Organ Procurement And Transplantation Network Research Articles

Impact of the 2016 Organ Procurement and Transplantation Network (OPTN) Pediatric Heart Allocation Policy Change on Use of Durable Ventricular Assist Devices and Heart Transplantation Rates in Children with Congenital Heart Disease versus Cardiomyopathy

<h3>Purpose</h3> In March 2016, the OPTN changed the pediatric heart allocation policy to prioritize congenital heart disease (CHD) patients on high inotropes for 1A listing to increase their heart transplantation (HT) rates than those with cardiomyopathy (CM). This study evaluates the use of durable ventricular assist devices (VADs) and HT in CHD versus CM patients before and after the policy change in the USA. <h3>Methods</h3> All patients ≤18-yrs-old listed for HT between December 2011 and November 2020 were included in the study. The cohort was stratified into those listed before (Era-1) and after (Era-2) the policy change. We analyzed demographics, listing status, ECMO, VADs use, waitlist duration and HT rates between CHD and CM patients. <h3>Results</h3> During the study period, 5,667 patients were listed for HT, with 3108 (55%) in Era-1 and 2559 (45%) in Era-2. Between Era-1 and Era-2, CHD patients were listed 1A in 67% vs 66% and 1B in 17% vs 12% whereas CM patients were listed 1A in 73% vs 49% and 1B in 8% vs 33% (p<0.01) (Table). In Era-2 compared to Era-1, ECMO use decreased in both CHD (5% vs 8%, p<0.01) and CM (6% vs 8%, p<0.01), conversely, durable VADs use increased significantly in both CHD (10% vs 5%, p<0.01) and CM (34% vs 25%, p <0.01) patients. Furthermore, the HT rate within 180 days of listing was unchanged in CHD (<b>53 % vs 51%, p=0.3</b>) and CM patients (<b>63% vs 64%, p=0.4</b>) in Era-2 compared to Era-1 (Figure). The waitlist duration for CHD patients increased from 73 to 83 days (p<0.01), but no significant change in CM patients (66 days). <h3>Conclusion</h3> The current allocation policy has positive impact on the use of VADs in both CHD and CM. However, there was no change in HT rates, no increase in listing as status 1A, and an increase in the waitlist duration among CHD patients. Future studies are needed to analyze the factors for the failure of the intended benefits of pediatric heart allocation policy changes.

Not everything that counts can be counted: Tracking long-term outcomes in pediatric liver transplant recipients

For pediatric liver transplant (LT) recipients, an ideal outcome is to survive and thrive into adulthood. However, outcomes reporting for all LT recipients typically rely on much shorter-term outcomes, 1-5years post-LT. Using Organ Procurement and Transplantation Network (OPTN) registry data from 1990 to 2018, this analysis seeks to determine if long-term follow-up and outcome data are complete for pediatric LT recipients age 0 to 12years who survive at least 1year post-LT without graft loss (n=9309). Of the 7948 pediatric transplant recipients who did not die or require re-LT, 1 in 6 was reported as lost to follow-up by their transplant center during long-term follow-up. Rates of lost to follow-up were highest in those transplanted between 1990 and 1999 and increased in early adulthood for all recipients. Almost 10% of pediatric LT recipients who remained in follow-up required relisting for LT. 8% of children remaining in follow-up had graft failure. Lost to follow-up may bias estimates of long-term outcomes and risk factors for poor outcomes. For those remaining in follow-up, graft failure and death continue to occur in the decades after LT. Continued proactive monitoring, management, and innovations are needed to truly optimize post-LT survival for all children.

