Recent Submissions

  • Cost-effectiveness of adrenaline for out-of-hospital cardiac arrest

    Gardiner, Dale C. (2020)
    BACKGROUND: The 'Prehospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug Administration In Cardiac Arrest' (PARAMEDIC2) trial showed that adrenaline improves overall survival, but not neurological outcomes. We sought to determine the within-trial and lifetime health and social care costs and benefits associated with adrenaline, including secondary benefits from organ donation. METHODS: We estimated the costs, benefits (quality-adjusted life years (QALYs)) and incremental cost-effectiveness ratios (ICERs) associated with adrenaline during the 6-month trial follow-up. Model-based analyses explored how results altered when the time horizon was extended beyond 6 months and the scope extended to include recipients of donated organs. RESULTS: The within-trial (6 months) and lifetime horizon economic evaluations focussed on the trial population produced ICERs of 1,693,003 (1,946,953) and 81,070 (93,231) per QALY gained in 2017 prices, respectively, reflecting significantly higher mean costs and only marginally higher mean QALYs in the adrenaline group. The probability that adrenaline is cost-effective was less than 1% across a range of cost-effectiveness thresholds. Combined direct economic effects over the lifetimes of survivors and indirect economic effects in organ recipients produced an ICER of 16,086 (18,499) per QALY gained for adrenaline with the probability that adrenaline is cost-effective increasing to 90% at a 30,000 (34,500) per QALY cost-effectiveness threshold. CONCLUSIONS: Adrenaline was not cost-effective when only directly related costs and consequences are considered. However, incorporating the indirect economic effects associated with transplanted organs substantially alters cost-effectiveness, suggesting decision-makers should consider the complexity of direct and indirect economic impacts of adrenaline. TRIAL REGISTRATION: ISRCTN73485024 . Registered on 13 March 2014.
  • Resumption of cardiac activity after withdrawal of life-sustaining measures

    Gardiner, Dale C. (2021)
    BACKGROUND: The minimum duration of pulselessness required before organ donation after circulatory determination of death has not been well studied. METHODS: We conducted a prospective observational study of the incidence and timing of resumption of cardiac electrical and pulsatile activity in adults who died after planned withdrawal of life-sustaining measures in 20 intensive care units in three countries. Patients were intended to be monitored for 30 minutes after determination of death. Clinicians at the bedside reported resumption of cardiac activity prospectively. Continuous blood-pressure and electrocardiographic (ECG) waveforms were recorded and reviewed retrospectively to confirm bedside observations and to determine whether there were additional instances of resumption of cardiac activity. RESULTS: A total of 1999 patients were screened, and 631 were included in the study. Clinically reported resumption of cardiac activity, respiratory movement, or both that was confirmed by waveform analysis occurred in 5 patients (1%). Retrospective analysis of ECG and blood-pressure waveforms from 480 patients identified 67 instances (14%) with resumption of cardiac activity after a period of pulselessness, including the 5 reported by bedside clinicians. The longest duration after pulselessness before resumption of cardiac activity was 4 minutes 20 seconds. The last QRS complex coincided with the last arterial pulse in 19% of the patients. CONCLUSIONS: After withdrawal of life-sustaining measures, transient resumption of at least one cycle of cardiac activity after pulselessness occurred in 14% of patients according to retrospective analysis of waveforms; only 1% of such resumptions were identified at the bedside. These events occurred within 4 minutes 20 seconds after a period of pulselessness. (Funded by the Canadian Institutes for Health Research and others.). Copyright © 2021 Massachusetts Medical Society.
  • Chapter 3.12 Organ donation

    Gardiner, Dale C. (2022)
  • Organ donation and transplantation

    Gardiner, Dale C. (2020)
    An ethical organ donation and transplantation program regarding deceased patients donors would balance the needs of the organ recipient with the needs of the organ donor and his or her family. The solution to achieve ethical balance is not easy. The donation community leans toward Kantian ethics to justify actions on the donor, while the transplant community tends toward utilitarian justifications that focus on recipient outcomes. Yet the responsibility to achieve balance lies with both communities (and their wider healthcare colleagues) to work together so that good end-of-life care for donors is achieved while simultaneously increasing the number and quality of deceased organ transplants. This chapter will use our personal knowledge of the British and Spanish organ donation and transplantation systems to ask if organ transplantation fosters or threatens end-of-life care in critical care and emergency medicine. Our conclusion is that by adopting a rule utilitarianism approach, ethical balance is more likely to be achieved. We propose three rules for any donation and transplantation program: (1) The exploration of organ donation for all patients dying in critical care and emergency medicine should be pursued, as organ donation might improve end-of-life care and can honor the ideal of a “good death”; (2) Organ donation must never compromise a “good death”; and (3) All parties should seek to build institutional trustworthiness.
  • 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

