A Machine Learning-Driven Virtual Biopsy System For Kidney Transplant Patients.

In kidney transplantation, day-zero biopsies are used to assess organ quality and discriminate between donor-inherited lesions and those acquired post-transplantation. However, many centers do not perform such biopsies since they are invasive, costly and may delay the transplant procedure. We aim to generate a non-invasive virtual biopsy system using routinely collected donor parameters. Using 14,032 day-zero kidney biopsies from 17 international centers, we develop a virtual biopsy system. 11 basic donor parameters are used to predict four Banff kidney lesions: arteriosclerosis, arteriolar hyalinosis, interstitial fibrosis and tubular atrophy, and the percentage of renal sclerotic glomeruli. Six machine learning models are aggregated into an ensemble model. The virtual biopsy system shows good performance in the internal and external validation sets. We confirm the generalizability of the system in various scenarios. This system could assist physicians in assessing organ quality, optimizing allograft allocation together with discriminating between donor derived and acquired lesions post-transplantation.

Differences in Organ Donation and Transplantation in States Within the United States and in European Countries: Is There a Benefit to Opting Out?

BACKGROUND: Organ donation in the United States currently requires explicit consent by an "opt-in" approach. Some European countries have reported an increase in donation rates with an "opt-out" strategy. We hypothesized that regional differences in decision making affect organ donation rates in different countries and suggest no single approach will reliably increase organ donation rates. METHODS: Donation and transplantation rates in European countries and states within the United States with populations of >10 million and a minimum organ donation rate of 10 donors per million were compared. 2016 International Registry in Organ Donation and Transplantation data and the 2016 Scientific Registry of Transplant Recipients annual report were used for European countries and US states, respectively. Comparisons by region and donation model were made. RESULTS: Deceased organ donor rates and transplants did not differ between opt-in and opt-out models. Living donation was increased in all opt-in entities. When comparing European countries, there was a trend toward higher organ donation rates in opt-out countries than in opt-in countries. Donation and transplantation rates of US states were higher than both European opt-in and opt-out countries. CONCLUSION: There were no differences in deceased donor organ donation when considering the donation consent model. These data do not support that an opt-out approach will increase the number of transplants in the United States.

Cross-cultural adaptation and psychometric validation of the Flodén ATODAI instrument in the North American context.

BACKGROUND: Intensive and critical-care nurses are the key to successful donor management in the critical-care setting. No studies measuring attitudes toward organ donor advocacy existed before 2011, when the 51-item Swedish "Attitudes Toward Organ Donor Advocacy Scale" was developed. The aim of this study was to translate, adapt and establish the psychometric properties of the North American version of the Flodén ATODAI (Attitudes Toward Organ Donor Advocacy Instrument) in terms of validity and reliability. METHODS: A multi-step approach was used: Initial translation; Back-translation; Review and synthesis of these translations; Expert panel (N = 7) rated the prefinal version of the instrument for content validity index (CVI); International panel made adjustments guided by the expert panel. Reliability testing with test and retest of the adjusted 46-item version was conducted using intraclass correlation coefficient (ICC), weighted kappa (Ò¡ Weight ), sign test, and Cronbach's alpha coefficient (α), (N = 50); and finally Delphi technique procedure with a preselected Delphi panel (N = 15). RESULTS: The CVI was determined to be greater than the 0.05 significance level. Item level (I-CVI) ranged 0.82-1.0, with a mean of 0.97. Scale level (S-CVI) on the entire instrument was 0.97. Test-retest procedure was performed to estimate stability. In total, 34 of the items had good-to-high ICC. Accepting an ICC of ≥ 0.70 resulted in a total of 24 items. Homogeneity reliability was estimated by α and was calculated for these items where α = 0.90. In total, 20 of the items had a substantial or almost perfect Ò¡ Weight and 23 showed a moderate Ò¡ Weight . None of the items showed systematical differences. The Delphi technique procedure was used on the 22 items with ICC < 0.70 resulted in adjustments establishing that consensus was achieved. CONCLUSIONS: Undertaking this multi-step, cross-cultural adaptation procedure has effectively ensured that the 46-item Flodén ATODAI [North American version] produces valid and reliable measurements.

Deceased organ donor screening for human immunodeficiency virus, hepatitis B virus and hepatitis C virus: Discordant serology and nucleic acid testing results.

