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.

Software para apoio à decisão logística no processo de captação e transplante de órgãos / Software de apoyo a la decisión logística en el proceso de obtención y trasplante de órganos / Software to support logistic decision in the process of organ acquisition and transplantation

Objetivo: desenvolver e avaliar um software para apoio à tomada de decisão dos profissionais da central de transplantes nas definições logísticas envolvidas no processo de captação e distribuição de órgãos para transplante. Método: estudo de produção tecnológica aplicada, sustentado pelo método Design Science Research Methodology. Participaram da etapa de avaliação da usabilidade dez enfermeiros da Central de Transplantes de Santa Catarina. A coleta de dados ocorreu de 1 a 20 de julho de 2021 por meio do questionário System Usability Scale. Resultados: o software utilizou linguagem JavaScript com ReactJS e PHP com Laravel, para o banco de dados PostgreSQL. A avaliação obteve escore médio de 98,25, sendo sua usabilidade considerada como melhor alcançável. Conclusão: o software demonstrou ser adequado e funcional, com fácil manuseio, reunindo informações integradas e objetivas. Representa um avanço na área, propondo uma inovação tecnológica para a gestão e apoio às decisões logísticas envolvidas no processo de captação e transplante de órgãos.

Objetivo: desenvolver e avaliar um software para apoio à tomada de decisão dos profissionais da central de transplantes nas definições logísticas envolvidas no processo de captação e distribuição de órgãos para transplante. Método: estudo de produção tecnológica aplicada, sustentado pelo método Design Science Research Methodology. Participaram da etapa de avaliação da usabilidade dez enfermeiros da Central de Transplantes de Santa Catarina. A coleta de dados ocorreu de 1 a 20 de julho de 2021 por meio do questionário System Usability Scale. Resultados: o software utilizou linguagem JavaScript com ReactJS e PHP com Laravel, para o banco de dados PostgreSQL. A avaliação obteve escore médio de 98,25, sendo sua usabilidade considerada como melhor alcançável. Conclusión: o software demonstrou ser adequado e funcional, com fácil manuseio, reunindo informações integradas e objetivas. Representa um avanço na área, propondo uma inovação tecnológica para a gestão e apoio às decisões logísticas envolvidas no processo de captação e transplante de órgãos.

Objective: to develop and evaluate a software to support the decision-making of transplant center professionals in the logistic definitions involved in the process of organ procurement and distribution for transplantation. Method: applied technological production study, supported by the Design Science Research Methodology method. Ten nurses from the Transplant Center of Santa Catarina participated in the usability evaluation stage. Data collection took place from 1 to 20 July 2021 through the System Usability Scale questionnaire. Results: the software used JavaScript language with ReactJS and PHP with Laravel, for the PostgreSQL database. The evaluation obtained a mean score of 98.25, and its usability is considered as best achievable. Conclusion: the software proved to be adequate and functional, with easy handling, gathering integrated and objective information. It represents a breakthrough in the area, proposing a technological innovation for the management and support to the logistic decisions involved in the process of organ procurement and transplantation.

Techniques for Closing the Abdominal Wall in Intestinal and Multivisceral Transplantation: A Systematic Review.

Short bowel syndrome is the most common etiology of intestinal failure, resulting from either resections of different intestinal segments or a congenital condition. Due to the absence or considerable reduction of intestinal loops in the abdominal cavity, patients with short bowel syndrome present with atrophy and muscle retraction of the abdominal wall, which leads to loss of abdominal domain and elasticity. This complication is an aggravating factor of intestinal transplantation since it can prevent the primary closure of the abdominal wall. A vast array of surgical techniques to overcome the challenges of the complexity of the abdominal wall have been described in the literature. The aim of our study was to review the modalities of abdominal wall closure in intestinal/multivisceral transplantation. Our study consisted of a systematic review following the methodological instructions described in the PRISMA guidelines. Duplicate studies and studies that did not meet the criteria for the systematic review were excluded, especially those without relevance and an explicit relationship with the investigated theme. After this step, 63 articles were included in our study. The results obtained with these techniques have been encouraging, but a high incidence of wound complications in some reports has raised concerns. There is no consensus among transplantation centers regarding which technique would be ideal and with higher success rates and lower rates of complications.

