American Society of Transplant Surgeons Normothermic Regional Perfusion Standards: Ethical, Legal, and Operational Conformance.

BACKGROUND: The American Society of Transplant Surgeons convened a multidisciplinary working group to address operational, ethical, and legal considerations surrounding normothermic regional perfusion (NRP) procurement. METHODS: The working group, comprising members from American Society of Transplant Surgeons and AST across various disciplines including transplant surgery, hepatology, critical care, and bioethics, collaborated to formulate recommendations and guidance for NRP procurement. RESULTS: The following topics were identified by the group as essential standards that need to be addressed for ethical, legal, and operational conformance: terminology; conceptualization of death in the context of NRP; and communication, logistics, and training and competency. CONCLUSIONS: Fourteen recommendations that support the ethical and legal acceptability of NRP in the United States and set expectations for the conduct of NRP procedures are provided.

Liver Transplant Costs and Activity After United Network for Organ Sharing Allocation Policy Changes.

Importance: A new liver allocation policy was implemented by United Network for Organ Sharing (UNOS) in February 2020 with the stated intent of improving access to liver transplant (LT). There are growing concerns nationally regarding the implications this new system may have on LT costs, as well as access to a chance for LT, which have not been captured at a multicenter level. Objective: To characterize LT volume and cost changes across the US and within specific center groups and demographics after the policy implementation. Design, Setting, and Participants: This cross-sectional study collected and reviewed LT volume from multiple centers across the US and cost data with attention to 8 specific center demographics. Two separate 12-month eras were compared, before and after the new UNOS allocation policy: March 4, 2019, to March 4, 2020, and March 5, 2020, to March 5, 2021. Data analysis was performed from May to December 2022. Main Outcomes and Measures: Center volume, changes in cost. Results: A total of 22 of 68 centers responded comparing 1948 LTs before the policy change and 1837 LTs postpolicy, resulting in a 6% volume decrease. Transplants using local donations after brain death decreased 54% (P < .001) while imported donations after brain death increased 133% (P = .003). Imported fly-outs and dry runs increased 163% (median, 19; range, 1-75, vs 50, range, 2-91; P = .009) and 33% (median, 3; range, 0-16, vs 7, range, 0-24; P = .02). Overall hospital costs increased 10.9% to a total of $46 360 176 (P = .94) for participating centers. There was a 77% fly-out cost increase postpolicy ($10 600 234; P = .03). On subanalysis, centers with decreased LT volume postpolicy observed higher overall hospital costs ($41 720 365; P = .048), and specifically, a 122% cost increase for liver imports ($6 508 480; P = .002). Transplant centers from low-income states showed a significant increase in hospital (12%) and import (94%) costs. Centers serving populations with larger proportions of racial and ethnic minority candidates and specifically Black candidates significantly increased costs by more than 90% for imported livers, fly-outs, and dry runs despite lower LT volume. Similarly, costs increased significantly (>100%) for fly-outs and dry runs in centers from worse-performing health systems. Conclusions and Relevance: Based on this large multicenter effort and contrary to current assumptions, the new liver distribution system appears to place a disproportionate burden on populations of the current LT community who already experience disparities in health care. The continuous allocation policies being promoted by UNOS could make the situation even worse.

Effect of revised organ transplant law in Japan on lung transplantation.

PURPOSE: To investigate how revision of the organ transplant law in Japan affected lung transplantation in this country. METHODS: Lung transplant candidates registered between January, 2000 and December, 2009 were designated as the pre-revision group (n = 396) and those registered between January, 2011 and December, 2020, as the post-revision group (n = 1326). Both groups were analyzed retrospectively using data collected by the Japanese Society of Lung and Heart-Lung Transplantation. RESULTS: The number of patients who underwent brain-dead donor lung transplantation (BDLT) increased significantly after the law amendment (32.2 vs. 13.8%, p < 0.01). The median waiting time for BDLT was significantly reduced (708 days vs. 1163 days, p < 0.01) and the mortality rate while waiting for BDLT improved significantly after the law amendment (33.1 vs. 42.6%, p < 0.01). In the post-revision group, 18 pediatric patients underwent BDLT. The 5-year survival rates after BDLT were comparable between the groups (73.5% in the pre-revision group vs. 73.2% in the post-revision group, p = 0.32). CONCLUSIONS: The organ transplant law revision shortened the waiting time for BDLT significantly and decreased the mortality rate while waiting for BDLT. The posttransplant outcomes in Japan remained favorable throughout the study period.

