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INTRODUCTION: The 2022 National Academy of Sciences, Engineering, and Medicine report on equity in organ transplantation highlighted limited transparency and accountability for organ offer declines and recommended prioritizing patient engagement in decisions regarding organ offers. Yet, there is no guidance on how to incorporate patients in organ offers. We elected to study the experiences of patients on the waitlist and their perception of a novel Organ Offer Review Card (OORC). METHODS: A prototype OORC was created using Donornet refusal codes. Sixty randomly selected kidney waitlist patients at a single center were asked to participate in a web-based survey focusing on current medical decision-making preferences and perceptions of the prototype OORC. RESULTS: Among the 43 patients reached, 17 (39.5%) completed the survey. Most participants (88.2%) expressed it was important to be involved in the decision-making about organ offers, with 100.0% of respondents wanting to know why an organ was declined. Regarding the prototype OORC, 94.1% thought it helped them understand the factors and priorities considered when selecting an organ, and 88.2% said it increased their belief that their team was acting in their best interest. CONCLUSION: An OORC could increase transparency and communication during the waitlist process while enhancing trust in the transplant team.
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Toma de Decisiones , Trasplante de Riñón , Obtención de Tejidos y Órganos , Listas de Espera , Humanos , Obtención de Tejidos y Órganos/normas , Masculino , Femenino , Persona de Mediana Edad , Encuestas y Cuestionarios , Donantes de Tejidos/provisión & distribución , Estudios de Seguimiento , Pronóstico , Adulto , Participación del PacienteRESUMEN
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.
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Consenso , Preservación de Órganos , Perfusión , Humanos , Perfusión/normas , Perfusión/métodos , Preservación de Órganos/normas , Preservación de Órganos/métodos , Donantes de Tejidos/provisión & distribución , Trasplante de Órganos/normas , Trasplante de Órganos/métodos , Selección de Donante/normas , Obtención de Tejidos y Órganos/normas , Obtención de Tejidos y Órganos/métodosRESUMEN
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.
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Preservación de Órganos , Trasplante de Órganos , Perfusión , Humanos , Trasplante de Órganos/ética , Trasplante de Órganos/legislación & jurisprudencia , Trasplante de Órganos/normas , Estados Unidos , Preservación de Órganos/ética , Preservación de Órganos/métodos , Preservación de Órganos/normas , Sociedades Médicas/normas , Terminología como Asunto , Obtención de Tejidos y Órganos/legislación & jurisprudencia , Obtención de Tejidos y Órganos/ética , Obtención de Tejidos y Órganos/normasRESUMEN
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.
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Trasplante de Órganos , Perfusión , Humanos , Perfusión/normas , Perfusión/métodos , Trasplante de Órganos/normas , Preservación de Órganos/normas , Preservación de Órganos/métodos , Estados Unidos , Sociedades Médicas/normas , Obtención de Tejidos y Órganos/normas , Abdomen/cirugía , Mentores , Terminología como Asunto , Documentación/normas , Cirujanos/normasAsunto(s)
Quistes , Enfermedad Hepática en Estado Terminal , Hepatopatías , Trasplante de Hígado , Humanos , Trasplante de Hígado/normas , Hepatopatías/terapia , Hepatopatías/diagnóstico , Quistes/diagnóstico , Quistes/terapia , Enfermedad Hepática en Estado Terminal/cirugía , Enfermedad Hepática en Estado Terminal/mortalidad , Enfermedad Hepática en Estado Terminal/diagnóstico , Índice de Severidad de la Enfermedad , Listas de Espera/mortalidad , Obtención de Tejidos y Órganos/normas , Obtención de Tejidos y Órganos/métodos , Obtención de Tejidos y Órganos/organización & administración , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND Like many other countries, Poland faces a shortage of transplantable organs despite implementing strategies to develop donation programs. Increasing the effectiveness of deceased organ donation programs requires the implementation of protocols and quality standards for the entire process. The aim of this study was to assess the organ donation potential in Warsaw hospitals (with and without implemented donation procedures) in the years 2017-2018, before the COVID-19 pandemic affected donation activity. The obtained results were compared with quality indicators established in the ODEQUS project and the European Commission project "Improving Knowledge and Practices in Organ Donation" (DOPKI). MATERIAL AND METHODS Retrospective analysis was performed of hospitalization and death causes (including deaths in the brain death mechanism) in the hospitals and intensive care units in 2017-2018. We divided 15 Warsaw hospitals into 2 groups: those with implemented quality programs for organ donation (n=4) and those without such programs (n=11). RESULTS Hospitals with procedures obtained significantly higher values than hospitals without procedures, but were lower than the values in DOPKI and ODEQUS. The success rate of the organ donation process after brain death recognition was comparable in all groups. The conversion rate to actual donors was 73% in hospitals with procedures compared to 68% in hospitals without procedures, significantly higher than in the 42% reported in the DOPKI project. CONCLUSIONS Low numbers of brain death declarations in Warsaw hospitals result from low recognition of deaths in the brain death mechanism. Implementing procedures at each hospital level will enable identification of critical points and comparison of solution outcomes.
