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.

An Ethics Committee's Evaluation of Normothermic Regional Perfusion (NRP) in 2018-Unsatisfactory Answers Then-and Now.

An adult university hospital ethics committee evaluated a proposed TA-NRP protocol in the fall of 2018. The protocol raised ethical concerns about violation of the Uniform Determination of Death Act and the prohibition known as the Dead Donor Rule, with potential resultant legal consequences. An additional concern was the potential for increased mistrust by the community of organ donation and transplantation. The ethics committee evaluated the responses to these concerns as unable to surmount the ethical and legal boundaries and the ethics committee declined to endorse the procedure. These concerns endure.

Assessment of Knowledge of Legal Provisions on Organ Donation and Transplantation amongst Healthcare Workers in Nigeria: A Cross-sectional Study.

BACKGROUND: Advancements in the medical field have made organ transplantation an attractive treatment option for patients when indicated. Shortage of organs and commodification of organs are major challenges encountered in organ donation and transplantation. These could potentially breed unethical practices, if the process is not well regulated. AIM: The aim of this study was to assess the knowledge of healthcare workers (HCWs) on the legal provisions regulating organ donation and transplantation in Nigeria. METHODOLOGY: This cross-sectional study was conducted amongst physicians and nurses across Nigeria. Knowledge of legal provisions on organ donation and transplantation was assessed using a validated questionnaire that had 21 questions derived from the National Health Act. Each correctly answered question was given 1 point with a total obtainable score of 21 points. A score of ≥14 points was classified as good knowledge. P <0.05 was considered significant. RESULTS: A total of 836 physicians and nurses with a mean age of 37.61 ± 9.78 years participated in the study. Females and physicians constituted 53.3% and 62.9% of the respondents, respectively. The mean knowledge score of the respondents was 9.70 ± 2.91 points. Eighty-three (9.9%) respondents had a good knowledge score. There was a significantly higher proportion of male HCWs (P < 0.037) and older HCWs (P = 0.017) with good knowledge of legal provisions. On logistic regression, age was the only factor found to be associated with good knowledge of legal provision (adjusted odds ratio: 3.92; confidence interval: 1.33-11.59; P = 0.01). CONCLUSION: The overall knowledge of legal provisions on organ donation and transplant was very poor amongst HCWs in Nigeria. There is a need to educate them on these provisions to curb unethical practices.

Uterine transplantation: legal and regulatory implications in England.

Uterus transplantation (UTx) is fast evolving from an experimental to a clinical procedure, combining solid organ transplantation with assisted reproductive technology. The commencement of the first human uterus transplant trial in the United Kingdom leads us to examine and reflect upon the legal and regulatory aspects closely intertwined with UTx from the process of donation to potential implications for fertility treatment and the birth of the resultant child. As the world's first ephemeral transplant, the possibility of organ restitution requires consideration and is discussed herein. TWEETABLE ABSTRACT: Uterine transplantation warrants a closer look at the legal frameworks on fertility treatment and transplantation in England.

Early impact of COVID-19 on transplant center practices and policies in the United States.

COVID-19 is a novel, rapidly changing pandemic: consequently, evidence-based recommendations in solid organ transplantation (SOT) remain challenging and unclear. To understand the impact on transplant activity across the United States, and center-level variation in testing, clinical practice, and policies, we conducted a national survey between March 24, 2020 and March 31, 2020 and linked responses to the COVID-19 incidence map. Response rate was a very high 79.3%, reflecting a strong national priority to better understand COVID-19. Complete suspension of live donor kidney transplantation was reported by 71.8% and live donor liver by 67.7%. While complete suspension of deceased donor transplantation was less frequent, some restrictions to deceased donor kidney transplantation were reported by 84.0% and deceased donor liver by 73.3%; more stringent restrictions were associated with higher regional incidence of COVID-19. Shortage of COVID-19 tests was reported by 42.5%. Respondents reported a total of 148 COVID-19 recipients from <1 to >10 years posttransplant: 69.6% were kidney recipients, and 25.0% were critically ill. Hydroxychloroquine (HCQ) was used by 78.1% of respondents; azithromycin by 46.9%; tocilizumab by 31.3%, and remdesivir by 25.0%. There is wide heterogeneity in center-level response across the United States; ongoing national data collection, expert discussion, and clinical studies are critical to informing evidence-based practices.

A review of policies and programmes for human organ and tissue donations and transplantations, WHO African Region.