Perception of Polish patients with cancer of the ethical and legal issues related to biobank research.

BACKGROUND: Although biobanks have become fundamental to many research centers and contribute to medical development, they generate many ethical and legal issues that may discourage patients from donating. MATERIALS AND METHODS: To understand patients' perception of ethical and legal issues related to biobanks we conducted a survey among 548 Polish patients with cancer. RESULTS: While 93.1% of patients with cancer declared themselves willing to donate biospecimens left over after a medical procedure to a biobank, most opted for one-time consent or study-specific consent, blanket consent being less frequently preferred. Many patients believed that future use of previously collected tissues require second contact. Most patients preferred pseudonymization over anonymization of the data, and supported donors' right to withdraw informed consent at any given moment. Finally, while personal health information was the most expected form of compensation for donation, most patients suggested that all parties, including the biobank concerned, the sponsors of the research, and the donors, should own the rights to cancer tissues donated and profit from the biobank research. Patients' opinions on the ethical and legal issues related to biobank research were associated with age, sex, religiosity, education level, and place of residence. CONCLUSIONS: Since biobanks generate ethical and legal issues related to informed consent, data protection and storage, as well as the sharing of biosamples, tissue ownership, and profit sharing, that may discourage patients from donation, when asking a patient for a donation, healthcare professionals should communicate in a donor-centered manner and address patients' ethical and moral concerns related to donation and offer resources to help manage these concerns.

National Consensus on Contraindications for Corneal Donation for Transplantation in Switzerland.

PURPOSE: To establish a national consensus on contraindications for corneal donation for transplantation in Switzerland. METHODS: Swisstransplant (SWT), the Swiss national foundation coordinating tissue and organ donations, convened a working group consisting of six national corneal surgeons and eye bankers and donation experts to create a contraindication list for corneal donation. The group reviewed available national and international guidelines and recommendations, while adhering to Swiss law and transplant regulations. In cases of opposing opinions, the group held follow-up meetings until a consensus was reached. A consensus was defined as agreement among all parties present. RESULTS: From March 2021 to November 2021, the study group held six meetings and created a standardized minimal contraindication list for corneal donation in Switzerland. Thanks to this list, SWT has created a mandatory working and documentation file for donor coordinators to use when evaluating multiorgan donors for corneal harvesting. The authors agreed that while the national consensus list provides standardized minimal contraindication criteria, local eye banks may choose to introduce additional, more rigorous criteria. CONCLUSION: Given that corneal transplantation is the most commonly performed transplantation, establishing a consensus on contraindications is crucial for recipient safety. The creation of a consensus on contraindications for corneal donation in Switzerland is an essential contribution to fulfil the legal requirements concerning quality assurance and provides sufficient high-quality donor tissue within the country. Therefore, periodic review and revision of the consensus is considered critical.

Influence of broader geographic allograft sharing on outcomes and cost in smaller lung transplant centers.

