Dale Gardiner

Extracorporeal membrane oxygenation (ECMO) assisted cardiopulmonary resuscitation or uncontrolled donation after the circulatory determination of death following out-of-hospital refractory cardiac arrest—An ethical analysis of an unresolved clinical dilemma

BACKGROUND The availability of extracorporeal membrane oxygenation (ECMO) assisted cardiopulmonary resuscitation (E-CPR), for use in refractory out-of hospital cardiac arrest (OHCA), is increasing. In parallel, some countries have developed uncontrolled donation after circulatory determination of death (uDCDD) programs using ECMO to preserve organs for transplantation purposes. AIM When facing a refractory OHCA, how does the medical team choose between initiating ECMO as part of an E-CPR protocol or ECMO as part of a uDCDD protocol? METHODS To answer these questions we conducted a literature review on E-CPR compared to uDCDD protocols using ECMO and analyzed the raised ethical issues. RESULTS Our analysis reveals that the inclusion criteria in E-CPR and uDCDD protocols are similar. There may be a non-negligible risk of including patients in a uDCDD protocol, when the patient might have been saved by the use of E-CPR. CONCLUSION In order to avoid the fatal error of letting a saveable patient die, safeguards are necessary. We recommend: (1) the development of internationally accepted termination of resuscitation guidelines that would have to be satisfied prior to inclusion of patients in any uDCDD protocol, (2) the choice regarding modalities of ongoing resuscitation during transfer should be focused on the primary priority of attempting to save the life of patients, (3) only centers of excellence in life-saving resuscitation should initiate or maintain uDCDD programs, (4) E-CPR should be clinically considered first before the initiation of any uDCDD protocol, and (5) there should be no discrimination in the availability of access to E-CPR.

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.

Family over rules? an ethical analysis of allowing families to overrule donation intentions

Abstract Millions of people want to donate their organs after they die for transplantation, and many of them have registered their wish to do so or told their family and friends about their decision. For most of them, however, this wish is unlikely to be fulfilled, as only a small number of deaths (1% in the United Kingdom) occur in circumstances where the opportunity to donate organs is possible. Even for those who do die in the “right” way and have recorded their wishes or live in a jurisdiction with a “presumed consent” system, donation often does not go ahead because of another issue: their families refuse to allow donation to proceed. In some jurisdictions, the rate of “family overrule” is over 10%. In this article, we provide a systematic ethical analysis of the family overrule of donation of solid organs by deceased patients, and examine arguments both in favor of and against allowing relatives to “veto” the potential donors intentions. First, we provide a brief review of the different consent systems in various European countries, and the ramifications for family overrule. Next, we describe and discuss the arguments in favor of permitting donation intentions to be overruled, and then the arguments against doing so. The “pro” arguments are: overrule minimises family distress and staff stress; families need to cooperate for donation to take place; families might have evidence regarding refusal; and failure to permit overrules could weaken trust in the donation system. The “con” arguments are: overrule violates the patients wishes; the family is too distressed and will regret the decision; overruling harms other patients; and regulations prohibit overrule. We conclude with a general discussion and recommendations for dealing with families who wish to overrule donation. Overall, overrule should only rarely be permitted.

Cardio-pulmonary resuscitation of brain-dead organ donors: a literature review and suggestions for practice

“Organ preserving cardiopulmonary resuscitation (OP‐CPR)” is defined as the use of CPR in cases of cardiac arrest to preserve organs for transplantation, rather than to revive the patient. Is it ethical to provide OP‐CPR in a brain‐dead organ donor to save organs that would otherwise be lost? To answer this question, we review the literature on brain‐dead organ donors, conduct an ethical analysis, and make recommendations. We conclude that OP‐CPR can benefit patients and families by fulfilling the wish to donate. However, it is an aggressive procedure that can cause physical damage to patients, and risks psychological harm to families and healthcare professionals. In a brain‐dead organ donor, OP‐CPR is acceptable without specific informed consent to OP‐CPR, although advance discussion with next of kin regarding this possibility is strongly advised. In a patient where brain death is yet to be determined, but there is known wish for organ donation, OP‐CPR would only be acceptable with a specific informed consent from the next of kin. When futility of treatment has not been established or it is as yet unknown if the patient wished to be an organ donor then OP‐CPR should be prohibited, in order to avoid any conflict of interest.

The ethics of extracorporeal membrane oxygenation in brain-dead potential organ donors.

Organ‐preserving extracorporeal membrane oxygenation (OP‐ECMO) is defined as the use of extracorporeal support for the primary purpose of preserving organs for transplantation, rather than to save the patients life. This paper discusses the ethics of using OP‐ECMO in donation after brain determination of death (DBDD) to avoid the loss of organs for transplantation. We review case reports in the literature and analyze the ethical issues raised. We conclude that there is little additional ethical concern in continuing OP‐ECMO in patients already on ECMO if they become brain dead. The implementation of OP‐ECMO in hemodynamically unstable brain‐dead patients is ethically permissible in certain clinical situations but requires specific consent from relatives if the patients wish to donate is not clear. If no evidence of a patients wish to donate is available, OP‐ECMO is not recommended. In countries with presumed consent legislation, failure to opt out should be considered as a positive wish to donate. If a patient is not‐yet brain‐dead or is undergoing testing for brain death, OP‐ECMO is not recommended. Further research on OP‐ECMO is needed to better understand the attitudes of professionals, families, and lay people to ensure agreement on key ethical issues.