    Harvey, Daniel J.; Gardiner, Dale C. (2020)
    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. Copyright © 2020 The Authors. American Journal of Transplantation published by Wiley Periodicals, Inc. on behalf of The American Society of Transplantation and the American Society of Transplant Surgeons.
  • Expanding controlled donation after the circulatory determination of death: Statement from an international collaborative

    Gardiner, Dale C. (2021)
    A decision to withdraw life-sustaining treatment (WLST) is derived by a conclusion that further treatment will not enable a patient to survive or will not produce a functional outcome with acceptable quality of life that the patient and the treating team regard as beneficial. Although many hospitalized patients die under such circumstances, controlled donation after the circulatory determination of death (cDCDD) programs have been developed only in a reduced number of countries. This International Collaborative Statement aims at expanding cDCDD in the world to help countries progress towards self-sufficiency in transplantation and offer more patients the opportunity of organ donation. The Statement addresses three fundamental aspects of the cDCDD pathway. First, it describes the process of determining a prognosis that justifies the WLST, a decision that should be prior to and independent of any consideration of organ donation and in which transplant professionals must not participate. Second, the Statement establishes the permanent cessation of circulation to the brain as the standard to determine death by circulatory criteria. Death may be declared after an elapsed observation period of 5 min without circulation to the brain, which confirms that the absence of circulation to the brain is permanent. Finally, the Statement highlights the value of perfusion repair for increasing the success of cDCDD organ transplantation. cDCDD protocols may utilize either in situ or ex situ perfusion consistent with the practice of each country. Methods to accomplish the in situ normothermic reperfusion of organs must preclude the restoration of brain perfusion to not invalidate the determination of death.
  • Oxygen saturation and haemodynamic changes prior to circulatory arrest: Implications for transplantation and resuscitation

    Gardiner, Dale C. (2019)
    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.
  • The rule of threes: Three factors that triple the likelihood of families overriding first person consent for organ donation in the UK

    Gardiner, Dale C. (2018)
    Between 1 April 2012 and 31 March 2015, 263 of the 2244 families in the UK whose loved ones had registered to donate organs for transplantation after their death on the NHS Organ Donor Register chose to override this decision; an override rate of 11.7%. Multivariable logistic regression analysis was applied to data relating to various aspects of the family approach in order to identify factors associated with such overrides. The factors associated with family overrides were failure to involve the Specialist Nurse for Organ Donation in the family approach (odds ratio 3.0), donation after circulatory death (odds ratio 2.7) and Black, Asian or Minority Ethnicity (odds ratio 2.7). This highlights the need to further engage with these groups in exploring donation as an end of life choice, and suggests that there may be, from the perspective of the family, fundamental differences between donation after brainstem death and circulatory death. It further adds to the body of data linking involvement of the Specialist Nurse for Organ Donation in the family approach to improved UK consent rates.
  • Donation after the circulatory determination of death: Some responses to recent criticisms

    Gardiner, Dale C.
    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.
  • Increasing organ donation rates by revealing recipient details to families of potential donors

    Gardiner, Dale C. (2018)
    Many families refuse to consent to donation from their deceased relatives or over-rule the consent given before death by the patient, but giving families more information about the potential recipients of organs could reduce refusal rates. In this paper, we analyse arguments for and against doing so, and conclude that this strategy should be attempted. While it would be impractical and possibly unethical to give details of actual potential recipients, generic, realistic information about the people who could benefit from organs should be provided to families before they make a decision about donation or attempt to over-rule it. Copyright © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
  • Conscientious objection to deceased organ donation by healthcare professionals

    Gardiner, Dale C. (2018)
    In this article, we analyse the potential benefits and disadvantages of permitting healthcare professionals to invoke conscientious objection to deceased organ donation. There is some evidence that permitting doctors and nurses to register objections can ultimately lead to attitudinal change and acceptance of organ donation. However, while there may be grounds for conscientious objection in other cases such as abortion and euthanasia, the life-saving nature of donation and transplantation renders objection in this context more difficult to justify. In general, dialogue between healthcare professionals is a more appropriate solution, and any objections must be justified with a strong rationale in hospitals where such policies are put in place.
  • An international legal review of the relationship between brain death and organ transplantation