OBJECTIVE: On November 24, 2017, Organ Procurement and Transplantation Network implemented a change to lung allocation replacing donor service area with a 250 nautical mile radius around donor hospitals. We sought to evaluate the experience of a small to medium size center following implementation. METHODS: Patients (47 pre and 54 post) undergoing lung transplantation were identified from institutional database from January 2016 to October 2019. Detailed chart review and analysis of institutional cost data was performed. Univariate analysis was performed to compare eras. RESULTS: Similar short-term mortality and primary graft dysfunction were observed between groups. Decreased local donation (68% vs 6%; P < .001), increased travel distance (145 vs 235 miles; P = .004), travel cost ($8626 vs $14,482; P < .001), and total procurement cost ($60,852 vs $69,052; P = .001) were observed postimplementation. We also document an increase in waitlist mortality postimplementation (6.9 vs 31.6 per 100 patient-years; P < .001). CONCLUSIONS: Following implementation of the new allocation policy in a small to medium size center, several changes were in accordance with policy intention. However, concerning shifts emerged, including increased waitlist mortality and resource utilization. Continued close monitoring of transplant centers stratified by size and location are paramount to maintaining global availability of lung transplantation to all Americans regardless of geographic residence or socioeconomic status.

Canadian Society of Transplantation White Paper: Ethical and Legal Considerations for Alcohol and Cannabis Use in Solid Organ Listing and Allocation.

Alcohol and cannabis use as a contraindication to organ transplantation is a controversial issue. Until recently, patients in Canada with alcohol-associated liver disease were required to demonstrate abstinence for 6 mo to receive a liver transplant. There is no equivalent rule that is applied consistently for cannabis use. There is some evidence that alcohol and cannabis use disorder pretransplant could be associated with worse outcomes posttransplantation. However, early liver transplantation for patients with alcohol-associated liver disease in France and in the United States has led to challenges of the 6-mo abstinence rule in Canada in the media. It has also resulted in several legal challenges arguing that the rule violates human rights laws regarding discrimination in the provision of medical services and that the rule is also unconstitutional (this challenge is still before the court). Recent legalization of cannabis use for adults in Canada has led to questions about the appropriateness of limiting transplant access based on cannabis use. The ethics committee of the Canadian Society of Transplantation was asked to provide an ethical analysis of cannabis and alcohol abstinence policies. Our conclusions were as follows: neither cannabis use nor the 6-mo abstinence rule for alcohol use should be an absolute contraindication to transplantation, and transplant could be offered to selected patients, further research should be conducted to ensure evidence-based policies; and the transplant community has a duty not to perpetuate stigma associated with alcohol and cannabis use disorders.

The new 'opt-out' organ donation English law: Is the NHS ready for this?

In May 2020, the new 'opt-out' organ donation law was passed in England. This law is a crucial step to help battle the long waiting lists of patients awaiting a transplant. This article aims to explore some of the challenges that the transplant teams may face with the new law, as well as raising awareness among the junior doctors, especially with the new COVID-19 transplant guidelines. Successful transplantations require immense training of healthcare professionals, fast retrieval services, pre- and postoperative care of patients, intensive care management, life-long follow-up and management of patients. Organ transplant surgery is a life-changing moment for a patient. Ultimately, commissioning groups, clinicians and managers need to work together, evaluate the changes required and enact thorough business plans to ensure the NHS is not overwhelmed. Together with increasing the awareness of organ donation within the public, the government needs to support the NHS to fund, train and manage transplant centres to welcome this much-awaited 'opt-out' organ donation law in England successfully.

[The limits of a principlist approach in the ethics of donation of elements and products of the human body. About some examples]. / Les limites d'une approche principiste dans l'éthique du don d'éléments et produits du corps humain. À propos d'exemples.

Voluntary, non-remunerated donations are fundamental principles with anonymity regarding donations of elements and products of the human body in France. Blood donation was a model to organize donation of organs, hematopoietic stem cell or gamete. These principles, which at first glance appear to be intangible, commonly accepted and transposable between the different types of donation, though reveal singularities regarding to a collective imagination, a biological reality, evolution of society, medicine and science. Through the study of these different principles applied to donated human body parts, this article aims to highlight the ethical limitations of a single principlist approach. The notions of anonymity, consent, voluntariness, non for profit, under their universal aknowledge, reveal variability of interpretation and scope due to the heterogeneous characteristics, implications and purposes between these donations of different elements and the uses made of them.

