Organ Procurement Transplant Network Research Articles

Pre-transplant Loco-Regional Therapy for Hepatocellular Carcinoma and Post-transplant Outcomes: A National Study.

The ultimate preferred treatment for hepatocellular carcinoma (HCC) complicated with cirrhosis and portal hypertension is an orthotopic liver transplant (OLT). Loco regional therapy (LRT) has emerged to prevent tumor growth and progression of disease beyond the Milan criteria to achieve transplant. There is a paucity of data regarding safety, posttransplant survival benefits, and tumor recurrence rate achieved by these LRT modalities. We aim to assess and compare the five-year survival rate and tumor recurrence rate with or without LRT in patients after OLT with diagnosed HCC utilizing the nation's largest dataset. This is a retrospective observational study approved by Saint Louis University institutional review board. We utilized the largest dataset from the years 2003-2013 where pertaining data were gathered from Organ Procurement Transplant Network (OPTN) standard analysis and research files (STAR) through novel linkages with Medicare bills. Descriptive and comparative statistics were performed. 2412 (51.6%) patients received any form of locoregional therapy (single or combination) out of 4669 total study sample size. The overall five-year survival in the study sample was 76.1%. There was statistically no significant improvement seen in five-year posttransplant survival in the group that received one mode of LRT (adjusted hazard ratio (aHR) 0.97, P<0.64) or a combination of LRT (aHR 0.94, P<0.58) in comparison to those that received none after adjusting donor and recipient clinical characteristics. However, five-year survival trended higher among those treated with combination therapy over those treated with single LRT or none. Overall HCC recurrence was 4.8%, while no significant difference was noted when comparing above-mentioned groups. Five-year posttransplant survival and HCC recurrence rate were also found to have no difference when compared between above-mentioned groups after adjusting explant pathology. This is the largest retrospective study comparing liver transplant patients with HCC who received LRT to none. Although it did not show any statistically significant benefit of single or combination of LRT on survival or tumor recurrence after liver transplant for HCC patients, the outcomes encourage the safe and feasible use of LRT as a bridging therapy. Our study also suggests an observed pattern of improved posttransplant survival and tumor recurrence rate with combination loco-regional therapy. Larger multicenter prospective studies will be required to achieve the effect size to determine the best therapies for maximizing patient survival cost-effectively.

Incomplete reporting of clinically significant acute rejection episodes in the national kidney transplant registry

Administrative claims data could provide a unique opportunity to identify acute rejection (AR) events using specific antirejection medications and to validate rejected data reported to the Organ Procurement and Transplantation Network. This retrospective cohort study examined differences in registry-reported events and those identified using claims data among adult kidney transplant recipients from 2012 to 2017 using Standard Analysis Files from the US Renal Data System. Rejection rates, survival estimates, and center-level differences were assessed using each approach. Among 45 880 first-time kidney transplant recipients, we identified 3841 AR events within 12 months of transplant reported by centers in the registry; claims data yielded 2945 events. Of all events occurring within 12 months of transplant, 48.5% were reported using registry only, 32.9% were identified using claims only, and 18.6% were identified using both approaches. A 3-year death-censored graft survival probability was 90.0%, 88.4%, and 81.2% (P < .001) for ARs identified using registry only, claims data only, and both approaches, respectively. The large discordance between registry-reported and claims-based events suggests incomplete and potentially inaccurate reporting of events in the Organ Procurement Transplant Network registry. These findings have important implications for analyses that use AR data and underscore the need for improved capture of clinically meaningful events.

Survival Outcomes After Double-Lung Transplantation for Refractory Lung-Limited Cancers and Incidence of Post-Transplant Lung Cancer.

