Meeting the Shortage of Human Cells and Tissues: The Andalusian Quality Assurance Programme for Tissue Donation.

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.

Review of the allocation criteria for heart transplant in Spain in 2023. SEC-Heart Failure Association/ONT/SECCE consensus document.

Heart transplant (HT) remains the best therapeutic option for patients with advanced heart failure (HF). The allocation criteria aim to guarantee equitable access to HT and prioritize patients with a worse clinical status. To review the HT allocation criteria, the Heart Failure Association of the Spanish Society of Cardiology (HFA-SEC), the Spanish Society of Cardiovascular and Endovascular Surgery (SECCE) and the National Transplant Organization (ONT), organized a consensus conference involving adult and pediatric cardiologists, adult and pediatric cardiac surgeons, transplant coordinators from all over Spain, and physicians and nurses from the ONT. The aims of the consensus conference were as follows: a) to analyze the organization and management of patients with advanced HF and cardiogenic shock in Spain; b) to critically review heart allocation and priority criteria in other transplant organizations; c) to analyze the outcomes of patients listed and transplanted before and after the modification of the heart allocation criteria in 2017; and d) to propose new heart allocation criteria in Spain after an analysis of the available evidence and multidisciplinary discussion. In this article, by the HFA-SEC, SECCE and the ONT we present the results of the analysis performed in the consensus conference and the rationale for the new heart allocation criteria in Spain.

Response to Intravenous N-Acetylcysteine Supplementation in Critically Ill Patients with COVID-19.

Administering N-acetylcysteine (NAC) could counteract the effect of free radicals, improving the clinical evolution of patients admitted to the Intensive Care Unit (ICU). This study aimed to investigate the clinical and biochemical effects of administering NAC to critically ill patients with COVID-19. A randomized controlled clinical trial was conducted on ICU patients (n = 140) with COVID-19 and divided into two groups: patients treated with NAC (NAC-treated group) and patients without NAC treatment (control group). NAC was administered as a continuous infusion with a loading dose and a maintenance dose during the study period (from admission until the third day of ICU stay). NAC-treated patients showed higher PaO2/FiO2 (p ≤ 0.014) after 3 days in ICU than their control group counterparts. Moreover, C-reactive protein (p ≤ 0.001), D-dimer (p ≤ 0.042), and lactate dehydrogenase (p ≤ 0.001) levels decreased on the third day in NAC-treated patients. Glutathione concentrations decreased in both NAC-treated (p ≤ 0.004) and control (p ≤ 0.047) groups after 3 days in ICU; whereas glutathione peroxidase did not change during the ICU stay. The administration of NAC manages to improve the clinical and analytical response of seriously ill patients with COVID-19 compared to the control group. NAC is able to stop the decrease in glutathione concentrations.

Family bereavement and organ donation in Spain: a mixed method, prospective cohort study protocol.

INTRODUCTION: There is a discrepancy in the literature as to whether authorising or refusing the recovery of organs for transplantation is of direct benefit to families in their subsequent grieving process. This study aims to explore the impact of the family interview to pose the option of posthumous donation and the decision to authorise or refuse organ recovery on the grieving process of potential donors' relatives. METHODS AND ANALYSIS: A protocol for mixed methods, prospective cohort longitudinal study is proposed. Researchers do not randomly assign participants to groups. Instead, participants are considered to belong to one of three groups based on factors related to their experiences at the hospital. In this regard, families in G1, G2 and G3 would be those who authorised organ donation, declined organ donation or were not asked about organ donation, respectively. Their grieving process is monitored at three points in time: 1 month after the patient's death, when a semistructured interview focused on the lived experience during the donation process is carried out, 3 months and 9 months after the death. At the second and third time points, relatives' grieving process is assessed using six psychometric tests: State-Trait Anxiety Inventory, Beck Depression Inventory-II, Inventory of Complicated Grief, The Impact of Event Scale: Revised, Posttraumatic Growth Inventory and Connor-Davidson Resilience Scale. Descriptive statistics (means, SDs and frequencies) are computed for each group and time point. Through a series of regression models, differences between groups in the evolution of bereavement are estimated. Additionally, qualitative analyses of the semistructured interviews are conducted using the ATLAS.ti software. ETHICS AND DISSEMINATION: This study involves human participants and was approved by Comité Coordinador de Ética de la Investigación Biomédica de Andalucía (CCEIBA) ID:1052-N-21. The results will be disseminated at congresses and ordinary academic forums. Participants gave informed consent to participate in the study before taking part.

