Legislación, ética y trasplante renal / Legislation, ethics and renal transfer

El trasplante renal (TR) es la mejor opciónterapéutica para los pacientes con insuficiencia renalcrónica en términos de supervivencia, calidad de viday relación coste-efectividad. La diferencia fundamentaldel TR con respecto a otras terapias es que su realización depende de la disponibilidad de órganos parauso clínico, disponibilidad que resulta insuficiente paracubrir las crecientes necesidades de trasplante de lapoblación. Otro aspecto relevante del trasplante esque conlleva el riesgo de transmisión de enfermedadesde donante a receptor, riesgo que puede minimizarse,pero no eliminarse por completo. Por sus característicasy su naturaleza única (el ser humano), el TR exige unaregulación específica que garantice la protección detodos los participantes en el proceso: los donantes y susfamilias, los pacientes con necesidad de un trasplante,los receptores de órganos y los profesionales sanitariosimplicados. En este artículo se revisan los estándaresético-legales que regulan la práctica de la donación y elTR a nivel internacional y se analiza el marco ético-legalque resulta de aplicación en España.(AU)

Kidney transplantation (KT) is the best therapeutic option for patients with end-stage renal diseasein terms of survival, quality of life and cost-effectiveness.The fundamental difference of KT with respect to othertherapies is that the process depends on the availabilityof organs for clinical use, availability that is insufficientto cover the increasing transplantation needs of the population. Another relevant feature of transplantation is thatit entails a risk of transmission of diseases from donor torecipient, 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 regulationthat guarantees the protection of all those who participate in the process: donors and their families, patientsin need of a transplant, recipients of organs and healthcare professionals involved. In this article, we reviewthe ethical-legal standards that regulate the practice ofkidney donation and transplantation at the internationallevel and analyze the ethical-legal framework that is applicable in Spain.(AU)

Monitoramento de tecnologias incorporadas no SUS: Monitoramento do transplante renal no Brasil: 2000 a 2015 / Monitoring of technologies incorporated into the SUS: Incorporation monitoring of kidney transplantation in Brazil: 2000 to 2015 / Monitoreo de tecnologías incorporadas al SUS: Monitoreo de la incorporación del trasplante de riñón en Brasil: 2000 a 2015

TECNOLOGIA: Neste documento discute-se o transplante renal (TxR) e as terapias imunossupressoras utilizadas na manutenção do enxerto. INDICAÇÃO: O TxR está indicado para pacientes com insuficiência renal crônica terminal (IRCT), doença caracterizada pela perda gradual da função renal. Algumas doenças estão associadas ao surgimento da IRCT, em especial a diabetes mellitus e hipertensão. CARACTERIZAÇÃO DA TECNOLOGIA: O transplante renal é uma terapia substitutiva para pacientes que apresentam perda elevada da função renal. É um dos tratamentos de escolha por ser mais custo-efetivo e oferecer melhor qualidade de vida aos pacientes. OBJETIVO: Analisar as características individuais, a sobrevida do enxerto e seus fatores associados em pacientes submetidos ao TxR atendidos pelo SUS. Além disso, avaliar a utilização da primeira linha dos esquemas de manutenção imunossupressora no Brasil, dispensados pelo Componente Especializado da Assistência Farmacêutica (CEAF). MÉTODOS: Foi construída uma coorte retrospectiva com todos os pacientes submetidos ao TxR no período entre 01/01/2000 e 31/12/2014 por meio do SUS. Os indivíduos foram acompanhados por pelo menos um ano, até 31/12/2015. Considerou-se como perda de enxerto o retorno às diálises, casos de óbito e retransplantes. RESUMO DOS RESULTADOS: Foram incluídos 47.876 indivíduos, dos quais a maioria (60,1%) era do sexo masculino. A sobrevida do enxerto após 16 anos de acompanhamento da coorte foi de 42%. Transplantes realizados em indivíduos de etnia amarela e com órgãos provenientes de doadores vivos apresentaram maior probabilidade de sobrevida. Em contrapartida, transplantes realizados em indivíduos idosos (maiores de 65 anos) apresentaram piores resultados. CONCLUSÃO: Os resultados aqui apresentados são de grande relevância para que se discuta a imunossupressão na manutenção dos enxertos do transplante renal e possibilitam uma visão do panorama atual dos procedimentos realizados no SUS

