Deceased by default: Consent systems and organ-patient mortality.

Previous research shows that countries with opt-out consent systems for organ donation conduct significantly more deceased-donor organ transplantations than those with opt-in systems. This paper investigates whether the higher transplantation rates in opt-out systems translate into equally lower death rates among organ patients registered on a waiting list (i.e., organ-patient mortality rates). We show that the difference between consent systems regarding kidney- and liver-patient mortality rates is significantly smaller than the difference in deceased-donor transplantation rates. This is likely due to different incentives between the consent systems. We find empirical evidence that opt-out systems reduce incentives for living donations, which explains our findings for kidneys. The results imply that focusing on deceased-donor transplantation rates alone paints an incomplete picture of opt-out systems' benefits, and that there are important differences between organs in this respect.

An international multicenter study of protocols for liver transplantation during a pandemic: A case for quadripartite equipoise.

BACKGROUND & AIMS: The outbreak of COVID-19 has vastly increased the operational burden on healthcare systems worldwide. For patients with end-stage liver failure, liver transplantation is the only option. However, the strain on intensive care facilities caused by the pandemic is a major concern. There is an urgent need for ethical frameworks to balance the need for liver transplantation against the availability of national resources. METHODS: We performed an international multicenter study of transplant centers to understand the evolution of policies for transplant prioritization in response to the pandemic in March 2020. To describe the ethical tension arising in this setting, we propose a novel ethical framework, the quadripartite equipoise (QE) score, that is applicable to liver transplantation in the context of limited national resources. RESULTS: Seventeen large- and medium-sized liver transplant centers from 12 countries across 4 continents participated. Ten centers opted to limit transplant activity in response to the pandemic, favoring a "sickest-first" approach. Conversely, some larger centers opted to continue routine transplant activity in order to balance waiting list mortality. To model these and other ethical tensions, we computed a QE score using 4 factors - recipient outcome, donor/graft safety, waiting list mortality and healthcare resources - for 7 countries. The fluctuation of the QE score over time accurately reflects the dynamic changes in the ethical tensions surrounding transplant activity in a pandemic. CONCLUSIONS: This four-dimensional model of quadripartite equipoise addresses the ethical tensions in the current pandemic. It serves as a universally applicable framework to guide regulation of transplant activity in response to the increasing burden on healthcare systems. LAY SUMMARY: There is an urgent need for ethical frameworks to balance the need for liver transplantation against the availability of national resources during the COVID-19 pandemic. We describe a four-dimensional model of quadripartite equipoise that models these ethical tensions and can guide the regulation of transplant activity in response to the increasing burden on healthcare systems.

Malleable Transplant Criteria: At What Cost?

An 18-year-old male who had been diagnosed at age 7 with a rare, progressive liver disease was referred to the transplant center and received a transplant, even though he did not meet the center's criteria for a patient with hepatopulmonary syndrome (HPS). Complications required relisting the patient urgently, but he eventually fully recovered; total hospital charges for his treatment exceeded $5 million. Reflection upon the case resulted in analysis of two ethical questions: primarily, clinician obligation to balance the provision of actuarially fair health care to society against the healing of a single patient; secondarily, the effects of malleable transplant criteria on trust in the patient selection process. We affirmed that physicians should not be principally responsible for justifying financial investment to society or for upholding beneficence beyond the individual physician and patient relationship in order to contain costs. We concluded, however, that such instances, when combined with manipulation of transplant center criteria, pose a potential threat to public trust. We therefore suggested that transplant centers maintain independent ethics committees to review such cases.

Liver transplantation for critically ill cirrhotic patients: Overview and pragmatic proposals.

Liver transplantation for critically ill cirrhotic patients with acute deterioration of liver function associated with extrahepatic organ failures is controversial. While transplantation has been shown to be beneficial on an individual basis, the potentially poorer post-transplant outcome of these patients taken as a group can be held as an argument against allocating livers to them. Although this issue concerns only a minority of liver transplants, it calls into question the very heart of the allocation paradigms in place. Indeed, most allocation algorithms have been centered on prioritizing the sickest patients by using the model for end-stage liver disease score. This has led to allocating increasing numbers of livers to increasingly critically ill patients without setting objective or consensual limits on how sick patients can be when they receive an organ. Today, finding robust criteria to deem certain cirrhotic patients too sick to be transplanted seems urgent in order to ensure the fairness of our organ allocation protocols. This review starts by fleshing out the argument that finding such criteria is essential. It examines five types of difficulties that have hindered the progress of recent literature on this issue and identifies various strategies that could be followed to move forward on this topic, taking into account the recent discussion on acute on chronic liver failure. We move on to review the literature along four axes that could guide clinicians in their decision-making process regarding transplantation of critically ill cirrhotic patients.

Ethical Analysis and Policy Recommendations Regarding Domino Liver Transplantation.

