Development of an improved Scientific Registry of Transplant Recipients deceased donor heart yield model using donor critical care data from the Donor Management Goal Registry cohort.

Organ procurement organizations (OPOs) face increasing regulatory scrutiny, and the performance of predictive models used to assess OPO performance is critical. We sought to determine whether adding deceased donor physiologic and critical care data to the existing Scientific Registry of Transplant Recipients (SRTR) heart yield model would improve the model's performance. Donor data and heart transplanted (yes/no), the outcome of interest, were obtained from the United Network for Organ Sharing Donor Management Goal (DMG) Registry for 19,141 donors after brain death from 25 OPOs. The data were split into training and testing portions. Multivariable LASSO regression was used to develop a statistical model incorporating DMG data elements with the existing components of the SRTR model. The DMG+SRTR and SRTR models were applied to the test data to compare the predictive performance of the models. The sensitivity (84-86%) and specificity (84-86%) were higher for the DMG+SRTR model compared to the SRTR model (71-75% and 76-77%, respectively). For the DMG+SRTR model, the C-statistic was 0.92-0.93 compared to 0.80-0.81 for the SRTR model. DMG data elements improve predictive performance of the heart yield model. The addition of DMG data elements to the Organ Procurement & Transplantation Network data collection requirements should be considered.

Augmenting the Unites States transplant registry with external mortality data: A moving target ripe for further improvement.

The Organ Procurement and Transplantation Network conducts a robust death verification process when augmenting the United States transplant registry with external sources of data. Process enhancements added over 35,000 externally verified deaths across waitlist candidates and transplant recipients for all organs beginning in April 2022. Ninety-four percent of added posttransplant deaths occurred beyond 5 years posttransplant, and over 74% occurred beyond 10 years. Deceased donor solid organ recipients transplanted from January 1, 2010, through October 31, 2020, were analyzed from January and July 2022 Organ Procurement and Transplantation Network Standard Transplant Analysis and Research and the Scientific Registry of Transplant Recipients Standard Analysis Files to quantify the impact of including vs excluding unverified deaths (not releasable to researchers) on posttransplant patient survival estimates. Across all organs, 1- and 5-year posttransplant survival rates were not substantially impacted; meaningful differences were observed in 10-year survival among kidney recipients. These findings bear important implications for anyone who utilized transplant registry data to examine long-term outcomes prior to the updated verification process. Users of transplant surveillance data should interpret results of long-term outcomes cautiously, particularly differences across subpopulations, and the transplant community should identify ways to improve data quality and minimize the reporting burden on transplant institutions.

New-onset Diabetes Mellitus After Adult Heart Transplantation and the Risk of Renal Dysfunction or Mortality.

BACKGROUND: Diabetes mellitus (DM) may occur either pre-heart transplantation (HT) or as new-onset DM post-HT. We sought to define the contemporary incidence of post-HT DM, evaluate risk factors for post-HT DM, and assess the impact of post-HT DM on major outcomes. METHODS: The cohort included International Society for Heart and Lung Transplantation Thoracic Organ Transplant Registry adult primary HT-alone recipients, transplanted January 1995-June 2017, who survived to 1 y post-HT. DM status was characterized as (1) no DM pre-HT or post-HT; (2) pre-HT DM; or (3) post-HT DM (onset within 5 y of HT). Cox proportional hazards models were constructed to identify risk factors for post-HT DM onset, as well as risk factors for post-HT severe renal dysfunction and death/retransplantation. RESULTS: Of 26 263 eligible subjects, 57% had no DM pre-HT or post-HT, 22% had pre-HT DM, and 21% had new-onset post-HT DM. Risk factors for the development of post-HT DM included use of tacrolimus or steroids at 1 y post-HT, as well as higher recipient age, female sex, ischemic cardiomyopathy, higher body mass index, pre-HT dialysis, and pre-HT steroid use. Post-HT DM within 5 y was associated with increased subsequent severe renal dysfunction (hazard ratio, 1.89; 95% confidence interval, 1.77-2.01) and death/retransplantation (hazard ratio, 1.38; 95% confidence interval, 1.32-1.45), compared with patients without post-HT DM. CONCLUSIONS: Post-HT DM is common, occurring in 21% of recipients within 5 y of HT. Post-HT DM is associated with increased risk of severe renal dysfunction and death or retransplantation.

The Effect of Acuity Circles on Deceased Donor Transplant and Offer Rates Across Model for End-Stage Liver Disease Scores and Exception Statuses.

