Ways to Overcome Organ Shortage: Increasing Donor Pool by Accepting Suboptimal Kidney Donors.

Many factors affect organ donations worldwide, including religious factors, legislative decisions, economic factors, presence of organ procurement organizations, cultural issues, the presence of commercial transplant, and other unknown factors. The number of patients with end-stage renal disease has increased by 6% worldwide. Even with more transplant procedures, these numbers have not combated the dramatically increased number of patients on wait lists. With regard to potential living donors, around 50% are either blood group or HLA incompatible with the recipient, which then requires patient desensitization or paired kidney donation or a combination of both. Survival rates of kidney donors and the general population are almost the same 35 to 40 years after donation. Although the renal consequences of diabetes after kidney donation are almost the same as that shown in the general population, other risk factors should be considered, such as hypertension, proteinuria, and low glomerular filtration rate, before donation. It is so far unknown whether donors with impaired glucose tolerance can safely donate. With diabetes, what was considered normal blood sugar in 1960 to 1990 is now considered frank diabetes. What was considered normal blood pressure is now considered hypertension. Because individuals with these parameters were accepted as organ donors in the past and have been shown to maintain good health, it is worth considering the safe use of organs from donors with early diabetes and hypertension. Whereas young donors may have not reached the age at which hypertension, diabetes, and other kidney diseases develop, older donors have the lowest likelihood of developing end-stage renal disease after donation. As a general approach, young donors can be accepted if they have high glomerular filtration rate, but young donors from certain ethnic minorities and/or extensive family history of chronic kidney disease and those less than 18 years old should not be considered.

Towards a standardized informed consent procedure for live donor nephrectomy: What do surgeons tell their donors?

INTRODUCTION: Living kidney donors comprise a unique group of "patients", undergoing an operation for the benefit of others. The informed consent process is therefore valued differently. Although this is a team effort, the surgeon is responsible for performing the donor nephrectomy, and often the one held accountable, should adverse events occur. Although there is some consensus on how the informed consent procedure should be arranged, practices vary. The aim of this study was to evaluate the surgical informed consent procedure for live donor nephrectomy, with special regards to disclosure of complications. METHODS: A web-based survey was sent to all kidney transplant surgeons (n = 50) in eight transplant centers with questions regarding the local procedure and disclosure of specific details. RESULTS: Response rate was 98% (n = 49), of which 32 (65%) were involved in living donor education; overall, transplant- (50%), vascular- (31%), and abdominal surgeons (13%), and urologists (6%) performed donor nephrectomies in the eight centers. Informed consent procedures varied, ranging from assumed to signed consent. Bleeding was the only complication every surgeon mentioned. Risk of death was always mentioned by 16 surgeons (50%), sometimes by 13 (41%), three surgeons (9%) never disclosed this disastrous complication. Reported mortality rates ranged from 0.003% to 0.1%. Mentioning frequencies for all other complications varied. CONCLUSION: Important complications are not always disclosed during the surgical informed consent process for live donor nephrectomy. Informed consent procedures vary. To optimally prepare living kidney donors for the procedure, a standardized informed consent procedure for live donor nephrectomy is highly recommended.

Towards a standardised informed consent procedure for live donor nephrectomy: the PRINCE (Process of Informed Consent Evaluation) project-study protocol for a nationwide prospective cohort study.

