Prácticas clínicas al final de la vida en pacientes con daño cerebral catastrófico en España: implicaciones para la donación de órganos / End-of-life practices in patients with devastating brain injury in Spain: implications for organ donation

OBJETIVO: Describir las prácticas clínicas al final de la vida relevantes para la donación de órganos en pacientes con daño cerebral catastrófico en España. DISEÑO: Estudio multicéntrico prospectivo de una cohorte retrospectiva. Periodo: 1 de noviembre de 2014 al 30 de abril de 2015. Ámbito: Sesenta y ocho hospitales autorizados para donación. PACIENTES: Pacientes fallecidos por daño cerebral catastrófico (posibles donantes). Edad: 1 mes-85 años. Variables de interés principales: Cuidado recibido, donación en muerte encefálica, donación en asistolia controlada, intubación/ventilación, notificación al coordinador de trasplantes. RESULTADOS: Se identificaron 1.970 posibles donantes. La mitad recibió tratamiento activo en una Unidad de Críticos (UC) hasta evolucionar a muerte encefálica (27%), sufrir una parada cardiorrespiratoria (5%), o hasta la limitación de tratamiento de soporte vital (19%). Del resto, un 10% ingresó en una UC para facilitar la donación y el 39% nunca ingresó en una UC. De los pacientes que evolucionaron a muerte encefálica (n=695), la mayoría derivaron en una donación eficaz (n=446; 64%). De los pacientes fallecidos tras limitación de tratamiento de soporte vital (n=537), 45 (8%) se convirtieron en donantes en asistolia eficaces. La ausencia de un programa de donación en asistolia controlada fue el motivo más frecuente de no donación. El 37% de los posibles donantes falleció sin intubar/ventilar, fundamentalmente porque el profesional responsable no consideró la donación tras descartar intubación terapéutica. El 36% de los posibles donantes no fue notificado al coordinador de trasplantes. CONCLUSIONES: Aunque el proceso de donación está optimizado en España, existen oportunidades para la mejora en la detección de posibles donantes fuera de UC y en la consideración de la donación en asistolia controlada en pacientes fallecidos tras limitación de tratamiento de soporte vital

OBJECTIVE: To describe end-of-life care practices relevant to organ donation in patients with devastating brain injury in Spain. DESIGN: A multicenter prospective study of a retrospective cohort. Period: 1 November 2014 to 30 April 2015. SETTING: Sixty-eight hospitals authorized for organ procurement. PATIENTS: Patients dying from devastating brain injury (possible donors). Age: 1 month-85 years. Primary endpoints: Type of care, donation after brain death, donation after circulatory death, intubation/ventilation, referral to the donor coordinator. RESULTS: A total of 1,970 possible donors were identified, of which half received active treatment in an Intensive Care Unit (ICU) until brain death (27%), cardiac arrest (5%) or the withdrawal of life-sustaining therapy (19%). Of the rest, 10% were admitted to the ICU to facilitate organ donation, while 39% were not admitted to the ICU. Of those patients who evolved to a brain death condition (n=695), most transitioned to actual donation (n=446; 64%). Of those who died following the withdrawal of life-sustaining therapy (n=537), 45 (8%) were converted into actual donation after circulatory death donors. The lack of a dedicated donation after circulatory death program was the main reason for non-donation. Thirty-seven percent of the possible donors were not intubated/ventilated at death, mainly because the professional in charge did not consider donation alter discarding therapeutic intubation. Thirty-six percent of the possible donors were never referred to the donor coordinator. CONCLUSIONS: Although deceased donation is optimized in Spain, there are still opportunities for improvement in the identification of possible donors outside the ICU and in the consideration of donation after circulatory death in patients who die following the withdrawal of life-sustaining therapy

How Spain Reached 40 Deceased Organ Donors per Million Population.

With 40 donors and more than 100 transplant procedures per million population in 2015, Spain holds a privileged position worldwide in providing transplant services to its patient population. The Spanish success derives from a specific organizational approach to ensure the systematic identification of opportunities for organ donation and their transition to actual donation and to promote public support for the donation of organs after death. The Spanish results are to be highlighted in the context of the dramatic decline in the incidence of brain death and the changes in end-of-life care practices in the country since the beginning of the century. This prompted the system to conceive the 40 donors per million population plan, with three specific objectives: (i) promoting the identification and early referral of possible organ donors from outside of the intensive care unit to consider elective non-therapeutic intensive care and incorporate the option of organ donation into end-of-life care; (ii) facilitating the use of organs from expanded criteria and non-standard risk donors; and (iii) developing the framework for the practice of donation after circulatory death. This article describes the actions undertaken and their impact on donation and transplantation activities.