Influence of Nutritional Parameters on the Evolution, Severity and Prognosis of Critically Ill Patients with COVID-19.

This study evaluated the clinical and nutritional status, the evolution over three days, and the relationship between nutritional, inflammatory, and clinical parameters of critically ill patients with COVID-19. A longitudinal study was conducted in the Intensive Care Unit of the Virgen de las Nieves University Hospital in Granada (Spain). The study population comprised patients with a positive polymerase chain reaction test for COVID-19 presenting critical clinical involvement. Clinical outcomes were collected, and inflammatory and nutritional parameters (albumin, prealbumin, transferrin, transferrin saturation index, cholesterol, triglycerides and Controlling Nutritional Status (CONUT) score) were determined. A total of 202 critical patients with COVID-19 were selected, presenting highly altered clinical-nutritional parameters. The evolution experienced by the patients on the third day of admission was a decrease in albumin (p < 0.001) and an increase in prealbumin (p < 0.001), transferrin (p < 0.002), transferrin saturation index (p < 0.018), and cholesterol (p < 0.001). Low levels of albumin, prealbumin (on the third day) and high CONUT score (on the third day) showed an association with higher mortality. Nutritional variables were inversely correlated with clinical and inflammatory parameters. Critically ill patients with COVID-19 have poor nutritional status related to a poor prognosis of disease severity and mortality.

Immunomodulation of Oxidative Stress during Organ Donation Process: Preliminary Results.

The objective was to quantify oxidative stress resulting from ischemia during the donation process, using malondialdehyde (MDA) measurement, and its modulation by the administration of melatonin. We designed a triple-blind clinical trial with donors randomized to melatonin or placebo. We collected donors by donation after brain death (DBD) and controlled donation after circulatory death (DCD), the latter maintained by normothermic regional perfusion (NRP). Melatonin or placebo was administered prior to donation or following limitation of therapeutic effort (LTE). Demographic variables and medical history were collected. We also collected serial measurements of MDA, at 60 and 90 min after melatonin or placebo administration. A total of 53 donors were included (32 from DBD and 21 from DCD). In the DBD group, 17 donors received melatonin, and 15 placebo. Eight DCD donors were randomized to melatonin and 13 to placebo. Medical history and cause for LTE were similar between groups. Although MDA values did not differ in the DBD group, statistical differences were observed in DCD donors during the 0-60 min interval: -4.296 (-6.752; -2.336) in the melatonin group and -1.612 (-2.886; -0.7445) in controls. Given the antioxidant effect of melatonin, its use could reduce the production of oxidative stress in controlled DCD.

El negocio de la medicina regenerativa y las células madre: confusión con implicaciones legales / The regenerative medicine and stem cell business: confusion with legal implications