Several resolutions, endorsed by the World Health Assembly and the United Nations General Assembly, articulate the need to improve the availability, quality and safety of organ and tissue donation and transplantation, as well as to prevent and combat trafficking in human organs. Here we assessed the implementation of these resolutions pertaining to organ and tissue donations and transplantations by sending out a questionnaire to all 47 countries in the World Health Organization African Region. From 33 countries that provided data, we identified several obstacles and challenges. Compared to other regions, there are very limited data on organ donation and transplantation. Most countries are lacking legal and regulatory frameworks, since they did not yet establish a specific or comprehensive legislation covering donation and transplantation of human organs and tissues. Countries also have a poor national capacity to perform organ and tissue transplantations and the organization and management of national programmes are weak. Funding, both from domestic and external sources, is insufficient to implement effective transplantations programmes and patients have inadequate financial protection. To address these challenges, we propose that countries and partners should develop and implement policies, strategies, plans and regulatory frameworks for all aspects of organ and tissue donations and transplantations, including fighting against organ trafficking and transplant tourism. Where donation and transplantation programmes exist, stakeholders should develop the skills of human resources, adopt technical standards and quality management procedures to improve donation and transplantation of human organs and tissues.

De nombreuses résolutions approuvées par l'Assemblée mondiale de la Santé et l'Assemblée générale des Nations Unies ont souligné le besoin d'améliorer la disponibilité, la qualité et la sécurité des dons et de transplantations d'organes et de tissus humains, de même que celui d'assurer la prévention et la lutte contre le trafic d'organes. Dans ce document, nous avons étudié la mise en œuvre de ces résolutions relatives aux dons et transplantations d'organes et de tissus, par le biais d'un questionnaire envoyé aux 47 pays appartenant à la région Afrique de l'Organisation mondiale de la Santé. Nous avons identifié de nombreux obstacles et défis dans les 33 pays qui nous ont transmis des données. Par rapport à d'autres régions, il existe très peu d'informations à ce propos. La plupart des pays ne possèdent pas de cadres juridiques et réglementaires car ils n'ont pas encore établi de législation spécifique ou exhaustive couvrant les dons et transplantations d'organes et de tissus. Certains manquent également de moyens au niveau national pour réaliser des greffes d'organes et de tissus, tandis que leur organisation et leur gestion des programmes nationaux sont inadaptées. Tant les fonds provenant de l'intérieur que ceux fournis par l'extérieur ne permettent pas d'instaurer des programmes de transplantation efficaces. Enfin, les patients ne bénéficient pas d'une protection financière suffisante. Afin de pouvoir relever ces défis, nous proposons que ces pays et leurs partenaires développent et appliquent des politiques, stratégies, projets et règles pour tous les aspects liés aux dons et transplantations d'organes et de tissus, y compris la lutte contre le trafic d'organes et le tourisme de la transplantation. Et là où des programmes de dons et de transplantations existent, les intervenants devraient acquérir des compétences en ressources humaines, mais aussi adopter des normes techniques et des procédures de gestion de la qualité afin d'optimiser les dons et transplantations d'organes et de tissus.

Diversas resoluciones que la Asamblea Mundial de la Salud y la Asamblea General de las Naciones Unidas aprobaron articulan la necesidad de mejorar la disponibilidad, la calidad y la seguridad de la donación y el trasplante de tejidos y órganos, así como de prevenir y combatir el tráfico de órganos humanos. En el presente documento se evalúa la implementación de estas resoluciones relacionadas con la donación y el trasplante de tejidos y órganos por medio del envío de un cuestionario a los 47 países de la Región de África de la Organización Mundial de la Salud. De los 33 países que suministraron los datos, se identificaron varios obstáculos y desafíos. En comparación con otras regiones, existen muy pocos datos sobre la donación y el trasplante de órganos. La mayoría de los países carecen de marcos normativos y legales, ya que todavía no han establecido una legislación específica o integral que aborde la donación y el trasplante de tejidos y órganos humanos. Los países también tienen una capacidad nacional deficiente para realizar los trasplantes de tejidos y órganos, además de que la organización y la gestión de los programas nacionales son débiles. El financiamiento, tanto de fuentes nacionales como internacionales, es insuficiente para implementar programas de trasplantes efectivos y los pacientes tienen una protección financiera inadecuada. Para hacer frente a estos desafíos, se propone que los países y los socios elaboren e implementen políticas, estrategias, programas y marcos normativos de todos los aspectos de la donación y el trasplante de tejidos y órganos, incluida la lucha contra el tráfico de órganos y el turismo de trasplantes. Cuando existan programas de donación y trasplante, las partes interesadas deberían desarrollar las habilidades de los recursos humanos y adoptar estándares técnicos y procedimientos de gestión de calidad para mejorar la donación y el trasplante de tejidos y órganos humanos.