Barriers to Pretransplant Immunization: A Qualitative Interview Study of Pediatric Solid Organ Transplant Stakeholders.

OBJECTIVES: To describe the experiences and beliefs of pediatric transplant stakeholders regarding factors that contribute to low pretransplant immunization rates. STUDY DESIGN: Semistructured interviews were conducted with transplant team members (hepatologists, cardiologists, nephrologists, transplant nurse coordinators, and transplant infectious diseases physicians), primary care physicians, and parents of heart, liver, and kidney transplant recipients at 3 geographically diverse large pediatric transplant centers in the US. Interviews were conducted between July 2017 and February 2020 until thematic saturation was reached within each stakeholder subgroup. Content analysis methodology was used to identify themes. RESULTS: Stakeholders participated in 30- to 60-minute interviews (16 transplant subspecialists, 3 transplant infectious diseases physicians, 11 transplant nurse coordinators, 12 primary care physicians, and 40 parents). Five central themes emerged: (1) gaps in knowledge about timing and safety of pretransplant immunizations, (2) lack of communication, coordination, and follow-up between team members regarding immunizations, (3) lack of centralized immunization records, (4) subspecialty clinic functioning as the medical home for transplant candidates but unable to provide all needed immunizations, and (5) differences between organ type in prioritization and completion of pretransplant immunization. CONCLUSIONS: There are multiple factors that contribute to low immunization rates among pediatric transplant candidates. New tools are needed to overcome these barriers and increase immunization rates in transplant candidates.

Original and generic preservation solutions in organ transplantation. A new paradigm?

Solid organ transplantation is a very complex process, in which the storage of the graft in a preservation solution is mandatory in order to extend ischemic times and contain further damage. The condition in which the organ is transplanted is critical for the outcome of the organ recipient. The recent emergence of generic versions of organ preservation solutions (solutions with the same composition and under the same legislation as the original versions, but with different brands) compelled us to study whether the standards are maintained when comparing the original and its generic counterpart. Along these lines, we discuss and comment on some aspects concerning this issue of general interest in the organ transplantation field.

Original and generic preservation solutions in organ transplantation. A new paradigm?

Abstract Solid organ transplantation is a very complex process, in which the storage of the graft in a preservation solution is mandatory in order to extend ischemic times and contain further damage. The condition in which the organ is transplanted is critical for the outcome of the organ recipient. The recent emergence of generic versions of organ preservation solutions (solutions with the same composition and under the same legislation as the original versions, but with different brands) compelled us to study whether the standards are maintained when comparing the original and its generic counterpart. Along these lines, we discuss and comment on some aspects concerning this issue of general interest in the organ transplantation field.

Brain death-induced cytokine release is not associated with primary graft dysfunction: a cohort study. / A liberação de citocinas induzida pela morte cerebral não está associada à disfunção primária do enxerto: um estudo de coorte.

OBJECTIVE: To examine the association between donor plasma cytokine levels and the development of primary graft dysfunction of organs transplanted from deceased donors. METHODS: Seventeen deceased donors and the respective 47 transplant recipients were prospectively included in the study. Recipients were divided into two groups: group 1, patients who developed primary graft dysfunction; and group 2, patients who did not develop primary graft dysfunction. Donor plasma levels of TNF, IL-6, IL-1ß, and IFN-γ assessed by ELISA were compared between groups. RESULTS: Sixty-nine organs were retrieved, and 48 transplants were performed. Donor plasma cytokine levels did not differ between groups (in pg/mL): TNF, group 1: 10.8 (4.3 - 30.8) versus group 2: 8.7 (4.1 - 33.1), p = 0.63; IL-6, group 1: 1617.8 (106.7 - 5361.7) versus group 2: 922.9 (161.7 - 5361.7), p = 0.56; IL-1ß, group 1: 0.1 (0.1 - 126.1) versus group 2: 0.1 (0.1 - 243.6), p = 0.60; and IFN-γ, group 1: 0.03 (0.02 - 0.2) versus group 2: 0.03 (0.02 - 0.1), p = 0.93). Similar findings were obtained when kidney transplants were analyzed separately. CONCLUSION: In this sample of transplant recipients, deceased donor plasma cytokines TNF, IL-6, IL-1ß, and IFN-γ were not associated with the development of primary graft dysfunction.

