Organ Donation Organization Architecture: Recommendations From an International Consensus Forum.

This report contains recommendations from 1 of 7 domains of the International Donation and Transplantation Legislative and Policy Forum (the Forum). The purpose is to provide expert guidance on the structure and function of Organ and Tissue Donation and Transplantation (OTDT) systems. The intended audience is OTDT stakeholders working to establish or improve existing systems. Methods: The Forum was initiated by Transplant Québec and co-hosted by the Canadian Donation and Transplantation Program partnered with multiple national and international donation and transplantation organizations. This domain group included administrative, clinical, and academic experts in OTDT systems and 3 patient, family, and donor partners. We identified topic areas and recommendations through consensus, using the nominal group technique. Selected topics were informed by narrative literature reviews and vetted by the Forum's scientific committee. We presented these recommendations publicly, with delegate feedback being incorporated into the final report. Results: This report has 33 recommendations grouped into 10 topic areas. Topic areas include the need for public and professional education, processes to assure timely referral of patients who are potential donors, and processes to ensure that standards are properly enforced. Conclusions: The recommendations encompass the multiple roles organ donation organizations play in the donation and transplantation process. We recognize the diversity of local conditions but believe that they could be adapted and applied by organ donation organizations across the world to accomplish their fundamental objectives of assuring that everyone who desires to become an organ donor is given that opportunity in a safe, equitable, and transparent manner.

A national pilot of donation after circulatory death (DCD) heart transplantation within the United Kingdom.

BACKGROUND: The United Kingdom (UK) was one of the first countries to pioneer heart transplantation from donation after circulatory death (DCD) donors. To facilitate equity of access to DCD hearts by all UK heart transplant centers and expand the retrieval zone nationwide, a Joint Innovation Fund (JIF) pilot was provided by NHS Blood and Transplant (NHSBT) and NHS England (NHSE). The activity and outcomes of this national DCD heart pilot program are reported. METHODS: This is a national multi-center, retrospective cohort study examining early outcomes of DCD heart transplants performed across 7 heart transplant centers, adult and pediatric, throughout the UK. Hearts were retrieved using the direct procurement and perfusion (DPP) technique by 3 specialist retrieval teams trained in ex-situ normothermic machine perfusion. Outcomes were compared against DCD heart transplants before the national pilot era and against contemporaneous donation after brain death (DBD) heart transplants, and analyzed using Kaplan-Meier analysis, chi-square test, and Wilcoxon's rank-sum. RESULTS: From September 7, 2020 to February 28, 2022, 215 potential DCD hearts were offered of which 98 (46%) were accepted and attended. There were 77 potential donors (36%) which proceeded to death within 2 hours, with 57 (27%) donor hearts successfully retrieved and perfused ex situ and 50 (23%) DCD hearts going on to be transplanted. During this same period, 179 DBD hearts were transplanted. Overall, there was no difference in the 30-day survival rate between DCD and DBD (94% vs 93%) or 90 day survival (90% vs 90%) respectively. There was a higher rate of ECMO use post-DCD heart transplants compared to DBD (40% vs 16%, p = 0.0006), and DCD hearts in the pre pilot era, (17%, p = 0.002). There was no difference in length of ICU stay (9 DCD vs 8 days DBD, p = 0.13) nor hospital stay (28 DCD vs 27 DBD days, p = 0.46). CONCLUSION: During this pilot study, 3 specialist retrieval teams were able to retrieve DCD hearts nationally for all 7 UK heart transplant centers. DCD donors increased overall heart transplantation in the UK by 28% with equivalent early posttransplant survival compared with DBD donors.

Muon tomography for the analysis of in-container vitrified products.

Alternate treatment routes for radioactive waste are a key research area for much of the nuclear industry, with potentially significant savings available through volume reduction of waste. Achieving this requires a full and demonstrable understanding of waste product behaviour. For this purpose, the UK's National Nuclear Laboratory (NNL) has been collaborating with the University of Glasgow and Lynkeos Technology to develop passive techniques for analysis of waste containers over a number of years. In this instance, novel muon tomographic techniques have been applied to the analysis of thermally treated nuclear waste surrogates as part of a project to build and deploy a first of a kind muon imaging system for nuclear waste. The system has been deployed at NNL's Central Laboratory, Cumbria, UK, to analyse products from a series of thermal treatment technology trials, funded by the Nuclear Decommissioning Authority (NDA) through the Direct Research Portfolio (DRP). Analysis of the waste products using this technique has proven the value of muon analysis in the development of waste management technologies, proving an ability to understand the homogeneity of products and direct further destructive testing. Results from three different thermal treatment trials are presented, with three different surrogate intermediate level waste (ILW) forms in each.