BACKGROUND To evaluate the role of double-lung transplantation (DLT) for lung cancer, the survival outcomes of patients who underwent DLT for lung cancer and the incidence of de novo lung cancer after DLT were assessed. MATERIAL AND METHODS Data from all cases reported in the literature were pooled for analysis and additional data were collected from the Organ Procurement Transplantation Network (OPTN) registry. Recurrence-free survival (RFS), overall survival (OS), and cancer-specific survival (CSS) of patients who underwent DLT for lung cancer were determined. Moreover, the incidence of de novo lung cancer and associated OS in lung transplant recipients were examined. RESULTS Of the 20 cases series and 15 cases from the OPTN registry, the 5-year RFS was 55.0% and 66.7% and the 5-year OS was 55.0% and 26.7%, respectively, and the median CSS was 48.0 (range, 2.0-144.0) and 27.7 (range, 0.2-66.6) months, respectively. In the OPTN data, the incidence of post-transplant lung cancer in patients who underwent DLT for the non-cancerous disease was 0.8% and the 5-year OS was 47.3%. CONCLUSIONS In conclusion, our integrated analysis of the case series and the OPTN registry demonstrated promising survival outcomes for patients with refractory bilateral lung cancer who underwent DLT. Although there are limitations to consider, the results of this study underscore the potential benefits of DLT in managing refractory lung-limited lung cancer.

Reimagining the United States organ procurement and transplant network.

The United States system of solid organ transplantation is overseen by the Organ Procurement Transplantation Network (OPTN). Recent announcements from the Health Resources and Services Administration (HRSA) indicate their clear intention to reform the system. We suggest that the original intention of the National Organ Transplant Act (NOTA) to require one entity to oversee transplantation is critical to integrate policy with the complex realities of organ procurement and transplantation practice. We suggest that a contemporary business platform model best captures the appropriate structure for coordinating organ transplantation, as the seamless exchange of organs between related groups is the essential function to facilitate. A business platform framework that includes public and private, academic and industry partners can best accomplish the important goal of equitable and efficient organ transplantation.

UNOS Decisions Impact Data Integrity of the OPTN Data Registry.

The Organ Procurement Transplant Network (OPTN)/United Network for Organ Sharing (UNOS) registry is an important national registry in the field of solid organ transplantation. Data collected are mission critical, given its role in organ allocation prioritization, program performance monitoring by both the OPTN and the Centers for Medicare & Medicaid Services, and countless observational analyses that helped to move the field forward. Despite the multifaceted importance of the OPTN/UNOS database, there are clear indications that investments in the database to ensure the quality and reliability of the data have been lacking. This analysis outlines 2 examples: (1) primary diagnosis for patients who are receiving a second transplant and (2) reporting peripheral vascular disease in kidney transplantation to illustrate the extensive challenges facing the veracity and integrity of the OPTN/UNOS database today. Despite guidance that repeat kidney transplant patients should be coded as "retransplant/graft failure" rather than their native kidney disease, only 59% of new incident patients are coded in this manner. Peripheral vascular disease prevalence more than doubled in a 20-y span when the variable became associated with risk adjustment. This article summarizes critical gaps in the OPTN/UNOS database, and we bring forward ideas and proposals for consideration as a path toward improvement.

Waitlist and post-transplant outcomes among candidates listed for liver transplant: Liver alone versus simultaneous liver kidney listings.

Data comparing waitlist and post-transplant outcomes of liver transplantation (LT) alone (LTA) versus simultaneous liver kidney (SLK) listings are limited. To examine 90-days waitlist and 1-year post-transplant outcomes of LT listings since Organ Procurement Transplant Network (OPTN) policy for SLK, who had cirrhosis with eGFR <30 mL/min or on dialysis at listing. Adults (08/2017-03/2021) with first LT listing (2628 SLK) were stratified on renal function from listing: acute kidney injury (AKI): rise of serum creatinine by ≥0.3 mg/dL or <42 days hemodialysis; chronic kidney disease (CKD): eGFR <60 mL/min for ≥90 days or ≥42 days hemodialysis. Among 7094 adults analyzed, 90-days competing cumulative waitlist mortality was 18.2% in LTA + CKD (n = 37), 15.3% in LTA + AKI (n = 3337), 15% in SLK + AKI (n = 2070), and 11% in SLK + CKD (n = 403), p < 0.001. On fine and gray model, compared to SLK + CKD, LTA + AKI had 1.4-fold waitlist mortality. On a median post-transplant follow up of 1 year, patient survival was similar comparing LTA versus SLK for AKI (89% each, p = 0.83), for CKD (93 vs. 86%, p = 0.55), but lower in recipients listed for SLK with no AKI or CKD (93 vs. 88%, p = 0.02), adjusted hazard ratio (95% CI) of 0.7 (0.4-1.2). Among 1024 LTA recipients without AKI or CKD from listing, 117 were listed for SLK, and their 1-year survival was poorer compared to LT alone listings (79 vs. 95%, p < 0.002, adjusted HR 3.6 (1.3-10.3); p = 0.015). Among candidates with renal dysfunction at listing for LT, those listed for LT alone should receive transplant promptly to optimise waitlist outcomes. Those listed for SLK should wait to receive both organs to optimise post-transplant outcomes.