OBJETIVO: Examinar a associação entre os níveis de citocinas no plasma do doador e o desenvolvimento de disfunção primária do enxerto de órgãos transplantados a partir de doadores falecidos. MÉTODOS: Foram incluídos no estudo de forma prospectiva 17 doadores falecidos e os respectivos 47 pacientes receptores de transplante. Os receptores foram divididos em dois grupos: grupo 1, de pacientes que desenvolveram disfunção primária do enxerto, e grupo 2, de pacientes que não desenvolveram disfunção primária do enxerto. Os níveis de TNF, IL-6, IL-1ß, e IFN-γ, avaliados por meio de ELISA, foram comparados entre os grupos. RESULTADOS: Obtiveram-se 69 órgãos, sendo realizados 48 transplantes. Os níveis plasmáticos de citocinas nos doadores não diferiram entre os grupos (em pg/mL): TNF no grupo 1, com 10,8 (4,3 - 30,8) versus no grupo 2, com 8,7 (4,1 - 33,1), com valor de p = 0,63; IL-6 no grupo 1: 1.617,8 (106,7 - 5.361,7) versus no grupo 2: 922,9 (161,7 - 5.361,7), com p = 0,56; IL-1ß, no grupo 1: 0,1 (0,1 - 126,1) versus no grupo 2: 0,1 (0,1 - 243,6), com p = 0,60; e IFN-γ, no grupo 1: 0,03 (0,02 - 0,2) versus no grupo 2: 0,03 (0,02 - 0,1), p = 0,93). Obtivemos resultados similares ao examinar separadamente os casos de transplante renal. CONCLUSÃO: Nesta amostra de receptores de transplante, os níveis plasmáticos das citocinas TNF, IL-6, IL-1ß e IFN-γ nos doadores não se associaram com o desenvolvimento de disfunção primária do enxerto.

A liberação de citocinas induzida pela morte cerebral não está associada à disfunção primária do enxerto: um estudo de coorte / Brain death-induced cytokine release is not associated with primary graft dysfunction: a cohort study

RESUMO Objetivo: Examinar a associação entre os níveis de citocinas no plasma do doador e o desenvolvimento de disfunção primária do enxerto de órgãos transplantados a partir de doadores falecidos. Métodos: Foram incluídos no estudo de forma prospectiva 17 doadores falecidos e os respectivos 47 pacientes receptores de transplante. Os receptores foram divididos em dois grupos: grupo 1, de pacientes que desenvolveram disfunção primária do enxerto, e grupo 2, de pacientes que não desenvolveram disfunção primária do enxerto. Os níveis de TNF, IL-6, IL-1β, e IFN-γ, avaliados por meio de ELISA, foram comparados entre os grupos. Resultados: Obtiveram-se 69 órgãos, sendo realizados 48 transplantes. Os níveis plasmáticos de citocinas nos doadores não diferiram entre os grupos (em pg/mL): TNF no grupo 1, com 10,8 (4,3 - 30,8) versus no grupo 2, com 8,7 (4,1 - 33,1), com valor de p = 0,63; IL-6 no grupo 1: 1.617,8 (106,7 - 5.361,7) versus no grupo 2: 922,9 (161,7 - 5.361,7), com p = 0,56; IL-1β, no grupo 1: 0,1 (0,1 - 126,1) versus no grupo 2: 0,1 (0,1 - 243,6), com p = 0,60; e IFN-γ, no grupo 1: 0,03 (0,02 - 0,2) versus no grupo 2: 0,03 (0,02 - 0,1), p = 0,93). Obtivemos resultados similares ao examinar separadamente os casos de transplante renal. Conclusão: Nesta amostra de receptores de transplante, os níveis plasmáticos das citocinas TNF, IL-6, IL-1β e IFN-γ nos doadores não se associaram com o desenvolvimento de disfunção primária do enxerto.

