Solid Organ Transplant Litigation at One of Europe's Largest University Hospitals.

Due to its intrinsic complexity and the principle of collective solidarity that governs it, solid organ transplantation (SOT) seems to have been spared from the increase in litigation related to medical activity. Litigation relating to solid organ transplantation that took place in the 29 units of the Assistance Publique-Hôpitaux de Paris and was the subject of a judicial decision between 2015 and 2022 was studied. A total of 52 cases of SOT were recorded, all in adults, representing 1.1% of all cases and increasing from 0.71% to 1.5% over 7 years. The organs transplanted were 25 kidneys (48%), 19 livers (37%), 5 hearts (9%) and 3 lungs (6%). For kidney transplants, 11 complaints (44%) were related to living donor procedures and 6 to donors. The main causes of complaints were early post-operative complications in 31 cases (60%) and late complications in 13 cases (25%). The verdicts were in favour of the institution in 41 cases (79%). Solid organ transplants are increasingly the subject of litigation. Although the medical institution was not held liable in almost 80% of cases, this study makes a strong case for patients, living donors and their relatives to be better informed about SOT.

Regulations and Procurement Surgery in DCD Liver Transplantation: Expert Consensus Guidance From the International Liver Transplantation Society.

Donation after circulatory death (DCD) donors are an increasingly more common source of livers for transplantation in many parts of the world. Events that occur during DCD liver recovery have a significant impact on the success of subsequent transplantation. This working group of the International Liver Transplantation Society evaluated current evidence as well as combined experience and created this guidance on DCD liver procurement. Best practices for the recovery and transplantation of livers arising through DCD after euthanasia and organ procurement with super-rapid cold preservation and recovery as well as postmortem normothermic regional perfusion are described, as are the use of adjuncts during DCD liver procurement.

A Less Restrictive Policy for Liver Transplantation in Coronavirus Disease 2019 Positive Patients, Based Upon Cycle Threshold Values.

Coronavirus disease 2019 drastically impacted solid organ transplantation. Lacking scientific evidence, a very stringent but safer policy was imposed on liver transplantation (LT) early in the pandemic. Restrictive transplant guidelines must be reevaluated and adjusted as data become available. Before LT, the prevailing policy requires a negative severe acute respiratory syndrome coronavirus 2 real-time polymerase chain reaction (RT-PCR) of donors and recipients. Unfortunately, prolonged viral RNA shedding frequently hinders transplantation. Recent data reveal that positive test results for viral genome are frequently due to noninfectious and prolonged convalescent shedding of viral genome. Moreover, studies demonstrated that the cycle threshold of quantitative RT-PCR could be leveraged to inform clinical transplant decision-making. We present an evidence-adjusted and significantly less restrictive policy for LT, where risk tolerance is tiered to recipient acuity. In addition, we delineate the pretransplant clinical decision-making, intra- and postoperative management, and early outcome of 2 recipients of a liver graft performed while their RT-PCR of airway swabs remained positive. Convalescent positive RT-PCR results are common in the transplant arena, and the proposed policy permits reasonably safe LT in many circumstances.

[The place of living-donor liver transplants in the Netherlands]. / De plaats van levertransplantatie met levende donor in Nederland.

There is a shortage of donor livers from deceased persons, which means there is a relatively high mortality rate among patients on the national liver-transplant waiting list in the Netherlands. This justifies expanding the current programme for liver transplants from living donors. The new law on donor organs law came into effect on 1 July 2020. The expectation is that this will lead to a greater supply of post-mortem donor livers. New methods for organ preservation could also lead to an increase in the number of available donor livers. An increase in the supply of donor livers could lead to changes in donor policy. These changes should take into consideration that a liver transplant from a living donor can take place earlier in the course of the disease and that the quality of the donor liver is better, which means that outcomes for the recipient are also better.

Current status of liver transplantation in Asia.