INTRODUCTION: Informed consent is mandatory for all (surgical) procedures, but it is even more important when it comes to living kidney donors undergoing surgery for the benefit of others. Donor education, leading to informed consent, needs to be carried out according to certain standards. Informed consent procedures for live donor nephrectomy vary per centre, and even per individual healthcare professional. The basis for a standardised, uniform surgical informed consent procedure for live donor nephrectomy can be created by assessing what information donors need to hear to prepare them for the operation and convalescence. METHODS AND ANALYSIS: The PRINCE (Process of Informed Consent Evaluation) project is a prospective, multicentre cohort study, to be carried out in all eight Dutch kidney transplant centres. Donor knowledge of the procedure and postoperative course will be evaluated by means of pop quizzes. A baseline cohort (prior to receiving any information from a member of the transplant team in one of the transplant centres) will be compared with a control group, the members of which receive the pop quiz on the day of admission for donor nephrectomy. Donor satisfaction will be evaluated for all donors who completed the admission pop-quiz. The primary end point is donor knowledge. In addition, those elements that have to be included in the standardised format informed consent procedure will be identified. Secondary end points are donor satisfaction, current informed consent practices in the different centres (eg, how many visits, which personnel, what kind of information is disclosed, in which format, etc) and correlation of donor knowledge with surgeons' estimation thereof. ETHICS AND DISSEMINATION: Approval for this study was obtained from the medical ethical committee of the Erasmus MC, University Medical Center, Rotterdam, on 18 February 2015. Secondary approval has been obtained from the local ethics committees in six participating centres. Approval in the last centre has been sought. RESULTS: Outcome will be published in a scientific journal. TRIAL REGISTRATION NUMBER: NTR5374; Pre-results.

When Opportunity Knocks Twice: Dual Living Kidney Donation, Autonomy and the Public Interest.

Living kidney transplantation offers the best treatment in terms of life-expectancy and quality of life for those with end-stage renal disease. The long-term risks of living donor nephrectomy, although real, are very small, with evidence of good medium-term outcomes. Who should be entitled to donate, and in which circumstances, is nevertheless a live question. We explore the ethical dimensions of a request by an individual to donate both of their kidneys during life: 'dual living kidney donation'. Our ethical analysis is tethered to a hypothetical case study in which a father asks to donate a kidney to each of his twin boys. We explore the autonomy of the protagonists, alongside different dimensions of the public interest, such as the need to protect not only the recipients, but also the donor and even the wider community. Whilst acknowledging objections to 'dual-donation', not least by reference to the harms that the donor might be expected to endure, we suggest there is a prima facie case for permitting this, provided that both donor and recipients are willing and that due attention is paid to such considerations as the autonomy and welfare of all parties, as well as to the wider ramifications of acting on such a request. We argue for broader interpretations of the concepts of autonomy and welfare, recognizing the importance of relationships and the relevance of more than merely physical well-being. Equipped with such a holistic assessment, we suggest there is a prima facie case for allowing 'dual living kidney donation'.

Seriously ill patients as living unspecified kidney donors: rationale and justification.

BACKGROUND: Between 2000 and December 2013, 106 live donor nephrectomies from anonymous living-donors were performed at the Erasmus MC Rotterdam; five of the donors (5.4%) had a life-threatening disease. The aim of the present report is to give the rational and justification for this procedure. METHODS: All five donors underwent the national standard living-donor screening procedure. Additionally, motivation to donate and psychologic stability were assessed by a psychologist using in-depth interview techniques and a psychologic complaints questionnaire. Post-donor nephrectomy follow-up consisted of standard questionnaires and clinical check-ups. RESULTS: One patient had cerebral and caudal ependymomas, one had severe and progressive emphysema, two had Huntington's disease and one had a grade 2 oligodendroglioma. The psychologic screening revealed genuine motivation, adequate risk perception, and normal sense of reality. No contraindications for donation were found. The five donor nephrectomies made nine kidney transplantations possible. All donors were satisfied with the donation procedure. Three donors died during follow-up (0.6-4.9 years) as a result of their disease. CONCLUSION: In the absence of apparent additional health risks, medical, and psychologic contraindications, we consider it ethically justified to accept an offer from a cognitively competent patient with a life-threatening disease in view of their self-reported satisfaction during follow-up. Although based on a limited number of patients, we conclude that a stricter psychologic screening for seriously ill donors compared to healthy unspecified anonymous donors to unspecified patients is not necessary.

Human trafficking for organ removal in India: a victim-centered, evidence-based report.

