Consensus Statement: Technical Standards for Thoracoabdominal Normothermic Regional Perfusion.

BACKGROUND: Thoracoabdominal normothermic regional perfusion (TA-NRP) has emerged as a powerful technique for optimizing organ procurement from donation after circulatory death donors. Despite its rapid adoption, standardized guidelines for TA-NRP implementation are lacking, prompting the need for consensus recommendations to ensure safe and effective utilization of this technique. METHODS: A working group composed of members from The American Society of Transplant Surgeons, The International Society of Heart and Lung Transplantation, The Society of Thoracic Surgeons, and The American Association for Thoracic Surgery was convened to develop technical guidelines for TA-NRP. The group systematically reviewed existing literature, consensus statements, and expert opinions to identify key areas requiring standardization, including predonation evaluation, intraoperative management, postdonation procedures, and future research directions. RESULTS: The working group formulated recommendations encompassing donor evaluation and selection criteria, premortem testing and therapeutic interventions, communication protocols, and procedural guidelines for TA-NRP implementation. These recommendations aim to facilitate coordination among transplant teams, minimize variability in practice, and promote transparency and accountability throughout the TA-NRP process. CONCLUSIONS: The consensus guidelines presented herein serve as a comprehensive framework for the successful and ethical implementation of TA-NRP programs in organ procurement from donation after circulatory death donors. By providing standardized recommendations and addressing areas of uncertainty, these guidelines aim to enhance the quality, safety, and efficiency of TA-NRP procedures, ultimately contributing to improved outcomes for transplant recipients.

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.

American Society of Transplant Surgeons Normothermic Regional Perfusion Standards: Abdominal.

BACKGROUND: Normothermic regional perfusion (NRP) has emerged as a vital technique in organ procurement, particularly in donation after circulatory death (DCD) cases, offering the potential to optimize organ utilization and improve posttransplant outcomes. Recognizing its significance, the American Society of Transplant Surgeons (ASTS) convened a work group to develop standardized recommendations for abdominal NRP in the United States. METHODS: The workgroup, comprising experts in NRP, DCD, and transplantation, formulated recommendations through a collaborative process involving revisions and approvals by relevant committees and the ASTS council. Four key areas were identified for standardization: Preprocedure communication, NRP procedure, Terminology and documentation, and Mentorship/credentialing. RESULTS: The recommendations encompass a range of considerations, including preprocedure communication protocols to facilitate informed decision-making by transplant centers and organ procurement organizations, procedural guidelines for NRP teams, uniform terminology to clarify the NRP process, and standards for mentorship and credentialing of NRP practitioners. Specific recommendations address logistical concerns, procedural nuances, documentation requirements, and the importance of ongoing quality assurance. CONCLUSIONS: The standardized recommendations for abdominal NRP presented in this article aim to ensure consistency, safety, and efficacy in the organ procurement process. By establishing clear protocols and guidelines, the ASTS seeks to enhance organ utilization, honor donor wishes, and uphold public trust in the donation process. Implementation of these recommendations can contribute to the advancement of NRP practices and improve outcomes for transplant recipients.

[The National German Transplantation Certification : Interdisciplinary and innovative]. / Zusatzweiterbildung Transplantationsmedizin : Interdisziplinär und innovativ.

The interdisciplinary additional advanced training in transplantation medicine (ZWB) has been passed with the (Model) Advanced Training Regulation 2018 and is now implemented in all federal states. It includes joint interdisciplinary contents that must be mastered by all disciplines and special skills that are specific to the individual disciplines. An organ-specific training is also possible. With its interdisciplinary approach the ZWB transplantation certification is pioneering the structure of modern transplantation centers and will thus further improve the quality of treatment for patients on the waiting lists for organ transplantation and for patients with transplanted organs.

Human Tracheal Transplantation.

