Transplant Care Research Articles

A novel psychosocial virtual reality intervention (BMT-VR) for patients undergoing hematopoietic stem cell transplantation: Pilot randomized clinical trial design and methods

BackgroundAlthough patients undergoing hematopoietic stem cell transplantation (HSCT) must cope with psychological distress and isolation during an extended transplant hospitalization, psychosocial interventions to address these unmet needs are lacking. Virtual reality offers an innovative modality to deliver a patient-centered psychosocial intervention to address psychosocial needs of patients undergoing HSCT. However, there are currently no supportive care interventions leveraging virtual reality in patients undergoing HSCT. ObjectiveTo describe the methods of a randomized clinical trial (RCT) to assess the feasibility and preliminary efficacy of a self-administered, virtual reality-delivered psychosocial intervention (BMT-VR) to improve psychological distress and quality of life (QOL) for patients hospitalized for HSCT. MethodsThis study entails a single-center RCT of BMT-VR compared to usual transplant care in 80 patients hospitalized for HSCT. Adult patients with hematologic malignancies hospitalized for autologous or allogeneic HSCT are eligible. BMT-VR includes psychoeducation about the HSCT process, psychosocial skill building to promote effective coping and acceptance, and self-care and positive psychology skills to promote post-HSCT recovery. The primary aim is to assess the feasibility defined a priori as ≥60% of eligible patients enrolling in the study, and of those enrolled and randomized to the BMT-VR, ≥ 60% completing 4/6 BMT-VR modules. Secondary objectives include assessing the preliminary effects on psychological distress and QOL. DiscussionThis is the first RCT of a virtual reality-delivered psychosocial intervention for the HSCT population. If deemed feasible, a future larger multi-site clinical trial can evaluate the efficacy of BMT-VR on outcomes for patients hospitalized for HSCT.

Brave new world: expanding home care in stem cell transplantation and advanced therapies with new technologies.

Hematopoietic stem cell transplantation and cell therapies like CAR-T are costly, complex therapeutic procedures. Outpatient models, including at-home transplantation, have been developed, resulting in similar survival results, reduced costs, and increased patient satisfaction. The complexity and safety of the process can be addressed with various emerging technologies (artificial intelligence, wearable sensors, point-of-care analytical devices, drones, virtual assistants) that allow continuous patient monitoring and improved decision-making processes. Patients, caregivers, and staff can also benefit from improved training with simulation or virtual reality. However, many technical, operational, and above all, ethical concerns need to be addressed. Finally, outpatient or at-home hematopoietic transplantation or CAR-T therapy creates a different, integrated operative system that must be planned, designed, and carefully adapted to the patient's characteristics and distance from the hospital. Patients, clinicians, and their clinical environments can benefit from technically improved at-home transplantation.

From intestinal failure to transplantation: Review on the current need for transplant indications under multidisciplinary transplant programs worldwide.

Intestinal failure, defined as the loss of gastrointestinal function to the point where nutrition cannot be maintained by enteral intake alone, presents numerous challenges in children, not least the timing of consideration of intestine transplantation. To describe the evolution of care of infants and children with intestinal failure including parenteral nutrition, intestine transplantation, and contemporary intestinal failure care. The review is based on the authors' experience supported by an in-depth review of the published literature. The history of parenteral nutrition, including out-patient (home) administration, and intestine transplantation are reviewed along with the complications of intestinal failure that may become indications for consideration of intestine transplantation. Current management strategies for children with intestinal failure are discussed along with changes in need for intestine transplantation, recognizing the difficulty in generalizing recommendations due to the high level of heterogeneity of intestinal pathology and residual bowel anatomy and function. Advances in the medical and surgical care of children with intestinal failure have resulted in improved transplant-free survival and a significant fall in demand for transplantation. Despite these improvements a number of children continue to fail rehabilitative care and require intestine transplantation as life-saving therapy or when the burden on ongoing parenteral nutrition becomes too great to bear.