End-of-life practices in patients with devastating brain injury in Spain: implications for organ donation. / Prácticas clínicas al final de la vida en pacientes con daño cerebral catastrófico en España: implicaciones para la donación de órganos.

OBJECTIVE: To describe end-of-life care practices relevant to organ donation in patients with devastating brain injury in Spain. DESIGN: A multicenter prospective study of a retrospective cohort. PERIOD: 1 November 2014 to 30 April 2015. SETTING: Sixty-eight hospitals authorized for organ procurement. PATIENTS: Patients dying from devastating brain injury (possible donors). Age: 1 month-85 years. PRIMARY ENDPOINTS: Type of care, donation after brain death, donation after circulatory death, intubation/ventilation, referral to the donor coordinator. RESULTS: A total of 1,970 possible donors were identified, of which half received active treatment in an Intensive Care Unit (ICU) until brain death (27%), cardiac arrest (5%) or the withdrawal of life-sustaining therapy (19%). Of the rest, 10% were admitted to the ICU to facilitate organ donation, while 39% were not admitted to the ICU. Of those patients who evolved to a brain death condition (n=695), most transitioned to actual donation (n=446; 64%). Of those who died following the withdrawal of life-sustaining therapy (n=537), 45 (8%) were converted into actual donation after circulatory death donors. The lack of a dedicated donation after circulatory death program was the main reason for non-donation. Thirty-seven percent of the possible donors were not intubated/ventilated at death, mainly because the professional in charge did not consider donation alter discarding therapeutic intubation. Thirty-six percent of the possible donors were never referred to the donor coordinator. CONCLUSIONS: Although deceased donation is optimized in Spain, there are still opportunities for improvement in the identification of possible donors outside the ICU and in the consideration of donation after circulatory death in patients who die following the withdrawal of life-sustaining therapy.

Implementation of a National Priority Allocation System for Hypersensitized Patients in Spain, Based on Virtual Crossmatch: Initial Results.

Access to kidney transplantation for patients with high levels of antibodies against HLA is a major challenge. This issue makes it difficult to detect compatible donors for those patients in a certain geographical area. Consequently, hypersensitized patients remain on the waiting list for long periods and their quality of life deteriorates. Our purpose was to increase access to transplantation for highly sensitized patients by developing a national priority allocation system based on virtual crossmatch. Between June 15, 2015, and May 15, 2016, 675 patients on the kidney transplant waiting list with calculated panel-reactive antibodies ≥98% and undergoing dialysis for at least 12 months were included in the study; 86.1% of the patients had previously received at least one transplant. Solid-phase immunoassays were used to identify class I and II HLA antibodies in all patients. Participating hospitals assigned to the program one of the kidneys of every identified brain-dead real donor between 18 and 70 years old. Survival data were collected for the recipients transplanted between June 15, 2015, and December 31, 2015. In all, 475 (290 male and 185 female) brain-dead donors were assigned to the program. Virtual crossmatch was negative for 191 (41%) donors, 149 offers were accepted, and 102 (21.8%) kidneys were transplanted. At the end of the study, patient and graft survival were both 93.4%. The implementation of a national prioritization system based on virtual crossmatch increased access to transplantation for highly sensitized patients, with excellent results in terms of patient and graft survival.

El trasplante hepático e intestinal en la población pediátrica / Liver and intestinal transplant in paediatric population

Nuestro modelo organizativo posibilita la realización anual de 1.000 trasplantes hepáticos, de los cuales el trasplante hepático pediátrico constituye el 5% y proporciona, en niños con hepatopatía grave, progresiva e irreversible, una supervivencia del 90% al año y superior al 80% a los 15 años de seguimiento. La principal indicación es la atresia de vías biliares seguida de hepatopatías metabólicas e insuficiencia hepática aguda, realizándose el 50% de los procedimientos en menores de 2 años y el 25-30% en el primer año de vida. La lista de espera se mantiene en torno a los 35 pacientes, con un promedio de 100 pacientes incluidos anualmente y 60 trasplantados tras un tiempo medio de espera de 136,3 días. La priorización de los candidatos utiliza el PELD como herramienta objetiva de apoyo en la toma de decisiones. No obstante, el progresivo envejecimiento de los donantes, con un perfil cada vez más alejado de los requerimientos de los pacientes infantiles incluidos en lista de espera, precisa impulsar estrategias como el trasplante hepático de donante vivo y la modalidad split, para incrementar las probabilidades de trasplante reduciendo la mortalidad en lista de espera y el tiempo de permanencia en la misma. El trasplante intestinal/multivisceral pediátrico registra una baja indicación pero conlleva unos requisitos que perfilan un donante muy infrecuente en nuestro país, lo que, unido a la ausencia de alternativas que contrarresten el impacto negativo de estas dificultades, lastra las probabilidades de trasplante de estos pacientes