Long-segment tracheal airway defects may be congenital or result from burns, trauma, iatrogenic intubation damage, or tumor invasion. Although airway defects <6 cm in length may be reconstructed using existing end-to-end reconstructive techniques, defects >6 cm continue to challenge surgeons worldwide. The reconstruction of long-segment tracheal defects has long been a reconstructive dilemma, and these defects are associated with significant morbidity and mortality. Many of these defects are not compatible with life or require a permanent extended-length tracheostomy that is fraught with complications including mucus plugging and tracheoesophageal fistula. Extensive circumferential tracheal defects require a reconstructive technique that provides a rigid structure able to withstand the inspiratory pressures, a structure that will biologically integrate, and contain functional ciliated epithelium to allow for normal mucociliary clearance. Tracheal transplantation has been considered the reconstructive "Holy Grail;" however, there has been a long-held scientific dogma that revascularization of the trachea was not possible. This dogma stifled research to achieve single-staged vascularized tracheal transplantation and prompted the introduction of many creative and inventive alternatives. Throughout history, alloplastic material, nonvascularized allografts, and homografts have been used to address this dilemma. However, these techniques have largely been unsuccessful. The recent introduction of a technique for single-staged vascularized tracheal transplantation may offer a solution to this dilemma and potentially a solution to management of the fatal tracheoesophageal fistula.

Construction of an Index System for Assessing Competences of Transplant Coordinators in China: A Delphi Survey.

BACKGROUND: Transplant coordinators (TCs) play a pivotal role in the entire donation process. Their professional competences have a direct impact on donation rates. However, few specific indicators are available for assessing TCs' professional competence. Therefore, it is imperative to develop an assessment index system to measure their competence. Our objective was to construct an index system for assessing TCs' professional competences. METHODS: Based on a literature review and semistructured interviews, a focus group and 12 TCs were enrolled to design the questionnaires. Then, a modified Delphi method was used. Two rounds of questionnaires were distributed to 21 experts from 7 provinces across multiple research areas between October 2020 and March 2021. The data were sorted and analyzed by a focus group. RESULTS: A combined assessment index system, namely, APT, including 3 constructs, the admittance assessment model (henceforth A), practical operation assessment model (P), and thousand-point performance assessment model (T), was constructed. This APT index system consisted of 3 first-level items, 8 second-level items, and 34 third-level items. CONCLUSIONS: The APT assessment system has been unanimously recognized by experts. This index system, as a precursor form, will further lay the foundation for formation of an assessment instrument and provide references for other countries.

OPTN/SRTR 2020 Annual Data Report: DOD.

SRTR uses data collected by OPTN to calculate metrics such as donation rate, organ yield, and rate of organs recovered for transplant but not transplanted. In 2020, there were 12,588 deceased donors, an increase from 11,870 in 2019; this number has been increasing since 2010. The number of deceased donor transplants increased to 33,303 in 2020, from 32,313 in 2019; this number has been increasing since 2012. The increase may be due in part to the rising number of deaths of young people amid the ongoing opioid epidemic. The number of organs transplanted included 18,410 kidneys, 962 pancreata, 8350 livers, 91 intestines, 3722 hearts, and 2463 lungs. Compared with 2019, transplants of all organs except pancreata and lung transplants increased in 2020, which is remarkable despite the pandemic caused by the SARS-CoV2 virus. In 2020, 4870 kidneys, 294 pancreata, 861 livers, 3 intestines, 39 hearts, and 115 lungs were discarded. The number of discards was similar to that of the previous year. In 2019, 4,324 kidneys, 346 pancreata, 867 livers, 5 intestines, 31 hearts, and 148 lungs were discarded. These numbers suggest an opportunity to increase numbers of transplants by reducing discards. Despite the pandemic, there was no dramatic increase in number of discards and an increase in total number of donors and transplants.

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.

Understanding Substance use Policies and Associated Ethical Concerns: A survey of Pediatric Transplant Centers.