Post-double lung transplantation survival outcomes of bilateral lung cancer and incidence of post-transplant lung cancer.

e21061 Background: To evaluate the role of double lung transplantation (DLT) for lung cancer, the survival outcomes of patients who underwent DLT for lung cancer and the incidence of lung cancer after DLT were assessed. Methods: Data from case series reported in the literature were pooled and collected from the Organ Procurement Transplantation Network (OPTN) and the International Society of Heart and Lung Transplantation (ISHLT) registries. We evaluated the recurrence-free survival (RFS), overall survival (OS), and cancer-specific survival (CSS) of patients who underwent DLT for lung cancer. Moreover, the incidence and OS of post-transplant lung cancer in patients who received transplants for the non-cancerous disease were examined. Results: Regarding patients who underwent DLT for lung cancer, in the pooled (n = 19), OPTN (n = 15), and ISHLT (n = 25) data, 5-year RFS was 52.6%, 66.7%, and 80.0%, and 5-year OS was 57.9%, 26.7%, and 36.0%, respectively. The median CSS was 48.0 (range, 6.0–144.0), 27.7 (range, 0.2–66.6), and 24.0 (range, 0.1–145.1) months. Additionally, the application of cardiopulmonary bypass was associated with lower tumor recurrence in the pooled data (p = 0.004). The incidence and 5-year OS post-transplant lung cancer in patients who underwent DLT for the non-cancerous disease were 0.8% and 47.3% in the OPTN data and 0.6% and 50.7% in the ISHLT data, respectively. Conclusions: We demonstrated that reasonable survival outcomes can be achieved with DLT in patients with bilateral lung cancer. Further studies are required to evaluate the risk of post-transplant lung cancer in patients undergoing DLT for bilateral lung cancer.

TOP5: Heart Transplant versus LVADs: Is destination therapy the new goal?

Background: With improving survival of patients following acute coronary syndromes and chronic heart failure, more patients are reaching the end stage of illness requiring heart transplantation (HT) as a finalgoal therapy. Mechanical circulatory support (MCS) devices like the left ventricular assist device (LVAD) play a major role as destination therapy or bridging therapy for this patient demographic. The improvement of modern LVADs paired with the increase of life expectancy, and the underwhelming engagement of HT donation in the US, ponders on the suggestibility of redirecting efforts for destination or bridging therapy for a growing population. This study assesses the tendencies of LVAD use in comparison to those of HT performance, and analyses the direct correlation with one another as predictive values for future directives in the AHF population. Methods: National data from the Organ Procurement & Transplantation Network (OPTN) was retrieved for the use of LVADs, the performance of primary HT and re-do HT over the last 30 years. Upon data retrieval, descriptive statistics were identified for 6 different groups (ages 18-34, 35-49, 50-64, above 65 years, and the collective adult cohort) including annual growth rate, and comparison within the group means. A regression analysis was performed to determine the variable relationship between LVAD placement and performance of HT. Results: Since 1992, a total of 75098 HT, and 21041 LVAD placements have been performed in the US. There is a significant difference in the number of HT and LVAD placements performed (LVAD vs PT: p=0.0001; LVAD vs re-do HT: p=0.0001). However, upon regression analysis, 64% of LVAD placement determines the subsequent bridging to HT, and the annual growth rate of LVAD placement has a positive significant correlation with the relatively sustained number of HT performed yearly (Coefficient of 0.87; Confidence interval 95%, p=0.000). When comparing LVAD placement to primary HT performance and re-do HT, a significant increase will continue to occur based on the thus-far determined growth rate across all age groups (p= 0.0001). Thus, suggestive that within the upcoming years, the number of LVADs placed will equal the amount of HT performed. Conclusions: With the continuance in evolution and improvement of LVADs in the AHF population and the uneven number of HT performed, this study outlines that the growing tendencies of MCS should be prioritized in lieu of HT availability or strategies to increase donation culture. The prioritization of MCS should aim for a better and comprehensive understanding of the role of these devices and adequate management in a long-term basis.Figure 1. LVAD, primary transplant and transplant repeat annual growth rate

Incidence, landscape and survival outcome of de novo malignancy after double lung transplantation.