Balancing supply and demand: Review of the 2018 donor heart allocation policy.

Heart transplant remains the most effective treatment for patients with end stage heart failure. Advances in mechanical circulatory support devices have changed the therapeutic landscape and contributed to a demographic shift in patients awaiting transplant. In the setting of a growing waitlist and concern for an inability of current policies to accurately account for patient acuity and equitable geographic distribution of organs, the United Network for Organ Sharing developed a new donor heart allocation policy which was introduced in 2018. The new policy creates more precise listing criteria to reflect patient acuity, addresses previously marginalized groups, and takes steps to address geographic inequalities.

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.

Factors associated with organ donation by trauma patients in Nova Scotia.

BACKGROUND: Trauma patients represent a significant pool of potential organ donors (PODs), and previous research suggests that this population is underutilized for organ donation (OD). Our objective was to assess factors associated with OD in the trauma population. METHODS: We retrospectively analyzed OD in Nova Scotia over a 7-year period (2009-2016) using data from the Nova Scotia Trauma Registry and Nova Scotia Legacy of Life Donor Registry. All trauma patients who died in the hospital were included. Multiple logistic regression was used to assess factors associated with donation. We also evaluated characteristics, donation types, and reasons for nondonation among trauma PODs. RESULTS: There were 689 trauma-related deaths in all hospitals in NS during the study period, of which 39.8% (274 of 689) met the Nova Scotia Trauma Registry definition of a POD. Data on OD were available for 108 of these patients who were referred to the Legacy of Life Program. The conversion rate was 84%. Compared with nondonors, organ donors were significantly younger, had a higher Abbreviated Injury Scale head score and a lower scene Glasgow Coma Scale score, were more likely to suffer ischemia from drowning or asphyxia and to require air transport, and were less likely to have comorbidities. Regression analysis showed that donation was associated with younger age (odds ratio [OR], 0.97; 95% confidence interval [CI], 0.95-0.99) and lower Glasgow Coma Scale score at the scene (OR, 0.76; 95% CI, 0.66-0.88). Odds of donation were increased with air transport compared with land ambulance (OR, 8.27; 95% CI, 2.07-33.08) and injury within Halifax Regional Municipality compared with injury outside Halifax Regional Municipality (OR, 4.64; 95% CI, 1.42-15.10). Among the 60 referred PODs who did not donate, family refusal of consent was the most common reason (28 [46.7%] of 60). CONCLUSION: Younger age, greater severity of injury, and shorter time to tertiary care were associated with OD in trauma patients. LEVEL OF EVIDENCE: Prognostic and Epidemiological, Level III.

A efetividade do processo de doação de órgãos frente a nova legislação / The effectiveness of the organ donation process fronts new legislation / La eficacia del proceso de donación de órganos frente a nueva legislaciónl

O decreto Nº 9.175, de 18 de outubro de 2017 trouxe consideráveis e necessárias mudanças ao texto da Lei de Doação de Órgãos, visando dar maior rapidez e garantia para que os procedimentos sejam realizados com pleno êxito, levando-se em consideração que o Brasil figura em posição privilegiada na lista dos países que mais realizam transplantes no mundo. Por este motivo, este estudo tem por objetivo verificar a efetividade da agilização da doação de órgãos frente a nova legislação brasileira. Utilizou-se como metodologia a revisão integrativa, com busca nos bancos de dados BVS, SciELO e LILACS, que levou a seleção de 10 artigos que analisados levaram a criação de três categorias temáticas: A Conduta da enfermagem frente ao Provável Doador; Fatores que levam a doação ou não de órgãos e A Efetividade da Nova Legislação na Agilização da Doação de Órgãos. Concluiu-se que fica nítida a necessidade de verificação mais aprofundada junto aos órgãos competentes, que forneçam dados a respeito da efetivação da doação de órgãos e que aumentem o número de publicações informando e auxiliando o profissional da saúde na minimização de filas e na melhoria de qualidade de vida daquele que tanto almeja uma chance de transplante.(AU)