El auge de la medicina regenerativa y el crecimiento de la oferta de terapias autólogas obtenidas a partir de sangre, células o tejidos de los propios pacientes se ha visto favorecido por la actual disponibilidad de diversos dispositivos comerciales de fácil manejo que permiten la elaboración de los productos y su aplicación dentro de un mismo procedimiento. Independientemente de las dudosas eficacia y seguridad de muchos de los tratamientos que se ofrecen bajo el reclamo de las células madre o la medicina regenerativa, la mayor parte de los centros y de los profesionales que ofrecen estos tratamientos desconocen los requisitos y las implicaciones legales de su uso. Una confusión frecuente consiste en no distinguir entre la autorización que requiere el propio dispositivo, considerado producto sanitario, y la autorización para el uso del producto obtenido, que en general se trata de un medicamento, ya sea de terapia avanzada o no, o de un trasplante. Por otra parte, es frecuente que estos tratamientos tengan un carácter experimental, por lo que su administración en ese caso, además de requerir la evaluación ética correspondiente y la autorización de diversos organismos reguladores, debe ofrecerse de forma gratuita y tras recabar el consentimiento informado del paciente y contratar una póliza de seguros específica. En este artículo se presentan, de forma resumida, los principales requisitos para la aplicación de estos productos biológicos autólogos, con el objetivo de que puedan servir de guía tanto para los profesionales que los prescriben como para aquellos que inspeccionan los centros donde se administran. Por último, se ofrecen algunas recomendaciones para los pacientes. (AU)

The rise of regenerative medicine and the growth of the offer of autologous therapies, obtained from blood, cells or tissues of the patients, have been favoured by the current availability of an increasing number of commercial devices. Most of these devices are easy to use, allowing the elaboration of products and its application within the same procedure. Regardless of the questionable efficacy and safety of many of the treatments offered under the claim of stem cells or regenerative medicine, most of the centres and professionals offering these treatments are unaware of the legal requirements and implications of their use. A common confusion consists in not distinguishing between the authorization required by the equipment itself, considered a medical device, and the authorization for the use of the product obtained, usually considered a medicinal product (whether advanced therapy or not) or a transplant. Moreover, these treatments frequently have an experimental nature. In that case, in addition to requiring the corresponding ethical evaluation and the authorization of various regulatory bodies, their administration must be offered free of charge, obtaining the patient's informed consent and after contracting a specific insurance policy. In this article we present a brief summary of the main requirements for the application of these autologous biological products with the aim of serving as a guide both for the professionals who prescribe them and for those who inspect the centres where the products are administered. Finally, we include some recommendations for patients. (AU)

Bad Prognosis in Critical Ill Patients with COVID-19 during Short-Term ICU Stay regarding Vitamin D Levels.

BACKGROUND AND AIMS: Vitamin D inadequacy may be involved in the mechanisms of SARS-CoV-2 infection and in potential risk factors for disease propagation or control of coronavirus disease 2019 (COVID-19). This study assessed a short-term evolution of vitamin D status and its influence upon different clinical parameters in critically ill patients with COVID-19. METHODS: A prospective analytical study in which 37 critically ill volunteers between 41 and 71 years of age with COVID-19 were evaluated at baseline and three days of intensive care unit (ICU) stay. 25-OH-D3 and 25-OH-D2 were analyzed by liquid chromatography-tandem mass spectrometry and total 25-OH-D levels were calculated as the sum of both. RESULTS: All patients presented low 25-OH-D levels at baseline, decreasing total 25-OH-D (p = 0.011) mainly through 25-OH-D2 (p = 0.006) levels during ICU stay. 25-OH-D2 levels decreased a mean of 41.6% ± 89.6% versus 7.0% ± 23.4% for the 25-OH-D3 form during the ICU stay. Patients who did not need invasive mechanical ventilation presented higher levels of 25-OH-D2 at baseline and follow-up. Lower 25-OH-D and 25-OH-D3 levels were associated with higher D-dimer at baseline (p = 0.003; p = 0.001) and at follow up (p = 0.029), higher procalcitonin levels (p = 0.002; p = 0.018) at follow up, and lower percentage lymphocyte counts (p = 0.044; p = 0.040) during ICU stay. CONCLUSIONS: Deficient vitamin D status in critical patients was established at the admission and further worsened after three days of stay. Lower vitamin D levels were related to key altered clinical and biochemical parameters on patients with SARS-CoV-2 infection. Given the different response of the 25-OH-D3 and 25-OH-D2 forms, it would be useful to monitor them on the evolution of the critically ill patient.