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COVID-19 , Hospitales , Obtención de Tejidos y Órganos , Humanos , Obtención de Tejidos y Órganos/estadística & datos numéricos , Obtención de Tejidos y Órganos/normas , Polonia , Estudios Retrospectivos , COVID-19/epidemiología , Hospitales/normas , Hospitales/estadística & datos numéricos , Muerte Encefálica , Masculino , Donantes de Tejidos/provisión & distribución , Femenino , Persona de Mediana Edad , SARS-CoV-2 , AdultoRESUMEN
Background A quality assurance programme for the tissue donation process was launched in Andalusia in 2020 to facilitate the integration of tissue donation into end-of-life care, and to respond to the growing need for human tissue for therapeutic purposes. The results of this programme are presented here. Methods After identifying the hospital departments in which to intensify the detection of tissue donors, expanding training activities and designing a specific data collection system for possible tissue donors who do not donate their tissues, the results of the donation activity were quantified and the causes of non-donation were analysed by applying the critical pathway for deceased tissue donation methodology. Results After an initial drop in activity, which coincided with the coronavirus pandemic, the number of tissue donors increased by 48.4% in 2022 compared to 2019. From the eligible donors, 83% were actual tissue donors and 71% were utilised donors. The modifiable causes of tissue donation loss, in order of frequency, were family refusal, followed by organisational or logistical issues, failure to notify or failure to identify possible donors, and failure to complete donor evaluation. Conclusion As a result of the collaboration of the various professionals involved in the programme, tissue donation activity has increased remarkably, the potential and effectiveness of the donation process have been evaluated, and areas for improvement have been identified, which we hope will lead to continuous improvement of the process.
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COVID-19 , Garantía de la Calidad de Atención de Salud , Donantes de Tejidos , Obtención de Tejidos y Órganos , Humanos , Obtención de Tejidos y Órganos/normas , Donantes de Tejidos/provisión & distribución , COVID-19/epidemiología , España , SARS-CoV-2 , Cuidado TerminalRESUMEN
The World Brain Death Project (WBDP) is a 2020 international consensus statement that provides historical background and recommendations on brain death/death by neurologic criteria (BD/DNC) determination. It addresses 13 topics including: (1) worldwide variance in BD/DNC, (2) the science of BD/DNC, (3) the concept of BD/DNC, (4) minimum clinical criteria for BD/DNC determination, (5) beyond minimum clinical BD/DNC determination, (6) pediatric and neonatal BD/DNC determination, (7) BD/DNC determination in patients on ECMO, (8) BD/DNC determination after treatment with targeted temperature management, (9) BD/DNC documentation, (10) qualification for and education on BD/DNC determination, (11) somatic support after BD/DNC for organ donation and other special circumstances, (12) religion and BD/DNC: managing requests to forego a BD/DNC evaluation or continue somatic support after BD/DNC, and (13) BD/DNC and the law. This review summarizes the WBDP content on each of these topics and highlights relevant work published from 2020 to 2023, including both the 192 citing publications and other publications on BD/DNC. Finally, it reviews questions for future research related to BD/DNC and emphasizes the need for national efforts to ensure the minimum standards for BD/DNC determination described in the WBDP are included in national BD/DNC guidelines and due consideration is given to the recommendations about social and legal aspects of BD/DNC determination.
