Maintaining the permanence principle of death during normothermic regional perfusion in controlled donation after the circulatory determination of death: Results of a prospective clinical study.

One concern about the use of normothermic regional perfusion (NRP) in controlled donation after the circulatory determination of death (cDCD) is that the brain may be perfused. We aimed to demonstrate that certain technical maneuvers preclude such brain perfusion. A nonrandomized trial was performed on cDCD donors. In abdominal normothermic regional perfusion (A-NRP), the thoracic aorta was blocked with an intra-aortic occlusion balloon. In thoracoabdominal normothermic regional perfusion (TA-NRP), the arch vessels were clamped and the cephalad ends vented to the atmosphere. The mean intracranial arterial blood pressure (ICBP) was invasively measured at the circle of Willis. Ten cDCD donors subject to A-NRP or TA-NRP were included. Mean ICBP and mean blood pressure at the thoracic and the abdominal aorta during the circulatory arrest were 17 (standard deviation [SD], 3), 17 (SD, 3), and 18 (SD, 4) mmHg, respectively. When A-NRP started, pressure at the abdominal aorta increased to 50 (SD, 13) mmHg, while the ICBP remained unchanged. When TA-NRP was initiated, thoracic aorta pressure increased to 71 (SD, 18) mmHg, but the ICBP remained unmodified. Recorded values of ICBP during NRP were 10 mmHg. In conclusion, appropriate technical measures applied during NRP preclude perfusion of the brain in cDCD. This study might help to expand NRP and increase the number of organs available for transplantation.

Assessing Outcomes of Patients Subject to Intensive Care to Facilitate Organ Donation: A Spanish Multicenter Prospective Study.

Intensive Care to facilitate Organ Donation (ICOD) consists of the initiation or continuation of intensive care measures in patients with a devastating brain injury (DBI) in whom curative treatment is deemed futile and death by neurological criteria (DNC) is foreseen, to incorporate organ donation into their end-of-life plans. In this study we evaluate the outcomes of patients subject to ICOD and identify radiological and clinical factors associated with progression to DNC. In this first prospective multicenter study we tested by multivariate regression the association of clinical and radiological severity features with progression to DNC. Of the 194 patients, 144 (74.2%) patients fulfilled DNC after a median of 25 h (95% IQR: 17-44) from ICOD onset. Two patients (1%) shifted from ICOD to curative treatment, both were alive at discharge. Factors associated with progression to DNC included: age below 70 years, clinical score consistent with severe brain injury, instability, intracranial hemorrhage, midline shift ≥5 mm and certain types of brain herniation. Overall 151 (77.8%) patients progressed to organ donation. Based on these results, we conclude that ICOD is a beneficial and efficient practice that can contribute to the pool of deceased donors.

Physical Examination of Potential Deceased Organ and Tissue Donors: An Overview of the European Landscape.

Physical examination (PE) of donors is essential to identify potential risks to the safety and efficacy of donated organs and tissues and is mandatory in the EU. However, no detailed guidance is available as to how PE should be performed. Health authorities (HA) and health professionals (HP) in member states of the European Committee on Organ Transplantation of the Council of Europe (CD-P-TO) and observer countries completed surveys relating to the regulatory requirements for PE and the professional practice of PE in their countries for organ and tissue donors. The HA survey addressed regulatory aspects, and the HP survey addressed professional practices, training, and respondents' opinions on the value of PE. These surveys revealed significant inter-country variation in the regulatory approach to PE and the performance of PE by professionals. Most respondents opined that PE was important and yielded valuable information in identifying contraindications to donation. There is no consensus at a regulatory or professional level as to how PE should be performed on organ and tissue donors. There is a requirement for agreed best practice guidelines in this area.

Access of non-residents to transplantation of deceased donor organs: practices and strategies in the European setting.

The access of non-resident patients to the deceased donor waiting list (DDWL) poses different challenges. The European Committee on Organ Transplantation of the Council of Europe (CD-P-TO) has studied this phenomenon in the European setting. A questionnaire was circulated among the Council of Europe member states to inquire about the criteria applied for non-residents to access their DDWL. Information was compiled from 28 countries. Less than 1% of recipients of deceased donor organs were non-residents. Two countries never allow non-residents to access the DDWL, four allow access without restrictions and 22 only under specific conditions. Of those, most give access to non-resident patients already in their jurisdictions who are in a situation of vulnerability (urgent life-threatening conditions). In addition, patients may be given access: (i) after assessment by a specific committee (four countries); (ii) within the framework of official cooperation agreements (15 countries); and (iii) after patients have officially lived in the country for a minimum length of time (eight countries). The ethical and legal implications of these policies are discussed. Countries should collect accurate information about residency status of waitlisted patients. Transparent criteria for the access of non-residents to DDWL should be clearly defined at national level.