Decree No. 9,175 of October 18, 2017 brought considerable and necessary changes to the text of the Organ Donation Law, with a view to speeding up and ensuring that procedures are carried out with full success, taking into account that the Brazil is in a privileged position in the list of countries that perform the most transplants in the world. For this reason, this study aims to verify the effectiveness of the agility of organ donation in front of the new Brazilian legislation. The integrative review was used as a methodology, with a search in the VHL, SciELO and LILACS databases, which led to the selection of 10 articles that analyzed led to the creation of three thematic categories: Nursing Conduct versus Probable Donor; Factors that lead to donation or not of organs and The Effectiveness of New Legislation in Streamlining Organ Donation. It was concluded that there is a clear need for more detailed verification to the competent organs, to provide data regarding the effectiveness of organ donation and to increase the number of publications informing and assisting the health professional in minimizing queues and improving quality of life of those who long for a chance of transplantation.(AU)

El Decreto No. 9.175, de 18 de octubre de 2017, trajo cambios considerables y necesarios al texto de la Ley de Donación de Órganos, con el objetivo de proporcionar mayor velocidad y garantía para que los procedimientos se lleven a cabo con pleno éxito, teniendo en cuenta que Brasil se encuentra en una posición privilegiada en la lista de países que realizan más trasplantes en el mundo. Por esta razón, este estudio tiene como objetivo verificar la efectividad de la donación racionalizada de órganos en virtud de la nueva legislación brasileña. La revisión integradora se utilizó como metodología, con una búsqueda en las bases de datos de BVS, SciELO y LILACS, lo que condujo a la selección de 10 artículos que analizados condujeron a la creación de tres categorías temáticas: la conducta de enfermería hacia el donante probable; Factores que conducen a la donación de órganos o no y La efectividad de la nueva legislación en la racionalización de la donación de órganos. Se concluyó que existe una clara necesidad de una verificación más profunda con los organismos competentes, para proporcionar datos sobre la efectividad de la donación de órganos y para aumentar el número de publicaciones que informan y ayudan al profesional de la salud a minimizar las colas y mejorar calidad de vida de quienes anhelan una posibilidad de trasplante.(AU)

The implementation and utilization of an organ donation dedicated medical advisory service: A descriptive study.

BACKGROUND: Obstacles encountered during the organ donation process may result in the loss of organs. A centralized medical advisory service (MAS), providing a 24/7/365 service, was established in 2007 to respond to queries from healthcare professionals regarding organ safety, brain death (BD) determination, and donor management. METHODS: Data collected from 2007 to 2017 included the number and context of the queries and the mean number of organs transplanted/donor. Since 2012, the number of six donor management goals (DMGs) met at the time of consent has been monitored. RESULTS: The number of queries relative to the number of potential donors increased from 12.4% (n = 78 queries) in 2007 to 48.2% (304 queries) in 2009 and has remained widely utilized, with most queries consistently related to organ safety. The context of the queries informed the formulation of protocols relating to donor infections and malignancy and identified difficulties regarding BD determination and subsequent implementation of solutions. A mean of 5.0 ± 0.7 DMGs was achieved, while the number of organs transplanted/donor increased from 3.4 in 2007 to 4.0 in 2017. CONCLUSION: We suggest that this model may provide a valuable resource to improve the safety, standardization, and quality of the donation process.

