, adult and pediatric). RESULTS: One hundred and six physicians responded to the survey and 12 participated in an interview. Fifty-two percent (55/106) of respondents had encountered a request for continued organ support after NDD within two years, 47% (26/55) of which involved threat of legal action. Requests for continued support following NDD ranged from appeals for time for family to gather before ventilator removal to disagreement with the concept of NDD. Common responses to requests included: consultation with an additional physician (54%), consultation with spiritual services (41%), and delay of one to three days for NDD acceptance (49%). Respondents with prior experience were less likely to recommend ancillary tests (P = 0.004) or consultation with bioethics services (P = 0.004). Qualitative analysis revealed perceptions that requests for continued organ support were driven by mistrust, tensions surrounding decision-making, and cultural differences rather than a lack of specific information about NDD. CONCLUSIONS: Family requests for continued somatic support following NDD were encountered by half our sample of Canadian critical care physicians. Mitigation strategies require attention to the multifaceted social contexts surrounding these complex scenarios.

RéSUMé: OBJECTIF: Au Canada, le diagnostic de décès neurologique (DDN) est légalement accepté en tant que décès, mais il est encore mal compris parfois. Dans certains cas, les familles demandent de maintenir artificiellement les fonctions vitales après un DDN. Les conflits peuvent dégénérer et devenir des contestations judiciaires formelles, provoquant de la détresse émotionnelle, financière et morale pour tous. Nous décrivons la prévalence, les caractéristiques et les expériences fréquemment vécues en lien avec des demandes de maintien artificiel des fonctions vitales après un DDN au Canada. MéTHODE: Méthodologie mixte combinant un sondage électronique anonyme à des entretiens semi-structurés de médecins intensivistes canadiens (448 praticiens, populations adulte et pédiatrique). RéSULTATS: Cent six médecins ont répondu au sondage et 12 ont participé à un entretien. Cinquante-deux pour cent (55/106) des répondants avaient déjà reçu une demande de maintien des fonctions vitales après un DDN au cours des deux dernières années, dont 47 % (26/55) étaient accompagnées de menaces de poursuite judiciaire. Les demandes de maintien continu à la suite d'un DDN allaient des requêtes de temps supplémentaire pour que la famille puisse se réunir avant de débrancher le respirateur aux désaccords quant au concept même de DDN. Les réponses fréquentes aux demandes étaient : la consultation d'un autre médecin (54 %), la consultation des services spirituels (41 %), et un délai d'un à trois jours pour accepter le DDN (49 %). Les répondants ayant déjà eu une expérience similaire avaient moins tendance à recommander des tests supplémentaires (P = 0,004) ou une consultation auprès des services de bioéthique (P = 0,004). L'analyse qualitative a révélé des perceptions selon lesquelles les demandes de maintien des soins étaient motivées par la méfiance, des tensions autour de la prise de décision et des différences d'ordre culturel plutôt que par le manque d'informations spécifiques concernant le DDN. CONCLUSION: La moitié de notre échantillon de médecins intensivistes canadiens ont déjà été confrontés à des demandes de la famille pour maintenir le soutien des fonctions vitales à la suite d'un DDN. Les stratégies de mitigation doivent tenir compte des contextes sociaux aux multiples facettes entourant ces situations complexes.

Heart donation and transplantation after circulatory determination of death: expert guidance from a Canadian consensus building process.