10574 Background: Organ transplant recipients are at greater risk of developing malignancies due to their immunosuppressive management. However, the incidence of post-transplant malignancy after double lung transplantation (DLT) has not been studied. This study investigated the incidence, trends, and most common types of post-transplant malignancy following DLT. Methods: Data extracted from the Organ Procurement Transplantation Network (OPTN) registry after DLT for non-cancerous disease. We evaluated the incidence of post-transplant malignancy, and assessed the annual and cumulative risk of each malignancy after DLT. And the overall survival (OS) of recipients with or without post-transplant malignancy was analyzed by Kaplan-Meire survival method. Results: A total of 23,935 cases were identified and analyzed from the OPTN database (13,768; 57.5% male, 10,167; 42.5% female). 5,629 cases (23.5%) were found to have post-transplant malignancy and 18,306 cases (76.5%) had no post-transplant malignancy. Among patients with post-transplant malignancy 3,785 (67.2%) were male and 1844 (32.8%) were female. Those with post-transplant malignancy had a longer OS compared to those without post-transplant malignancy (P &lt; 0.001). While the median OS was 97.2 months and 5-year survival rate was 83.6% in recipients with post-transplant malignancy, the median OS was 36.7 months and 5-year survival rate was 67.3% in For those without post-transplant malignancy. The risk for post-transplant malignancy was greatest during the first 3-5 years post-transplantation. The most common types of post-transplant malignancies were squamous cell skin cancer (n = 2711, 48.2%), basal cell skin cancer (n = 965, 17.1%), lymphoma (n = 570, 10.1%), lung cancer (n = 187, 3.3%), colorectal cancer (n = 184, 3.3%). Conclusions: The lifetime incidence of post-transplant malignancy following DLT was identified to be 20.1% and those with post-transplant malignancy had a longer OS compared to those without post-transplant malignancy. Further studies are needed to investigate the underlying mechanism for the increased risk of malignancy following DLT and its association with OS.

Inverse association of post-transplant malignancy and graft failure on survival outcome following double lung transplantation.

10629 Background: Graft failure (GF) and post-transplant malignancy (PTM) are common causes of death in lung transplantation. Immunosuppression to prevent graft failure is known to lead to de novo malignancies after solid organ transplantation. Here, we assess the relationship between graft failure and de novo malignancies after double lung transplantation (DLT). Methods: Data extracted from the Organ Procurement Transplantation Network (OPTN) registry were analyzed. DLT cases for non-cancerous diseases were selected. We evaluated the overall survival (OS) of recipients with or without PTM (PTM+ or PTM-), and that of recipients with or without GF (GF+ or GF-) after DLT. The association between GF and PTM was investigated. Results: Among 23,935 DLT recipients, there were 5,629 cases (23.5%) of PTM+ and 18,306 cases (76.5%) of PTM -, and 2,316 cases (9.7%) of GF+ and 21,619 cases (90.3%) of GF- following DLT. Among GF+ cases, the prevalence of acute, hyperacute, and chronic rejection after DLT was 1,962 cases (84.7%). The OS in recipients with GF+ was worse than that in recipients with GF- (p &lt; 0.001). However, inversely, the OS in recipients with PTM+ was better than that of recipients with PTM- (p &lt; 0.001). When patients were categorized into four categories by each factor (GF-, GF+, PTM+, PTM-), the GF rate was lower in recipients with PTM+ than in those with PTM- [GF+/PTM+ (n = 368, 1.5%) versus GF+/PTM- (n = 1,948, 8.1%)] (p &lt; 0.001), and the PTM+ rate was higher in recipients with GF- than in those with GF+ [GF-/PTM+ (n = 5,261, 22.0%) versus GF+/PTM+ (n = 368, 1.5%)] (p &lt; 0.001). And the GF-/PTM+ group showed the best prognosis with 97.3 months of median OS, and the GF+/PTM- group showed the worst prognosis with 36.8 months of median OS (p &lt; 0.001). Conclusions: Recipients who developed PTM following DLT had longer OS compared with those who did not. And the GF rate was significantly lower in recipients with PTM compared to those without PTM. Further research is needed to investigate the underlying mechanism of the inverse association between PTM and GF in DLT recipients.