Our organizational model allows an annual 1,000 liver transplants. Pediatric liver transplantation constitutes 5% of such activity and provides, in children with severe, progressive and irreversible liver disease, a 1 year-survival of 90% and more than 80% after 15 years of follow-up. The main indication is biliary atresia followed by metabolic liver disease and acute liver failure. Around half of the procedures are performed in children under two years and 25-30% in the first year of life. The waiting list remains at around 35 patients, with an average of 100 patients enrolled annually and 60 of them finally transplanted after an average of 136.3 days on the waiting list. The prioritization of the candidates uses the PELD as an objective tool for decision-making. However, the progressive aging of donors, with a profile increasingly different from the requirements of the pediatric patients included in the waiting list, requires strategies such as living donor liver transplantation and the split liver transplantation, to increase the probability of transplant while reducing both time and mortality on the waiting list at the same time. Pediatric intestinal transplantation registers a low indication but involves strict requirements that outline a very uncommon donor in our country which, together with the absence of alternatives that outweigh the impact of these difficulties, penalizes the chances of transplant for these patients

[Liver and intestinal transplant in paediatric population]. / El trasplante hepático e intestinal en la población pediátrica.

Our organizational model allows an annual 1,000 liver transplants. Pediatric liver transplantation constitutes 5% of such activity and provides, in children with severe, progressive and irreversible liver disease, a 1 year-survival of 90% and more than 80% after 15 years of follow-up. The main indication is biliary atresia followed by metabolic liver disease and acute liver failure. Around half of the procedures are performed in children under two years and 25-30% in the first year of life. The waiting list remains at around 35 patients, with an average of 100 patients enrolled annually and 60 of them finally transplanted after an average of 136.3 days on the waiting list. The prioritization of the candidates uses the PELD as an objective tool for decision-making. However, the progressive aging of donors, with a profile increasingly different from the requirements of the pediatric patients included in the waiting list, requires strategies such as living donor liver transplantation and the split liver transplantation, to increase the probability of transplant while reducing both time and mortality on the waiting list at the same time. Pediatric intestinal transplantation registers a low indication but involves strict requirements that outline a very uncommon donor in our country which, together with the absence of alternatives that outweigh the impact of these difficulties, penalizes the chances of transplant for these patients.

Intensive care practices in brain death diagnosis and organ donation.

We conducted a multicentre study of 1844 patients from 42 Spanish intensive care units, and analysed the clinical characteristics of brain death, the use of ancillary testing, and the clinical decisions taken after the diagnosis of brain death. The main cause of brain death was intracerebral haemorrhage (769/1844, 42%), followed by traumatic brain injury (343/1844, 19%) and subarachnoid haemorrhage (257/1844, 14%). The diagnosis of brain death was made rapidly (50% in the first 24 h). Of those patients who went on to die, the Glasgow Coma Scale on admission was ≤ 8/15 in 1146/1261 (91%) of patients with intracerebral haemorrhage, traumatic brain injury or anoxic encephalopathy; the Hunt and Hess Scale was 4-5 in 207/251 (83%) of patients following subarachnoid haemorrhage; and the National Institutes of Health Stroke Scale was ≥ 15 in 114/129 (89%) of patients with strokes. Brain death was diagnosed exclusively by clinical examination in 92/1844 (5%) of cases. Electroencephalography was the most frequently used ancillary test (1303/1752, 70.7%), followed by transcranial Doppler (652/1752, 37%). Organ donation took place in 70% of patients (1291/1844), with medical unsuitability (267/553, 48%) and family refusal (244/553, 13%) the main reasons for loss of potential donors. All life-sustaining measures were withdrawn in 413/553 of non-donors (75%).

Spanish consensus document for acceptance and rejection of kidneys from expanded criteria donors.

In the recent years, more than 60% of available deceased donors are either older than 50 yr or have significant vascular comorbidities. This makes the acceptance and rejection criteria of renal allografts very rigorous, especially in cases of younger recipients, and at the same time encourages live donations. In our country, there is a lack of homogeneity in the percentages of use of expanded criteria donor (ECD) allografts between the different autonomous communities. Furthermore, the criteria vary greatly, and in some cases, great importance is given to the biopsy while in others very little. In this study, we present a unified and homogenous criteria agreed upon by consensus of a 10-member Panel representing major scientific societies related to renal transplantation in Spain. The criteria are to be used in accepting and/or rejecting kidneys from the so-called ECDs. The goal was to standardize the use of these organs, to optimize the results, and most importantly to provide for the maximum well being of our patients. Finally, we believe that after taking into account the Panel's thorough review of specific scientific literature, this document will be adaptable to other national renal transplant programmes.