TECHNOLOGY: Kidney transplantation (TxR) and immunosuppression therapy used in posttransplant period. USE: TxR is indicated for patients with end-stage renal disease (IRCT), a disease characterized by gradual loss of renal function. Among the diseases associated with the onset of IRCT, it is worth mentioning hypertension and diabetes mellitus. CHARACTERISTICS OF TECHNOLOGY: TxR is a substitutive therapy for patients who experience high loss of renal function. It is one of the treatments of choice due to its cost-effectiveness and better outcomes in quality of life. OBJECTIVE: To assess the characteristics and survival of the individuals undergoing TxR treated by SUS, as well as data on effectiveness and use of drugs provided by the Componente Especializado da Assistência Farmacêutica (CEAF). METHODS: A retrospective cohort was performed with all patients who underwent a TxR in the period between 01/01/2000 and 31/12/2014 through SUS. The individuals were followed up for at least one year, until 31/12/2015. All cases of death and retransplantation were considered as graft loss. SUMMARY OF THE RESULTS: A total of 47,876 individuals were included, of whom the majority (60.1%) were male. The graft survival probability after 15 years of follow-up was 42%. Transplants performed in individuals of yellow ethnicity and with organs from living donors were more likely to survive. In contrast, transplants performed in elderly individuals (older than 65 years) showed worse results. CONCLUSION: The results presented here are of great relevance for discussing immunosuppression in the maintenance of kidney transplant grafts and provide an overview of the current panorama of procedures performed at SUS.

TECNOLOGÍA: trasplante de riñón y terapia de inmunosupresión utilizada en pós-trasplante. Uso: TxR está indicado para pacientes con enfermedad renal en etapa terminal (IRCT), una enfermedad caracterizada por la pérdida gradual de la función renal. Entre las enfermedades asociadas con la aparición de IRCT, cabe mencionar la hipertensión y la diabetes mellitus. CARACTERÍSTICAS DE LA TECNOLOGÍA: TxR es una terapia sustitutiva para pacientes que experimentan una alta pérdida de la función renal. Es uno de los tratamientos de elección debido a su rentabilidad y mejores resultados en calidad de vida. OBJETIVO: Evaluar las características y la supervivencia de los individuos sometidos a TxR tratados por SUS, así como los datos sobre la efectividad y el uso de medicamentos proporcionados por el Componente Especializado da Assistência Farmacêutica (CEAF). MÉTODOS: se realizó una cohorte retrospectiva con todos los pacientes que se sometieron a una TxR en el período comprendido entre el 01/01/2000 y el 31/12/2014 a través del SUS. Los individuos fueron seguidos durante al menos un año, hasta el 31/12/2015. Todos los casos de muerte y trasplante se consideraron como pérdida del injerto. RESUMEN DE LOS RESULTADOS: se incluyeron un total de 47.876 individuos, de los cuales la mayoría (60,1%) eran hombres. La probabilidad de supervivencia del injerto después de 15 años de seguimiento fue del 42%. Los trasplantes realizados en individuos de etnia amarilla y con órganos de donantes vivos tenían más probabilidades de sobrevivir. En contraste, los trasplantes realizados en personas de edad avanzada (mayores de 65 años) mostraron peores resultados. CONCLUSIÓN: Los resultados presentados aquí son de gran relevancia para analizar la inmunosupresión en el mantenimiento de los injertos de trasplante de riñón y proporcionar una visión general del panorama actual de los procedimientos realizados en el SUS.

Survey on attitudes toward brain-dead and living donor transplantation in medical students: a cross-sectional study in Japan.

BACKGROUND: Although a shortage in organ donation is a critical problem in Japan, understanding of and attitude toward organ transplantation in medical students have not been sufficiently reported. METHODS: Between 2013 and 2018, we surveyed 702 medical students in the fifth-year clinical training in our urology department. The survey concerned (1) knowledge of Japanese transplantation law, which was amended in 2010, and (2) whether the respondents had an organ donor card and had agreed to be a brain-dead donor or a living donor in kidney transplantation with specific reasons for their choices. RESULTS: All 702 students answered the survey. Of 657 students who provided valid answers to the first section, 402 (61%) recognized the amendment to the Japanese transplantation law, and only 11 (1.7%) fully understood its contents. Of 702 students, 194 (28%) had a donor card, 384 (55%) agreed to be a brain-dead donor, and 529 (75%) agreed to be a living donor in kidney transplantation. As the specific reasons for their choices, only a few medical students wrote reasons based on their medical standpoint, and more students wrote emotional reasons. CONCLUSIONS: The understanding of and attitude toward organ transplantation were not remarkably high in the fifth-year medical students in Japan. To solve the donor shortage problem, education about organ transplantation may need to be more effective.

Living-unrelated kidney donor transplantation: Legalization in exceptional circumstances?