SHIFTing goals in cystic fibrosis—managing extrapulmonary disease in the era of CFTR modulator therapy; Proceedings of the International Shaping Initiatives and Future Trends (SHIFT) Symposium

AbstractBackgroundCystic fibrosis (CF) is a life‐shortening multisystem genetic disease. Although progressive pulmonary disease is the predominant cause of morbidity and mortality, improvements in treatment for CF‐related lung disease, with associated increase in longevity, have increased the prevalence of extrapulmonary manifestations1.MethodsTo discuss these issues, a multidisciplinary meeting of international leaders and experts in the field was convened in November 2021 at the Shaping Initiatives and Future Trends Symposium with the goal of highlighting shifting management paradigms in CF. The main topics covered were: (1) nutrition and obesity, (2) exocrine pancreas, (3) CF‐related diabetes, (4) CF liver disease, (5) CF‐related bone disease, and (6) post‐lung transplant care. This document summarizes the proceedings, highlighting the key priorities and important research questions that were discussed.ResultsImproved life expectancy, the advent of cystic fibrosis transmembrane conductance regulator modulators, and the increasing appreciation of the heterogeneity or spectrum of disease are leading to a shift in management for patients with cystic fibrosis. Care should be individualized to ensure that increased longevity is accompanied by improved extra‐pulmonary care and reduced morbidity.

Nursing care in autologous hematopoietic progenitor transplantation

Nursing care in autologous hematopoietic progenitor transplantation

A placebo-controlled, crossover trial to investigate the efficacy of tiotropium bromide or placebo added to usual care in stable symptomatic post-hematopoietic stem cell transplantation (HSCT) bronchiolitis obliterans syndrome (BOS)

BackgroundDespite the fundamental progress in hematopoietic stem cell transplant, this treatment is also associated with complications. Graft-versus-host disease is a possible complication of HSCT. Bronchiolitis obliterans syndrome (BOS) is the pulmonary form of this syndrome. Due to the high morbidity and mortality rate of BOS, various studies have been conducted in the field of drug therapy for this syndrome, although no standard treatment has yet been proposed. According to the hypotheses about the similarities between BOS and chronic obstructive pulmonary disease, the idea of using tiotropium bromide as a bronchodilator has been proposed.Method/designA randomized, double-blind, placebo-controlled, and crossover clinical trial is being conducted to evaluate the efficacy of tiotropium in patients with BOS. A total of 20 patients with BOS were randomly assigned (1:1) to receive a once-daily inhaled capsule of either tiotropium bromide (KP-Tiova Rotacaps 18 mcg, Cipla, India) or placebo for 1 month. Patients will receive tiotropium bromide or placebo Revolizer added to usual standard care. Measurements will include spirometry and a 6-min walking test.Ethics/disseminationThis study was approved by the Research Ethics Committees of Imam Khomeini Hospital Complex, Tehran University of Medical Science. Recruitment started in September 2022, with 20 patients randomized. The treatment follow-up of participants with tiotropium is currently ongoing and is due to finish in April 2024. The authors will disseminate the findings in peer-reviewed publications, conferences, and seminar presentations.Trial registrationIranian Registry of Clinical Trial (IRCT) IRCT20200415047080N3. Registered on 2022–07-12, 1401/04/21.

Atención farmacéutica en enfermedades respiratorias: situación y oportunidades de la farmacia hospitalaria en España