Policy corner: ischemic cholangiopathy associated with donation after cardiac death.

1Baylor All Saints Medical Center at Fort Worth, Fort Worth, Texas, USA 2Baylor Medical Center, Dallas, Texas, USA Correspondence James F. Trotter, Hepatology Section, Baylor Medical Center, 3500 Gaston Avenue 4 Roberts, Transplant, Dallas, TX 75246, USA. E-mail: [email protected] Abbreviations: DCD, donor by cardiac death; OPTN, Organ Procurement Transplantation Network.

Differential donor management of pediatric vs adult organ donors and potential impact on pediatric lung transplantation

Despite clinical progress over time, a shortage of suitable donor organs continues to limit solid organ transplantation around the world. Lungs are the organs most likely to be assessed as unsuitable during donor management among all transplantable organs. Although the number of lung transplants performed in children is limited, death on the wait list remains a barrier to transplant success for many potential transplant candidates. Optimizing organ donor management can yield additional organs for transplant candidates. We accessed the Donor Management Goal (DMG) Registry to evaluate the efficiency and efficacy of donor management in the procurement of lungs for transplantation. Further, we stratified donors by age and compared pediatric age cohorts to adult cohorts with respect to attainment of donor management target goals and successful pathway to transplantation. We utilized recipient data from the Organ Procurement Transplantation Network (OPTN) to put this data into context. The DMG bundle consists of nine physiologic parameters chosen as end-points guiding donor management for potential organ donors. The number of parameters fulfilled has been regarded as an indication of efficacy of donor management. We noted a markedly lower number of organ donors in the pediatric age group compared to adults. On the other hand, the number of donors greatly exceeds the number of infants, children and adolescents who undergo lung transplantation. Organs transplanted per donor peaks in the adolescent age group. At initial donor referral, DMG bundle attainment is lower in all age groups and improves during donor management. With respect to oxygenation, there is less overall improvement in younger donors compared to older donors during donor management. When donors who yield lungs for transplantation are compared to those whose lungs were not transplanted, oxygenation improved more substantially during donor management. Furthermore, improved oxygenation correlated with the total number of organs transplanted per donor. In the face of continued wait list mortality on the pediatric lung transplant wait list, the number of young donors may not be a limiting factor. We believe that this dataset provides evidence that management of young pediatric donors is not as consistent or efficient as the management of older donors, potentially limiting the number of life-saving organs for pediatric lung transplant candidates. Across all ages, optimizing donor lung management may increase the potential to transplant multiple other organs.

Updated U.S. Public Health Service Guideline for Testing of Transplant Candidates Aged

The U.S. Public Health Service (PHS) has periodically published recommendations about reducing the risk for transmission of HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) through solid organ transplantation (1-4). Updated guidance published in 2020 included the recommendation that all transplant candidates receive HIV, HBV, and HCV testing during hospital admission for transplant surgery to more accurately assess their pretransplant infection status and to better identify donor transmitted infection (4). In 2021, CDC was notified that this recommendation might be unnecessary for pediatric organ transplant candidates because of the low likelihood of infection after the perinatal period and out of concern that the volume of blood drawn for testing could negatively affect critically ill children.* CDC and other partners reviewed surveillance data from CDC on estimates of HIV, HBV, and HCV infection rates in the United States and data from the Organ Procurement & Transplantation Network (OPTN)† on age and weight distributions among U.S. transplant recipients. Feedback from the transplant community was also solicited to understand the impact of changes to the existing policy on organ transplantation. The 2020 PHS guideline was accordingly updated to specify that solid organ transplant candidates aged <12 years at the time of transplantation who have received postnatal infectious disease testing are exempt from the recommendation for HIV, HBV, and HCV testing during hospital admission for transplantation.