The prevalence of end-stage renal disease (ESRD) morbidity and mortality is mounting. Kidney transplantation offers a good means of survival and improves longevity of patients with ESRD. However, not everyone is fortunate to benefit from this lifesaving renal replacement therapy due to the lack of available kidneys, one of the many reasons. It eventually expands the number of patients on waiting list of kidney transplantation. At present, deceased and living-related kidney donor transplantation models are widely used, but with limited success to keep up with the pace of burgeoning ESRD. A debate over the legalization of unrelated living kidney donor transplantation has erupted lately. This short review articles focuses on issues surrounding kidney transplantation in Pakistan and draws an informed conclusion regarding pragmatic legalization of unrelated living kidney donor transplantation in exceptional circumstances. Finally, this article also offers a food for thought for countries facing analogous picture in the field of kidney transplantation.

In sickness and in health: Living HIV positive kidney donation from a wife to her husband, with 7 years' post-transplant follow-up.

Human immunodeficiency virus (HIV) infection was traditionally considered an absolute contraindication for kidney transplantation. After the introduction of ART, several studies have demonstrated comparable patient and graft outcomes between HIV-negative and HIV-positive kidney recipients. The US Congress passed the HIV Organ Policy Equity (HOPE) Act in 2013, which permits research in the area of HIV-positive to HIV-positive transplantation. HIV-infected living donation is also permitted under the HOPE Act. However, there is a concern regarding the safety of kidney donation in an HIV-infected person, given the risk of renal disease associated with HIV infection. We report here the case of successful kidney transplantation from HIV-positive living donor to HIV-positive recipient performed in our center on July 2012. To the best of our knowledge, this is the earliest case done in this medical context to be reported in the literature, therefore, potentially carrying several important messages to the transplantation community. In the present case, the living-donor kidney transplant was performed between a married couple infected with same strain of HIV-1, both on effective ART with efficiently suppressed viral replication and satisfactory pre-transplantation immune status.

Should minors and young adults qualify as potential live kidney donors? The views of international transplant professionals.

Although live kidney donation (LD) has become an increasingly common procedure, European and US transplant centres disagree as to whether minors and young adults should qualify as donor candidates. Therefore, we aimed to better understand the attitudes and viewpoints of transplant professionals. We conducted fourteen in-depth interviews with a purposive sample of international transplant professionals from various professional backgrounds. Data analysis was guided by QUAGOL, a systematic approach based on the constant-comparative method. Professionals expressed a cautionary view, worrying about the uncertain long-term medical and psychosocial consequences of LD at a young age. They also worried that young individuals' decisions are more likely to be influenced by their psychosocial developmental stage or family pressure. As these concerns were more significant for minors as compared to young adults, minors were deemed ineligible for LD except for in highly exceptional circumstances. Professionals' attitudes were also influenced by the expected benefits for the recipient and the availability of therapeutic alternatives, as well as the strength of the donor-recipient relationship. More prospective research on the long-term medical and psychological outcomes in young adult donors is likely to shed more light on the acceptability of LD by adolescents and young adults.

The future of HIV Organ Policy Equity Act is now: the state of HIV+ to HIV+ kidney transplantation in the United States.

PURPOSE OF REVIEW: We report the current state of HIV+ to HIV+ kidney transplantation in the United States and remaining challenges in implementing this practice nationally. RECENT FINDINGS: The HIV Organ Policy Equity (HOPE) Act, which was the first step in unlocking the potential of HIV+ organ donors, mandates clinical research on HIV+ to HIV+ transplantation. As of March 2019, there have been 57 HOPE donors, including both true and false positive HOPE donors resulting in more than 120 transplants. SUMMARY: The HOPE Act, signed in 2013, reversed the federal ban on the transplantation of organs from HIV+ donors into HIV+ recipients. Ongoing national studies are exploring the safety, feasibility, and efficacy of both kidney and liver transplantation in this population. If successfully and fully implemented, HIV+ to HIV+ transplantation could attenuate the organ shortage for everyone waiting, resulting in a far-reaching public health impact.

Dramatic secular changes in prognosis for kidney transplant candidates in the United States.