Evaluation of Deceased Donation Simulation

Deceased donation occurs at times of significant family distress and it is usually not possible to ‘train’ during these periods. Therefore, learning occurs either in a piecemeal fashion on the job or in classrooms, based on theory and quite removed from the real world of the intensive care environment. Simulation allows staff training and development in a safe environment while enacting real-time events. Nottingham University Hospitals Trust Donation Committee felt that simulation may be an appropriate tool for staff to develop skills in the deceased donation process. A one-day simulation pilot was planned collaboratively with the Trent Simulation and Clinical Skills Centre. This successful pilot demonstrated that simulation was an effective environment to train staff in deceased donation and had the ability to benefit both participants and faculty. A second deceased donation simulation day, unchanged in format, was delivered and the combined outline and results for both days are reported. The intention in future is to support all regional intensive care, emergency medicine and neurosurgery trainees to attend a deceased donation simulation day during their training and to package the course so that it is freely available to other interested centres.

Intensive Care Staff Attitudes to Deceased Organ Donation

Intensive care staff may harbour mixed emotions toward organ donation after circulatory death. We wished to compare these attitudes to donation after brainstem death, as well as explore attitudes toward Specialist Nurses in Organ Donation, who have been embedded into UK intensive care units since 2008. At the Mid-Trent Critical Care Network (MTCCN) annual conference, participants were asked, in small group workshops, to write down words they associated with donation after brainstem death, controlled donation after circulatory death and Specialist Nurses in Organ Donation. The words were later collated and assigned to have either a positive or negative association by three blinded individuals: a medical lawyer, a hospital communications manager and a final year medical student. One hundred and eight intensive care staff participated: 24 (22%) doctors, 61 (57%) nurses and 23 (21%) allied health professionals; 75 (69%) of the participants were female. Participants at the workshop offered a total of 211 words, 93 associated with donation after brainstem death (44%) and 118 (56%) associated with controlled donation after circulatory death. The numbers of positive and negative words associated with the two forms of donation were significantly different (p<0.001) (donation after brainstem death - 68 positive words, 25 negative words; donation after circulatory death - 29 positive words, 89 negative words). This difference remained significant (p<0.001) even after all words (n=48) that did not have unanimous agreement between the three blinded word assigners were excluded. Significantly more positive words (95) were attributed to the Specialist Nurse in Organ Donation than negative words (18) (p<0.001). We conclude that this group of intensive care staff were generally positive toward donation after brainstem death and the embedded Specialist Nurse in Organ Donation, but could harbour negative attitudes toward controlled donation after circulatory death. Only by continuing to address the opinions of healthcare professionals will donation after circulatory death become a usual and not an unusual event.

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 patients 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.

Oxygen saturation and haemodynamic changes prior to circulatory arrest: Implications for transplantation and resuscitation:

Aims To describe the progression of oxygen saturations and blood pressure observations prior to death. Introduction The progression of physiological changes around death is unknown. This has important implications in organ donation and resuscitation. Donated organs have a maximal warm ischaemic threshold. In hypoxic cardiac arrest, an understanding of pre-cardiac arrest physiology is important in prognosticating and will allow earlier identification of terminal states. Methods Data were examined for all regional patients over a two-year period offering organ donation after circulatory death. Frequent observations were taken contemporaneously by the organ donation nurse at the time of and after withdrawal of intensive care. Results In all, 82 case notes were examined of patients aged 0 to 76 (median 52, 4 < 18 years). From withdrawal of intensive care to death took a mean of 28.5 min (range 4 to 185). A terminal deterioration in saturations (from an already low baseline) commenced 14 min prior to circulatory arrest, followed by a blood pressure fall commencing 8 min prior to circulatory arrest, and finally a rapid fall in heart rate commencing 4 min prior to circulatory arrest. Two patients had a warm ischaemic time of greater than 30 min; 15 patients had a warm ischaemia time of 10 min or greater; and 53 patients had a warm ischaemia time of 5 min or less. It was observed that 0/82 patients had saturations of less than 40% for more than 3 min prior to cardiac arrest and 74/82 for more than 2 min. Conclusions There is a perimortem sequence of hypoxia, then hypotension, and then bradycardia. The heart is extremely resistant to hypoxia. A warm ischaemic time of over 30 min is rare.

Donation After the Circulatory Determination of Death: Some Responses to Recent Criticisms

This article defends the criterion of permanence as a valid criterion for declaring death against some well-known recent objections. We argue that it is reasonable to adopt the criterion of permanence for declaring death, given how difficult it is to know when the point of irreversibility is actually reached. We claim that this point applies in all contexts, including the donation after circulatory determination of death context. We also examine some of the potentially unpalatable ramifications, for current death declaration practices, of adopting the irreversibility criterion.