BACKGROUND: Enhancements in the national transplant law to prohibit commercial transplants in India have curbed the trade. Yet, the human rights abuse of human trafficking for organ removal (HTOR) continues in various transplant centers throughout India. METHODS: Beginning in September 2010 until May 2012, in-depth interviews were conducted with 103 victims of HTOR in India in which victims described their experiences of a commercial kidney removal in compelling detail. Victims were located in Tamil Nadu, and reference is made to the broader study that included 50 additional victims in small towns and villages in West Bengal and Karnataka. RESULTS: Fourteen cases (14%) in Tamil Nadu and an additional 20 cases (40%) from West Bengal and Karnataka occurred between 2009 to May 2012. The cases in Tamil Nadu ranged in age from 19 to 55 years, with an average age of 33 years in Erode and 36 years in Chennai. Fifty-seven percent of the victims in Erode are female, and 87% of the victims in Chennai are female. Twelve percent of the individuals were widowed or abandoned, 79% were married, and 91% were parents with an average of two kids. Of those interviewed, 28% had no formal education, 19% had some primary schooling, 22% had some secondary schooling, and no individuals reported schooling above high school. All victims interviewed lived in abject poverty with monthly income levels well below the national average. The majority of victims reported long lasting health, economic, social, and psychological consequences. No matter the reason expressed for an organ sale, all victims reported that they would not have agreed to the organ removal if their economic circumstances were not so dire. One hundred percent of the victims interviewed expressed that they need assistance to cope with these consequences. CONCLUSIONS: Human trafficking for an organ removal continues in private transplant centers throughout India, service to foreign patients is ongoing, and victims' consequences are long lasting. A rights-based response to HTOR that invokes a universal commitment to prevent, protect, and suppress its continued practice is recommended. The United Nations Trafficking Protocol is the key international instrument to address trafficking of persons, including for organ removal. India has signed the UN Trafficking Protocol and should ratify it to better address this form of human trafficking.

Are bans on kidney sales unjustifiably paternalistic?

This paper challenges the view that bans on kidney sales are unjustifiably paternalistic, that is, that they unduly deny people the freedom to make decisions about their own bodies in order to protect them from harm. I argue that not even principled anti-paternalists need to reject such bans. This is because their rationale is not hard paternalism, which anti-paternalists repudiate, but soft paternalism, which they in principle accept. More precisely, I suggest that their rationale is what Franklin Miller and Alan Wertheimer call 'group soft paternalism'. Group soft paternalistic policies restrict the freedom of autonomous individuals, not for their own good (hard paternalism), but as an unavoidable consequence of seeking to protect other, non-autonomous individuals from harms that they have not voluntarily chosen (soft paternalism). Group soft paternalism supports prohibiting kidney sales on three conditions: (1) that such sales are potentially harmful to vendors, (2) that many vendors would suffer impaired autonomy, and (3) that distinguishing between autonomous and non-autonomous vendors and interfering only with the latter is unfeasible. I provide reasons for thinking that these conditions will often hold.

Live liver donation, ethics and practitioners: 'I am between the two and if I do not feel comfortable about this situation, I cannot proceed'.

This paper discusses the views of 17 healthcare practitioners involved with transplantation on the ethics of live liver donations (LLDs). Donations between emotionally related donor and recipients (especially from parents to their children) increased the acceptability of an LLD compared with those between strangers. Most healthcare professionals (HCPs) disapproved of altruistic stranger donations, considering them to entail an unacceptable degree of risk taking. Participants tended to emphasise the need to balance the harms of proceeding against those of not proceeding, rather than calculating the harm-to-benefits ratio of donor versus recipient. Participants' views suggested that a complex process of negotiation is required, which respects the autonomy of donor, recipient and HCP. Although they considered that, of the three, donor autonomy is of primary importance, they also placed considerable weight on their own autonomy. Our participants suggest that their opinions about acceptable risk taking were more objective than those of the recipient or donor and were therefore given greater weight. However, it was clear that more subjective values were also influential. Processes used in live kidney donation (LKD) were thought to be a good model for LLD, but our participants stressed that there is a danger that patients may underestimate the risks involved in LLD if it is too closely associated with LKD.

The case for kidney donation before end-of-life care.