[The regenerative medicine and stem cell business: confusion with legal implications]. / El negocio de la medicina regenerativa y las células madre: confusión con implicaciones legales.

The rise of regenerative medicine and the growth of the offer of autologous therapies, obtained from blood, cells or tissues of the patients, have been favoured by the current availability of an increasing number of commercial devices. Most of these devices are easy to use, allowing the elaboration of products and its application within the same procedure. Regardless of the questionable efficacy and safety of many of the treatments offered under the claim of stem cells or regenerative medicine, most of the centres and professionals offering these treatments are unaware of the legal requirements and implications of their use. A common confusion consists in not distinguishing between the authorization required by the equipment itself, considered a medical device, and the authorization for the use of the product obtained, usually considered a medicinal product (whether advanced therapy or not) or a transplant. Moreover, these treatments frequently have an experimental nature. In that case, in addition to requiring the corresponding ethical evaluation and the authorization of various regulatory bodies, their administration must be offered free of charge, obtaining the patient's informed consent and after contracting a specific insurance policy. In this article we present a brief summary of the main requirements for the application of these autologous biological products with the aim of serving as a guide both for the professionals who prescribe them and for those who inspect the centres where the products are administered. Finally, we include some recommendations for patients.

Promoting the ethical use of safe and effective cell-based products: the Andalusian plan on regenerative medicine.

With regard to regenerative medicine, the expectations generated over the last two decades and the time involved in developing this type of therapies, together with the availability of devices that allow point-of-care treatments through the rapid isolation of cellular or plasma products from patients in the operating theater, represent the perfect breeding ground for the offering of unproven or unregulated therapies on a global scale. A multidisciplinary approach-one based on the collaboration of institutions that, from the perspective of their area of competence, can contribute to reversing this worrying situation-to this problem is essential. It is a priority for local health authorities to take measures that are adapted to the particular situation and regulatory framework of their respective territory. In this article, the authors present the regenerative medicine action plan promoted by the Andalusian Transplant Coordination (i.e., the action plan for the largest region in Spain), highlighting the aspects the authors believe are fundamental to its success. The authors describe, in summary form, the methodology, phases of the plan, actions designed, key collaborators, important milestones achieved and main lessons they have drawn from their experience so that this can serve as an example for other institutions interested in promoting the ethical use of this type of therapy.

Bioética en donación y trasplante de órganos / Bioethics in donation and organ transplants / Bioètica en donació i trasplantament d'òrgans

Los intensivistas constituyen la columna vertebral del modelo español de donación y trasplantes. En el proceso de información a familiares en la donación en asistolia no controlada hay que respetar la autonomía, no hacer maleficencia y velar por la justicia. Este procedimiento solo se activará una vez que todas las opciones de tratamientos posibles, incluida la E-CPR donde se disponga de ella, se hayan descartado por no indicación o se hayan demostrado inútiles. El uso de catéter para bloqueo aórtico con monitorización de presión arterial radial izquierda evita el problema ético de la reanimación indeseada en la donación en asistolia controlada, al garantizar que la circulación al corazón y al cerebro no se restaure después del inicio de la ECMO tras el fallecimiento. Los intensivistas deben recordar que, para los profesionales que atienden a pacientes en los escenarios del final de la vida, ofrecer la opción de la donación de órganos y tejidos, es una obligación para respetar la autonomía de nuestros pacientes

The intensivists constitute the cornerstone of the Spanish model of donation and transplants. In the process of informing relatives in uncontrolled donation after circulatory death, autonomy must be respected, not maleficence and justice must be observed. This procedure will only be activated once all possible treatment options, including E-CPR where available, have been ruled out due to non-indication or futility. The use of a catheter for an aortic block with left radial blood pressure monitoring avoids the ethical problem of unwanted resuscitation in controlled donation after circulatory death, by ensuring that circulation to the heart and brain is not restored after the onset of ECMO after the death. Intensivists should remember that, for professionals who care for patients in end-of-life scenarios, offering the option of organ and tissue donation is an obligation to respect the autonomy of our patients