In spite of early adoption of the brain death legislation, and all efforts at promoting deceased donation, various social, economic and cultural factors have acted as road blocks to the furthering of deceased donor liver transplantation (DDLT) in most Asian societies. On the other hand, Asian liver transplant centers have been the pioneers, innovators, and technical advancement catalysts for the world to follow, especially with regards to living donor liver transplantation (LDLT). With some high volume centers performing more than 200 LDLTs a year with good outcomes in the donor and recipient, techniques to expand the living donor pool have also been adopted like ABO-incompatible, paired exchange and dual lobe living donor liver transplants. Although large multicenter, and registry data as regards safety and outcomes of minimally invasive donor hepatectomy are awaited, expert centers have pioneered, and now regularly perform purely laparoscopic and robotic living donor hepatectomies, especially in Korea.

Current status of liver transplantation in Latin America.

The lack of adequate financial coverage, education, and the organization has been the main limiting factor for the development of transplantation in Latin America. As occurred worldwide, the number of patients on liver waiting lists in Latin America grows disproportionately compared to the number of liver transplantations (LTs) performed. Although many law modifications have been made in the last year, most countries lack social awareness about the importance of donation and the irreversibility of brain death. The mechanisms and norms for organ procurement and infrastructure development, capable of supporting this high demand, are still in slow progress in most countries. Access to LT in the region is very heterogeneous. While some countries have no active LT programs so far, others are an international model of a public transplantation system (Brazil) or a national information system (Argentina). While some countries have only a few LT centers, others have too many LT centers performing an inadequate low number of LTs. Disparity to access transplantation remains the major challenge in the region. Cultural and educational efforts have to be accompanied by transparent public policies that will likely increase organ donation and activity in transplantation. The purpose of this article is to review the trends and current activity in LT within Latin America, based on prior publications and the information available in each country of the region.

Constitutional Challenges to Liver Transplant Policy.

BACKGROUND: Liver transplant candidacy determination can be contentious. When transplantation is declined for reasons perceived as violating fundamental rights or discriminating against a protected class-for example, age, race, religion, nationality-the case may involve a constitutional claim. Judicial review of such cases may result in decisions with sweeping implications for transplant policy. METHODS: We reviewed all published court opinions involving liver transplantation in 2 legal databases (Lexis Nexus and WestLaw). We included all cases that involved a denial of liver transplant candidacy in violation of constitutional rights. RESULTS: The search returned 1562 cases: 290 involved the denial of insurance coverage for a transplant due to a patient's failure to abstain from drinking, 273 cases involved incarcerated inmates who were denied a liver transplant, 2 involved a constitutional claim for patient requesting a bloodless transplant for religious reasons, and 2 cases arose from age discrimination in transplant criteria. These cases highlight legal pitfalls related to the First Amendment (religious freedom), Eighth Amendment (cruel and unusual punishment), and the Fourteenth Amendment (equal protection and due process). CONCLUSIONS: The risk of a constitutional claim highlights concrete steps needed to ensure the equity of transplant policy. These include efforts to standardize transplant candidacy criteria across payers for candidates with alcohol-related liver disease and advanced age. Efforts to constrain emerging liabilities related to the citizenship of transplant candidates and the definition of donor service areas are also discussed.

State-Based Liver Distribution: Broad Sharing With Less Harm to Vulnerable and Underserved Communities Compared With Concentric Circles.

Allocation of livers for transplantation faces regulatory pressure to move toward broader sharing. A current proposal supported by the United Network for Organ Sharing Board of Directors relies on concentric circles, but its effect on socioeconomic inequities in access to transplant services is poorly understood. In this article, we offer a proposal that uses the state of donation as a unit of distribution, given that the state is a recognized unit of legal jurisdiction and socioeconomic health in many contexts. The Scientific Registry of Transplant Recipients liver simulated allocation model algorithm was used to generate comparative estimates of regional transplant volume and the impact of these considered changes with regard to vulnerable and high-risk patients on the waiting list and to disparities in wait-list access. State-based liver distribution outperforms the concentric circle models in overall system efficiency, reduced discards, and minimized flights for organs. Furthermore, the efflux of organs from areas of greater sociodemographic vulnerability and lesser wait-list access is more than 2-fold lower in a state-based model than in concentric circle alternatives. In summary, we propose that a state-based system offers a legally defensible, practical, and ethically sound alternative to geometric zones of organ distribution.