Over recent decades, numerous clinical advances and policy changes have affected outcomes for candidates of kidney transplantation in the United States. We examined the national Scientific Registry for Transplant Recipients for adult (18+) solitary kidney transplant candidates placed on the waiting list for primary listing from 2001 to 2015. We evaluated rates of mortality, transplantation, and waitlist removal. Among 340 115 candidates there were significant declines in mortality (52 deaths/1000 patient years in 2001-04 vs 38 deaths/1000 patient years in 2012-15) and transplant rates (304 transplants/1000 patient years in 2001-04 vs 212 transplants/1000 patient years in 2012-15) and increases in waitlist removals (15 removals/1000 patient years in 2001-04 vs 25/1000 patient years in 2012-15) within the first year after listing. At 5 years an estimated 37% of candidates listed in 2012-15 were alive without transplant as compared to 22% in 2001-04. Declines in mortality over time were significantly more pronounced among African Americans, candidates with longer dialysis duration, and those with diabetes (P < .001). Cumulatively, results indicate dramatic changes in prognoses for adult kidney transplant candidates, likely impacted by selection criteria, donor availability, regulatory oversight, and clinical care. These trends are important considerations for prospective policy development and research, clinical and patient decision-making, and evaluating the impact on access to care.

Changes in Simultaneous Liver-kidney Transplant Allocation Policy May Impact Postliver Transplant Outcomes.

BACKGROUND: Previous simultaneous liver-kidney (SLK) transplant allocation was based on serum creatinine, a metric that disadvantaged women relative to men. A recent SLK transplant policy change uses estimated glomerular filtration rate (eGFR), which accounts for sex-based differences in creatinine. METHODS: To understand the impact of this new policy, we analyzed nonstatus 1 adults listed for liver transplantation (LT) from May 2007 to July 2014, excluding those with exceptions. We defined patients who met the new SLK policy as having an eGFR <60 mL/min for 90 days, with a final eGFR <30 mL/min. RESULTS: Of 40979 candidates, 1683 would have met only the new criteria (N-SLK), 2452 would have met only the old criteria (O-SLK), and 1878 would have met both criteria (B-SLK). Compared to those in the B-SLK or O-SLK groups, those in the N-SLK group were significantly more likely to be female (52% versus 36% versus 39%, P < 0.001). Cox-regression analysis demonstrated that in adjusted analysis those in the N-SLK group were significantly less likely to die postliver transplant (hazard ratio [HR], 0.0; P < 0.001). Further, in Cox regression subgroup analyses, both in women (HR 0.04; P < 0.001) and in men (HR, 0.02, P < 0.001) those in the N-SLK group who underwent liver transplant were significantly less likely to die postliver transplant, even after adjustment for confounders. CONCLUSIONS: We anticipate that implementation of the new SLK policy will increase the proportion of women and decrease the proportion of men who are listed for SLK but may not improve posttransplant survival. Our data highlight the need for monitoring of SLK outcomes after implementation of the new policy.

Expanding renal transplantation organ donor pool in Nigeria.

Kidney transplantation is the gold standard for end-stage renal disease. All over the world there are several challenges preventing sufficient organ donation to meet the growing needs of patients on the waiting list. One major challenge which is common to most countries is the shortage of organs from willing living donors. Many countries, especially, the developed countries, have devised several models of expanding their donor pools to meet the growing needs of patients on the waiting list. Nigeria, a developing country has very low kidney transplantation rate even though some progress have been made in making the procedure feasible in about a dozen hospitals in Nigeria. One very major challenge has been the shortage of donor organ supply. This paper intends to proffer suggestions on how to expand the organ donor pool in Nigeria.

Understanding the sex disparity in living kidney donation.

Living donors are the preferred source of organs for kidney transplantation, which is the treatment modality of choice for end-stage kidney disease. Health care systems widely promote living kidney donation. However, women are consistently overrepresented among living donors. The reasons behind the sex-based disparity in living kidney donation remain poorly understood. Compared to women, men possess a greater amount of kidney function, and the higher deceased donation rate among men reflects their higher overall kidney quality. A plausible medical explanation for the sex-based disparity in living kidney donation includes an uncompromising emphasis on preserving donor health, with less emphasis placed on organ quality, which is the main criterion in deceased donor selection. On the other hand, consent to deceased donation is also greater in women, indicating their greater desire to donate even though fewer women actually become deceased donors. Therefore, nonmedical reasons for the sex disparity in living donation must be sought. Increased empathic distress or emotional memory; a greater sense of responsibility, urgency, and impulsiveness with increased reaction to empathy; a different body image; and a different social status may all contribute to greater living kidney donation in women. Economic inequity may be the singular explanation when personal worth links to economic worth. To better understand the sex disparity in living kidney donation, we need better data on the reasons behind both nondonation and donor rejection after evaluation in clinical practice. Nondirected living kidney donation provides unique opportunities to minimize factors such as emotional distress, empathy, and impulsiveness. More liberal acceptance criteria for donors with isolated medical abnormalities and testing legitimate donor reimbursement strategies based on actual income levels rather than a fixed amount can assist in both ascertaining the reasons behind the sex disparity in living kidney donation and increasing overall living kidney donation rates.