Controlled donation after circulatory determination of death (DCD), where death is determined after cardiac arrest, has been responsible for the largest quantitative increase in Canadian organ donation and transplants, but not for heart transplants. Innovative international advances in DCD heart transplantation include direct procurement and perfusion (DPP) and normothermic regional perfusion (NRP). After death is determined, DPP involves removal and reanimation of the arrested heart on an ex situ organ perfusion system. Normothermic regional perfusion involves surgically interrupting (ligating the aortic arch vessels) brain blood flow after death determination, followed by restarting the heart and circulation in situ using extracorporeal membrane oxygenation. The objectives of this Canadian consensus building process by a multidisciplinary group of Canadian stakeholders were to review current evidence and international DCD heart experience, comparatively evaluate international protocols with existing Canadian medical, legal, and ethical practices, and to discuss implementation barriers. Review of current evidence and international experience of DCD heart donation (DPP and NRP) determined that DCD heart donation could be used to provide opportunities for more heart transplants in Canada, saving additional lives. Although candid discussion identified a number of potential barriers and challenges for implementing DCD heart donation in Canada, it was determined that DPP implementation is feasible (pending regulatory approval for the use of an ex situ perfusion device in humans) and in alignment with current medical guidelines for DCD. Nevertheless, further work is required to evaluate the consistency of NRP with current Canadian death determination policy and to ensure the absence of brain perfusion during this process.

RéSUMé: Le don contrôlé après un décès circulatoire (DDC), cas dans lequel le décès est déterminé après un arrêt cardiaque, est à l'origine de la plus forte augmentation quantitative des dons et des transplantations d'organes au Canada, sauf pour les transplantations cardiaques. Parmi les progrès internationaux novateurs dans la transplantation cardiaque après DDC, citons l'obtention directe et perfusion (ODP) et la circulation régionale normothermique (CRN). Une fois le décès déterminé, l'ODP consiste à retirer et réanimer le cœur arrêté sur un système de perfusion ex situ. La circulation régionale normothermique consiste à interrompre de manière chirurgicale (en ligaturant les vaisseaux de l'arc aortique) le flux sanguin au cerveau après la détermination du décès, puis à redémarrer le cœur et la circulation in situ utilisant l'oxygénation par membrane extracorporelle (ECMO). Les objectifs de ce processus canadien d'établissement de consensus par un groupe multidisciplinaire d'intervenants canadiens étaient d'examiner les données probantes et les expériences internationales actuelles en matière de DDC, d'évaluer comparativement les protocoles internationaux par rapport aux pratiques médicales, juridiques et éthiques canadiennes existantes, et de discuter des obstacles à la mise en œuvre de tels protocoles. L'examen des données probantes et des expériences internationales actuelles en matière de don de cœur après DDC (ODP et CRN) a permis de déterminer que le don de cœur après DDC pourrait être utilisé afin de faire de plus nombreuses transplantations cardiaques au Canada, sauvant ainsi des vies supplémentaires. Bien que des discussions aient permis d'identifier plusieurs obstacles et défis potentiels à la mise en œuvre du don cardiaque après DDC au Canada, il a été déterminé que la mise en œuvre de l'ODP est réalisable (en attente de l'approbation réglementaire pour l'utilisation d'un dispositif de perfusion ex situ chez l'humain) et en accord avec les directives médicales actuelles concernant le DDC. Néanmoins, d'autres travaux sont nécessaires pour évaluer la conformité de la CRN aux politiques canadiennes actuelles de détermination de la mort et pour garantir l'absence de perfusion cérébrale au cours de ce processus.

Ideal body position for epinephrine autoinjector administration.

Background: Epinephrine is the first-line therapy for patients with anaphylaxis, and intramuscular (IM) delivery is shown to be superior to subcutaneous (SC) delivery. There currently is no consensus on the ideal body position for epinephrine autoinjector (EAI) administration. Objective: We designed this study to investigate whether SC tissue depth (SCTD) is affected by body position (e.g., standing, sitting, supine), which can potentially impact delivery of EAI into the IM space. Methods: Volunteer adults (ages ≥ 18 years) from a military medical treatment facility in the United States were recruited to participate in this study. SCTD of the vastus lateralis was measured via ultrasound at standing, sitting, and supine body positions. Subjects' age, sex, and body mass index (BMI) were collected. Statistical analysis was performed to compare average SCTD between body positions, sex, and BMI. Results: An analysis of variance of 51 participants (33 men and 18 women) did not reveal statistically significant difference in SCTD among standing, sitting, and supine body positions. It did show a significantly greater SCTD in women than in men (2.72 ± 1.36 cm versus 1.10 ± 0.38 cm; p < 0.001). There was no significant association observed between BMI and SCTD in this study. Conclusion: Body position did not seem to significantly change the distance between skin and thigh muscle in adults. This would suggest that there might not be an ideal body position for EAI administration. Therefore, in case of anaphylaxis, prompt administration of epinephrine is recommended at any position.

