Changing to an Opt Out System for Organ Donation-Reflections From England and Netherlands.

Recently England and Netherlands have changed their consent system from Opt In to Opt Out. The reflections shared in this paper give insight and may be helpful for other nation considering likewise. Strong support in England for the change in legislation led to Opt Out being introduced without requiring a vote in parliament in 2019. In Netherlands the bill passed by the smallest possible majority in 2018. Both countries implemented a public campaign to raise awareness. In England registration on the Donor Register is voluntary. Registration was required in Netherlands for all residents 18 years and older. For those not already on the register, letters were sent by the Dutch Government to ask individuals to register. If people did not respond they would be legally registered as having "no objection." After implementation of Opt Out in England 42.3% is registered Opt In, 3.6% Opt Out, and 54.1% has no registration. In contrast in Netherlands the whole population is registered with 45% Opt In, 31% Opt Out and 24% "No Objection." It is too soon to draw conclusions about the impact on the consent rate and number of resulting organ donors. However, the first signs are positive.

Immediate impact of COVID-19 on transplant activity in the Netherlands.

The rapid emergence of the COVID-19 pandemic is unprecedented and poses an unparalleled obstacle in the sixty-five year history of organ transplantation. Worldwide, the delivery of transplant care is severely challenged by matters concerning - but not limited to - organ procurement, risk of SARS-CoV-2 transmission, screening strategies of donors and recipients, decisions to postpone or proceed with transplantation, the attributable risk of immunosuppression for COVID-19 and entrenched health care resources and capacity. The transplant community is faced with choosing a lesser of two evils: initiating immunosuppression and potentially accepting detrimental outcome when transplant recipients develop COVID-19 versus postponing transplantation and accepting associated waitlist mortality. Notably, prioritization of health care services for COVID-19 care raises concerns about allocation of resources to deliver care for transplant patients who might otherwise have excellent 1-year and 10-year survival rates. Children and young adults with end-stage organ disease in particular seem more disadvantaged by withholding transplantation because of capacity issues than from medical consequences of SARS-CoV-2. This report details the nationwide response of the Dutch transplant community to these issues and the immediate consequences for transplant activity. Worrisome, there was a significant decrease in organ donation numbers affecting all organ transplant services. In addition, there was a detrimental effect on transplantation numbers in children with end-organ failure. Ongoing efforts focus on mitigation of not only primary but also secondary harm of the pandemic and to find right definitions and momentum to restore the transplant programs.

[Waiting list registration for kidney transplants must improve]. / Wachtlijstregistratie niertransplantatie moet beter.

OBJECTIVE: To investigate how the composition of the waiting list for postmortem kidney transplant has developed, and whether the waiting list reflects actual demand. DESIGN: Retrospective research and cohort study. METHOD: We used data from the period 2000-2014 from the Dutch Transplant Foundation, 'RENINE' and Eurotransplant. This concerned data on postmortem kidney donation, live donor transplants, the waiting list and kidney transplantation. RESULTS: The postmortem kidney transplant waiting list included transplantable (T) and non-transplantable (NT) patients. The number of T-patients declined from 1271 in 2000 to 650 in 2014, and the median waiting time between the start of dialysis and postmortem kidney transplant decreased from 4.1 years in 2006 to 3.1 years in 2014. The total number of patients on the waiting list, however, increased from 2263 in 2000 to 2560 in 2014 and in the same period the number of new patient registrations increased from 772 to 1212. In about 80% of the NT-patients the reason for their NT status was not registered. A cohort analysis showed that NT-patients have a 2-times lower chance of a postmortem kidney transplant and a 2-times higher chance of leaving the waiting list without transplantation or of live-donor transplantation. CONCLUSION: The demand for donor kidneys remains high. The increased number of transplants resulted in a declining waiting list for T-patients while the total waiting list is getting longer. Waiting list registration and maintenance need to be improved, to give better insight into the real demand.

Controlled donation after circulatory death in the Netherlands: more organs, more efforts.

BACKGROUND: The Netherlands was one of the first countries in Europe to stimulate controlled donation after circulatory death (cDCD) at a national level in addition to donation after brain death (DBD). With this program the number of organ transplants increased, but it also proved to have challenges as will be shown in this 15-year review. METHODS: Data about deceased organ donation in the Netherlands, from 2000 until 2014, were analysed taking into account the whole donation process from donor referral to the number of organs transplanted. RESULTS: Donor referral increased by 58%, from 213 to 336 donors per year, and the number of organs transplanted rose by 42%. Meanwhile the contribution of cDCD donors increased from 14% in 2000 to 54% in 2014 among all referrals. The organs were transplanted from 92-99% of referred DBD donors, but this percentage was significantly lower for cDCD donors and also decreased from 86% in 2000-2002 to 67% in 2012-2014. In 16% of all referred cDCD donors, organs were not recovered because donors did not die within the expected two-hour time limit after withdrawal of life- upporting treatment. Furthermore, cDCD is more often performed at a higher donor age, which is associated with a lower percentage of transplanted organs. CONCLUSION: Although cDCD resulted in more transplants, the effort in donor recruitment is considerably higher. Important challenges in cDCD that need further attention are the time limit after withdrawal of life-supporting treatment and donor age, as well as the possibilities to stimulate non-renal transplants including the heart by machine preservation.