Kidney Transplantation in Single Ventricle Palliated Patients: A Pediatric Cardiac Care Consortium Study

<h3>Purpose</h3> Development of chronic kidney disease is well described in patients with complex congenital heart disease such as palliated single ventricle patients. It is also well known that presence of kidney disease contributes to morbidity and mortality in these patients. However, there is no study if the progression of kidney disease in these patients necessitates kidney transplantation and risk factors associated with need for kidney transplantation (KTX). <h3>Methods</h3> A retrospective cohort study of patients undergoing single ventricle palliation in the Pediatric Cardiac Care Consortium (PCCC), a large US-based registry. Outcomes and transplants were captured in the PCCC and by linkage with the Organ Procurement Transplant Network (OPTN) through 2019. <h3>Results</h3> Between 1982 -2019, 7751 patients with SV palliation were seen at US centers and 6385 patients had identifiers allowing appropriate linkage with OPTN database. Of these, 14 patients (0.22%) underwent KTX. Patients undergoing KTX were predominantly male (71%), white race (64.3%) and underwent KTX at a mean age of 21 (±9) years, mean time to KTX from last cardiac surgery 15.2 (±8.7) years. Cardiac diagnostic group was systemic right ventricle in 8/14 (57%). At follow-up, 11/14 (78%) were alive while 3/14 (22%) died at a mean age of 29 (±10.6) years. There were no differences in the demographic and diagnosis between those who received KTX versus those who did not. However, at follow up only 50.4% of patients without KTX were alive compared to 78.6% in the KTX group (p=0.03) while the mean age at death was 1 (0, 14) years in non-KTX group compared to 33.0 (17.0, 37.0) years in the KTX group (p= 0.011). Two patients needed kidney transplantation after heart transplantation. <h3>Conclusion</h3> First of its kind study shows that kidney transplantation is rarely performed in patients with single ventricle palliation although kidney disease is well documented in this population. This study findings potentially reflect selection bias and survival bias. We plan to elucidate the same further. Need for KTX appears to be higher in males with systemic right ventricle anatomy in the second or early third decade. Given that there is high mortality in the overall cohort, and given improved survival of patients undergoing combined heart kidney transplantation, further studies should focus on patient selection and early intervention.

Abstract 10672: Long-Term Need for Heart Transplantation and Post-Transplantation Survival After Fontan Palliation

Introduction: Fontan palliation for single ventricle frequently leads to heart failure and need for transplant; timing and factors associated with post-Fontan transplant, as well as post-transplant outcomes are not well understood. Methods: This is a retrospective cohort study of patients undergoing Fontan in the Pediatric Cardiac Care Consortium (PCCC), a large US-based registry of pediatric cardiac interventions. Deaths and transplants were captured in the PCCC and by linkage with the National Death Index and the Organ Procurement Transplant Network through 2019. Results: Between 1982 and 2003, 2,071 patients were enrolled in the PCCC and had their Fontan between 1988 and 2011. During Fontan hospitalization 151 deaths and 6 transplant listings occurred; 201 additional deaths and 148 listings occurred after discharge (Figure A). Cumulative incidence of transplant listing was 7.1% (95% CI 6.0-8.3) with the median time post Fontan being 11.1 years (IQR 5.3 - 13.8). After adjustment for risk factors, systemic right ventricle (HR 2.69; 95% CI 1.87 - 3.88) and &gt;30-day length of stay after Fontan (HR 2.29; 95% 1.51 - 3.48) were associated with transplant listing. Among listed patients, 112 (73%) underwent isolated heart transplant, 2 (1%) underwent heart-liver transplant, 20 (13%) died on the waitlist, and 20 (13%) are alive without transplant. One-year post-transplant survival was 70% for transplants before 2010 and 95% after 2010 (Figure B). Graft failure was associated with transplant before 2010 (HR 6.34; 95% CI 2.21-18.2), diagnosis of hypoplastic left heart syndrome (HR 3.71; 95% CI 1.38 - 9.92), and bilirubin &gt;2mg/dl at time of transplant (HR 2.79; 95% CI 1.03 - 7.58). Conclusion: Need for heart transplant is frequent post Fontan, but many die without listing. With significant improvements in post-transplant outcomes in recent years, timely transplant evaluation before significant end-organ dysfunction may improve survival for patients with single ventricle.