Initial lung transplantation experience with uncontrolled donation after cardiac death in North America.

Uncontrolled donation after cardiac death (uDCD) has the potential to ameliorate the shortage of suitable lungs for transplant. To date, no lung transplant data from these donors are available from North America. We describe the successful use of these donors using a simple method of in situ lung inflation so that the organ can be protected from warm ischemic injury. Forty-four potential donors were approached, and family consent was obtained in 30 cases (68%). Of these, the lung transplant team evaluated 16 uDCDs on site, and 14 were considered for transplant pending ex vivo lung perfusion assessment. Five lungs were ultimately used for transplant (16.7% use rate from consented donors). The mean warm ischemic time was 2.8 hours. No primary graft dysfunction grade 3 was observed at 24, 48, or 72 hours after transplant. Median intensive care unit stay was 5 days (range: 2-78 days), and median hospital stay was 17 days (range: 8-100 days). The 30-day mortality was 0%. Four of 5 patients are alive at a median of 651 days (range: 121-1254 days) with preserved lung function. This study demonstrates the proof of concept and the potential for uDCD lung donation using a simple donor intervention.

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.

Organ donation in patients on extracorporeal membrane oxygenation: considerations for determination of death and withdrawal of life support.

The use of extracorporeal membrane oxygenation (ECMO) is increasing globally, although mortality in this setting remains high. Patients on ECMO may be potential organ donors in the context of withdrawal of life-sustaining measures (WLSM) or neurologic determination of death (NDD). Nevertheless, there are currently no Canadian standards to guide clinicians on NDD or WLSM for the purposes of organ donation in this patient population. Apnea testing remains fundamental to determining NDD and is an area where ECMO may alter routine procedures. In this review, we outline protocols for the performance of apnea testing and WLSM for patients supported with ECMO, highlighting important technical and physiologic considerations that may affect the determination of death. In addition, we review important considerations for NDD in ECMO, including management of potential confounders, strategies for controlling oxygen and carbon dioxide levels during apnea testing, and the appropriate use of ancillary tests to support NDD. In the context of ECMO support, there is limited evidence to guide NDD and WLSM for the purposes of organ donation. Drawing upon extensive clinical experience, we provide protocols for these processes and review other important considerations in an effort to maximize donor potential in this growing patient population.

RéSUMé: L'utilisation de l'oxygénation extracorporelle (ECMO) augmente dans le monde, malgré le fait que la mortalité associée demeure élevée. Les patients sous ECMO pourraient être des donneurs d'organes potentiels dans le cadre d'une interruption des mesures de maintien des fonctions vitales ou d'un diagnostic de décès neurologique (DDN). À l'heure actuelle il n'existe cependant aucune norme canadienne pour guider les cliniciens en matière de DDN ou d'interruption des mesures de maintien des fonctions vitales aux fins de dons d'organes dans cette population de patients. Le test d'apnée demeure fondamental pour poser un DDN mais il s'agit d'un domaine dans lequel l'ECMO pourrait modifier les interventions de routine. Dans ce compte rendu, nous décrivons des protocoles pour la réalisation d'un test d'apnée et l'interruption des mesures de maintien des fonctions vitales chez des patients sous ECMO. Nous soulignons certaines considérations techniques et physiologiques importantes qui pourraient avoir un impact sur le diagnostic de décès. En outre, nous passons en revue certaines considérations importantes pour le DDN sous ECMO, notamment la prise en charge de facteurs confondants potentiels, les stratégies pour contrôler les niveaux d'oxygène et de dioxyde de carbone pendant le test d'apnée, et l'utilisation adaptée de tests complémentaires pour appuyer le DDN. Dans le cadre d'un maintien des fonctions vitales sous ECMO, il n'existe que peu de données probantes pour guider le DDN et l'interruption des mesures de maintien des fonctions vitales aux fins d'un don d'organes. En nous fondant sur notre vaste expérience clinique, nous proposons des protocoles pour ces processus et passons en revue d'autres considérations importantes afin de maximiser le potentiel de dons dans cette population de patients grandissante.