ObjectiveRespiratory diseases present a challenge for the healthcare system due to their prevalence and clinical impact. The aim of this study was to explore the current situation of hospital pharmacy in the field of respiratory diseases. MethodObservational, cross-sectional study, with a national scope, divided into 2 parts. In an initial phase, the activity and level of pharmaceutical care in respiratory diseases was evaluated through an online questionnaire using REDCap. The survey was addressed to department chiefs and consisted of 17 items, divided into 2 modules: general data and general activity. The second phase was open to hospital pharmacists, with the aim of exploring their opinion on care, training, and improvement needs. The number of items in this phase was 19, divided into 5 modules: general data, pharmaceutical care, competencies, training and degree of satisfaction. ResultsIn the first phase, 23 hospitals were included. Most of them (n=20) had a pharmacist in charge of respiratory diseases. However, a large proportion of them dedicated less than 40% of their working day to this activity. The pharmacist's activity occurred at the level of external patients (n=20), hospitalized patients (n=16), and secondarily in management (n=8). Integration is greater in pathologies such as asthma, IPF, pulmonary hypertension, and bronchiectasis. Participation in committees was present in 15 hospitals, with variability in pathologies and degree of involvement. In the second phase, 164 pharmacists participated, who considered pharmaceutical care in cystic fibrosis, asthma and lung transplant as a priority. Fifty-one percent considered integration to be adequate and 91% considered it necessary to implement prioritization criteria. Professional competencies ranged from 6.5-6.9 out of 10 points. Only 45% of participants had received specific training in the last four years, indicating greater priority for asthma, pulmonary hypertension and IPF. ConclusionsMost centers have pharmacists specialized in respiratory diseases. However, there is room for improvement in terms of sub specialization, participation in multidisciplinary committees, implementation of prioritization criteria, diversification in pathologies treated, as well as greater specific training in this area.

Investigating the Impact of AI on Shared Decision-Making in Post-Kidney Transplant Care (PRIMA-AI): Protocol for a Randomized Controlled Trial.

Patients after kidney transplantation eventually face the risk of graft loss with the concomitant need for dialysis or retransplantation. Choosing the right kidney replacement therapy after graft loss is an important preference-sensitive decision for kidney transplant recipients. However, the rate of conversations about treatment options after kidney graft loss has been shown to be as low as 13% in previous studies. It is unknown whether the implementation of artificial intelligence (AI)-based risk prediction models can increase the number of conversations about treatment options after graft loss and how this might influence the associated shared decision-making (SDM). This study aims to explore the impact of AI-based risk prediction for the risk of graft loss on the frequency of conversations about the treatment options after graft loss, as well as the associated SDM process. This is a 2-year, prospective, randomized, 2-armed, parallel-group, single-center trial in a German kidney transplant center. All patients will receive the same routine post-kidney transplant care that usually includes follow-up visits every 3 months at the kidney transplant center. For patients in the intervention arm, physicians will be assisted by a validated and previously published AI-based risk prediction system that estimates the risk for graft loss in the next year, starting from 3 months after randomization until 24 months after randomization. The study population will consist of 122 kidney transplant recipients >12 months after transplantation, who are at least 18 years of age, are able to communicate in German, and have an estimated glomerular filtration rate <30 mL/min/1.73 m2. Patients with multi-organ transplantation, or who are not able to communicate in German, as well as underage patients, cannot participate. For the primary end point, the proportion of patients who have had a conversation about their treatment options after graft loss is compared at 12 months after randomization. Additionally, 2 different assessment tools for SDM, the CollaboRATE mean score and the Control Preference Scale, are compared between the 2 groups at 12 months and 24 months after randomization. Furthermore, recordings of patient-physician conversations, as well as semistructured interviews with patients, support persons, and physicians, are performed to support the quantitative results. The enrollment for the study is ongoing. The first results are expected to be submitted for publication in 2025. This is the first study to examine the influence of AI-based risk prediction on physician-patient interaction in the context of kidney transplantation. We use a mixed methods approach by combining a randomized design with a simple quantitative end point (frequency of conversations), different quantitative measurements for SDM, and several qualitative research methods (eg, records of physician-patient conversations and semistructured interviews) to examine the implementation of AI-based risk prediction in the clinic. ClinicalTrials.gov NCT06056518; https://clinicaltrials.gov/study/NCT06056518. PRR1-10.2196/54857.

(1111) - The First Implementation of On-Site MMDx in Heart Transplant Care in Europe: The Initial Experiences

(1111) - The First Implementation of On-Site MMDx in Heart Transplant Care in Europe: The Initial Experiences

Outcomes and Long-Term Survival of Adolescent and Young Adult Patients Admitted to the Intensive Care Unit Following Allogeneic Hematopoietic Stem Cell Transplantation: A Single-Center Experience of 152 Patients.