Evolving ethical issues with advances in uterus transplantation.

While uterus transplantation was once considered only a theoretical possibility for patients with uterine factor infertility, researchers have now developed methods of transplantation that have led to successful pregnancies with multiple children born to date. Because of the unique and significant nature of this type of research, it has been undertaken with collaboration not only with scientists and physicians but also with bioethicists, who paved the initial path for research of uterus transplantation to take place. As the science of uterus transplantation continues to advance, so too must the public dialogue among obstetrician/gynecologists, transplant surgeons, bioethicists, and other key stakeholders in defining the continued direction of research in addition to planning for the clinical implementation of uterus transplantation as a therapeutic option. Given the rapid advances in this field, the time has come to revisit the fundamental questions raised at the inception of uterus transplantation and, looking forward, determine the future of this approach given emerging data on the procedure's impact on individuals, families, and society.

Assessment of Somatic Support Process for Pregnant Brain Death Patients Occurring in a Transition Country Between Asia and Europe from Medical, Ethical, Legal and Religious Aspects.

In spite of the fact that brain death during pregnancy is not a common occurrence, it is an important ethical problem for all cultures and religions can have a significant influence on the donation decision after brain death. Therefore, this study aimed to present the case of a pregnant patient developing brain death which occurred in our intensive care unit and to compare the medical, ethical and legal problems relating to pregnant cases developing brain death with 24 cases in the literature. A 21-year-old 19-week pregnant case with gestational diabetes was monitored in the anesthesia intensive care unit and developed brain death due to intracranial mass and intraventricular hemorrhage. Though brain death is a situation well understood by organ transplant professionals, brain death developing in pregnant patients still involves many medical, ethical and legal problems.

[An ethical evaluation of presumed consent for organ donation in Switzerland]. / Une évaluation éthique du consentement présumé pour le don d'organes en Suisse.

Following a current trend in European countries, Switzerland is about to decide to adopt (or reject) a presumed consent legislation for organ donation. In such a system, every citizen is considered as a potential organ donor except in case of expressed refusal during lifetime. The presumed consent system raises ethical and practical issues that need to be carefully understood and weighed before deciding on its fate. This article reviews the most pressing ethical issues and provides the empirical data necessary for assessing the presumed consent legislation in Switzerland. At the end of the analysis, the reader will be able to form her own informed opinion on the issue.

A l'image d'autres pays européens, la Suisse est sur le point de décider d'adopter (ou de rejeter) une législation du consentement présumé pour le don d'organes. Dans un tel système, tout citoyen est considéré comme donneur potentiel, sauf en cas de refus exprimé de son vivant. Le consentement présumé soulève des enjeux éthiques et pratiques qu'il importe de comprendre et pondérer soigneusement avant de statuer sur son sort. Cet article fournit les principales clefs d'analyse ainsi que les données empiriques nécessaires à cet exercice. Au terme de l'analyse, le lecteur pourra se forger une opinion informée et réfléchie sur le sujet.

Restructuring the Organ Procurement and Transplantation Network contract to achieve policy coherence and infrastructure excellence.

The Organ Procurement and Transplantation Network (OPTN) went up for competitive bid again this year, yet this contract has been held by only 1 entity since its inception. The OPTN's scope has grown steadily, and it now embraces several disparate missions: to operate the computing and coordination infrastructure that maintains waitlists and makes organ offers in priority order, to regulate transplant centers and organ procurement organizations, to follow and protect living donors, and to decide organ allocation policy in concert with the many voices of the transplant community. The contracting process and performance work statement continue to discourage both innovative approaches to the OPTN and competitive bids outside of United Network for Organ Sharing (UNOS), with evaluation criteria that either disqualify or strongly disadvantage new applicants. The performance work statement also emphasizes bureaucratic tasks while obligating the OPTN contractor to the specific committee structure that has impeded decision-making and tended to preserve the status quo in controversial matters. Finally, the UNOS computing infrastructure is antiquated and requires months to years to implement small changes. Restructuring the OPTN contract to separate the information technology requirements from the policy/regulatory responsibilities might allow more nimble and effective specialty contractors to offer their capabilities in service of the national transplant enterprise.