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Muerte Encefálica , Humanos , Muerte Encefálica/diagnóstico , Obtención de Tejidos y Órganos/normasRESUMEN
As an alternative to static cold storage (SCS), advanced perfusion techniques such as normothermic regional perfusion and ex-situ perfusion (normothermic or hypothermic) have emerged as a way to improve the ischemic injury suffered by donation after circulatory death (DCD) livers. Multiple studies have been published that have demonstrated superior post-DCD liver transplant outcomes when using advanced perfusion compared with SCS. In particular, these studies have shown lower rates of ischemic cholangiopathy with advanced perfusion. In addition to the improved post-liver transplant outcomes, studies have also demonstrated higher rates of liver utilization from DCD donors when advanced perfusion is used compared with SCS. Given the high rates of graft loss in patients who develop ischemic cholangiopathy, the significant reduction seen in DCD donor livers that have undergone advanced perfusion represents a key step in more broad utilization of these livers. With such compelling evidence from multiple trials, it seems reasonable to ask the question: should advanced perfusion be the standard of care for DCD liver transplant?
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Trasplante de Hígado , Preservación de Órganos , Perfusión , Donantes de Tejidos , Obtención de Tejidos y Órganos , Humanos , Preservación de Órganos/métodos , Perfusión/métodos , Nivel de Atención , Obtención de Tejidos y Órganos/normas , Obtención de Tejidos y Órganos/métodos , Donantes de Tejidos/provisión & distribuciónRESUMEN
BACKGROUND: Donor interventions, including medications, protocols, and medical devices administered to donors, can enhance transplantable organ quality and quantity and maximize transplantation success. However, there is paucity of high-quality evidence about their effectiveness, in part because of ethical, practical, and regulatory challenges, and lack of guidance about conduct of donor intervention randomized controlled trials (RCTs). METHODS: With the vision to develop authoritative guidance for conduct of donor intervention RCTs, we convened a workshop of Canadian-United Kingdom experts in organ donation and transplantation ethics, research, and policy to identify stakeholders, explore unique challenges, and develop research agenda to inform future work in this promising field. RESULTS: Donor intervention trials should consider perspectives of broad group of stakeholders including donors, transplant recipients, and their families; researchers in donation and transplantation; research ethics boards; and healthcare providers and administrators involved in donation and transplantation. Unique challenges include (1) research ethics (living versus deceased status of the donor at the time of intervention, intervention versus outcomes assessment in different individuals, harm-benefit analysis in donors versus recipients, consent, and impact on research bystanders); (2) outcome data standardization and linkage; and (3) regulatory and governance considerations. CONCLUSIONS: Donor intervention RCTs hold potential to benefit organ transplantation outcomes but face unique research ethics, outcome data, and regulatory challenges. By developing research agenda to address these challenges, our workshop was an important first step toward developing Canada-United Kingdom guidance for donor intervention RCTs that are poised to improve the quality and availability of transplantable organs.
