Toward Transparency and Trust: Assessing and Addressing Key Ethical Concerns in Normothermic Regional Perfusion.

Normothermic Regional Perfusion, or NRP, is a method of donated organ reperfusion using cardiopulmonary bypass or a modified extracorporeal membrane oxygenation (ECMO) circuit after circulatory death while leaving organs in the dead donor's corpse. Despite its potential, several key ethical issues remain unaddressed by this technology.

The Ethics of Extracorporeal Membrane Oxygenation: Revisiting the Principles of Clinical Bioethics.

BACKGROUND: Extracorporeal life support has become accepted as a rescue therapy for cardiopulmonary shock, and there have been over 100,000 extracorporeal membrane oxygenation (ECMO) cases since 1987. Rapid growth has presented ethical challenges and concerns. Here, we discuss core principles of bioethics in an attempt to more thoroughly appreciate the ethical concerns and considerations raised by use of this technology. METHODS: An extensive literature review was performed on current papers on ECMO and ethics. In this paper, we utilized 3 case studies to highlight 4 major tenets of bioethics as they relate to use of ECMO: autonomy, beneficence, nonmaleficence, and justice. RESULTS: Case studies presented involved unique perspectives on utilization of ECMO and a careful balance of benefits and harms as they relate to autonomy, beneficence, nonmaleficence and justice. We present nuanced interpretations of autonomy (eg, physician autonomy) and justice (eg, various providers interpret and offer ECMO differently). An additional challenge includes contending with potentially prolonged clinical courses and/or complications that either result directly from cannulation for ECMO or indirectly from being subject to ensuing extreme conditions and prolongation of life that medical science has yet to fully understand. CONCLUSIONS: ECMO programs continue to grow in number and capacity. A deep appreciation of the bioethical dimensions of this technology and its application must be pursued, understood and applied to individual patient scenarios.

Ethical factors determining ECMO allocation during the COVID-19 pandemic.

BACKGROUND: ECMO is a particularly scarce resource during the COVID-19 pandemic. Its allocation involves ethical considerations that may be different to usual times. There is limited pre-pandemic literature on the ethical factors that ECMO physicians consider during ECMO allocation. During the pandemic, there has been relatively little professional guidance specifically relating to ethics and ECMO allocation; although there has been active ethical debate about allocation of other critical care resources. We report the results of a small international exploratory survey of ECMO clinicians' views on different patient factors in ECMO decision-making prior to and during the COVID-19 pandemic. We then outline current ethical decision procedures and recommendations for rationing life-sustaining treatment during the COVID-19 pandemic, and examine the extent to which current guidelines for ECMO allocation (and reported practice) adhere to these ethical guidelines and recommendations. METHODS: An online survey was performed with responses recorded between mid May and mid August 2020. Participants (n = 48) were sourced from the ECMOCard study group-an international group of experts (n = 120) taking part in a prospective international study of ECMO and intensive care for patients during the COVID-19 pandemic. The survey compared the extent to which certain ethical factors involved in ECMO resource allocation were considered prior to and during the pandemic. RESULTS: When initiating ECMO during the pandemic, compared to usual times, participants reported giving more ethical weight to the benefit of ECMO to other patients not yet admitted as opposed to those already receiving ECMO, (p < 0.001). If a full unit were referred a good candidate for ECMO, participants were more likely during the pandemic to consider discontinuing ECMO from a current patient with low chance of survival (53% during pandemic vs. 33% prior p = 0.002). If the clinical team recommends that ECMO should cease, but family do not agree, the majority of participants indicated that they would continue treatment, both in usual circumstances (67%) and during the pandemic (56%). CONCLUSIONS: We found differences during the COVID-19 pandemic in prioritisation of several ethical factors in the context of ECMO allocation. The ethical principles prioritised by survey participants were largely consistent with ECMO allocation guidelines, current ethical decision procedures and recommendations for allocation of life-sustaining treatment during the COVID-19 pandemic.

On "Not Recommending" ECMO.