Improving quality of withdrawal of life-sustaining measures in organ donation: a framework and implementation toolkit.

BACKGROUND: Donation after circulatory determination of death (DCD) is responsible for the largest increase in deceased donation over the past decade. When the Canadian DCD guideline was published in 2006, it included recommendations to create standard policies and procedures for withdrawal of life-sustaining measures (WLSM) as well as quality assurance frameworks for this practice. In 2016, the Canadian Critical Care Society produced a guideline for WLSM that requires modifications to facilitate implementation when DCD is part of the end-of-life care plan. METHODS: A pan-Canadian multidisciplinary collaborative was convened to examine the existing guideline framework and to create tools to put the existing guideline into practice in centres that practice DCD. RESULTS: A set of guiding principles for implementation of the guideline in DCD practice were produced using an iterative, consensus-based approach followed by development of four implementation tools and three quality assurance and audit tools. CONCLUSIONS: The tools developed will aid DCD centres in fulsomely adapting the Canadian Critical Care Society Withdrawal of Life-Sustaining Measures guideline.

RéSUMé: CONTEXTE : Au cours des dix dernières années, le don d'organe après un décès cardiocirculatoire (DDC) a été à l'origine de la plus importante augmentation de dons provenant d'individus décédés. Les lignes directrices canadiennes sur le DDC, publiées en 2006, recommandaient la création de politiques et de procédures standard pour l'interruption des traitements de maintien des fonctions vitales (TMFV) ainsi que celle de cadres d'assurance de la qualité pour cette pratique. En 2016, la Société canadienne de soins intensifs a publié des recommandations concernant les TMFV; ces recommandations nécessitent des modifications pour pouvoir être facilement mises en œuvre lorsque le DDC fait partie du plan de soins de fin de vie. MéTHODE : Un groupe collaboratif multidisciplinaire pancanadien s'est réuni afin d'examiner le cadre établi par les lignes directrices existantes et créer des outils pour mettre en œuvre ces recommandations dans les centres pratiquant le DDC. RéSULTATS : En utilisant une approche itérative et consensuelle, un ensemble de principes directeurs a été créé pour mettre en œuvre des directives concernant la pratique du DDC : quatre outils d'implantation et trois outils d'assurance de la qualité et d'audit ont été mis au point. CONCLUSION : Les outils créés aideront les centres de DDC à adapter de manière plus complète les Lignes directrices pour l'interruption des traitements de maintien des fonctions vitales de la Société canadienne de soins intensifs.

Patient engagement in a Canadian consensus forum for heart donation after circulatory determination of death.

PURPOSE: Heart donation and transplantation following circulatory determination of death has yet to be performed in Canada. A consensus forum was held to provide expert guidance to inform policy with a comprehensive patient partner strategy. This paper describes the process used to create fulsome patient partner engagement resulting in mutually beneficial policy development in this complex area. METHODS: A wide-ranging process for involving patient partners in this area included pre-meeting education, in-meeting expert support, full participation and permission to step back if desired, and post-meeting debriefing. Following the meeting, a questionnaire was used to guide a debrief discussion with patient partners and steering committee members who co-authored this paper. RESULTS: Five key themes arose that echoed the sentiments and contributions made by patient partners, including: 1) a strong desire to improve the system, 2) gratitude and honour, 3) expert support and process, 4) simplification of complex concepts, and 5) mutual benefit expressed by patient partners and healthcare professionals. CONCLUSION: Despite the complexity of the content and the emotionally sensitive nature of discussions around deceased organ donation, a well-planned strategy to involve patient partners is important, impactful, and central to the process. This suggests a broad interprofessional audience can engage with properly prepared and supported patient partners to strengthen and focus dialogue and outputs in the development of health policy in the donation and transplant sector.