Prognostic factors reliably predicting outcomes for critically ill adolescent and young adult (AYA) patients undergoing allogeneic hematopoietic cell transplantation (allo-HSCT) are lacking. We assessed transplant and intensive care unit (ICU)-related factors impacting patient outcomes. AYA patients who underwent allo-HSCT and required ICU admission at a Tertiary care Centre, during the period of 2003-2013, were included in this retrospective review. This was a non-interventional study. Only outcomes after the first allo-HSCT and index ICU admissions were analyzed. Disease-, transplant-, and ICU-related variables were analyzed to identify risk factors predictive of survival. Overall, 152 patients were included (males, 60.5%); median age at transplantation was 24 years (interquartile range [IQR] 18-32.5); median age at admission to the ICU was 25.8 years (IQR 19-34). Eighty-four percent underwent transplantation for a hematological malignancy; 129 (85%) received myeloablative conditioning. Seventy-one percent of ICU admissions occurred within the first year after allo-HSCT. ICU admission was primarily due to respiratory failure (47.3%) and sepsis (43.4%). One hundred and three patients (68%) died within 28 days of ICU admission. The 1- and 5-year overall survival rates were 19% and 17%, respectively. Main causes for ICU-related death were refractory septic shock with multiorgan failure (n = 49, 32%) and acute respiratory distress syndrome (ARDS) (n = 39, 26%). Univariate analysis showed that ICU mortality was associated with an Acute Physiology and Chronic Health Evaluation (APACHE) II score >20, a sequential organ failure assessment (SOFA score) > 12, a high lactate level, anemia, thrombocytopenia, leukopenia, hyperbilirubinemia, a high international normalized ratio (INR) and acute graft-versus-host disease (GVHD). Multivariate analysis identified thrombocytopenia, high INR, and acute GVHD as independent predictors of mortality. In AYA allo-HSCT patients admitted to the ICU, mortality remains high. Higher SOFA and APACHE scores, the need for organ support, thrombocytopenia, coagulopathy, and acute GVHD predict poor outcomes.

Scientific substantiation of conceptual directions of development of the system of donation and transplantation

the article is devoted to the substantiation of the conceptual directions for the development of the system of organ donation and transplantation in the regions of Ukraine. The main principles of development are revealed. The basis for the formation of a modern conceptual model of the regional system of organ donation and transplantation has been laid. Materials and methods. To achieve the goals, the work used general scientific methods of analysis, synthesis, generalization, interpretation of scientific data, as well as systemic and structural-functional approaches. Results. Presents the conceptual directions for the development of the regional system of organ donation and transplantation, in the form of a set of principles (from Latin principium - beginning, basis) underlying the development of the system under consideration. The implementation of conceptual directions in modeling a modern conceptual model of the regional system of organ donation and transplantation will provide a model for the formation of strategic management mechanisms, will be the key to the development of regional transplant practice, the provision of affordable highly qualified transplant care to the population, sustainable socio-economic development of the system in the long term. Conclusions. The developed conceptual directions for the development of the system of organ donation and transplantation in the regions of Ukraine are a priority basis for the formation of a modern conceptual model of the regional system of organ donation and transplantation. The system of organ donation and transplantation in the regions of Ukraine is at the beginning of its formation and needs optimization of many organizational processes, which should be carried out systematically, comprehensively and purposefully on the basis of scientifically based principles, legislatively for the benefit of the population of the region.

An update of palliative care in lung transplantation with a focus on symptoms, quality of life and functional outcomes.

Palliative care (PC) in lung transplantation is increasingly acknowledged for its important role in addressing symptoms, enhancing functionality, and facilitating advance care planning for patients, families, and caregivers. The present review provides an update in PC management in lung transplantation. Research confirms the effectiveness of PC for patients with advanced lung disease who are undergoing transplantation, showing improvements in symptoms and reduced healthcare utilization. Assessment tools and patient-reported outcome measures for PC are commonly used in lung transplant candidates, revealing discrepancies between symptom severity and objective measures such as exercise capacity. The use of opioids to manage dyspnea and cough in the pretransplant period is deemed safe and does not heighten risks posttransplantation. However, the integration of PC support in managing symptoms and chronic allograft dysfunction in the posttransplant period has not been as well described. Palliative care support should be provided in the pretransplant and select peri-operative and posttransplant periods to help support patient quality of life, symptoms, communication and daily function.