Exchange of best practices within the European Union: surgery standardization of abdominal organ retrieval.

Considering the growing organ demand worldwide, it is crucial to optimize organ retrieval and training of surgeons to reduce the risk of injury during the procedure and increase the quality of organs to be transplanted. In the Netherlands, a national complete trajectory from training of surgeons in procurement surgery to the quality assessment of the procured organs was implemented in 2010. This mandatory trajectory comprises training and certification modules: E-learning, training on the job, and a practical session. Thanks to the ACCORD (Achieving Comprehensive Coordination in Organ Donation) Joint Action coordinated by Spain and co-funded under the European Commission Health Programme, 3 twinning activities (led by France) were set to exchange best practices between countries. The Dutch trajectory is being adapted and implemented in Hungary as one of these twinning activities. The E-learning platform was modified, tested by a panel of Hungarian and UK surgeons, and was awarded in July 2013 by the European Accreditation Council for Continuing Medical Education of the European Union of Medical Specialists. As a pilot phase for future national training, 6 Hungarian surgeons from Semmelweis University are being trained; E-learning platform was fulfilled, and practical sessions, training-on-the-job activities, and evaluations of technical skills are ongoing. The first national practical session was recently organized in Budapest, and the new series of nationwide selected candidates completed the E-learning platform before the practical. There is great potential for sharing best practices and for direct transfer of expertise at the European level, and especially to export this standardized training in organ retrieval to other European countries and even broader. The final goal was to not only provide a national training to all countries lacking such a program but also to improve the quality and safety criteria of organs to be transplanted.

[More potential organ donors than actual donations in 52 intensive-care units in the Netherlands, 2001-2004]. / Orgaandonorpotentieel in 52 intensivecareafdelingen in Nederland groter dan het aantal gerealiseerde donatieprocedures, 2001-2004.

OBJECTIVE: To assess the number of potential organ donors and the main reasons why organ donation is not performed. DESIGN: Retrospective. METHOD: The number of potential heart-beating (HB) and non-heart-beating (NHB) donors was assessed by reviewing the medical records of 588o patients who died between 2001 and 2004 in 52 intensive-care units (ICUs) in 30 hospitals. The number of actual donations was also assessed. RESULTS: The potential of HB donors was 2.5 to possibly 6.6% of all ICU deaths and HB donation was performed in 1.9% of all ICU deaths. The potential of NHB donors of category III was at least 4.2% of all ICU deaths and NHB donation was performed in 1.0% of all ICU deaths. The main difficulty in the donation process was objection from family members, which was reported in 45% of all potential HB and NHB donors and in 59% of all donation requests to relatives. Of the potential HB and NHB donors 7.3% were not identified as potential donors. CONCLUSION: These results confirm that organ-donor potential is greater than the number of actual donations. Objection from family members is the main limiting factor.

[Favourable results of the first 2 years of the Dutch paired, living donor, kidney exchange programme]. / Gunstige resultaten van de eerste 2 jaar van het Nederlandse gepaarde-donorruilprogramma voor nierdonatie met een levende donor.

OBJECTIVE: To assess the results of the paired, living donor, kidney exchange protocol in the Netherlands. DESIGN: Descriptive. METHODS: In January 2004, all 7 Dutch kidney transplantation centres implemented a paired, living donor, kidney exchange protocol for donor-recipient combinations in which direct kidney transplantation is not possible. The Dutch Transplantation Foundation is responsible for the allocation, in which new donor-recipient combinations are created in accordance with four allocation criteria: blood group, match probability, time on the waiting list, and age difference between the donors. The results of the first 2 years of this programme have now been assessed. RESULTS: From January 2004 until December 2005, the national programme registered a total of 116 donor-recipient combinations, including 62 blood type incompatible pairs and 54 positive cross-match pairs. In 8 matching procedures, 58 newly created donor-recipient combinations had negative cross matches. 49 patients (42%) were transplanted. CONCLUSION: The Dutch living donor exchange programme for kidney transplantation appears to be very successful, with 42% effective transplantations in the first 2 years.