RéSUMé: OBJECTIF: Le don et la greffe cardiaque à la suite d'un décès circulatoire n'ont encore jamais été réalisés au Canada. Un forum de consensus a été organisé dans le but de formuler des recommandations spécifiques qui guideraient les politiques avec une stratégie globale incluant les patients partenaires. Cet article décrit le processus utilisé pour susciter une implication complète des patients partenaires, avec pour résultat la mise au point de politiques mutuellement bénéfiques dans ce domaine complexe. MéTHODE: Nous avons amorcé un vaste processus pour impliquer les patients partenaires dans ce domaine, processus qui a consisté en une formation préliminaire avant la rencontre, le soutien d'experts pendant la rencontre, la participation complète et la permission de se retirer du processus si désiré, et le débriefing après la rencontre. À la suite de la rencontre, un questionnaire a servi à orienter les discussions de débriefing avec les patients partenaires et les membres du comité directeur ayant collaboré à cet article. RéSULTATS: Cinq thèmes clés sont ressortis des discussions, faisant écho aux sentiments et aux contributions des patients partenaires, soit : 1) un profond désir d'améliorer le système, 2) la gratitude et l'honneur, 3) le soutien par et un processus d'experts, 4) la simplification des concepts complexes, et 5) les avantages mutuels exprimés par les patients partenaires et les professionnels de la santé. CONCLUSION: Malgré la complexité du contenu et la nature émotionnellement sensible des discussions entourant le don d'organes après décès, une stratégie bien planifiée d'implication des patients partenaires est importante, a un impact et doit être placée au centre du processus. Cela suggère qu'une vaste équipe interprofessionnelle peut s'impliquer auprès de patients partenaires bien préparés et convenablement soutenus; une telle approche permettra de renforcer et de concentrer le dialogue et les résultats lors de la mise au point de politiques de santé dans le secteur du don et de la greffe.

Acceptability of cardiac donation after circulatory determination of death: a survey of the Canadian public.

PURPOSE: Cardiac transplantation is a definitive therapy for end-stage heart failure, but demand exceeds supply. Cardiac donation after circulatory determination of death (cardiac DCDD) can be performed using direct procurement and perfusion (DPP), where cardiac activity is restored after heart recovery, or (NRP), where brain blood supply is surgically interrupted, circulation to the thoraco-abdominal organs is restored within the donor's body, followed by heart recovery. While cardiac DCDD would increase the number of heart donors, uptake of programs has been slowed in part because of ethical concerns within the medical community. These debates have been largely devoid of discussion regarding public perceptions. We conducted a national survey of public perceptions regarding cardiac DCDD. METHODS: We surveyed 1,001 Canadians about their attitudes towards cardiac DCDD using a rigorously designed and pre-tested survey. RESULTS: We found that 843 of 1,001 respondents (84.2%; 95% confidence interval [CI], 81.8 to 86.3) accepted the DPP approach, 642 (64.1%; 95% CI, 61.1 to 67.0) would agree to donate their heart using DPP, and 696 (69.5%; 95% CI, 66.6 to 72.3) would consent to the same for a family member. We found that 779 respondents of 1,001 respondents (77.8%; 95% CI, 75.1 to 80.3) accepted the NRP approach, 587 (58.6%; 95% CI, 55.5 to 61.6) would agree to donate their heart using NRP, and 636 (63.5%; 95% CI, 60.5 to 66.4) would consent to the same for a family member. Most respondents supported the implementation of DPP (738 respondents or 73.7%; 95% CI, 70.9 to 76.3) and NRP (655 respondents or 65.4%; 95% CI, 62.4 to 68.3) in Canada. CONCLUSION: The results of this national survey of public attitudes towards cardiac DCDD will inform the implementation of cardiac DCDD programs in a manner that is consistent with public values.