First-of-a-kind muography for nuclear waste characterization.

In the last decade, there has been a surge in the number of academic research groups and commercial companies exploiting naturally occurring cosmic-ray muons for imaging purposes in a range of industrial and geological applications. Since 2009, researchers at the University of Glasgow and the UK National Nuclear Laboratory (NNL) have pioneered this technique for the characterization of shielded nuclear waste containers with significant investment from the UK Nuclear Decommissioning Authority and Sellafield Ltd. Lynkeos Technology Ltd. was formed in 2016 to commercialize the Muon Imaging System (MIS) technology that resulted from this industry-funded academic research. The design, construction and performance of the Lynkeos MIS is presented along with first experimental and commercial results. The high-resolution images include the identification of small fragments of uranium within a surrogate 500-litre intermediate level waste container and metal inclusions within thermally treated GeoMelt® R&D Product Samples. The latter of these are from Lynkeos' first commercial contract with the UK National Nuclear Laboratory. The Lynkeos MIS will be deployed at the NNL Central Laboratory facility on the Sellafield site in Summer 2018 where it will embark upon a series of industry trials.This article is part of the Theo Murphy meeting issue 'Cosmic-ray muography'.

A pilot to examine the logistical and feasibility issues in testing deceased tissue donors for vCJD using tonsil as the analyte.

Transplanted tissues have transmitted transmissible spongiform encephalopathies and in the UK there have been more cases of variant Creutzfeldt-Jakob disease (vCJD) than elsewhere in the world. A pilot study was undertaken to look at the feasibility of testing for vCJD in deceased donors using tonsillar tissue. This pilot showed that obtaining consent for removal and testing tonsil tissue was feasible. Donor eligibility for inclusion in the pilot was limited to tissue donors from the National Health Service Blood and Transplant, Tissue Services and to donors shared with the Corneal Transplant Service Eye Banks. Obtaining tonsillar tissue in the immediate post-mortem period was limited by the presence of rigor mortis. Tonsillar tissue was suitable for routine analysis for the presence of prion associated with vCJD in deceased tissue donors. Production and processing of tissue was straightforward and a low assay background was obtained from most samples. Since palatine and lingual tonsil tissue can be obtained in pairs it was possible, in the majority of cases, to set aside an intact sample for confirmatory testing if required. In one instance a sample was reactive by Western blot. However, the pattern of reactivity was not typical for that obtained from vCJD patients. Unfortunately the sample was not of sufficient quality for the confirmatory test to provide a conclusive result.

Evaluation of the experiences of family members whose deceased relative donated tissues at the NHSBT dedicated donation facility in Speke, Liverpool.

Donation of human tissue for transplant and research has historically been facilitated within the hospital mortuary. In 2006 NHSBT Tissue Services opened the Dedicated Donation Facility [DDF], the first facility in the UK dedicated to the donation of tissues under strictly controlled conditions. Nine family members who had agreed and experienced the transfer of their deceased relative to the DDF for tissue donation participated in a service evaluation applying qualitative data collection methods and framework analysis. The evaluation aimed to: understand the decision-making process of family members who agreed to their deceased relative being moved to the DDR for tissue donation; identify any concerns that family members had; gather the views of family members regarding the 'service' provided to them by NHSBT Tissue Services. Family members were unaware of the possibility of tissue donation. The process of reasoning behind both agreeing to tissue donation and movement of the deceased to the DDF by family members was fundamentally, 'the benefit to others' that tissue donation would bring, and fulfilling the wishes of the deceased [when known]. Family decision making was facilitated by: (i) a positive rapport with the requester, (ii) satisfaction with the information provided to the family about what would happen, and (iii) trust in that what was being said would happen. Family members were satisfied with the service provided to them by Tissue Services and confident in agreeing to the transfer of their deceased relative to the dedicated facility for tissue donation.

Exclusion of deceased donors post-procurement of tissues.