    Gardiner, Dale C. (2018)
    The "dead-donor rule" states that, in any case of vital organ donation, the potential donor should be determined to be dead before transplantation occurs. In many countries around the world, neurological criteria can be used to legally determine death (also referred to as brain death). Nevertheless, there is considerable controversy in the bioethics literature over whether brain death is the equivalent of biological death. This international legal review demonstrates that there is considerable variability in how different jurisdictions have evolved to justify the legal status of brain death and its relationship to the dead-donor rule. In this article, we chose to review approaches that are representative of many different jurisdictions-the United States takes an approach similar to that of many European countries; the United Kingdom's approach is followed by Canada, India, and influences many other Commonwealth countries; Islamic jurisprudence is applicable to several different national laws; the Israeli approach is similar to many Western countries, but incorporates noteworthy modifications; and Japan's relatively idiosyncratic approach has received some attention in the literature. Illuminating these different justifications may help develop respectful policies regarding organ donation within countries with diverse populations and allow for more informed debate about brain death and the dead-donor rule. Copyright 2018 The Journal of Clinical Ethics. All rights reserved.
  • Circulatory arrest, brain arrest and death determination

    Gardiner, Dale C. (2018)
    Technological advances, particularly in the capacity to support, replace or transplant failing organs, continue to challenge and refine our understanding of human death. Given the ability to reanimate organs before and after death, both inside and outside of the body, through reinstitution of oxygenated circulation, concepts related to death of organs (e.g. cardiac death) are no longer valid. This paper advances the rationale for a single conceptual determination of death related to permanent brain arrest, resulting from primary brain injury or secondary to circulatory arrest. The clinical characteristics of brain arrest are the permanent loss of capacity for consciousness and loss of all brainstem functions. In the setting of circulatory arrest, death occurs after the arrest of circulation to the brain rather than death of the heart. Correspondingly, any intervention that resumes oxygenated circulation to the brain after circulatory arrest would invalidate the determination of death.
  • European vignettes in donation after circulatory death

    Gardiner, Dale C. (2017)
    Donation after circulatory death (DCD) is increasing in Europe, yet there is widespread variability in practice. Insight into actual practice is difficult to acquire simply by analyzing protocols and laws from each individual country. For this reason, the 3 DCD vignettes in this article have been constructed to outline routine and standard DCD practice in the United Kingdom, the Netherlands, and Spain. These imagined vignettes reflect a "typical" case, based on the authors' extensive experience with DCD but are not real patient cases. They are a resource aimed at stimulating discussion regarding European organ donation practice and provide a knowledge bank for those wanting to establish a DCD program in their country. It is our hope that by providing these vignettes, the wider organ donation and transplant community, as well as philosophers and the public, will have a better understanding of what DCD really is and what it really isn't.
  • Critical care in the emergency department: Organ donation

    Gardiner, Dale C. (2016)
    Organ transplantation is associated with improved outcomes for some patients with end-stage organ failure; however, the number of patients awaiting a transplant exceeds the available organs. Recently, an extended role has been proposed for EDs in the recognition and management of potential donors. The present review presents an illustrative case report and considers current transplantation practice in the UK. Ethical and legal considerations, the classification of deceased donors and future developments promising greater numbers of organs are discussed. Copyright Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
  • Determination of death in donation after circulatory death: An ethical propriety

    Gardiner, Dale C. (2018)
    PURPOSE OF REVIEW: The recently developed donation after circulatory death (DCD) heart transplant technique, pioneered by Papworth Hospital in the UK, involves the use of extracorporeal perfusion technologies to restart the donor heart in situ and thereby restore the donor's own circulation, after first isolating the donor's cerebral circulation. By restoring the circulation in the deceased donor, even if the cerebral circulation is excluded, the Papworth technique challenges the acceptability of death determination in DCD. RECENT FINDINGS: This study uses as its exemplar case the Papworth DCD heart technique to review and make wider comment about death determination in DCD. We seek to answer three challenges to ethical propriety raised by the Papworth technique: death determination using the permanence standard (common to all DCD practice); restoration of heart contractility and circulation in the body; and active prevention of the restoration of brain circulation by use of a cross-clamp to isolate the cerebral circulation. SUMMARY: The Papworth technique for heart DCD does not compromise the permanence standard for declaring death and therefore respects the dead donor rule in the UK, but perhaps elsewhere the law would need to change to refer to the cessation of circulation in the brain.
  • Family over rules? An ethical analysis of allowing families to overrule donation intentions

    Gardiner, Dale C. (2017)
    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 donor's 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 patient's 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.
  • Factors influencing the family consent rate for organ donation in the UK

    Gardiner, Dale C. (2016)
    The refusal rate for organ donation in the UK is 42%, among the highest in Europe. We extracted data on every family approach for donation in UK ICUs or Emergency Departments between 1st April 2012 and 30th September 2013, and performed multiple logistic regression to identify modifiable factors associated with consent. Complete data were available for 4703 of 4899 approaches during the study period. Consent for donation after brain death was 68.9%, and for donation after circulatory death 56.5% (p Copyright © 2016 The Association of Anaesthetists of Great Britain and Ireland.

View more