Behavioral economics-A framework for donor organ decision-making in pediatric heart transplantation.

The high discard rate of pediatric donor hearts presents a major challenge for children awaiting heart transplantation. Recent literature identifies several factors that contribute to the disparities in pediatric donor heart usage, including regulatory oversight, the absence of guidelines on pediatric donor heart acceptance, and variation among transplant programs. However, a likely additional contributor to this issue are the behavioral factors influencing transplant team decisions in donor offer scenarios, a topic that has not yet been studied in detail. Behavioral economics and decision psychology provide an excellent foundation for investigating decision-making in the pediatric transplant setting, offering key insights into the behavior of transplant professionals. We conducted a systematic review of published literature in pediatric heart transplant related to behavioral economics and the psychology of decision-making. In this review, we draw on paradigms from these two domains in order to examine how existing aspects of the transplant environment, including regulatory oversight, programmatic variation, and allocation systems, may precipitate potential biases surrounding donor offer decisions. Recognizing how human decision behavior influences donor acceptance is a first step toward improving utilization of potentially viable pediatric donor hearts.

Summary of Spanish recommendations on intensive care to facilitate organ donation.

With the aim of consolidating recommendations about the practice of initiating or continuing intensive care to facilitate organ donation (ICOD), an ad hoc working group was established, comprising 10 intensivists designated by the Spanish Society of Intensive Care and Coronary Units (SEMICYUC) and the Spanish National Transplant Organization (ONT). Consensus was reached in all recommendations through a deliberative process. After a public consultation, the final recommendations were institutionally adopted by SEMICYUC, ONT, and the Transplant Committee of the National Health-Care System. This article reports on the resulting recommendations on ICOD for patients with a devastating brain injury for whom the decision has been made not to apply any medical or surgical treatment with a curative purpose on the grounds of futility. Emphasis is made on the systematic referral of these patients to donor coordinators, the proper assessment of the likelihood of brain death and medical suitability, and on transparency in communication with the patient's family. The legal and ethical aspects of ICOD are addressed. ICOD is considered a legitimate practice that offers more patients the opportunity of donating their organs upon their death and helps to increase the availability of organs for transplantation.

How Do Healthcare Providers Feel About Family Presence During Cardiopulmonary Resuscitation?

The presence of patients' families during cardiopulmonary resuscitation (CPR) is a controversial topic, due to its repercussions for clinical practice. While family members' presence may help them to overcome their grief, it could be detrimental, as it may case posttraumatic stress disorder (PTSD), and there is the possibility that family members may interfere with the procedure. For these reasons, families' presence during CPR has rejected by some healthcare providers. To research concerns about families' presence among providers dealing with CPR in the Fundación Hospital Alcorcón (Madrid), I performed this study. Of the 190 providers surveyed, 115 submitted a complete questionnaire. The most frequently reported concerns were interference (78.3 percent of respondents), and PTSD (69.6 percent of respondents). Fewer pediatric providers were concerned about PTSD than other providers (41.2% percent versus 74.5 percent, p = 0.01). Providers were reluctant to offer families the option of being present unless they had requested it, and would only permit it under certain conditions. Having a staff member to support the family was of great value to most respondents. The author believes families have a negative right to be present during CPR and so should be invited to stay.

When is directed deceased donation justified? Practical, ethical, and legal issues.

This paper explores whether directed deceased organ donation should be permitted, and if so under which conditions. While organ donation and allocation systems must be fair and transparent, might it be "one thought too many" to prevent directed donation within families? We proceed by providing a description of the medical and legal context, followed by identification of the main ethical issues involved in directed donation, and then explore these through a series of hypothetical cases similar to those encountered in practice. Ultimately, we set certain conditions under which directed deceased donation may be ethically acceptable. We restrict our discussion to the allocation of organs to recipients already on the waiting list.

Prevention of Trafficking in Organs, Tissues, and Cells.