The EU Tissues and Cells Directive (2004/23/EC, 2006/17/EC, 2006/86/EC) (EUTCD) provides standards for quality and safety for all aspects of banking of tissues and cells for clinical applications. Commission Directive 2006/17/EC stipulates that the complete donor record with all the medical information is assessed for suitability before releasing tissues for clinical use. The aim of this study was to investigate the medical reasons for post-procurement donor exclusion, to identify the various potential sources for gathering information about donors' medical and behavioural history and to evaluate their contribution to maximising the safety of donations. Information was collected from the Tissue Services (TS) records of 1000 consecutive deceased donors submitted to National Health Service Blood and Transplant (NHSBT) medical officers for authorisation for release for subsequent tissue processing and then for transplantation. Of the 1000 donors 60 (6%) were excluded because they did not fulfil the donor selection requirements of the EUTCD and NHSBT donor selection guidelines. The main reasons for medical exclusion were the presence of significant local or systemic infection in 32 donors (53% of those excluded for medical reasons) and a history of past or occult malignancy in 9 donors (15% of those excluded for medical reasons) which was not identified prior to procurement. The information leading to post-procurement exclusion was obtained from autopsy reports in 35 of the 60 excluded donors for medical reasons (58%) and from the general practitioner for 10 donors (17% of those excluded for medical reasons). In summary, careful evaluation of complete donor records reduces the potential risk of disease transmission by tissue allografts and ensures compliance with regulations and guidelines. The findings may lead to changes in donor selection policies with the aim of improving efficiency without compromising safety.

Effects of early and late intervention with epoetin alpha on left ventricular mass among patients with chronic kidney disease (stage 3 or 4): results of a randomized clinical trial.

It is not known whether prevention of anemia among patients with chronic kidney disease would affect the development or progression of left ventricular (LV) hypertrophy. A randomized controlled trial was performed with 155 patients with chronic kidney disease (creatinine clearance, 15 to 50 ml/min), with entry hemoglobin concentrations ([Hb]) of 110 to 120 g/L (female patients) or 110 to 130 g/L (male patients). Patients were monitored for 2 yr or until they required dialysis; the patients were randomized to receive epoetin alpha as necessary to maintain [Hb] between 120 and 130 g/L (group A) or between 90 and 100 g/L (group B). [Hb] increased for group A (from 112 +/- 9 to 121 +/- 14 g/L, mean +/- SD) and decreased for group B (from 112 +/- 8 to 108 +/- 13 g/L) (P < 0.001, group A versus group B). On an intent-to-treat analysis, the changes in LV mass index for the groups during the 2-yr period were not significantly different (2.5 +/- 20 g/m(2) for group A versus 4.5 +/- 20 g/m(2) for group B, P = NS). There was no significant difference between the groups in 2-yr mean unadjusted systolic BP (141 +/- 14 versus 138 +/- 13 mmHg) or diastolic BP (80 +/- 6 versus 79 +/- 7 mmHg). The decline in renal function in 2 yr, as assessed with nuclear estimations of GFR, also did not differ significantly between the groups (8 +/- 9 versus 6 +/- 8 ml/min per 1.73 m(2)). In conclusion, maintenance of [Hb] above 120 g/L, compared with 90 to 100 g/L, had similar effects on the LV mass index and did not clearly affect the development or progression of LV hypertrophy. The maintenance of [Hb] above 100 g/L for many patients in group B might have been attributable to the relative preservation of renal function.

Laparoscopic placement of peritoneal dialysis catheters: 7 years experience.

BACKGROUND: Since 1994 we have placed all peritoneal dialysis (Tenckhoff) catheters at our hospital laparoscopically using a technique that incorporates suture fixation into the pelvis. The purpose of this study was to determine the long-term outcome of this approach. METHOD: Perioperative and follow-up data for all patients undergoing placement of a peritoneal dialysis catheter at the Royal Adelaide Hospital were collected prospectively and managed on unit specific and hospital wide computerized databases. A total of 148 procedures were carried out in 123 patients from March 1994 to November 2001. Follow-up ranged from 3 to 68 months (median, 42 months). All procedures were undertaken or supervised by one surgeon, and catheters were routinely sutured into the pelvis at laparoscopy. RESULTS: There was no perioperative mortality in this series, and only one catheter could not be placed laparoscopically. This was in a patient with extensive intra-abdominal adhesions. Mean operative time was 27 min (range, 10-100 min), and mean postoperative stay was 2.8 days (range, 1-12 days). Seven (5%) patients experienced peri/postoperative haemorrhage, and four of these underwent surgical re-exploration. Twenty-five (17%) catheters are still used for dialysis. Thirty-four (23%) catheters were removed when the recipient received a subsequent renal transplant, and 42 (28%) patients died during follow-up. Forty-six (31%) patients required catheter revision or removal because of technical problems; 26 (18%) recurrent peritonitis or exit site infection; and 20 (14%) catheter blockage. Twenty-eight reinsertion procedures were carried out in 25 patients. Ten (7%) patients developed port site hernias at late follow-up, and required hernioplasty. Catheter migration leading to malfunction (poor drainage) occurred in eight (5%) patients only. CONCLUSIONS: Laparoscopic placement of peritoneal dialysis catheters is a safe and effective procedure. The majority of patients will dialyse successfully using this technique. Suturing the catheter tip into the pelvis is associated with a low rate of catheter migration.