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Trasplante de Órganos , Ensayos Clínicos Controlados Aleatorios como Asunto , Donantes de Tejidos , Obtención de Tejidos y Órganos , Humanos , Reino Unido , Canadá , Ensayos Clínicos Controlados Aleatorios como Asunto/ética , Ensayos Clínicos Controlados Aleatorios como Asunto/normas , Trasplante de Órganos/ética , Donantes de Tejidos/ética , Donantes de Tejidos/provisión & distribución , Obtención de Tejidos y Órganos/ética , Obtención de Tejidos y Órganos/normas , Participación de los Interesados , Proyectos de Investigación/normasAsunto(s)
Trasplante de Hígado , Donantes de Tejidos , Obtención de Tejidos y Órganos , Humanos , Trasplante de Hígado/tendencias , Trasplante de Hígado/métodos , Trasplante de Hígado/efectos adversos , Trasplante de Hígado/normas , Donantes de Tejidos/provisión & distribución , Donantes de Tejidos/estadística & datos numéricos , Obtención de Tejidos y Órganos/métodos , Obtención de Tejidos y Órganos/tendencias , Obtención de Tejidos y Órganos/estadística & datos numéricos , Obtención de Tejidos y Órganos/normas , Selección de Donante/normas , Selección de Donante/métodos , Selección de Donante/tendenciasRESUMEN
The cornea is the most frequently transplanted human tissue, and corneal transplantation represents the most successful allogeneic transplant worldwide. In order to obtain good surgical outcome and visual rehabilitation and to ensure the safety of the recipient, accurate screening of donors and donor tissues is necessary throughout the process. This mitigates the risks of transmission to the recipient, including infectious diseases and environmental contaminants, and ensures high optical and functional quality of the tissues. The process can be divided into 3 stages: (1) donor evaluation and selection before tissue harvest performed by the retrieval team, (2) tissue analysis during the storage phase conducted by the eye bank technicians after the retrieval, and, (3) tissue quality checks undertaken by the surgeons in the operating room before transplantation. Although process improvements over the years have greatly enhanced safety, quality, and outcome of the corneal transplants, a lack of standardization between centers during certain phases of the process still remains, and may impact on the quality and number of transplanted corneas. Here we detail the donor screening process for the retrieval teams, eye bank operators. and ophthalmic surgeons and examine the limitations associated with each of these stages.
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Trasplante de Córnea , Bancos de Ojos , Garantía de la Calidad de Atención de Salud , Donantes de Tejidos , Humanos , Trasplante de Córnea/métodos , Trasplante de Córnea/normas , Bancos de Ojos/normas , Selección de Donante/normas , Selección de Donante/métodos , Córnea , Obtención de Tejidos y Órganos/normas , Enfermedades de la Córnea/cirugíaRESUMEN
Given liver transplantation organ scarcity, selection of recipients and donors to maximize post-transplant benefit is paramount. Several scores predict post-transplant outcomes by isolating elements of donor and recipient risk, including the donor risk index, Balance of Risk, pre-allocation score to predict survival outcomes following liver transplantation/survival outcomes following liver transplantation (SOFT), improved donor-to-recipient allocation score for deceased donors only/improved donor-to-recipient allocation score for both deceased and living donors (ID2EAL-D/-DR), and survival benefit (SB) models. No studies have examined the performance of these models over time, which is critical in an ever-evolving transplant landscape. This was a retrospective cohort study of liver transplantation events in the UNOS database from 2002 to 2021. We used Cox regression to evaluate model discrimination (Harrell's C) and calibration (testing of calibration curves) for post-transplant patient and graft survival at specified post-transplant timepoints. Sub-analyses were performed in the modern transplant era (post-2014) and for key donor-recipient characteristics. A total of 112,357 transplants were included. The SB and SOFT scores had the highest discrimination for short-term patient and graft survival, including in the modern transplant era, where only the SB model had good discrimination (C ≥ 0.60) for all patient and graft outcome timepoints. However, these models had evidence of poor calibration at 3- and 5-year patient survival timepoints. The ID2EAL-DR score had lower discrimination but adequate calibration at all patient survival timepoints. In stratified analyses, SB and SOFT scores performed better in younger (< 40 y) and higher Model for End-Stage Liver Disease (≥ 25) patients. All prediction scores had declining discrimination over time, and scores relying on donor factors alone had poor performance. Although the SB and SOFT scores had the best overall performance, all models demonstrated declining performance over time. This underscores the importance of periodically updating and/or developing new prediction models to reflect the evolving transplant field. Scores relying on donor factors alone do not meaningfully inform post-transplant risk.