Due to the widening gap between supply and demand, patients who need a liver transplant due to metabolic disease may be asked to serve as domino liver donors-to have their native liver transplanted into another candidate. We here analyze the ethical problems surrounding informed consent for the implant and explant procedures in transplant candidates who will serve as domino donors, using the case of a child with maple syrup urine disease. We discuss the need for 2 distinct consent processes separated in time to ensure that potential domino donors (or their surrogates) give a truly voluntary consent. We propose a Domino Donor Advocate-based on the concept of the independent living donor advocate to help the patient and/or his or her surrogates consider the risks, benefits and alternatives. Finally, we evaluate the Organ Procurement and Transplantation Network policy regarding "therapeutic organ donation" and propose several modifications to ensure that the decision by the potential domino donor (and/or his or her surrogate) is voluntary and informed.

Swaps and Chains and Vouchers, Oh My!: Evaluating How Saving More Lives Impacts the Equitable Allocation of Live Donor Kidneys.

Live kidney donation involves a delicate balance between saving the most lives possible and maintaining a transplant system that is fair to the many thousands of patients on the transplant waiting list. Federal law and regulations require that kidney allocation be equitable, but the pressure to save patients subject to ever-lengthening waiting times for a transplant has been swinging the balance toward optimizing utility at the expense of justice. This article traces the progression of innovations created to make optimum use of a patient's own live donors. It starts with the simplest - direct donation by family members - and ends with voucher donations, a very recent and unique innovation because the donor can donate 20 or more years before the intended recipient is expected to need a kidney. In return for the donation, the intended recipient receives a voucher that can be redeemed for a live kidney when it is needed. Other innovations that are discussed include kidney exchanges and list paired donation, which are used to facilitate donor swaps when donor/recipient pairs have incompatible blood types. The discussion of each new innovation shows how the equity issues build on each other and how, with each new innovation, it becomes progressively harder to find an acceptable balance between utility and justice. The article culminates with an analysis of two recent allocation methods that have the potential to save many additional lives, but also affirmatively harm some patients on the deceased donor waiting list by increasing their waiting time for a life-saving kidney. The article concludes that saving additional lives does not justify harming patients on the waiting list unless that harm can be minimized. It also proposes solutions to minimize the harm so these new innovations can equitably perform their intended function of stimulating additional transplants and extending the lives of many transplant patients.

Liver paired exchange: Can the liver emulate the kidney?

Kidney paired exchange (KPE) constitutes 12% of all living donor kidney transplantations (LDKTs) in the United States. The success of KPE programs has prompted many in the liver transplant community to consider the possibility of liver paired exchange (LPE). Though the idea seems promising, the application has been limited to a handful of centers in Asia. In this article, we consider the indications, logistical issues, and ethics for establishing a LPE program in the United States with reference to the principles and advances developed from experience with KPE. Liver Transplantation 24 677-686 2018 AASLD.

Wickedness, Moral Responsibility, and Access to Transplantable Livers.

Under the current conditions of scarcity of transplantable livers, difficult decisions need to be made about access. There is a growing consensus that it is morally justified to give people with ARESLD lower priority than those whose need is not self-caused. The purpose of this article is to critically examine the conditions under which such prioritization is morally justified, by challenging arguments put forth by Walter Glannon and Daniel Brudney. There are serious theoretical and practical problems with these views, which have to do with the nature and scope of the (putative) moral duty not to contribute to the competition for scarce transplantable livers, and the difficulty in determining whether people are responsible for their weakness or even wickedness of character. These problems need to be resolved if we are to be morally justified in determining access based on causal and moral responsibility for being in need.

Opioid and opioid substitution therapy in liver transplant candidates: A survey of center policies and practices.

This national survey sought to determine the practices and policies pertaining to opioid and opioid substitution therapy (OST) use in the selection of liver transplant (LT) candidates. Of 114 centers, 61 (53.5%) responded to the survey, representing 49.2% of the LT volume in 2016. Only two programs considered chronic opioid (1 [1.6%]) or OST use (1 [1.6%]) absolute contraindications to transplant, while 63.9% and 37.7% considered either one a relative contraindication, respectively. The majority of programs did not have a written policy regarding chronic opioid use (73.8%) or OST use (78.7%) in LT candidates. Nearly half (45.9%) of centers agreed that there should be a national consensus policy addressing opioid and OST use. The majority of responding LT centers did not consider opioid or OST use in LT candidates to be absolute contraindications to LT, but there was significant variability in center practices. These surveys also demonstrated a lack of written policies in the assessment of the candidacy of such patients. The results of our survey identify an opportunity to develop a national consensus statement regarding opioid and OST use in LT candidates to bring greater uniformity and equity into the selection of LT candidates.

Geographic Disparities in Liver Availability: Accidents of Geography, or Consequences of Poor Social Policy?