Doação de órgãos e tecidos humanos: a transplantação na Espanha e no Brasil / Organ donation and human tissues: transplantation in Spain and Brazil / Donación de órganos y tejidos humanos: el trasplante en España y en Brasil

Resumo A partir de dados brasileiros e espanhóis, este artigo aborda aspectos relevantes da doação e transplantes de órgãos, como a relação entre oferta e demanda, legislação vigente, custos e possíveis estratégias para aumentar taxas de doação e melhorar de forma geral o processo de transplantes. O objetivo deste artigo é apresentar dados empíricos atuais que incrementem o conhecimento relevante para a avaliação bioética. Os dois países se destacam: o Brasil por ter o maior sistema público de transplantes de órgãos do mundo, e a Espanha por manter há décadas o maior índice de doadores efetivos por milhão de pessoas. Análise inicial dos dados sugere a necessidade de lidar mais abertamente com os interesses dos afetados e a opinião pública, criando articulação sistêmica entre legislação, políticas públicas baseadas em evidências e pesquisa.

Abstract This essay, based on data referring to Brazil and Spain, addresses aspects relevant to the scenario of organ donation and transplantation, such as the relationship between supply and demand, current legislation, costs, and possible improvements to increase donation rates and performance in the transplantation process as a whole. The objective is to present current empirical data that increase the relevant empirical knowledge for the bioethical evaluation in an organized way. The two countries stand out when it comes to transplants, Brazil, because it has the largest public system of organ transplants in the world; Spain, for decades the highest rate of effective donor per million inhabitants. Our initial data analyses suggest the need to deal more explicitly with the interests of those affected and with the public opinion, within a systemic articulation between legislation, evidence-based public policies, and research.

Resumen A partir de datos brasileños y españoles, este artículo aborda aspectos relevantes de la donación y el trasplante de órganos, como la relación entre oferta y demanda, la legislación vigente, los costos y las posibles estrategias para aumentar las tasas de donación y mejorar de forma general el proceso de trasplante. El objetivo de este artículo es presentar datos empíricos actuales que incrementen el conocimiento relevante para la evaluación bioética. Los dos países se destacan: Brasil, por poseer el mayor sistema público de trasplante de órganos del mundo; España, por mantener desde hace décadas el mayor índice de donadores efectivos por cada millón de personas. Un análisis inicial de los datos sugiere la necesidad de lidiar más abiertamente con los intereses de los afectados y con la opinión pública, creando una articulación sistémica entre legislación, políticas públicas basadas en evidencias e investigación.

[Compulsory organ donation-a controversial topic]. / Verpflichtung zur Organspende ­ ein kontroverses Thema.

The number of organ donations in Germany has continuously fallen in recent years. The proposed Transplantation Act stipulates that every German citizen is considered an organ donor if he/she has not objected during his/her lifetime. This proposal has received wide approval, but also much criticism. The German Society for Urology, the German Society for Surgery, the German Society for Nephrology and the German Transplantation Society have all spoken out in press releases in favor of the introduction of an opt out (presumed consent) solution. The German Bundestag will decide on the proposed bill in autumn.

Allograft for knee ligament surgery: an American perspective.

PURPOSE: Allografts are frequently use for ligamentous reconstruction at the knee. In the United States, tissue donation and distribution are highly regulated processes with thorough oversight from private and government entities. Allograft is widely available in the United States and allograft procurement is a large industry with varying procurement, sterilization, processing, and distribution procedures. It is important to understand allograft regulation and processing which may affect graft mechanical properties and biological graft integration. METHODS: English-language literature, United States government and regulatory agency statues pertaining to allograft procurement, distribution, and usage were reviewed and the findings summarized. RESULTS: During the processing of allograft, multiple factors including sterilization procedures, irradiation, storage conditions, and graft type all affect the biomechanical properties of the allograft tissue. Biological incorporation and ligamentization of allograft does occur, but at a slower rate compared with autograft. For ligamentous reconstruction around the knee, allograft offers shorter operative time, no donor-site morbidity, but has shown an increased risk for graft failure compared to autograft. CONCLUSION: This article reviews the regulations on graft tissue within the United States, factors affecting the biomechanics of allograft tissue, differences in allograft tissue choices, and the use of allograft for anterior cruciate ligament reconstruction and multiligamentous knee injury reconstruction. LEVEL OF EVIDENCE: V.