Trafficking in human organs, cells, and tissues has long been a source of concern for health authorities and professionals, and several international ethical guidance documents and national laws have affirmed the prohibition of trade in these substances of human origin (SoHOs). However, despite considerable attention to the issue of organ trafficking, this remains a substantial and widespread problem internationally. In contrast, trafficking in cells, tissues, and medical products derived from SoHOs has received comparatively little attention, and the extent and nature of such trafficking remain largely unknown. Consequently, as part of the 2023 Global Summit on Convergence in Transplantation held in Santander, Spain, an ethics working group was assigned the task of formulating actionable recommendations to support the prevention of trafficking in all SoHOs. In reporting on this work, we review factors that may influence the persistent trafficking of SoHOs, explore the potential difficulties associated with the collection and reporting of data about suspected trafficking activities, and argue that more practical and consistent guidance, training, and regulatory frameworks are needed internationally to support effective reporting, sharing of data, and collaborative responses to suspected trafficking cases. We also discuss the importance of psychosocial evaluation of living donors as a strategy to detect and prevent organ trafficking and strive to advance the implementation of this well-established recommendation by outlining minimum standards for psychosocial evaluation of living donors.

Toward Equity in Global Access to SoHO-based Therapies: Recommendations for Action.

Therapies derived from substances of human origin (SoHOs) such as organs, cells, and tissues provide life-saving or life-changing treatment for millions of people worldwide each year. However, many people lack timely access to SoHO-based therapies because of insufficient supplies of these exceptional health resources and/or broader barriers in access to healthcare. Despite well-established governmental commitments to promote health equity in general and equity of access to SoHOs in particular, information about inequities in access to most SoHO-based therapies is scarce. Furthermore, the issue of equitable allocation of SoHO-based therapies has received little attention from policymakers and ethicists, except in the context of organ allocation for transplantation. Consequently, the extent and nature of potential inequities within and between countries are largely unknown, and few sources of guidance are available to support progress toward equity in global access to SoHO-based therapies. We present here the findings of an international ethics working group convened in preparation for the 2023 Global Summit on Convergence in Transplantation, organized in Santander, Spain. The group sought to assess potential gaps in knowledge about inequities involving SoHO-based therapies, to elucidate systemic factors that may influence access to these therapies, and to consider how policies and frameworks governing access to and allocation of SoHO-based therapies may promote equity when it is necessary to define boundaries in access because of insufficiency of supply. In discussing these challenges, we also outline several recommendations for action by governments and health authorities.

Supporting Financial Neutrality in Donation of Organs, Cells, and Tissues.

The avoidance of financial gain in the human body is an international ethical standard that underpins efforts to promote equity in donation and transplantation and to avoid the exploitation of vulnerable populations. The avoidance of financial loss due to donation of organs, tissues, and cells is also now recognized as an ethical imperative that fosters equity in donation and transplantation and supports the well-being of donors and their families. Nevertheless, there has been little progress in achieving financial neutrality in donations in most countries. We present here the findings of an international ethics working group convened in preparation for the 2023 Global Summit on Convergence in Transplantation, held in Santander, Spain, which was tasked with formulating recommendations for action to promote financial neutrality in donation. In particular, we discuss the potential difficulty of distinguishing interventions that address donation-related costs from those that may act as a financial incentive for donation, which may inhibit efforts to cover costs. We also outline some practical strategies to assist governments in designing, implementing, and evaluating policies and programs to support progress toward financial neutrality in donation.

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.

Uterus Transplantation as a Surgical Innovation.

Uterus transplantation (UTx) research has been introduced in several countries, with trials in Sweden and the United States producing successful outcomes. The growing interest in developing UTx trials in other countries, such as Spain, the Netherlands, Japan, and Australia, raises important questions regarding the ethics of surgical innovation research in the field of UTx. This paper examines the current state of UTx in the context of the surgical innovation paradigm and IDEAL framework and discusses the ethical challenges faced by those considering the introduction of new trials. We argue that UTx remains an experimental procedure at a relatively early stage of the IDEAL framework, especially in the context of de novo trials, where protocols are likely to deviate from those used previously and where researchers are likely to have limited experience of UTx. We conclude that countries considering the introduction of UTx trials should build on the strengths of the reported outcomes to consolidate the evidence base and shed light on the uncertainties of the procedure. Authorities responsible for the ethical governance of UTx trials are advised to draw on the ethical framework used in the oversight of surgical innovation.

Organ and Tissue Donation Consent Model and Intent to Donate Registries: Recommendations From an International Consensus Forum.