Recently, a redistricting proposal intended to equalize Model for End-stage Liver Disease score at transplant recommended expanding liver sharing to mitigate geographic variation in liver transplantation. Yet, it is unclear whether variation in liver availability is arbitrary and a disparity requiring rectification or reflects differences in access to care. We evaluate the proposal's claim that organ supply is an "accident of geography" by examining the relationship between local organ supply and the uneven landscape of social determinants and policies that contribute to differential death rates across the United States. We show that higher mortality leading to greater availability of organs may in part result from disproportionate risks incurred at the local level. Disparities in public safety laws, health care infrastructure, and public funding may influence the risk of death and subsequent availability of deceased donors. These risk factors are disproportionately prevalent in regions with high organ supply. Policies calling for organ redistribution from high-supply to low-supply regions may exacerbate existing social and health inequalities by redistributing the single benefit (greater organ availability) of greater exposure to environmental and contextual risks (e.g. violent death, healthcare scarcity). Variation in liver availability may not be an "accident of geography" but rather a byproduct of disadvantage.

Fair is fair: We must re-allocate livers for transplant.

The 11 original regions for organ allocation in the United States were determined by proximity between hospitals that provided deceased donors and transplant programs. As liver transplants became more successful and demand rose, livers became a scarce resource. A national system has been implemented to prioritize liver allocation according to disease severity, but the system still operates within the original procurement regions, some of which have significantly more deceased donor livers. Although each region prioritizes its sickest patients to be liver transplant recipients, the sickest in less liver-scarce regions get transplants much sooner and are at far lower risk of death than the sickest in more liver-scarce regions. This has resulted in drastic and inequitable regional variation in preventable liver disease related death rate.A new region districting proposal - an eight district model - has been carefully designed to reduce geographic inequities, but is being fought by many transplant centers that face less scarcity under the current model. The arguments put forth against the new proposal, couched in terms of fairness and safety, will be examined to show that the new system is technologically feasible, will save more lives, and will not worsen socioeconomic disparity. While the new model is likely not perfect, it is a necessary step toward fair allocation.

Global lessons in graft type and pediatric liver allocation: A path toward improving outcomes and eliminating wait-list mortality.

Current literature and policy in pediatric liver allocation and organ procurement are reviewed here in narrative fashion, highlighting historical context, ethical framework, technical/procurement considerations, and support for a logical way forward to an equitable pediatric liver allocation system that will improve pediatric wait-list and posttransplant outcomes without adversely affecting adults. Where available, varying examples of successful international pediatric liver allocation and split-liver policy will be compared to current US policy to highlight potential strategies that can be considered globally. Liver Transplantation 23:86-95 2017 AASLD.

Toward a Conceptualization of the Content of Psychosocial Screening in Living Organ Donors: An Ethical Legal Psychological Aspects of Transplantation Consensus.

BACKGROUND: Across Europe, transplant centers vary in the content of the psychosocial evaluation for eligible living organ donors. To identify whether a common framework underlies this variation in this evaluation, we studied which psychosocial screening items are most commonly used and considered as most important in current psychosocial screening programs of living organ donors. METHODS: A multivariate analytic method, concept mapping, was used to generate a visual representation of the "psychosocial" screening items of living kidney and liver donors. A list of 75 potential screening items was derived from a systematic literature review and sorted and rated for their importance and commonness by multidisciplinary affiliated health care professionals from across Europe. Results were discussed and fine-tuned during a consensus meeting. RESULTS: The analyses resulted in a 6-cluster solution. The following clusters on psychosocial screening items were identified, listed from most to least important: (1) personal resources, (2) motivation and decision making, (3) psychopathology, (4) social resources, (5) ethical and legal factors, and (6) information and risk processing. CONCLUSIONS: We provided a conceptual framework of the essential elements in psychosocial evaluation of living donors which can serve as a uniform basis for the selection of relevant psychosocial evaluation tools, which can be further tested in prospective studies.

Ethical dilemmas in psychiatric evaluations in patients with fulminant liver failure.

PURPOSE OF REVIEW: Fulminant hepatic failure (FHF) is one of the more dramatic and challenging syndromes in clinical medicine. Time constraints and the scarcity of organs complicate the evaluation process in the case of patients presenting with FHF, raising ethical questions related to fairness and justice. The challenges are compounded by an absence of standardized guidelines. RECENT FINDINGS: Acetaminophen overdose, often occurring in patients with histories of psychiatric illness and substance dependence, has emerged as the most common cause of FHF. The weak correlations between psychosocial factors and nonadherence, as per some studies, suggest that adherence may be influenced by systematic factors. Most research suggests that applying rigid ethical parameters in these patients, rather than allowing for case-dependent flexibility, can be problematic. SUMMARY: The decision to transplant in patients with FHF has to be made in a very narrow window of time. The time-constrained process is fraught with uncertainties and limitations, given the absence of patient interview, fluctuating medical eligibility, and limited data. Although standardized scales exist, their benefit in such settings appears limited. Predicting compliance with posttransplant medical regimens is difficult to assess and raises the question of prospective studies to monitor compliance.