Acuity circles (AC), the new liver allocation system, was implemented on February 4, 2020. Difference-in-differences analyses estimated the effect of AC on adjusted deceased donor transplant and offer rates across Pediatric End-Stage Liver Disease (PELD) and Model for End-Stage Liver Disease (MELD) categories and types of exception statuses. The offer rates were the number of first offers, top 5 offers, and top 10 offers on the match run per person-year. Each analysis adjusted for candidate characteristics and only used active candidate time on the waiting list. The before-AC period was February 4, 2019, to February 3, 2020, and the after-AC period was February 4, 2020, to February 3, 2021. Candidates with PELD/MELD scores 29 to 32 and PELD/MELD scores 33 to 36 had higher transplant rates than candidates with PELD/MELD scores 15 to 28 after AC compared with before AC (transplant rate ratios: PELD/MELD scores 29-32, 2.34 3.324.71 ; PELD/MELD scores 33-36, 1.70 2.513.71 ). Candidates with PELD/MELD scores 29 or higher had higher offer rates than candidates with PELD/MELD scores 15 to 28, and candidates with PELD/MELD scores 29 to 32 had the largest difference (offer rate ratios [ORR]: first offers, 2.77 3.955.63 ; top 5 offers, 3.90 4.394.95 ; top 10 offers, 4.85 5.305.80 ). Candidates with exceptions had lower offer rates than candidates without exceptions for offers in the top 5 (ORR: hepatocellular carcinoma [HCC], 0.68 0.770.88 ; non-HCC, 0.73 0.810.89 ) and top 10 (ORR: HCC, 0.59 0.650.71 ; non-HCC, 0.69 0.750.81 ). Recipients with PELD/MELD scores 15 to 28 and an HCC exception received a larger proportion of donation after circulatory death (DCD) donors after AC than before AC, although the differences in the liver donor risk index were comparatively small. Thus, candidates with PELD/MELD scores 29 to 34 and no exceptions had better access to transplant after AC, and donor quality did not notably change beyond the proportion of DCD donors.

Kidney accelerated placement project: Outcomes and lessons learned.

Opportunities continue to be lost with a high rate of kidneys recovered for transplant but not utilized, particularly those considered less than ideal quality. The Organ Procurement and Transplantation Network (OPTN) Organ Center is tasked with allocating arguably the most difficult-to-place kidneys, and we hypothesized an accelerated placement pathway would increase utilization of kidneys placed by the Organ Center. The Kidney Accelerated Placement (KAP) project, implemented by the Organ Center from July 18, 2019 to July 15, 2020, aimed to offer kidneys with a high kidney donor profile index to programs that had a history of accepting such organs. We compared OPTN kidney match run, donor, and transplant recipient data during the project period and 1 year prior. There was no statistically significant change in the percentage of KAP-eligible donors accepted during the project period (16.4%) compared to the prior year (17.5%). Conversion from acceptance to transplant was higher under KAP (72.7% vs. 71.2%), though not significant. Waiting to accelerate placement after kidneys have been declined by multiple transplant programs locally and regionally is an intervention that may come too late to effectively increase utilization. Transplant rates of nationally shared and marginal kidneys remain a challenge, and future iterations of this project should be investigated.

Inactive status is an independent predictor of liver transplant waitlist mortality and is associated with a transplant centers median meld at transplant.

BACKGROUND: Approximately 30% of patients on the liver transplant waitlist experience at least one inactive status change which makes them temporarily ineligible to receive a deceased donor transplant. We hypothesized that inactive status would be associated with higher mortality which may differ on a transplant centers' or donor service areas' (DSA) Median MELD at Transplant (MMaT). METHODS: Multi-state models were constructed (OPTN database;06/18/2013-06/08/2018) using DSA-level and transplant center-level data where MMaT were numerically ranked and categorized into tertiles. Hazards ratios were calculated between DSA and transplant center tertiles, stratified by MELD score, to determine differences in inactive to active transition probabilities. RESULTS: 7,625 (30.2% of sample registrants;25,216 total) experienced at least one inactive status change in the DSA-level cohort and 7,623 experienced at least one inactive status change in the transplant-center level cohort (30.2% of sample registrants;25,211 total). Inactive patients with MELD≤34 had a higher probability of becoming re-activated if they were waitlisted in a low or medium MMaT transplant center or DSA. Transplant rates were higher and lower re-activation probability was associated with higher mortality for the MELD 26-34 group in the high MMaT tertile. There were no significant differences in re-activation, transplant probability, or waitlist mortality for inactivated patients with MELD≥35 regardless of a DSA's or center's MMaT. CONCLUSION: This study shows that an inactive status change is independently associated with waitlist mortality. This association differs by a centers' and a DSAs' MMaT. Prioritization through care coordination to resolve issues of inactivity is fundamental to improving access.

