key: cord-0977035-h7n4nw4w authors: Holm, Are M.; Mehra, Mandeep R.; Courtwright, Andrew; Teuteberg, Jeffrey; Sweet, Stuart; Potena, Luciano; Singer, Lianne G.; Torres, Marta F.; Shullo, Michael A.; Benza, Raymond; Ensminger, Stephan; Aslam, Saima title: Ethical Considerations regarding Heart and Lung Transplantation and Mechanical Circulatory Support during the COVID-19 Pandemic: An ISHLT COVID-19 Task Force Statement date: 2020-04-25 journal: J Heart Lung Transplant DOI: 10.1016/j.healun.2020.04.019 sha: f3c93c4cb37cfbb9ef72fa002e5839acdf8e4ba1 doc_id: 977035 cord_uid: h7n4nw4w Abstract To understand the challenges for thoracic transplantation and mechanical circulatory support during the current COVID-19 pandemic, we propose separating the effects of the pandemic into 5 distinct stages from a healthcare system perspective. We discuss how the classical ethical principles of utility, justice and efficiency may need to be adapted, and we give specific recommendations for thoracic transplantation and mechanical circulatory support centers to balance their clinical decisions and strategies for advanced heart and lung disease during the current pandemic. The COVID-19 pandemic has disrupted healthcare services, requiring rationing of people and resources.(1, 2) Resource intensive therapy for advanced heart and lung failure will need to adapt to this new reality. We outline the classical ethical framework that guides heart and lung transplantation and mechanical circulatory support (MCS) and discuss adaptations to this construct during different stages of the ongoing pandemic. Generally, heart and lung transplantation centers face unique challenges. These include safe management of the waitlisted patient, including bridging strategies, assessment and recovery of deceased organ donors, including the need for long-distance travel, complex surgery, multidisciplinary post-operative care with uncertain rates of complications, and transitional care for rehabilitation facility or home management. Ensuing are frequent clinic visits and surveillance testing, especially in the first few months. Similarly complicated care pathways and team engagement are required for MCS implantation. General ethical principles that govern the field include non-maleficence (do no harm), beneficence (do good), and respect for persons (autonomy). Some additional principles, such as utility, justice, and efficiency need to be addressed before the circumstances of the crisis standards of care during the different stages of the pandemic are discussed. Utility is defined as maximizing the expected overall good based on considerations of patient survival, graft survival, quality of life (QoL), availability of alternative treatments, and age.(3) Since heart and lungs are vital organs, and re-transplantation is often not available, patient and graft survival are often coincident. QoL is an important consideration, but due to scarcity of organs for transplant and challenges in standardization of QoL assessments, improvement in QoL plays a lesser role in utility estimation for thoracic transplantation.(4) When considering utility in terms of survival benefit, recipient age may also be relevant (although not determinative) as older age may be a risk marker for poor outcome. Justice is a commitment to equitable access and fair allocation of donated organs. This includes considerations of medical urgency, likelihood of finding a suitable organ in the future, waiting list time, first versus repeat transplants, age, and geographical fairness. Medical urgency means that those who are most severely ill should be given highest priority, even if this may reduce overall utility. In addition, a commitment to justice may require prioritization of candidates who have reduced access to the donor pool because of factors such as immunological sensitization. In contrast, waiting list time plays a lesser role when survival is the main determinant of priority. Age in the context of a just distribution of a lifesaving treatment is interpreted as giving priority to those who have passed through "fewer life cycles" (childhood, young adulthood, middle age, and old age).(5, 6) Few thoracic transplant centers have operationalized this by defining an upper age limit for transplantation, but in some organ allocation systems, children are given priority. Geographical fairness in thoracic transplantation and MCS is problematic, as organ exchange may be limited by geographical distance (USA) or by regional or national borders. Efficiency is the moral commitment to make the most out of scarce resources and to avoid waste.