Abstract 12085: Impact of Pre-Fontan Hemodynamics on Long-Term Outcomes of Patients With Fontan Palliation

Introduction: Fontan procedure for single ventricle (SV) is frequently preceded by cardiac catheterization. The impact of pre-Fontan hemodynamics on long-term outcomes is not completely understood. Methods: This is a cohort study of patients undergoing Fontan in the Pediatric Cardiac Care Consortium (PCCC), a US-based registry of congenital heart surgeries. Deaths and transplants were captured through 2019 in the PCCC and by linkage with the National Death Index and the Organ Procurement Transplant Network. The relationship between pre-Fontan hemodynamics and post-Fontan transplant-free survival were evaluated with Kaplan Meier (KM) and Cox regression with adjustment for age at Fontan, sex, era of surgery, Fontan type, and type of systemic ventricle. Results: Between 1986 and 2003, 1498 patients were enrolled in the PCCC and underwent pre-Fontan cardiac catheterization. Table 1 demonstrates the relationship of patient characteristics on the risk of death or transplant after Fontan discharge. After adjustment for other risk factors PVRi (aHR 1.28; 95% CI 1.09 - 1.49) and mPAP (aHR 1.07; 95% CI 1.02- 1.12) were the main factors associated with risk of death or transplant. KM survival curves stratified by PVRi and mPAP tertile depict the loss of transplant-free survival years for the top tertile of mean PAP (&gt;13 mmHg) or PVRi (&gt;2.3 WU m 2 ) (Figures A and B). Conclusions: This study of a large cohort of single ventricle patients demonstrates that abnormal pre-Fontan hemodynamics are associated with increased risk of death or transplant even many years after Fontan procedure. Such data may help to guide therapeutic considerations and monitoring intensity after Fontan completion.

A challenge to equity in transplantation: Increased center-level variation in short-term mechanical circulatory support use in the context of the updated U.S. heart transplant allocation policy

The United States National Organ Procurement Transplant Network (OPTN) implemented changes to the adult heart allocation system to reduce waitlist mortality by improving access for those at greater risk of pre-transplant death, including patients on short-term mechanical circulatory support (sMCS). While sMCS increased, it is unknown whether the increase occurred equitably across centers. The OPTN database was used to assess changes in use of sMCS at time of transplant in the 12 months before (pre-change) and after (post-change) implementation of the allocation system in October 2018 among 5,477 heart transplant recipients. An interrupted time series analysis comparing use of bridging therapies pre- and post-change was performed. Variability in the proportion of sMCS use at the center level pre- and post-change was determined. In the month pre-change, 9.7% of patients were transplanted with sMCS. There was an immediate increase in sMCS transplant the following month to 32.4% - an absolute and relative increase of 22.7% and 312% (p < 0.001). While sMCS use was stable pre-change (monthly change 0.0%, 95% CI [-0.1%,0.1%]), there was a continuous 1.2%/month increase post-change ([0.6%,1.8%], p < 0.001). Center-level variation in sMCS use increased substantially after implementation, from a median (interquartile range) of 3.85% (10%) pre-change to 35.7% (30.6%) post-change (p < 0.001). Use of sMCS at time of transplant increased immediately and continued to expand following heart allocation policy changes. Center-level variation in use of sMCS at the time of transplant increased compared to pre-change, which may have negatively impacted equitable access to heart transplantation.

Association between ethnicity and kidney transplant waitlist outcomes beyond estimated post‐transplant survival score