Liver Transplant in Colombia.

Liver transplantation began in Colombia in 1979. It is one of the most active countries in this field in Latin America but has faced problems with the regulation and appropriate management of solid organ transplantations, including transplant tourism, which is a worldwide problem. There is a well-structured donation and transplant network regulated by the government in all the stages of the process. In 2017, the country was ranked fourth for the number of liver transplantations (LTs) performed in Latin America, after Brazil, Argentina, and Uruguay, with a rate of 5.6 LTs per million population. Current regulatory bodies were created to coordinate and provide transparency and equality to transplant recipients. This article describes the evolution, government commissions, assignation criteria, and current status of LT in Colombia.

Similarities and Differences in Allocation Policies for Pediatric Liver Transplantation Across the World.

OBJECTIVES: We aimed to investigate national allocation policies for pediatric liver transplantation (LT). METHOD: A survey was prepared by the European Society for Paediatric Gastroenterology Hepatology and Nutrition Hepatology Committee in collaboration with the North American Studies of Pediatric Liver Transplantation consortium. The survey was sent to pediatric hepatologists and transplant surgeons worldwide. National data were obtained from centrally based registries. RESULTS: Replies were obtained from 15 countries from 5 of the world continents. Overall donation rate varied between 9 and 35 per million inhabitants. The number of pediatric LTs was 4 to 9 per million inhabitants younger than 18 years for 13 of the 15 respondents. In children younger than 2 years mortality on the waiting list (WL) varied between 0 and 20%. In the same age group, there were large differences in the ratio of living donor LT to deceased donor LT and in the ratio of split liver segments to whole liver. These differences were associated with possible discrepancies in WL mortality. CONCLUSIONS: Similarities but also differences between countries were detected. The described data may be of importance when trying to reduce WL mortality in the youngest children.

Changes in Simultaneous Liver-kidney Transplant Allocation Policy May Impact Postliver Transplant Outcomes.

BACKGROUND: Previous simultaneous liver-kidney (SLK) transplant allocation was based on serum creatinine, a metric that disadvantaged women relative to men. A recent SLK transplant policy change uses estimated glomerular filtration rate (eGFR), which accounts for sex-based differences in creatinine. METHODS: To understand the impact of this new policy, we analyzed nonstatus 1 adults listed for liver transplantation (LT) from May 2007 to July 2014, excluding those with exceptions. We defined patients who met the new SLK policy as having an eGFR <60 mL/min for 90 days, with a final eGFR <30 mL/min. RESULTS: Of 40979 candidates, 1683 would have met only the new criteria (N-SLK), 2452 would have met only the old criteria (O-SLK), and 1878 would have met both criteria (B-SLK). Compared to those in the B-SLK or O-SLK groups, those in the N-SLK group were significantly more likely to be female (52% versus 36% versus 39%, P < 0.001). Cox-regression analysis demonstrated that in adjusted analysis those in the N-SLK group were significantly less likely to die postliver transplant (hazard ratio [HR], 0.0; P < 0.001). Further, in Cox regression subgroup analyses, both in women (HR 0.04; P < 0.001) and in men (HR, 0.02, P < 0.001) those in the N-SLK group who underwent liver transplant were significantly less likely to die postliver transplant, even after adjustment for confounders. CONCLUSIONS: We anticipate that implementation of the new SLK policy will increase the proportion of women and decrease the proportion of men who are listed for SLK but may not improve posttransplant survival. Our data highlight the need for monitoring of SLK outcomes after implementation of the new policy.

Drs Bramhall and Bawa-Garba and the rightful domain of the criminal law.