The VA Transplant Program: A rebuttal to criticism and a look to the future.

The Department of Veterans Affairs (VA) Transplant Program was established decades ago, is well resourced, and provides timely and high quality solid organ transplant care and services to a Nation of Veterans. In the past few years, the VA Transplant Program has received criticism that can be characterized as follows: the location of VA Transplant Centers (VATCs) requires Veterans to travel considerable distances for transplant care and services; the National Surgery Office (NSO) that provides oversight limits the number of active VATCs; Veterans Health Administration (VHA) policy limits referral of Veterans to non-VA transplant centers (community care); and the VA Transplant Program does not provide living donor transplant procedures. The MISSION Act of 2018 (Public Law 115-182) was enacted in part to address these themes by promoting community care and living donation. This article provides perspective regarding the VA Transplant Program and rebuttal to stated criticism: Travel to a transplant center is not isolated to the VA; the NSO does not limit VATC activation; current VHA policy authorizes community care; and the VA Transplant Program currently performs living donor procedures. The MISSION Act, as intended, has the potential to decrease referrals to the VA Transplant Program by 30%.

Impact of the OPTN transmissible diseases policy and US PHS increased risk donor guidelines on living donor candidates.

Donor-derived human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) transmissions in transplantation have led to policies mandating assessment of donor behavioral history, and disclosure of donor increased risk (IR) status to recipients. Organ Procurement Transplantation Network (OPTN) policy safeguards were promulgated in the context of deceased donation, with its narrow time window for organ utilization and uncertainty about donor history. These policies have been applied to living donation without substantive data on risk of disease transmission in living donor transplantation. Unlike for deceased donors, the OPTN does not collect data on living donor IR status. Given the feasibility of thorough living donor evaluation via already-mandated lab tests and clinical assessments, living donor IR assessment and associated disclosures may have limited benefit in improving recipient informed consent. Applying the current IR policy to living donors may also introduce unintended consequences to donors and recipients, causing donors psychological harm, delays in donation to avoid IR status disclosure, and potential withdrawal from donation. We suggest strategies that reduce risk of harm to donor candidates while maintaining policy compliance, and review additional approaches for evaluating risk of disease transmission in living donor candidates. Data on the risk of disease transmission by living donors are needed to inform policy modification.

National landscape of HIV+ to HIV+ kidney and liver transplantation in the United States.

The HIV Organ Policy Equity (HOPE) Act, enacted on November 21, 2013, enables research on the transplantation of organs from donors infected with human immunodeficiency virus (HIV) (HIV+) into HIV+ individuals who, prior to transplantation, are infected with HIV. In 2015, the Organ Procurement and Transplantation Network revised organ allocation policies on November 21, and on November 23, the Secretary of Health and Human Services published research criteria and revised the Final Rule accordingly. The HOPE Act appears to be underutilized to date. As of December 31, 2018, there were 56 donors recovered (50 donors transplanted) resulting in 102 organs transplanted (31 liver, 71 kidney). As of December 31, 2018, 212 registrations were indicated on the waiting list as willing to accept an HIV+ kidney or liver, most of which were waiting in active status. Due to the limited number of transplants performed to date, definitive safety conclusions cannot be reached at this time, though current data suggest that 1-year patient and graft survival does not deviate in a major way from that observed in HIV+ recipients of non-HIV+ organs or non-HIV+ recipients. As safety data are reviewed and disseminated, it is anticipated that HOPE participation will increase should safety signals remain low.

Progress in multiple genetically modified minipigs for xenotransplantation in China.

Pig-to-human organ transplantation provides an alternative for critical shortage of human organs worldwide. Genetically modified pigs are promising donors for xenotransplantation as they show many anatomical and physiological similarities to humans. However, immunological rejection including hyperacute rejection (HAR), acute humoral xenograft rejection (AHXR), immune cell-mediated rejection, and other barriers associated with xenotransplantation must be overcome with various strategies for the genetic modification of pigs. In this review, we summarize the outcomes of genetically modified and cloned pigs achieved by Chinese scientists to resolve the above-mentioned problems in xenotransplantation. It is now possible to knockout several porcine genes associated with the expression of sugar residues, antigens for (naturally) existing antibodies in humans, including GGTA1, CMAH, and ß4GalNT2, and thereby preventing the antigen-antibody response. Moreover, insertion of human complement- and coagulation-regulatory transgenes, such as CD46, CD55, CD59, and hTBM, can further overcome effects of the humoral immune response and coagulation dysfunction, while expression of regulatory factors of immune responses can inhibit the adaptive immune rejection. Furthermore, transgenic strategies have been developed by Chinese scientists to reduce the potential risk of infections by endogenous porcine retroviruses (PERVs). Breeding of multi-gene low-immunogenicity pigs in China is also presented in this review. Lastly, we will briefly mention the preclinical studies on pig-to-non-human primate xenotransplantation conducted in several centers in China.