ABSTRACT Objective: To examine the association between donor plasma cytokine levels and the development of primary graft dysfunction of organs transplanted from deceased donors. Methods: Seventeen deceased donors and the respective 47 transplant recipients were prospectively included in the study. Recipients were divided into two groups: group 1, patients who developed primary graft dysfunction; and group 2, patients who did not develop primary graft dysfunction. Donor plasma levels of TNF, IL-6, IL-1β, and IFN-γ assessed by ELISA were compared between groups. Results: Sixty-nine organs were retrieved, and 48 transplants were performed. Donor plasma cytokine levels did not differ between groups (in pg/mL): TNF, group 1: 10.8 (4.3 - 30.8) versus group 2: 8.7 (4.1 - 33.1), p = 0.63; IL-6, group 1: 1617.8 (106.7 - 5361.7) versus group 2: 922.9 (161.7 - 5361.7), p = 0.56; IL-1β, group 1: 0.1 (0.1 - 126.1) versus group 2: 0.1 (0.1 - 243.6), p = 0.60; and IFN-γ, group 1: 0.03 (0.02 - 0.2) versus group 2: 0.03 (0.02 - 0.1), p = 0.93). Similar findings were obtained when kidney transplants were analyzed separately. Conclusion: In this sample of transplant recipients, deceased donor plasma cytokines TNF, IL-6, IL-1β, and IFN-γ were not associated with the development of primary graft dysfunction.

Immunosuppressants in Brazil: underlying drivers of spending trends, 2010-2015.

BACKGROUND: Immunosuppressants are recommended for treatment of autoimmune diseases, and in transplant therapy. The high cost of these drugs has been causing an important impact on global pharmaceutical spending. OBJECTIVE: Analyzing immunosuppressant expenditure in Brazil, using data from the Federal Procurement System database (SIASG), between 2010 and 2015. METHODS: The pharmaceutical products were classified in accordance with the Anatomical, Therapeutic and Chemical (ATC) classification system recommended by World Health Organization (WHO) and aggregated by volume and by expenditure. The expenditure variation was decomposed into three broad categories: price effects, quantity effects, and drug mix effects. RESULTS: During the period, annual expenditure increased by 49%, ranging from USD 494.5 million in 2010 to USD 738.7 million in 2015, while purchased quantities increased by 294%, ranging from 49.8 million in 2010 to 196.5 million in 2015. Two factors drove expenditures: the quantity effect and the drug-mix effect. CONCLUSION: These findings may contribute to understand immunosuppressant spending trends and the factors that influence them in order to formulate effective cost containment strategies and design optimum drug policy. Rigorous evaluations are recommended to reduce the drug-mix effect, including systems to monitor price, effectiveness, safety, therapeutic value and budget impact of pharmaceutical innovations.

Toward dual hematopoietic stem-cell transplantation and solid-organ transplantation for sickle-cell disease.

Sickle-cell disease (SCD) leads to recurrent vaso-occlusive crises, chronic end-organ damage, and resultant physical, psychological, and social disabilities. Although hematopoietic stem-cell transplantation (HSCT) is potentially curative for SCD, this procedure is associated with well-recognized morbidity and mortality and thus is ideally offered only to patients at high risk of significant complications. However, it is difficult to identify patients at high risk before significant complications have occurred, and once patients experience significant organ damage, they are considered poor candidates for HSCT. In turn, patients who have experienced long-term organ toxicity from SCD such as renal or liver failure may be candidates for solid-organ transplantation (SOT); however, the transplanted organs are at risk of damage by the original disease. Thus, dual HSCT and organ transplantation could simultaneously replace the failing organ and eliminate the underlying disease process. Advances in HSCT conditioning such as reduced-intensity regimens and alternative donor selection may expand both the feasibility of and potential donor pool for transplantation. This review summarizes the current state of HSCT and organ transplantation in SCD and discusses future directions and the clinical feasibility of dual HSCT/SOT.