Els intensivistes constitueixen la columna vertebral del model espanyol de donació I trasplantaments. En el procés d'informació als familiars en la donació en assistòlia no controlada cal respectar l'autonomia, no fer maleficència I vetllar per la justícia. Aquest procediment solament s'ha d'activar una cop totes les opcions de tractaments possibles, inclosa l'E-CPR on es disposi d'ella, s'hagin descartat, bé per no indicació o bé perquè s'hagin demostrat inútils. L'ús de catèter per a bloqueig aòrtic amb monitoratge de pressió arterial radial esquerra evita el problema ètic de la reanimació indesitjada en la donació en assistòlia controlada, en garantir que la circulació al cor I al cervell no es restauri després de l'inici de la ECMO post- defunció. Els intensivistes han de recordar que per als professionals que atenen pacients en els escenaris del final de la vida oferir l'opció de la donació d'òrgans I teixits, és una obligació a fi de respectar l'autonomia dels nostres pacients

Rutas emocionales en las experiencias profesionales de los equipos de coordinación de trasplantes / Emotional paths of professional experiences in transplant coordinators

ANTECEDENTES Y OBJETIVO: Conocer las experiencias en la práctica profesional de equipos de coordinación de trasplantes y explorar sus vivencias emocionales, estrategias de afrontamiento, necesidades y demandas en relación con la entrevista de donación. MATERIALES Y MÉTODOS: Diseño exploratorio, transversal, multicéntrico, con metodología cualitativa, basado en la teoría fundamentada y análisis de contenido de cuestionarios con preguntas abiertas y entrevistas semiestructuradas, realizado con 22 profesionales pertenecientes a equipos de coordinación de trasplantes del Sistema Sanitario Público de Andalucía. Las categorías empleadas en el análisis fueron: trabajo de coordinación: percepciones, funciones, impacto y consecuencias; aspectos positivos/gratificantes y negativos/difíciles de la coordinación de trasplantes; la entrevista de donación; estrategias de afrontamiento; necesidades, demandas y propuestas. RESULTADOS: Los equipos de coordinación de trasplantes tienen una visión polarizada sobre su trabajo, que describen como reto y oportunidad, evidenciando, por una parte, su satisfacción y compromiso profesional y, por otra parte, las dificultades y exigencias que representan factores de estrés con impacto en sus percepciones, estilos de vida, identidad profesional o salud física y psíquica. Los aspectos más gratificantes se relacionan con la excelencia profesional, trasplantes exitosos y la relación con pacientes y familiares. La entrevista de donación es el momento de mayor estrés, ante el cual se generan diferentes rutas emocionales, condicionadas por la experiencia en la coordinación, la respuesta familiar y su interpretación y la autoevaluación profesional. Las principales demandas profesionales se orientan hacia estrategias formativas, terapia grupal y apoyo institucional. CONCLUSIONES: Ante la complejidad e intensidad emocional del trabajo de coordinación, se requieren intervenciones de capacitación para mejorar la salud y gestión emocional de sus profesionales