The neonatologist was describing the dire situation, the complexity of the fetus's anomalies, and the options-comfort care, some resuscitation-and finished by saying, "We would not recommend ECMO …" "We would not recommend" is a curious phrase. There is something ambiguous, very nebulous about it, something passive, noncommittal, maybe even deflective. As a bioethics researcher, I wondered how this phrase is interpreted, how it influences parents' moral deliberation over their options.

Emerging issues in the ethical utilization of pediatric extracorporeal membrane oxygenation.

PURPOSE OF REVIEW: As we have refined our extracorporeal membrane oxygenation (ECMO) capabilities and enhanced our ability to care for children with illnesses previously deemed lethal, the patient populations for whom ECMO is a medically appropriate intervention have expanded. Such expansion has prompted consideration of evolving ethical issues. In this review, we highlight several of the emerging ethical issues in pediatric ECMO. RECENT FINDINGS: Expansion of ECMO into increasingly diverse pediatric populations has prompted several ethical questions. First, some have found that there are specific clinical settings in which ECMO ought to be obligatory. Second, expanded use of ECMO may prompt disagreements among healthcare providers or between providers and family members regarding decisions about decannulation. Finally, analysis of the ethical challenges associated with integration of other disruptive healthcare modalities into patient care, will allow us insight into how to assure ethical expansion of pediatric ECMO. SUMMARY: Expansion of pediatric ECMO highlights several ethical issues including whether ECMO is ever ethically obligatory, how to ethically decannulate a patient when survival is deemed unlikely, and how to guide expansion of pediatric ECMO based upon lessons learned from the implementation of other disruptive healthcare interventions into practice.

Streptococcus pyogenes purpura fulminans and septic shock: A case highlighting the ethical considerations of high-risk extracorporeal membrane oxygenation.

Separately, refractory septic shock and purpura fulminans have very poor outcomes. The ethics involved in offering extracorporeal membrane oxygenation to very high-risk patients is complex. We report a novel case of refractory shock requiring veno-arterial extracorporeal membrane oxygenation and continuous renal replacement therapy due to Streptococcus pyogenes bacteremia with purpura fulminans to highlight the ethical challenges in offering extracorporeal membrane oxygenation to a patient with such a poor likelihood of survival.

Ethical Considerations for Mechanical Support.

Extracorporeal life support can support patients with severe forms of cardiac and respiratory failure. Uncertainty remains about its optimal use owing in large part to its resource-intensive nature and the high acuity illness in supported patients. Specific issues include the identification of patients most likely to benefit, the appropriate duration of support when prognosis is uncertain, and what to do when patients become dependent on extracorporeal life support but no longer have hope for recovery or transplantation. Careful deliberation of ethical principles and potential dilemmas should be made when considering the use of extracorporeal life support in advanced cardiopulmonary failure.

Practice Patterns and Ethical Considerations in the Management of Venovenous Extracorporeal Membrane Oxygenation Patients: An International Survey.

OBJECTIVES: To characterize physicians' practices and attitudes toward the initiation, limitation, and withdrawal of venovenous extracorporeal membrane oxygenation for severe respiratory failure and evaluate factors associated with these attitudes. DESIGN: Electronic, cross-sectional, scenario-based survey. SETTING: Extracorporeal membrane oxygenation centers affiliated with the Extracorporeal Life Support Organization and the International Extracorporeal Membrane Oxygenation Network. SUBJECTS: Attending-level physicians with experience managing adult patients receiving venovenous extracorporeal membrane oxygenation. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Five-hundred thirty-nine physicians in 39 countries across six continents completed the survey. Factors that influenced the decision to limit extracorporeal membrane oxygenation initiation included older patient age (46.9%), additional organ failures (37.7%), and prolonged mechanical ventilation (35.1%). Patient comorbidities (70.5%), patient's wishes (56.0%), and etiology of respiratory failure (37.7%) were factors that influenced the decision to withdraw extracorporeal membrane oxygenation. In multivariable analysis, factors associated with increased odds of withdrawing life-sustaining therapies included pulmonary fibrosis, stroke, surrogate's desire to withdraw, lack of knowledge regarding patient's or surrogate's wishes in the setting of fibrosis, not initiating extracorporeal membrane oxygenation in the baseline scenario, and respondent religiosity. Factors associated with decreased odds of withdrawal included practicing in an environment where it is not legally possible to make decisions against patient or surrogate wishes. Most respondents (90.5%) involved other physicians in treatment decisions for extracorporeal membrane oxygenation patients, whereas only 53.2%, 45.3%, and 29.5% of respondents involved surrogates, awake patients, or bedside nurses, respectively. CONCLUSIONS: Patient and physician-level factors were associated with decision-making regarding extracorporeal membrane oxygenation initiation and withdrawal, including patient prognosis and knowledge of patient or surrogate wishes. Respondents reported low rates of engaging in shared decision-making when managing patients receiving extracorporeal membrane oxygenation.