Quality measures in pre-liver transplant care by the Practice Metrics Committee of the American Association for the Study of Liver Diseases.

The liver transplantation (LT) evaluation and waitlisting process is subject to variations in care that can impede quality. The American Association for the Study of Liver Diseases (AASLD) Practice Metrics Committee (PMC) developed quality measures and patient-reported experience measures along the continuum of pre-LT care to reduce care variation and guide patient-centered care. Following a systematic literature review, candidate pre-LT measures were grouped into 4 phases of care: referral, evaluation and waitlisting, waitlist management, and organ acceptance. A modified Delphi panel with content expertise in hepatology, transplant surgery, psychiatry, transplant infectious disease, palliative care, and social work selected the final set. Candidate patient-reported experience measures spanned domains of cognitive health, emotional health, social well-being, and understanding the LT process. Of the 71 candidate measures, 41 were selected: 9 for referral; 20 for evaluation and waitlisting; 7 for waitlist management; and 5 for organ acceptance. A total of 14 were related to structure, 17 were process measures, and 10 were outcome measures that focused on elements not typically measured in routine care. Among the patient-reported experience measures, candidates of LT rated items from understanding the LT process domain as the most important. The proposed pre-LT measures provide a framework for quality improvement and care standardization among candidates of LT. Select measures apply to various stakeholders such as referring practitioners in the community and LT centers. Clinically meaningful measures that are distinct from those used for regulatory transplant reporting may facilitate local quality improvement initiatives to improve access and quality of care.

Therapeutic agents for machine perfusion of donor organs

Background. The urgency of the unmet need for transplant care dictates the necessity to use organs from suboptimal donors. Machine perfusion, which is actively developing at the present time, is designated to solve this problem. The literature presents novel technologies of ex vivo and in vivo machine perfusion of donor organs, which make it possible to improve their functions and perform a successful transplant. The most promising areas of research both in animals and in humans may be identified by reviewing the literature sources on this subject.The aim was to analyze the world experience of using therapeutic agents in machine perfusion of donor organsMaterial and methods: sources from 2015 to 2023 found in PubMed, Google Scholar, eLibrary databasesConclusion. The rapid progress in lung, liver and kidney transplantation has made it possible to use grafts from asystolic donors for patients in urgent need of donor organs. In turn, these advances have also prompted the study of potential therapeutic agents that can be used during perfusion.

Developing a genetic testing panel for evaluation of morbidities in kidney transplant recipients

Cardiovascular disease, infection, malignancy, and thromboembolism are major causes of morbidity and mortality in kidney transplant recipients (KTR). Prospectively identifying monogenic conditions associated with post-transplant complications may enable personalized management. Therefore, we developed a transplant morbidity panel (355 genes) associated with major post-transplant complications including cardiometabolic disorders, immunodeficiency, malignancy, and thrombophilia. This gene panel was then evaluated using exome sequencing data from 1590 KTR. Additionally, genes associated with monogenic kidney and genitourinary disorders along with American College of Medical Genetics (ACMG) secondary findings v3.2 were annotated. Altogether, diagnostic variants in 37 genes associated with Mendelian kidney and genitourinary disorders were detected in 9.9% (158/1590) of KTR; 25.9% (41/158) had not been clinically diagnosed. Moreover, the transplant morbidity gene panel detected diagnostic variants for 56 monogenic disorders in 9.1% KTRs (144/1590). Cardiovascular disease, malignancy, immunodeficiency, and thrombophilia variants were detected in 5.1% (81), 2.1% (34), 1.8% (29) and 0.2% (3) among 1590 KTRs, respectively. Concordant phenotypes were present in half of these cases. Reviewing implications for transplant care, these genetic findings would have allowed physicians to set specific risk factor targets in 6.3% (9/144), arrange intensive surveillance in 97.2% (140/144), utilize preventive measures in 13.2% (19/144), guide disease-specific therapy in 63.9% (92/144), initiate specialty referral in 90.3% (130/144) and alter immunosuppression in 56.9% (82/144). Thus, beyond diagnostic testing for kidney disorders, sequence annotation identified monogenic disorders associated with common post-transplant complications in 9.1% of KTR, with important clinical implications. Incorporating genetic diagnostics for transplant morbidities would enable personalized management in pre- and post-transplant care.