(7) Care for patients with advanced heart and lung disease may be resource intensive, and more so in some than others. In thoracic transplant, efficiency consideration is used to avoid futile transplants of scarce organs. Apart from that, however, most official allocation rules for heart or lung transplantation do not reduce priority of patients expected to consume greater resources. In summary, the estimation of survival benefit, with categorical emphasis on saving imminently threatened lives ("Rule of Rescue") and the utilitarian estimation of expected survival, are the dominating factors for organ allocation in thoracic transplantation or MCS. Generally, efficiency and other aspects of distributive justice play a lesser role. In order to analyze how to adjust treatment strategies for advanced heart and lung disease, we propose separating the effects of the COVID-19 pandemic from a healthcare system perspective into different stages. Not all programs, centers or health systems will go through all stages, but the challenges and ethical dilemmas faced in a particular stage may be similar (Figure 1 ). During this stage, the number of patients with COVID-19 admitted to the hospital is low (or zero) but expected to increase. There are sufficient resources but elective activities at the hospital may be preemptively reduced. Some travel restrictions and social distancing within the community may have been introduced, affecting scheduled care of patients. Risks from a health system perspective include underutilization of available resources, and incomplete preparation for upcoming stages. Table 1) . Rationing in medicine is the allocation of insufficient resources and withholding a potentially beneficial treatment because of scarcity. Another principle that may gain increased importance in organ allocation for transplant is the chance that a specific candidate may be offered a suitable organ in a timely manner. During the pandemic, it is expected that the number of organs available for transplant will decrease. Some transplant candidates have a limited donor pool, such as sensitized patients. When the expected time to wait between available organs is long, the rare occurrence of a matching organ may be given more weight in the allocation than it would in times of usual organ availability. In other words, a good match may count more than urgency. The expected reduction in transplant or MCS volume may have additional effects. For strategies to bridge a critically ill patient to transplantation, the expected bridging time may become too long to justify priority in times of resource scarcity. Conversely, the reduced availability of organs may justify increased use of durable MCS or alternative treatment strategies that previously may have been considered inferior to transplant. considerations about the effects of reduced transplant volumes and longer wait times. These may require engagement with regulatory agencies. Current evidence to guide treatment for COVID-19 is anecdotal and difficult to interpret and thus there is a moral imperative to gain evidence regarding efficacy/ toxicity of various investigative clinical approaches. Additionally, China has been accused of tolerating organ procurement from executed prisoners. (19) While suspicion of such unethical standards have hitherto barred publications, exceptions have been made during the COVID-19 pandemic in order to gain early evidence regarding the disease. (20) Recommendation: It is a moral obligation for the transplant and MCS community to participate in COVID-19 related research protocols, where possible, and to encourage patients to consent in order to gain evidence-based treatment recommendations in this patient population. (21) Global collaboration is absolutely essential during a pandemic. Scientifically unproven practices should be used with great caution, if at all, due to the risk of doing harm. In the Overwhelmed stage of the pandemic, thoracic transplant candidates and recipients must compete for ICU resources with COVID-19 and non-COVID-19 critically ill patients. Importantly, the prognosis of a patient following thoracic transplant or MCS may be better than that of some patients with COVID-19. In fact, collateral damage caused by withheld treatment may be a substantial part of the cumulative total losses caused by the pandemic. (5, 22) While it is important to prepare for a significant reduction in transplant activity in the worst stages of the pandemic , it is important that this reduction is balanced. How to prioritize for such balance should be discussed early. In the Overwhelmed stage of the pandemic, the ability to design plans for optimal resource reallocation may be reduced (Figure 2) . This should also be remembered when considering repurposing of HCW. While there are some large dedicated centers, thoracic transplantation or MCS is often done at units where many of the transplant or MCS professionals are not uniquely dedicated to this particular task. At such centers, activity may be outcompeted and is vulnerable to a preemptive shut down both already in the Anticipation stage and during the Active and Overwhelmed stages. In a few countries, if a transplant center is shut-down, transplant candidates may be referred to other centers that are in different stages of the pandemic or are larger. Whether it is justified for the other center to prioritize its own patients, would require a different set of ethical considerations, since there may be contracts with the existing patients that should be respected. However, the imperative to save lives would suggest acceptance of such referrals. Based on current allocation rules and geographic limitations, such referrals are possible only in some countries. Data from Spain and Italy show a dramatic reduction (up to 60%) in the number of organs recovered and US data shows a similar trend.