In the wake of two recent high-profile, controversial cases involving the prosecution and conviction of Drs Bramhall and Bawa-Garba, this article considers when it is socially desirable to criminalise doctors' behaviour, exploring how the matters of harm, public wrongs and the public interest can play out to justify-or not, as the case may be-the criminal law's intervention. Dr Bramhall branded his initials on patients' livers during transplant surgery, behaviour acknowledged not to have caused his patients any harm by way of injury to their organs. Dr Bawa-Garba misdiagnosed and failed to properly assess a 6-year-old boy with pneumonia and sepsis under her care, who subsequently died. Taking account of contextual and public interest concerns, can and should there be exceptions to imposing criminal liability where a doctor's behaviour is deemed grossly negligent and a significant contribution to a patient's death? And is it really appropriate to subject a doctor to penal sanction where he may have committed a private wrong against a patient, but does not set back their interests?

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.

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.

Quality measurement and improvement in liver transplantation.

There is growing interest in the quality of health care delivery in liver transplantation. Multiple stakeholders, including patients, transplant providers and their hospitals, payers, and regulatory bodies have an interest in measuring and monitoring quality in the liver transplant process, and understanding differences in quality across centres. This article aims to provide an overview of quality measurement and regulatory issues in liver transplantation performed within the United States. We review how broader definitions of health care quality should be applied to liver transplant care models. We outline the status quo including the current regulatory agencies, public reporting mechanisms, and requirements around quality assurance and performance improvement (QAPI) activities. Additionally, we further discuss unintended consequences and opportunities for growth in quality measurement. Quality measurement and the integration of quality improvement strategies into liver transplant programmes hold significant promise, but multiple challenges to successful implementation must be addressed to optimise value.

New paradigms for organ allocation and distribution in liver transplantation.

PURPOSE OF REVIEW: The 'Final Rule,' issued by the Health Resources and Service Administration in 2000, mandated that liver allocation policy should be based on disease severity and probability of death, and - among other factors - should be independent of a candidate's residence or listing. As a result, the Organ Procurement Transplantation Network/United Network for Organ Sharing (UNOS) has explored policy changes addressing geographic disparities without compromising outcomes. RECENT FINDINGS: Major paradigm shifts are underway in U.S. liver allocation policy. New hepatocellular carcinoma exception policy incorporates tumor characteristics associated with posttransplantation outcomes, whereas a National Liver Review Board will promote a standardized process for awarding exception points. Meanwhile, following extensive debate, new allocation policy aims to reduce geographic disparity by broadening sharing to the UNOS region and 150-mile circle around the donor hospital for liver transplant candidates with a calculated model for end-stage liver disease score at least 32. Unnecessary organ travel will be reduced by granting 3 'proximity points' to candidates within the same donation service area (DSA) as a liver donor or within 150 nautical miles of the donor hospital, regardless of DSA or UNOS region. SUMMARY: This review provides an evaluation of major policy changes in liver allocation from 2016 to 2018.

Liver Simulated Allocation Modeling: Were the Predictions Accurate for Share 35?

BACKGROUND: The liver simulated allocation model (LSAM) can be used to study likely effects of liver transplant allocation policy changes on organ offers, acceptance, waitlist survival, and posttransplant survival. Implementation of Share 35 in June 2013 allowed for testing how well LSAM predicted actual changes. METHODS: LSAM projections for 1 year of liver transplants before and after the Share 35 policy change were compared with observed data during the same period. Numbers of organs recovered, organ sharing, transplant rates, and waitlist mortality rates (per 100 waitlist years) were evaluated by LSAM and compared with observed data. RESULTS: Candidate, recipient, and donor characteristics in the LSAM cohorts were similar to those in the observed population before and after Share 35. LSAM correctly predicted more accepted organs and fewer discarded organs with Share 35. LSAM also predicted increased regional and national sharing, consistent with observed data, although the magnitude was overestimated. Transplant rates were correctly projected to increase and waitlist death rates to decrease. CONCLUSIONS: Although the absolute number of transplants was underestimated and waitlist deaths overestimated, the direction of change was consistent with observed data. LSAM correctly predicted change in discarded organs, regional and national sharing, waitlist mortality, and transplants after Share 35 implementation.