White kidney transplant candidates have the highest pre-transplant mortality rate compared to other ethnicities. The reason for a higher mortality rate is not well-understood. Estimated post-transplant survival (EPTS) score has been used to predict patient survival after transplant and may be associated with pre-transplant survival. First-time kidney transplant candidates listed between 2015 and 2018 were identified from the Organ Procurement Transplantation Network database. Individuals listed for multiple organs, at multiple centers, and age <18years were excluded. We examined the impact of ethnicity on waitlist mortality and delisting. A total of 114806 candidates were included. The study population was categorized into four groups which were 43% white, 28% Black, 19.2% Hispanic, and 9.8% "other ethnicities." At 5.2years, the cumulative incidences of death and delist were 32%, 31%, 29%, and 26%, respectively. Compared to whites, adjusted subdistribution hazard ratio (aSHR) for death and delist among Black, Hispanics, and "other ethnicities" were 0.92 (95% CI 0.89-0.95), 0.89 (95% CI 0.85-0.91), and 0.76 (95% CI 0.72-0.80) after adjustment by EPTS along with other factors, respectively. After adjusting for EPTS score along with additional confounding factors and functional status at initial listing, white ethnicity was independently associated with an increased risk for death and delist.

Long Term Outcomes of Tetralogy of Fallot With Absent Pulmonary Valve (from the Pediatric Cardiac Care Consortium)

Tetralogy of Fallot with absent pulmonary valve (TOF-APV) is a rare form of tetralogy with unique challenges due to the combination of pulmonary annular stenosis, severe pulmonary regurgitation, and airway compression secondary to aneurysmal dilatation of the pulmonary arteries. Data on the long-term outcomes of repaired TOF-APV are scarce. We used the Pediatric Cardiac Care Consortium (PCCC), a large US-based registry, to describe the postrepair transplant-free survival of patients with TOF-APV. We queried the PCCC for patients operated for TOF-APV between 1982 and 2003. Death or transplant events were ascertained from the PCCC and by linkage with the US National Death Index and the Organ Procurement Transplantation Network through December 2019. A total of 126 patients were identified with TOF-APV repair (primary n = 119, staged n = 7). The majority of them were repaired with a right ventricular to pulmonary artery conduit (n = 80, 64%) and 43 (34%) with transannular patch. In-hospital mortality occurred in 31 patients (25%); post discharge and over a median period of 19 years (IQR 0.37 to 23.7 years), 5 patients died and 2 underwent heart transplant, one of whom subsequently died. The 25-year transplant-free survival post discharge after TOF-APV repair was 92%, which was similar with the outcome of patients with simple TOF undergoing non-valve sparing procedures (94% log-rank test p = 0.455; aHR 1.37; 95% CI: 0.63 to 2.97, p = 0.432). In conclusion, early in-hospital mortality is high for TOF-APV; however, once repaired and survived to discharge, long term survival is similar to simple TOF with non-valve sparing procedures.

Impact of antibody induction on the outcomes of new onset diabetes after kidney transplantation: a registry analysis.

We conducted this observational study to examine the impact of antibody inductions administered at kidney transplant (KT) on outcomes of 5year exposure to post-transplant diabetes (PTDM) in adult deceased-donor kidney transplant recipients (DDKTRs). We also studied the risk of PTDM associated with antibody inductions. Using 2000-2016 Organ Procurement Transplantation Network data, we employed multivariable Cox models to determine the adjusted hazard ratios (HR) of death, and overall and death-censored graft loss (OAGL, DCGL; respectively) at the 5year landmark period in antibody induction cohorts with and without PTDM at the 1year post-transplant index time point. We used multivariable logistic regression in determining the risk factors for PTDM. All multivariable analyses were adjusted for the potential confounding effects of maintenance immunosuppression, steroid regimens, and other relevant covariates. 48,031 adult DDKTRs were classified into cohorts based on antibody induction at transplant: (anti-thymocyte globulin) ATG (n = 26, 788); (alemtuzumab) ALM (n = 5916); and interleukin-2 receptor antagonist (IL-2RA) (n = 15,327). PTDM was a risk factor for 5year OAGL and death, not DCGL [(HR = 1.25, CI = 1.16-1.36), (HR = 1.13, CI = 1.06-1.21), and (HR = 1.05, CI = 0.96-1.16); respectively]. Induction regimens were not risk factors for 5year outcomes in DDKTRs with and without PTDM. Risk factors for PTDM included DDKTR obesity, age > / = 50years, acute rejection, and ATG induction, among others. In adult DDKTRs, after controlling the confounding effects of clinically relevant variables including maintenance and steroid regimens, PTDM at 1year post-transplant is associated with death and OAGL, not DCGL in the following 5 years: induction received at KT did not modify these associations.