Psychosocial risk factors, such as substance use, have been linked to poor post-transplant outcomes for solid organ transplant patients, including poor medication adherence, increased risk for rejection, and even graft failure. Despite universal consensus that substance use is an increasing problem among youth, many pediatric transplant centers do not have policies in place to address substance use and no universal guidelines exist regarding assessment during the pre-transplant evaluation in this population. An online survey was administered via REDCap™ and directed toward medical leaders (ie, medical and surgical directors) of national heart, kidney, and liver transplant centers. Questions examined the following: perspectives on the need for a universal transplant center policy on pediatric substance use, abuse, and dependence; timing and frequency of evaluation for substance use; specific substances which would elicit respondents' concerns; and ethical concerns surrounding substance use. Data were analyzed using descriptive statistics. Data were collected from 52 respondents from 38 transplant centers, with the majority (n = 40; 77%) reporting no substance use policy in place for pediatric transplant patients. However, many endorsed concerns if a pediatric patient was found to be using specific substances. Our findings further highlight the need for a universal substance use policy across pediatric solid organ transplant centers. The results from the distributed survey will help to provide guidelines and best practices when establishing a universal policy for substance use.

Single bilateral ovarian venous return in uterine transplant: Validation in an orthotopic auto-transplant model in the Yucatan minipig.

BACKGROUND: Uterine transplant (UT) represents an opportunity to treat absolute uterine infertility. However, the use of uterine veins for venous return, in addition to ovarian veins, significantly increases the risk of ureteral wounds in the living donor and UT time for the recipient. Our aim was to demonstrate that dual ovarian venous return is sufficient for graft viability and survival. METHODS: Uterine orthotopic auto-transplant was performed under general anaesthesia in six Yucatan minipig sows. The uterus graft was implanted with termino-lateral anastomoses between the ovarian and external iliac veins, and between the uterine and external iliac arteries, respectively. RESULTS: The macroscopic physical aspect of the graft was adequate in 83 % of the sows (5/6) 30 min after reperfusion with a surgical time of 439±54 min (mean anastomosis time: 153±49 min). Two sows died the day after surgery. In the four remaining sows, two uteri were necrotic and two were adequately vascularized on Day 7. CONCLUSIONS: the learning curve was relatively fast, the sole use of bilateral ovarian venous return is possible and might reduce post-surgery morbidity in human living donors as well as UT time for the recipient.

Islets Transplantation at a Crossroads - Need for Urgent Regulatory Update in the United States: Perspective Presented During the Scientific Sessions 2021 at the American Diabetes Association Congress.

Clinical islet allotransplantation has been successfully regulated as tissue/organ for transplantation in number of countries and is recognized as a safe and efficacious therapy for selected patients with type 1 diabetes mellitus. However, in the United States, the FDA considers pancreatic islets as a biologic drug, and islet transplantation has not yet shifted from the experimental to the clinical arena for last 20 years. In order to transplant islets, the FDA requires a valid Biological License Application (BLA) in place. The BLA process is costly and lengthy. However, despite the application of drug manufacturing technology and regulations, the final islet product sterility and potency cannot be confirmed, even when islets meet all the predetermined release criteria. Therefore, further regulation of islets as drugs is obsolete and will continue to hinder clinical application of islet transplantation in the US. The Organ Procurement and Transplantation Network together with the United Network for Organ Sharing have developed separately from the FDA and BLA regulatory framework for human organs under the Human Resources & Services Administration to assure safety and efficacy of transplantation. Based on similar biologic characteristics of islets and human organs, we propose inclusion of islets into the existing regulatory framework for organs for transplantation, along with continued FDA oversight for islet processing, as it is for other cell/tissue products exempt from BLA. This approach would reassure islet quality, efficacy and access for Americans with diabetes to this effective procedure.

Principles of immunisation in children with solid organ transplant.