BACKGROUND: Before the 2014 policy change pertaining to infectious disease screening, many organ procurement organizations (OPOs) were supplementing serologic screening of deceased organ donors with nucleic acid testing (NAT) for human immunodeficiency virus (HIV-1), hepatitis B virus (HBV), and hepatitis C virus (HCV). The number of seronegative, NAT-positive donors has not been directly measured. METHODS: HIV, HBV, and HCV screening results of 11 229 donor referrals evaluated from 2010 to 2013 were obtained from 3 OPO-affiliated laboratories, capturing 35% of all donors in the United States. Laboratories used either polymerase chain reaction assay or transcription-mediated amplification assay to test 9643 deceased donors by NAT. RESULTS: The NAT results were positive in 21 (0.2%), 1 (0.02%), and 11 (0.1%) donors who were seronegative for HIV, HBV, and HCV, respectively. All discordant HIV-1 results were from one laboratory using a polymrease chain reaction assay. Thirteen of the reactive HIV NAT results in seronegative referrals were repeated and were non-reproducibly positive (NRP). Ten (0.1%), 452 (7.8%), and 197 (2.2%) of HIV-, HBV-, and HCV-seropositive donors, respectively, were negative by NAT. CONCLUSIONS: This study highlights the importance of robust quality assurance to minimize NRP NAT results. NAT may allow for increased utilization of organs from HBV- and HCV-seropositive, NAT-negative donors.

Transmission of Trypanosoma cruzi by heart transplantation.

BACKGROUND: Trypanosoma cruzi infection (i.e., Chagas disease) is an unusual complication that can occur after solid-organ transplantation and that can result in severe illness or death. In 2006, there were 2 heart transplant recipients in Los Angeles, California, reported to have acute trypanosomiasis during the same month. We conducted an investigation to determine the source of these infections. METHODS: We reviewed the medical, organ procurement, and donor transfusion and transplantation records of these 2 heart transplant recipients. The 2 heart transplant recipients were interviewed regarding any kind of natural exposure and were screened for parasites by obtaining blood and other tissue samples for buffy coat, culture, and polymerase chain reaction. Serum samples from the heart transplant recipients, organ donors, and blood donors were tested for T. cruzi antibodies by use of immunofluorescence assay and radioimmunoprecipitation assay. Tissue samples from the organ donors were examined by use of polymerase chain reaction and immunohistochemical staining. Other recipients of organs from the same donors were monitored for T. cruzi infection by use of polymerase chain reaction and immunofluorescence assay. RESULTS: Both heart transplant recipients had no apparent risk factors for preexisting T. cruzi infection. Both were seronegative but tested positive for the parasite, indicating recent infection. Both recipients died despite medical treatment. The organ donors tested positive for T. cruzi antibodies by use of radioimmunoprecipitation assay; the blood donors were seronegative. Six other patients had received a liver or kidney from these organ donors. None showed evidence of T. cruzi infection. CONCLUSIONS: To our knowledge, this is the first report of T. cruzi transmission associated with heart transplantation. Clinicians and public health authorities should be aware that manifestations of Chagas disease can occur after transplantation, requiring rapid evaluation, diagnosis, and treatment.

Cadaveric organ donor recruitment at Los Angeles County Hospital: improvement after formation of a structured clinical, educational and administrative service.

BACKGROUND/AIMS: There remains a critical shortage of cadaveric organs. At a large inner city level one trauma centre, several strategies were devised and combined to (a). optimize the physiologic status of potential donors, (b). promote awareness of the donation process among health care professionals and (c). perform quality control on the organ donation system - all in an effort to improve organ donation rates. Resuscitative and maintenance protocols were devised and implemented through a multidisciplinary team approach for patients diagnosed with brain death. We report the effect this approach has had on organ donation in a single centre. METHOD: A death record review (DRR) by the local organ procurement agency (OPO) was used to identify the number of patients diagnosed with brain death at Los Angeles County Hospital each year from 1995 through 2001. Data were collected to determine the number of these potential donors that eventually underwent organ donation. Data were collected for two time intervals: Phase I (1995-98) and Phase II (1999-2001). During Phase I, there was no focused institutional programme for the approach to potential donors. During Phase II, an institutional programme including the following characteristics was implemented: 1). donor resuscitation protocol, 2). assignment of a dedicated OPO coordinator liaison to interact with families, hospital personnel and the coroner's office, 3). assignment of the primary role of stabilization and care of potential donors and the integration of all medical services to the trauma service, and 4). biweekly conferences to review policies, protocols, and outcomes of donor management strategies. RESULTS: From 1995 to 2001 there was a large increase in patient referrals for donor evaluation from 86 (Phase I) to 124 (Phase II). There was a smaller increase in the number of suitable donors: Phase I (mean: 51/year) and Phase II (mean: 63/year). There was, however, an increase in the mean number of actual organ donors from 14.2/year to 25.7/year from Phase I to Phase II and an increase in organs donated from 29 to 49. Organ donor declines decreased from 53% (Phase I) to 39% (Phase II). CONCLUSIONS: Strategies to increase the number of cadaveric organs available for organ transplantation are crucial. A strategy combining prompt identification of potential organ donors, institution of resuscitative protocols, a multidisciplinary team approach, educational activities and utilization of personnel expert in organ procurement led to a marked increase in the number of organ donors and the number of organs donated at a single institution. Wider application of this approach should prove successful in increasing organ donation in a similar fashion in other institutions.