How Should ECMO Initiation and Withdrawal Decisions Be Shared?

Extracorporeal membrane oxygenation (ECMO) is a new technology used to rescue patients with severe circulatory or respiratory failure and help bridge them to recovery or to definitive therapies like device implantation or organ transplantation. The increasing availability and success of ECMO has generated numerous ethical questions about its use and potential misuse. This commentary on a case of a patient who is no longer a candidate for transplant but wishes to continue ECMO identifies strategies clinicians can use to reconcile competing responsibilities.

Should Long-Term Life-Sustaining Care Be Started in Emergency Settings?

Decision making on behalf of an incapacitated patient is challenging, particularly in the context of venoarterial extracorporeal membrane oxygenation (VA-ECMO), a medically complex, high-risk, and costly intervention that provides cardiopulmonary support. In the absence of a surrogate and an advance directive, the clinical team must make decisions for such patients. Because states vary in terms of which decisions clinicians can make, particularly at the end of life, the legal landscape is complicated. This commentary on a case of withdrawal of VA-ECMO in an unrepresented patient discusses Extracorporeal Life Support Organization guidelines for decision making, emphasizing the importance of proportionality in a benefits-to-burdens analysis.

Educating Resident and Fellow Physicians on the Ethics of Mechanical Circulatory Support.

Mechanical circulatory support (MCS) such as extracorporeal membrane oxygenation, left ventricular assist devices and total artificial hearts have altered the natural history of heart failure, and specialists in the fields of cardiology and cardiothoracic surgery are faced with more complex ethical considerations than ever before. Residency and fellowship training programs, however, do not have formal curricula in medical ethics as it applies to MCS. In response, this article proposes that ethics be integrated into graduate medical education with a focus on the following 6 constructs: patient best interest, respect for autonomy, informed consent, shared decision making, surrogate decision making, and end-of-life care. Curricula should offer learning experiences that help physicians navigate common ethical challenges encountered in practice.

What Should We Learn From Early Hemodialysis Allocation About How We Should Be Using ECMO?

Early hemodialysis allocation deliberations should inform our current considerations of what constitutes reasonable uses of extracorporeal membrane oxygenation. Deliberative democracy can be used as a strategy to gather a plurality of views, consider criteria, and guide policy making.

Decisions to Withdraw Extracorporeal Membrane Oxygenation Support: Patient Characteristics and Ethical Considerations.

OBJECTIVE: To describe the prevalence and context of decisions to withdraw extracorporeal membrane oxygenation (ECMO), with an ethical analysis of issues raised by this technology. PATIENTS AND METHODS: We retrospectively reviewed medical records of adults treated with ECMO at Mayo Clinic in Rochester, Minnesota, from January 1, 2010, through December 31, 2014, from whom ECMO was withdrawn and who died within 24 hours of ECMO separation. RESULTS: Of 235 ECMO-supported patients, we identified 62 (26%) for whom withdrawal of ECMO was requested. Of these 62 patients, the indication for ECMO initiation was bridge to transplant for 8 patients (13%), bridge to mechanical circulatory support for 3 (5%), and bridge to decision for 51 (82%). All the patients were supported with other life-sustaining treatments. No patient had decisional capacity; for all the patients, consensus to withdraw ECMO was jointly reached by clinicians and surrogates. Eighteen patients (29%) had a do-not-resuscitate order at the time of death. CONCLUSION: For most patients who underwent treatment withdrawal eventually, ECMO had been initiated as a bridge to decision rather than having an established liberation strategy, such as transplant or mechanical circulatory support. It is argued that ethically, withdrawal of treatment is sometimes better after the prognosis becomes clear, rather than withholding treatment under conditions of uncertainty. This rationale provides the best explanation for the behavior observed among clinicians and surrogates of ECMO-supported patients. The role of do-not-resuscitate orders requires clarification for patients receiving continuous resuscitative therapy.