Living donor kidney exchange for both ABO-incompatible and crossmatch positive donor-recipient combinations.

BACKGROUND: Strategies to decrease the wait time for kidney transplantation include the use of living donor kidneys. However, it is not always possible to donate directly, due to ABO blood type incompatibility or a positive crossmatch. Therefore, other options were explored, including a program for living donor kidney exchange. METHODS: All Dutch kidney transplantation centers agreed on a common donor kidney exchange protocol. The Dutch Transplantation Foundation is responsible for the allocation, crossmatches are centrally performed, and exchanges take place on an anonymous basis. Donors travel to the recipient centers. Surgical procedures are simultaneously scheduled. RESULTS: From January 2004, we registered in total 116 combinations consisting of blood type-incompatible pairs (n = 62) and positive crossmatch pairs (n = 54). In eight match procedures we created 58 new donor-recipient combinations with negative crossmatches, including six triplets and 20 doublets. It proved to be significantly (P = .0014) less difficult to find a solution for the crossmatch-positive combinations than for the blood type-incompatible combinations (67% vs 35%). CONCLUSION: The Dutch national living donor kidney exchange program resulted in a 50% success rate. Combining blood type-incompatible and crossmatch-positive donor-recipient pairs in one program is a realistic option for all blood type combinations.

The Dutch algorithm for allocation in living donor kidney exchange.

The shortage of kidneys from brain-dead donors for transplantation has made it necessary to look for alternatives. Living kidney donation is one possibility. However, because of ABO blood group incompatibility or immunological reasons, transplantation of kidneys from a living donor is not always possible. The seven Dutch kidney transplantation centers have developed a joint protocol for crossover, or paired donor exchange, kidney transplantation. To ensure a fair chance for all participating donor-recipient pairs, the Dutch Transplantation Foundation has developed an allocation algorithm to match compatible donor-recipient pairs. A crossover match is performed every 3 months. The computer program developed by the Dutch Transplantation Foundation to match compatible donor-recipient pairs calculates the match probability (MP) of every potential recipient. The MP takes into account the peak panel-reactive antibodies (%PRA) of the recipient, the incidence within the crossover donor population of (compatible) ABO blood group, and HLA unacceptables of the recipient. The potential recipient with the lowest MP, in other words, the recipient with the smallest chance of finding a compatible donor in the pool, is ranked first. Until now, three matches have been performed in the Netherlands. A total of 53 pairs from all seven Dutch transplantation centers have participated. For 22 of the pairs a compatible donor-recipient pair was found.

Participants' judgements of the European Donor Hospital Education Programme (EDHEP): an international comparison.

The European Donor Hospital Education Programme (EDHEP) is a one-day workshop, aimed at providing guidelines for breaking the news of the death of a relative and for raising the issue of organ donation with bereaved relatives. Participants' judgements of the workshop in the Netherlands and in the United Kingdom were compared to determine whether EDHEP meets doctors' and nurses' training needs in breaking bad news and requesting organ donation. In both countries EDHEP appears to be greatly appreciated by intensive care medical and nursing staff; the judgements are more positive in the United Kingdom than in the Netherlands. It seems that, irrespective of their professional experience, intensive care staff consider EDHEP a valuable teaching programme that increases confidence in communicating with bereaved relatives about death and organ donation.

Organ transplantation and European Community law: the case of non-residents.

OBJECTIVES: The role of the European Union in influencing health care policies in member states is of increasing importance. The Eurotransplant Foundation is an organization which provides donor organs to the most suitable transplant recipients. It covers a region of five countries (Austria, Belgium, Germany, Luxembourg, The Netherlands). As there is a severe shortage of donor organs within its region, registration of so-called non-resident patients on the waiting lists aggravates this shortage. Could European Community law, especially rules on competition, limit Eurotransplant's freedom to introduce a restrictive policy on non-residents? If so, could participating transplant centres or patients initiate legal action against Eurotransplant to stop the execution of such a policy? METHODS: Quantitative descriptive data on organ donation and use by the Eurotransplant Foundation during 1994 and 1995, by residents and non-residents. Analysis on basis of economic and legal framework. RESULTS: Solidarity between potential donors and potential recipients is organized in a different manner in an organization such as Eurotransplant as compared to a national organization under national law. National regulations may introduce a restrictive policy for the acceptance of non-resident patients. Eurotransplant--as a matter of its own policy--has to consider international solidarity. The scope of the non-resident issue is dealt with, and it is explained why it is considered to be a problem. On the basis of a discussion of the economic and the legal framework for a non-resident policy, an answer to the question is suggested. CONCLUSION: It might be possible for Eurotransplant to introduce a restrictive policy on the admission of non-residents without violating the European Community Treaty.