Should advanced perfusion be the standard of care for donation after circulatory death liver transplant?

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?

The transformative potential of artificial intelligence in solid organ transplantation.

Solid organ transplantation confronts numerous challenges ranging from donor organ shortage to post-transplant complications. Here, we provide an overview of the latest attempts to address some of these challenges using artificial intelligence (AI). We delve into the application of machine learning in pretransplant evaluation, predicting transplant rejection, and post-operative patient outcomes. By providing a comprehensive overview of AI's current impact, this review aims to inform clinicians, researchers, and policy-makers about the transformative power of AI in enhancing solid organ transplantation and facilitating personalized medicine in transplant care.

Advancements in autologous peripheral nerve transplantation care: a review of strategies and practices to facilitate recovery.

Autologous peripheral nerve transplantation, a pioneering technique in nerve injury treatment, has demonstrated remarkable progress. We examine recent nursing strategies and methodologies tailored to various anatomical sites, highlighting their role in postoperative recovery enhancement. Encompassing brachial plexus, upper limb, and lower limb nerve transplantation care, this discussion underscores the importance of personalized rehabilitation plans, interdisciplinary collaboration, and innovative approaches like nerve electrical stimulation and nerve growth factor therapy. Moreover, the exploration extends to effective complication management and prevention strategies, encompassing infection control and pain management. Ultimately, the review concludes by emphasizing the advances achieved in autologous peripheral nerve transplantation care, showcasing the potential to optimize postoperative recovery through tailored and advanced practices.

Use of induction therapy post-heart transplantation: Clinical practice recommendations based on systematic review and network meta-analysis of evidence.

The use of induction therapy (IT) agents in the early post-heart transplant period remains controversial. The following recommendations aim to provide guidance on the use of IT agents, including Basiliximab and Thymoglobulin, as part of routine care in heart transplantation (HTx). We recruited an international, multidisciplinary panel of 15 stakeholders, including patient partners, transplant cardiologists and surgeons, nurse practitioners, pharmacists, and methodologists. We commissioned a systematic review on benefits and harms of IT on patient-important outcomes, and another on patients' values and preferences to inform our recommendations. We used the GRADE framework to summarize our findings, rate certainty in the evidence, and develop recommendations. The panel considered the balance between benefits and harms, certainty in the evidence, and patient's values and preferences, to make recommendations for or against the routine post-operative use of Thymoglobulin or Basiliximab. The panel made recommendations on three major clinical problems in HTx: (1) We suggest against the routine post-operative use of Basiliximab compared to no IT, (2) we suggest against the routine use of Thymoglobulin compared to no IT, and (3) for those patients for whom IT is deemed desirable, we suggest for the use of Thymoglobulin as compared to Basiliximab. This report highlights gaps in current knowledge and provides directions for clinical research in the future to better understand the clinical utility of IT agents in the early post heart transplant period, leading to improved management and care.

Социально-психологический контур пациента при трансплантации органов.

The article reveals for the first time the content of the patient’s socio-psychological contour, as the totality of his social connections and interactions with various people (institutions), as well as the dynamics that arise as a result of this interaction from the moment the need for transplantation arises, in the perioperative and post-transplantation periods in a psychological context. The variety of factors, as well as the technological, medical and psychological complexity of the process of organ transplantation for planets living in a certain social environment, creates the need for an integrated approach to the organization of medical care for transplantation, taking into account the contour developed by the authors.