Vaccine-preventable diseases (VPD) are a significant risk to paediatric solid organ transplant (SOT) recipients on lifelong immunosuppressive therapy. Children progressing to end-stage organ dysfunction are unable to mount a robust immune response. Hence, it is important to plan vaccination early in the course of disease, especially if a child is anticipated to be a SOT candidate. Vaccine recommendations need to be individualised in this population based on vaccine history and serology. Catch-up or accelerated schedules may be used to complete vaccinations before transplant. Post-transplant, immunisation is recommenced in consultation with the transplant team taking into context the time since transplant and the intensity of the immunosuppressive regime. Inactivated vaccines are safe post-transplant but postexposure prophylaxis may still be required in children with inadequate immunity to VPD. Specific vaccines may be advised for SOT recipients travelling abroad (in consultation with a travel clinic) or those entering high-risk professions. Additionally, the vaccination status of all household members and close contacts should be reviewed and optimised, offering additional protection to the transplant recipient.

COVID-19 and Abdominal Transplant: A Stepwise Approach to Practice During Pandemic Conditions.

BACKGROUND: The novel severe acute respiratory syndrome coronavirus (SARS-CoV-2) disease has transformed innumerable aspects of medical practice, particularly in the field of transplantation. MAIN BODY: Here we describe a single-center approach to creating a generalizable, comprehensive, and graduated set of recommendations to respond in stepwise fashion to the challenges posed by these conditions, and the underlying principles guiding such decisions. CONCLUSIONS: Creation of a stepwise plan will allow transplant centers to respond in a dynamic fashion to the ongoing challenges posed by the COVID-19 pandemic.

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.

There are no best practices in a pandemic: Organ donation within the COVID-19 epicenter.

LiveOnNY, the organ procurement organization (OPO) for the greater New York metropolitan area, suspended several best practices to manage the rising referrals of deaths from hospitals during the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. On April 2, 2020 hospitals in the donor service area were notified that coronavirus disease 2019 (COVID-19) referrals should be deferred. Still, only 2% of referred patients to the OPO in April 2020 were on ventilators and considered possible organ donors, versus a baseline of 11% in 2019. Few of these deaths were unrelated to COVID-19. Accordingly, organ donors declined to 10 in April (from 26 in March). Despite the exclusion of marginal donors and organs, the implementation of COVID-19 donor testing, and the availability of local procurement surgeons, only 1 organ (a liver) was accepted by a transplant center outside of New York State and 8 organs (5 livers, 4 kidneys) were transplanted in state; 11 organs (1 liver, 10 kidneys) were discarded. Allocation was unsuccessful for 11 additional organs (1 liver, 4 kidneys, 4 hearts, 2 lungs). Despite the obstacles, organ donation remained an important model of collaboration and satisfaction for the health care community in the pandemic's US epicenter. Declining COVID-19 deaths led to the resumption of the comprehensive referral policy on May 6, 2020, with improvement to 18 donors in May.

Triage during the COVID-19 epidemic in Spain: better and worse ethical arguments.

The COVID-19 pandemic has generated an imbalance between the clinical needs of the population and the effective availability of advanced life support (ALS) resources. Triage protocols have thus become necessary. Triage decisions in situations of scarce resources were not extraordinary in the pre-COVID-19 era; these protocols abounded in the context of organ transplantation. However, this prior experience was not considered during the COVID-19 outbreak in Spain. Lacking national guidance or public coordination, each hospital has been forced to put forth independent and autonomous triage protocols, most of which were, nonetheless, based on common ethical principles and clinical criteria. However, controversial, non-clinical criteria have also been defended by Spanish scientific societies and public institutions, including setting an age cut-off value for unilaterally withholding ALS, using 'social utility' criteria, prioritising healthcare professionals or using 'first come, first served' policies. This paper describes the most common triage criteria used in the Spanish context during the COVID-19 epidemic. We will highlight our missed opportunities by comparing these criteria to those used in organ transplantation protocols. The problems posed by subjective, non-clinical criteria will also be discussed. We hope that this critical review might be of use to countries at earlier stages of the epidemic while we learn from our mistakes.