Extracorporeal cardiopulmonary resuscitation in out-of-hospital cardiac arrest: Ethical considerations.

Out-of-hospital cardiac arrest (OHCA) continues to be a leading cause of mortality worldwide. In Canada over 40,000 cardiac arrests that occur each year, a majority occur unexpectedly outside of the hospital setting. However, the reality is that without rapid and appropriate treatment within minutes, most victims will die before reaching the hospital. In the late 1980s case reports identifying favorable outcomes with the use of extracorporeal cardiopulmonary resuscitation (eCPR) in out-of-hospital cardiac arrest (OHCA) began to be reported. Since then case reports, observational studies, propensity analysis, and a systematic review of international practices continues to suggest eCPR as a feasible intervention for refractory ventricular fibrillation (VF) and pulseless ventricular tachycardia (VT) in select adult patients. However, in spite of this mounting base of evidence, clinicians continue to report concerns over a paucity of robust data showing definitive eCPR effectiveness compared with conventional resuscitation. This review will explore the ethical issues related to the impact eCPR might have on the orthodoxy pertaining to current resuscitation strategies, the impact of shifting decision-making on families particularly in dealing with a "bridge to nowhere" scenario, a call to accounting for greater data integrity and improved outcome reporting to assess eCPR effectiveness, and addressing the "Should we just do it" question. A recommendation is proposed for the creation of an ethics consultation service to assist families and staff in dealing with the invariable value conflicts and stresses likely to arise.

Outcomes and associated ethical considerations of long-run pediatric ECMO at a single center institution.

PURPOSE: Survival of neonatal and pediatric patients undergoing extracorporeal membrane oxygenation (ECMO) ≥ 21 days has not been well described. We hypothesized that patients would have poor survival and increased long-term complications. METHODS: Retrospective, single center, review and case analysis. Tertiary-care university children's hospital including neonatal, pediatric and cardiac intensive care units. After institutional review board approval, the charts of all patients < 18 years of age undergoing ECMO for ≥ 21 continuous days were performed, and they were compared to comparative patients undergoing shorter runs. Overall survival, incidence of complications, and post-discharge recovery were recorded. RESULTS: Overall survival was 36% in patients undergoing ≥ 21 days of ECMO (N = 14). 5/8 patients with cardiopulmonary failure from acquired etiologies survived versus 0/6 patients with congenital anomalies. 1/5 survivors achieved complete recovery with no neurologic deficits. The remaining survivors suffer from multiple medical and neurodevelopmental morbidities. CONCLUSION: ECMO support for ≥ 21 days is associated with poor survival, particularly in neonates with congenital anomalies. Long-term outcomes for survivors ought to be carefully weighed and discussed with parents given the high incidence of neurologic morbidities in this population.

Setting Expectations for ECMO: Improving Communication Between Clinical Teams and Decision Makers.

Transplant medicine is fraught with clinical-ethical issues. It is not uncommon to have ethicists on transplant teams to help navigate ethically complex cases and ethical questions. Clinical ethicists work in hospitals and/or other healthcare institutions identifying and addressing value-laden conflict and ethical uncertainties. As ethicists, we set out to describe our process and involvement in cases involving extracorporeal membrane oxygenation (ECMO). Our work centers on monitoring and optimizing communication among clinicians, families, and patients, with the goals of (1) aligning patient/family understanding of the nature and purpose of ECMO while encouraging realistic expectations for possible outcomes, and (2) proactively mitigating the moral distress of providers involved in complex ECMO cases. We close with recommendations for how to measure the impact of ethicists' involvement in ECMO cases.