Donation after cardiac death (DCD) is associated with many problems, including ischemic injury, high rates of delayed allograft function, and frequent organ discard. Furthermore, many potential DCD donors fail to progress to asystole in a manner that would enable safe organ transplantation and no organs are recovered. DCD protocols are based upon the principle that the donor must be declared dead prior to organ recovery. A new protocol is proposed whereby after a donor family agrees to withdrawal of life-sustaining treatments, premortem nephrectomy is performed in advance of end-of-life management. Since nephrectomy should not cause the donor's death, this approach satisfies the dead donor rule. The donor family's wishes are best met by organ donation, successful outcomes for the recipients, and a dignified death for the deceased. This proposal improves the likelihood of achieving these objectives.

Carcinoma de células renales del túbulo colector / Collecting duct renal cell carcinoma

Introducción: El carcinoma renal de los conductos colectores de Bellini es un tumor renal escasamente prevalente, con baja supervivencia cáncer-específica, aunque realmente se desconoce su tasa de respuesta a terapias antiangiogénicas. Objetivos: Se revisa de manera retrospectiva una serie de tumores de túbulo colector con especial énfasis en la indicación de terapias diana y en los resultados de la misma. Material y métodos: Análisis retrospectivo del carcinoma renal de túbulo colector tratados en nuestra institución desde enero 2000 a junio 2010, teniendo en cuenta la edad del paciente, el sexo, el motivo de consulta, los antecedentes oncológicos, el lado de afectación, el tratamiento quirúrgico, otras características anatomopatológicas, el tamaño tumoral, la estadificación TNM (2009), el tratamiento adyuvante y el tiempo de supervivencia. Resultados: Se describen 6 pacientes, 5 varones y una mujer; con una media de edad de 75 (±7,7) años. Cuatro de ellos (66,6%) presentaban enfermedad diseminada al diagnóstico. Cinco(83,3%) fueron tratados mediante nefrectomía radical y tres (50%) recibieron tratamiento sistémico adyuvante, sin respuesta. La mediana de supervivencia fue 5,5 meses (4,75-14,75). Sólo dos pacientes (33,3%), ambos con enfermedad localizada al diagnóstico, se encuentran en remisión completa. Conclusión: El carcinoma renal de túbulo colector es una enfermedad con mal pronóstico, escasa supervivencia y mala respuesta a terapias diana (AU)

Introduction: Bellini’s renal cell collecting duct carcinoma is a rarely prevalent renal tumour, with low cancer-specific survival, although its rate of response to antiangiogenic therapies is unknown. Objectives: We retrospectively revise a series of collecting duct tumours, with special emphasis on the indication of target therapies and on their results. Materials and methods: Retrospective analysis of renal cell collecting duct carcinoma treated at our institution from January 2000 to June 2010, taking into account the patient’s age, sex, reason for the consultation, oncological background, side of the affection, surgical treatment, other anatomopathological characteristics, tumour size, TNM clinical staging (2009), adjuvant treatment and survival time. Results: Six patients are described, five men and one woman, with a mean age of 75 (± 7.7) years. Four of them (66.6%) presented disseminated disease upon diagnosis. Five (83%) were treated with radical nephrectomy and three (50%) received systemic adjuvant treatment, without response. The means survival was 5.5 months (4.75-14.75). Only 2 patients (33.3%), both with localized disease upon diagnosis, are in complete remission. Conclusion: Renal cell collecting duct carcinoma is a disease with a bad prognosis, little surviva land bad response to target therapies (AU)

Ethical issues with nondirected ("good samaritan") kidney donation for transplantation.

"Good samaritan" donation has been of great interest in Italy. At the request of the Presidency of the Council of Ministers, the National Committee on Bioethics expressed its opinion on the matter. While highlighting its controversial aspects, the assessment was favorable. The National Council for Health established working criteria. Yet eminent bioethicists sharing the same values have reached discordant conclusions. Legal developments leading to the authorization of living donor kidney transplants from blood relatives or emotionally close individuals may offer a path for ethical assessment of the practice.