Increase in Alcoholic Hepatitis as an Etiology for Liver Transplantation in the United States: A 2004-2018 Analysis.

BACKGROUND: Changing opinions on the alcohol abstinence requirement have led to increased liver transplantation (LT) for alcoholic hepatitis (AH). We aimed to determine the trend in LT for AH in the United States and overall and graft survival rates. METHODS: Adult liver-alone and liver-kidney registrations added to the Organ Procurement and Transplantation Network waiting list between 2004 and 2018 were divided into 3 periods (2004-2009, 2010-2013, 2014-2018). Kaplan-Meier survival models illustrated patient and graft survival. RESULTS: Between 2004 and 2018, 529 AH patients were registered for and 254 received LT. By periods, 116, 73, and 340 patients were registered for and 49, 17, and 188 patients received LT, respectively, indicating a increase in LT for AH from 2014 to 2018. Yearly registrants from 2014 to 2018 were 32, 47, 51, 70, and 140, and recipients were 16, 24, 24, 38, and 88, respectively, indicating increases of 338% and 450% in registrants and recipients, respectively, since 2014. AH patients had the highest 1- and 3-year posttransplant survival (93.2% and 87.3%, respectively) and graft survival (90.4% and 84.8%, respectively) comparing to other LT recipients. CONCLUSIONS: LT for AH in the United States is at an all-time high with an increased overall patient and graft survival.

Informed Clustering of Donation Service Areas for Improved Benchmarking.

The donation community continuously strives to collaborate and share effective practices to further the mission of saving and healing lives. Donation service areas in which the Organ Procurement Organizations (OPOs) work are multifaceted in their demographics, inciting the Organ Procurement and Transplantation Network to consider a more holistic and objective measure of similarity rather than the size of population alone or locational proximity alone. This would allow OPOs, as a part of their quality improvement efforts, to learn from and mentor other organizations that are dealing with similar challenges. By incorporating multiple informative characteristics together, we can distinguish those likenesses only revealed by taking into account multiple factors simultaneously. We used statistical approaches that take many characteristics of interest describing a donation service area and purposely excluded performance measures that an OPO may be able to influence by their own practices. Unsupervised learning methods combined the original characteristics into a smaller number of new variables, eliminating correlation and overlap in information from the original characteristics, and clustered donation service areas based on the general characteristics and population of the area. This analysis is a first step in providing a different perspective for OPOs to learn from other organizations that may face similar challenges, as well as to share best practices and open new lines of communication.

The Impact of Axillary Lymph Node Surgery on Breast Skin Thickening During and After Radiation Therapy for Breast Cancer.

PURPOSE: This prospective study was conducted to determine predictors of epidermal thickening during and after whole-breast radiation therapy (XRT) using objective measurements acquired with ultrasound. METHODS AND MATERIALS: After breast-conserving surgery, 70 women received a definitive course of whole-breast XRT (50 Gy plus boost). Prior to XRT, at week 6 of XRT, and 6 weeks after XRT, patients underwent objective ultrasound measurements of epidermal thickness over the lumpectomy cavity and all 4 quadrants of the treated breast. A skin thickness ratio (STRA) was then generated normalizing for corresponding measurements taken of the untreated breast. RESULTS: Baseline measurements indicated that 87% of patients had skin thickening in the treated versus untreated breast (mean increase, 27%; SD, 0.29) prior to XRT. The STRA increased significantly by week 6 of XRT (mean, 25%; SD, 0.46) and continued to increase significantly 6 weeks after XRT (mean, 33%; SD, 0.46) above baseline measurements (P<.001 for both time points). On multivariate analysis, breast volume (P=.003) and surgical evaluation of the axilla with full lymph node dissection (P<.05) predicted for more severe changes in the STRA 6 weeks after XRT compared with baseline. STRA measurements correlated with physician ratings of skin toxicity according to Radiation Therapy Oncology Group grading criteria. CONCLUSIONS: This is one of the first studies to objectively document that lymph node surgery affects XRT-induced skin thickening in patients with breast cancer. Surgical evaluation of the axilla with complete lymph node dissection was associated with the most severe XRT-induced skin changes after XRT completion. These results may inform future studies aimed at minimizing side effects of XRT and surgery, particularly when surgical lymph node assessments may not alter breast cancer management or outcome.