Consent model and intent to donate registries are often the most public facing aspects of an organ and tissue donation and transplantation (OTDT) system. This article describes the output of an international consensus forum designed to give guidance to stakeholders considering reform of these aspects of their system. Methods: This Forum was initiated by Transplant Québec and cohosted by the Canadian Donation and Transplantation Program partnered with multiple national and international donation and transplantation organizations. This article describes the output of the consent and registries domain working group, which is 1 of 7 domains from this Forum. The domain working group members included administrative, clinical, and academic experts in deceased donation consent models in addition to 2 patient, family, and donor partners. Topic identification and recommendation consensus was completed over a series of virtual meetings from March to September 2021. Consensus was achieved by applying the nominal group technique informed by literature reviews performed by working group members. Results: Eleven recommendations were generated and divided into 3 topic groupings: consent model, intent to donate registry structure, and consent model change management. The recommendations emphasized the need to adapt all 3 elements to the legal, societal, and economic realities of the jurisdiction of the OTDT system. The recommendations stress the importance of consistency within the system to ensure that societal values such as autonomy and social cohesion are applied through all levels of the consent process. Conclusions: We did not recommend one consent model as universally superior to others, although considerations of factors that contribute to the successful deployment of consent models were discussed in detail. We also include recommendations on how to navigate changes in the consent model in a way that preserves an OTDT system's most valuable resource: public trust.

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.

[Legislaction, ethics and kidney transplantation.] / Legislación, ética y trasplante renal.

Kidney transplantation (KT) is the best therapeutic option for patients with end-stage renal disease in terms of survival, quality of life and cost-effectiveness. The fundamental difference of KT with respect to other therapies is that the process depends on the availability of organs for clinical use, availability that is insufficient to cover the increasing transplantation needs of the population. Another relevant feature of transplantation is that it entails a risk of transmission of diseases from donor to recipient, a risk that can be minimized, but not completely eliminated. Due to its characteristics and its unique nature (the human being), KT requires a specific regulation that guarantees the protection of all those who participate in the process: donors and their families, patients in need of a transplant, recipients of organs and healthcareprofessionals involved. In this article, we reviewthe ethical-legal standards that regulate the practice of kidney donation and transplantation at the international level and analyze the ethical-legal framework that is applicable in Spain.

El trasplante renal (TR) es la mejor opción terapéutica para los pacientes con insuficiencia renal crónica en términos de supervivencia, calidad de vida y relación coste-efectividad. La diferencia fundamental del TR con respecto a otras terapias es que su realización depende de la disponibilidad de órganos para uso clínico, disponibilidad que resulta insuficiente para cubrir las crecientes necesidades de trasplante de la población. Otro aspecto relevante del trasplante es que conlleva el riesgo de transmisión de enfermedades de donante a receptor, riesgo que puede minimizarse, pero no eliminarse por completo. Por sus características y su naturaleza única (el ser humano), el TR exige una regulación específica que garantice la protección detodos los participantes en el proceso: los donantes y sus familias, los pacientes con necesidad de un trasplante, los receptores de órganos y los profesionales sanitariosimplicados. En este artículo se revisan los estándares ético-legales que regulan la práctica de la donación y el TR a nivel internacional y se analiza el marco ético-legal que resulta de aplicación en España.

[National recommendations on pediatric donation]. / Recomendaciones nacionales sobre donación pediátrica.

Despite being an international reference in donation and transplantation, Spain needs to improve pediatric donation, including donation after the circulatory determination of death. The present article, a summary of the consensus report prepared by the Organización Nacional de Trasplantes and the Spanish Pediatrics Association, intends the facilitation of donation procedures in newborns and children and the analysis of associated ethical dilemma. The ethical basis for donation in children, the principles of clinical assessment of possible donors, the criteria for the determination of death in children, intensive care management of donors, basic concepts of donation after the circulatory determination of death and the procedures for donation in newborns with severe nervous system's malformation incompatible with life, as well as in children receiving palliative care are commented. Systematically considering the donation of organs and tissues when a child dies in conditions consistent with donation is an ethical imperative and must become an ethical standard, not only because of the need of organs for transplantation, but also to ensure family centered care.

ISHLT consensus statement on donor organ acceptability and management in pediatric heart transplantation.

The number of potential pediatric heart transplant recipients continues to exceed the number of donors, and consequently the waitlist mortality remains significant. Despite this, around 40% of all donated organs are not used and are discarded. This document (62 authors from 53 institutions in 17 countries) evaluates factors responsible for discarding donor hearts and makes recommendations regarding donor heart acceptance. The aim of this statement is to ensure that no usable donor heart is discarded, waitlist mortality is reduced, and post-transplant survival is not adversely impacted.