Xenotransplantation in China: Present status.

The main obstacle to organ transplantation is the shortage of organs from deceased individuals. Especially in China, the ratio of patients on the waiting list versus the transplant recipients is 30:1. Therefore, there is an urgent need for organ donors. Genetically modified pig organs have proved to be a new source for xenotransplantation, and Chinese scientists have made considerable progress in this area during recent years. In this paper, we review four important aspects of the xenotransplantation field in China. First, a large variety of genetically modified pigs have been generated by Chinese scientists: all these genetically modified pigs and the purpose of these modifications will be summarized. Second, the preclinical research in pig-to-nonhuman primate xenotransplantation is outlined. The survival time and major biochemical parameters for the xenografts are summarized. Third, regarding the bench-to-bed approach, more suitable organs have been developed for xenotransplantation in humans, and in particular, pig islet transplantation into diabetic patients as well as pig-to-human cornea and skin transplantation. Fourth, we briefly address the regulations and prospects for recruiting xenotransplantation experts in China. Based on recent progress, we anticipate that genetically modified pigs will offer suitable organs for the treatment of end-stage organ diseases in humans in the near future. Given the recent influx of world-renowned scientists in xenotransplantation to China, our country will definitely become one of the major centers of xenotransplantation research and development in the world.

Transplant community perceptions of the benefits and drawbacks of alternative quality metrics for regulation.

BACKGROUND: There is concern that the metrics currently used to regulate transplant centers, one-year patient and graft survival, may have adverse consequences including decreasing higher risk donor organ acceptance and transplant volume. This raises questions about whether alternative measures would be more appropriate. METHODS: We surveyed American Society of Transplant Surgeons (ASTS) and American Society of Transplantation (AST) members (n = 270) to characterize perceptions of several metrics that are used for regulation, are publicly reported, or have been suggested elsewhere, regarding their effectiveness, amenability to risk adjustment, and predicted effects on volume, mortality, and waitlist size. RESULTS: Respondents rated one-year patient and graft survival the most effective measure of quality of care (mean scores = 7.44, 7.31, respectively, out of 10) and most amenable to risk adjustment (mean scores = 6.26, 6.13, respectively). Most respondents believed alternative metrics would not impact their center's volume, waitlist size, or one-year transplant mortality. However, some did predict unintended consequences; for example, some believed using one-year waitlist mortality, one-year mortality of patients listed, or one-year mortality of patients referred for transplant would decrease the number of transplants performed (48.6%, 46.7%, and 48.3% of respondents, respectively). DISCUSSION: Despite previously published concerns with existing regulatory metrics, most participants did not believe any metrics would outperform one-year patient and graft survival.

Presumed Consent: A Potential Tool for Countries Experiencing an Organ Donation Crisis.

BACKGROUND: There is currently an inadequate supply of allografts to meet the number of transplant candidates worldwide. A number of controversial policies, including implementation of a presumed consent organ donation system, have been considered to rectify the organ donation crisis. AIMS: A secondary retrospective data analysis aimed to assess the impact of switching to a presumed consent organ donation model on organ donation rates. METHODS: Deceased organ donation rates were compared before and after countries adopted presumed consent. RESULTS: Six countries met entry criteria. All six countries had an increase in liver donation rates, while 4 out of the six countries had an increase in kidney donation rates. The overall mean (± SD) liver donation rate was 3.23 (± 0.97) per million population (pmp) before the transition and 6.46 (± 1.81) pmp after the transition (p < 0.0001). The overall mean (± SD) kidney donation rate was 17.94 (± 3.34) pmp before the transition and 26.58 (± 4.23) pmp after the transition (p < 0.0001). The percentage increase in liver and kidney donation rates varied among countries, ranging from 28 to 1186%. CONCLUSION: The transition from explicit to presumed consent was associated with a significant increase in liver donation rates in all countries that met our criteria, while the effect on kidney donation rates was partially realized. Although presumed consent alone is unlikely to explain the increase in donation rates, the adoption of such a policy may prove to be a worthwhile risk for countries experiencing consistently low organ donation rates.