Application of game-like simulations in the Spanish Transplant National Organization.

Twenty years ago, the Spanish National Transplant Organization (NTO) started a management and organizational system, known as the Spanish Model, that has allowed the NTO to occupy a privileged world position regarding deceased donation rates, which have been 33-35 donors per million population in recent years. One of the key elements of this model is its instructional approach. Two years ago, the NTO started the project "educ@nt" in close collaboration with the e-UCM research group of the University Complutense of Madrid to support and maximize its successful professional training system. As a result, 3 game-like simulations have been developed representing the different procedural steps of the suprahospital level of the transplantation process. These simulations represent the donor and organ evaluation, the allocation of organs applying the corresponding geographic and clinical criteria, and the logistics of transportation. Simulations are based on 10 representative teaching cases that help students become familiar with the most common cases arriving in the NTO. For the 2nd consecutive year, these simulations have been used in different courses around Spain.

Donación en asistolia no controlada: necesidad, oportunidad y reto / Uncontrolled non-heart beating donation: need, opportunity and challenge

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Continuously evaluating performance in deceased donation: the Spanish quality assurance program.

The Spanish Quality Assurance Program applied to the process of donation after brain death entails an internal stage consisting of a continuous clinical chart review of deaths in critical care units (CCUs) performed by transplant coordinators and periodical external audits to selected centers. This paper describes the methodology and provides the most relevant results of this program, with information analyzed from 206,345 CCU deaths. According to the internal audit, 2.3% of hospital deaths and 12.4% of CCU deaths in Spain yield potential donors (clinical criteria consistent with brain death). Out of the potential donors, 54.6% become actual donors, 26% are lost due to medical unsuitability, 13.3% due to refusals to donation, 3.1% due to maintenance problems and 3% due to other reasons. Although the national pool of potential donors after brain death has progressively decreased from 65.2 per million population (pmp) in 2001 to 49 pmp in 2010, the number of actual donors after brain death has remained at about 30 pmp. External audits reveal that the number of actual donors could be 21.6% higher if all potential donors were identified and preventable losses avoided. We encourage other countries to develop similar comprehensive approaches to deceased donation performance.

Benchmarking in the process of donation after brain death: a methodology to identify best performer hospitals.

A benchmarking approach was developed in Spain to identify and spread critical success factors in the process of donation after brain death. This paper describes the methodology to identify the best performer hospitals in the period 2003-2007 with 106 hospitals throughout the country participating in the project. The process of donation after brain death was structured into three phases: referral of possible donors after brain death (DBD) to critical care units (CCUs) from outside units, management of possible DBDs within the CCUs and obtaining consent for organ donation. Indicators to assess performance in each phase were constructed and the factors influencing these indicators were studied to ensure that comparable groups of hospitals could be established. Availability of neurosurgery and CCU resources had a positive impact on the referral of possible DBDs to CCUs and those hospitals with fewer annual potential DBDs more frequently achieved 100% consent rates. Hospitals were grouped into each subprocess according to influencing factors. Hospitals with the best results were identified for each phase and hospital group. The subsequent study of their practices will lead to the identification of critical factors for success, which implemented in an adapted way should fortunately lead to increasing organ availability.

International practices of organ donation.

Organ donation and transplant rates vary widely across the globe, but there remains an almost universal shortage of deceased donors. The unmet need for transplants has resulted in many systematic approaches to increase donor rates, but there have also been practices that have crossed the boundaries of legal and ethical acceptability. Recent years have seen intense interest from international political organizations, led by the World Health Organization, and professional bodies, led by The Transplantation Society. Their efforts have focused on the development of a series of legal and ethical frameworks, designed to encourage all countries to eradicate unacceptable practices while introducing programmes that strive to achieve national or regional self-sufficiency in meeting the need for organ transplants. These programmes should seek to reduce both the need for transplantation and also develop deceased donation to its maximum potential. Living donation remains the mainstay of transplantation in many parts of the world, and many of the controversial--and unacceptable--areas of practice are found in the exploitation of living donors. However, until lessons are learnt, and applied, from countries with highly developed deceased donor programmes, these abuses of human rights will be difficult to eradicate. A clear international framework is now in place to achieve this.

El diagnóstico de la muerte encefálica en Latinoamérica / The diagnosis of brain death in Latin America

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