(11, 23) A major cause is the lack of availability of critical care beds in the Overwhelmed stage, during which access is restricted to patients with the highest chance of survival. However, the concept of "utility" in allowing and managing potential organ donors should be seen as the utility of saving many lives through organ donation, not as scarce capacity wasted on a futile effort to achieve an unlikely survival. Recommendation: Similar rationing for all kinds of treatment and a commitment to maximize the number of lives saved suggests the development of an appropriate process to allocate critical care resources to patients who may become organ donors. Simultaneously, it must be acknowledged that the organ procurement process involves several risks during the pandemic, (22) The pandemic, in its various stages and variable penetrance across different regions, will challenge the way we manage patients with advanced heart and lung disease. Grim as the situation may be today, a few benefits may ensue. The current pandemic will force healthcare systems to be better prepared for the next pandemic, for a local epidemic, or even for the next influenza season. Our abilities to communicate digitally with our patients and with each other will improve and may be valuable in the future. Importantly, allocation rules and follow up strategies may change as a result of the pandemic and the decisions made during this time. Finally, we may have increased our ability to collaborate, nationally and internationally, both through scientific societies, through scholarly journals and through other channels. The ongoing pandemic is an unprecedented event since the advent of solid organ transplantation and certainly involves many challenges, including a re-framing of ethical principles. (27) Task Force Activities and overseen by the co-chairs. The Board determined that the Task Force work was not required to follow the typical Standards and Guidelines process and delegated document approval to the Executive Committee. After development of the document, all members of the ISHLT COVID-19 task force who were not writing group members provided reviews; in addition the document was reviewed and approved by the ISHLT Executive committee, including 2 members that served as independent reviewers and who were not part of the COVID-19 task force. What Other Countries Can Learn From Italy During the COVID-19 Pandemic A consensus document for the selection of lung transplant candidates: 2014--an update from the Pulmonary Transplantation Council of the International Society for Heart and Lung Transplantation Fair Allocation of Scarce Medical Resources in the Time of Covid-19 Principles for allocation of scarce medical interventions The ethics and reality of rationing in medicine Rationing in the intensive care unit Clinical Characteristics of Coronavirus Disease 2019 in China Do chronic respiratory diseases or their treatment affect the risk of SARS-CoV-2 infection? A Framework for Rationing Ventilators and Critical Care Beds During the COVID-19 Pandemic Transplantation ethics Italian Society of Anesthesia A, Resuscitation and Intensive Care (Società Italiana di Clinical ethics recommendations for the allocation of intensive care treatments Saving those who can't wait INTERMACS profiles and outcomes of ambulatory advanced heart failure patients: A report from the REVIVAL Registry Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention How to handle scientific articles on organ transplantation coming from China in 2019? The obligation to participate in biomedical research COVID-19: A global transplant perspective on successfully navigating a pandemic Epidemiology of COVID-19 Among Children in China The Sarah Murnaghan debacle: a health policy perspective on transplant candidate selection Coronavirus disease 2019: Utilizing an ethical framework for rationing absolutely scarce healthcare resources in transplant allocation decisions Table 1. Risk and opportunities for thoracic transplant and MCS through different stages of the COVID-19 pandemic 1. As above 2. Less resources than before.1. As above 2. Evaluate experiences broadly and redesign workflow and strategies.Allocate donor organs/MCS as above, incorporating experiences acquired during the pandemic.