BACKGROUND AND OBJECTIVE: To look at transplant coordinators professional narratives and explore their emotional experiences, coping strategies, needs and demands in relation to the donation interview. MATERIALS AND METHODS: Exploratory, transversal, multicenter design, using grounded theory, qualitative approach and content analysis of open-ended questionnaire and semistructured interviews with 22 transplant coordinators from the Andalusian Public Health System. Categories of analysis: Transplant coordination: perceptions, functions, impact and consequences; Positive/gratifying aspects and negative/ difficult aspects; Donation interview; Coping strategies; Needs, demands and suggestions. RESULTS: Transplant coordinators maintain a polarized perspective on their work, which they describe as a challenge and an opportunity. They highlight both their satisfaction and professional commitment as their work difficulties and requirements, which represent stress factors with an impact on professionals' perceptions, life styles, identity or physical and psychical life. Most gratifying work aspects refer to professional excellence, successful transplants and relationship with patients and their families. The donation interview is considered to be the most stressful moment, in response to which coordinators develop different emotional paths, conditioned by their experience, families' response to donation and its interpretation by the health team and professional (self) evaluation. Main professional demands are training strategies, group therapies and institutional support. CONCLUSIONS: The complexity and emotional intensiveness of transplant coordination require special interventions aiming to enable professionals towards an improvement of their emotional heath and management

Emotional paths of professional experiences in transplant coordinators. / Rutas emocionales en las experiencias profesionales de los equipos de coordinación de trasplantes.

BACKGROUND AND OBJECTIVE: To look at transplant coordinators' professional narratives and explore their emotional experiences, coping strategies, needs and demands in relation to the donation interview. MATERIALS AND METHODS: Exploratory, transversal, multicenter design, using grounded theory, qualitative approach and content analysis of open-ended questionnaire and semistructured interviews with 22 transplant coordinators from the Andalusian Public Health System. Categories of analysis: Transplant coordination: perceptions, functions, impact and consequences; Positive/gratifying aspects and negative/ difficult aspects; Donation interview; Coping strategies; Needs, demands and suggestions. RESULTS: Transplant coordinators maintain a polarized perspective on their work, which they describe as a challenge and an opportunity. They highlight both their satisfaction and professional commitment as their work difficulties and requirements, which represent stress factors with an impact on professionals' perceptions, life styles, identity or physical and psychical life. Most gratifying work aspects refer to professional excellence, successful transplants and relationship with patients and their families. The donation interview is considered to be the most stressful moment, in response to which coordinators develop different emotional paths, conditioned by their experience, families' response to donation and its interpretation by the health team and professional (self) evaluation. Main professional demands are training strategies, group therapies and institutional support. CONCLUSIONS: The complexity and emotional intensiveness of transplant coordination require special interventions aiming to enable professionals towards an improvement of their emotional heath and management.

False-Positive Tumor During Organ Retrieval: All Cats Are Gray in the Dark.

OBJECTIVE: Efforts to expand the organ donor pool to meet growing transplant demands remains a top priority, as does maintaining the quality and safety standards of potential recipients. There is a short window of time from organ retrieval to decision making on organ acceptance, based on the available data. Furthermore, the limitations of intraoperative biopsy can often lead to donor or organ refusal due to a suspected tumor, which, if not confirmed in the final biopsy, results in the loss of a transplant opportunity. METHODS: Donor characteristics and organs discarded on suspicion of neoplastic disease at the time of extraction were analyzed in Andalusia between January 2014 and July 2018. The variable analysis included sociodemographic data, type of donor, location of the potential malignancy, histopathologic examination, and discarded organs. RESULTS: A total of 43 cases were identified. The organs of 33 donors (76.7%) were discarded. Kidneys were the most frequent location for a suspected tumor (44%), followed by the liver (21%). In 18 of the 43 cases (42%), the suspected malignancy was not confirmed, and of these, only 3 livers and 1 kidney were implanted. Sixty potentially transplantable organs were discarded, including those that would have been extracted and/or implanted in the absence of a suspected tumor. CONCLUSIONS: These results highlight the need not only to improve the accuracy of intraoperative biopsies but to seek new decision-making strategies for the short interval after organ retrieval. This involves avoiding both extremes of donation contraindications, while maintaining quality and safety standards.

El papel clave de los equipos de emergencias extrahospitalarias en los programas de donación en asistolia no controlada en Andalucía / Key role for out-of-hospital emergency teams in non-heart-beating donor programs in Andalusia

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