One-Year Mortality Is Not a Reliable Indicator of Lung Transplant Center Performance

BackgroundIn the United States, the Organ Procurement and Transplant Network (OPTN) uses 1-year mortality as the primary measure of transplant center quality. We sought to evaluate the reliability of mortality outcomes in lung transplantation and to compare statistical methods of program performance evaluation. MethodsWe used the Standard Transplant Analysis and Research files from the United Network for Organ Sharing to identify lung transplant recipients from 2013 to 2018 in the United States. We stratified hospitals on the basis of 30-day, 1-year, and 5-year survival by risk adjustment, reliability adjustment with empirical Bayes technique, and hierarchical bayesian mixed effects models currently used by the OPTN. We measured variation in mortality rates and identification of performance outliers between techniques. ResultsWe identified 12,769 recipients in 69 centers. Reliability adjustment reduced variation in hospital outcomes and had a large impact on hospital mortality rankings. For example, with 1-year mortality, 28% (5 hospitals) of the “best” hospitals (top 25%) and 18% (3 hospitals) of the “worst” hospitals (bottom 25%) were reclassified after reliability adjustment. The overall reliability of 1-year mortality was low at 0.42. Compared with the bayesian method used by the OPTN, reliability adjustment identified fewer outliers. The 5-year survival reached a higher reliability plateau with a lower volume of cases required. ConclusionsThe reliability of 1-year mortality in lung transplantation is low, whereas 5-year survival estimates may be more reliable at lower case volumes. Reliability adjustment yielded more conservative measures of center performance and fewer outliers compared with current bayesian methods.

OPTN/SRTR 2020 Annual Data Report: COVID

OPTN/SRTR 2020 Annual Data Report: COVID

OPTN/SRTR 2020 Annual Data Report: Introduction

OPTN/SRTR 2020 Annual Data Report: Introduction

OPTN/SRTR 2020 Annual Data Report: VCA

The first vascularized composite allograft (VCA) transplant in the United States was performed in 1998 in a 40-year-old man who received a laryngeal transplant after experiencing severe trauma to the throat 20 years before. The following VCA was a hand transplant in 1999 in a 37-year-old man who lost his left hand 13 years before. Since then, the field of VCA transplantation has made significant strides. On July 3, 2014, the Or gan Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) oversight of VCA procurement and transplant in the United States went into effect. In the last decade, the number of candidates listed for and transplanted with VCA has increased. While patient demographic data, whether listed candidates or patients undergoing VCA transplant, is limited by sample size, the trend is a predominance toward a young/middle-aged, White population. Overall outcomes data have been promising, with the vast majority of VCA transplants resulting in functioning grafts.

Changing opportunities for liver transplant for patients with hepatocellular carcinoma.

Aim was to study the early impact of acuity circle-based allocation implementation system on liver transplantation for hepatocellular carcinoma (HCC) patients. We assessed characteristics of HCC and non-HCC deceased donor orthotopic liver transplants (OLT) in the year before (2/2019-2/2020) and after (3/2020-2/2021) introduction of the acuity circle policy using the Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) database. Total OLTs reduced from 6699 in the preacuity circle era to 6660 in the postacuity circle era (-.6%); this decrease is mostly driven by a decrease in HCC transplants (1529 to 1351; -11.6%). Six out of 11 regions had a reduction in the absolute number and percentage of HCC transplants with significant reductions in regions 2 (-37.8%, p<.001) and 4 (-28.3%, p=.001). The introduction of median model for end-stage liver disease (MELD) at transplant minus 3 (MMaT-3) exception points, has created differential opportunities for HCC patients, in low-MELD as opposed to high-MELD areas, despite having the same disease. This effect has become more prominent following the implementation of acuity circle-based allocation system. Ongoing investigation of these trends is needed to ensure that HCC patients are not disparately disadvantaged due to their location.

Long-term outcomes after repair for anomalous right coronary artery from the pulmonary artery.

Anomalous right coronary artery from pulmonary artery (ARCAPA) is a rare congenital heart disease that can lead to abnormal coronary perfusion and a need for surgical repair. Here, we report the outcomes of patients who underwent ARCAPA surgery within the Pediatric Cardiac Care Consortium (PCCC), a North American registry of interventions for paediatric heart diseases. We queried the PCCC for patients undergoing surgical repair for ARCAPA at <18 years of age between 1982 and 2003. Outcomes were obtained from the PCCC and after linkage with the National Death Index (NDI) and the Organ Procurement and Transplantation Network (OPTN) through 2019. Twenty-four patients (males: 15) were identified having surgery for ARCAPA at a median age of 5.8 (IQR 2.7-10.3) years. Of them, 23 cases were considered "simple" (without major intracardiac disease) and one "complex" (co-existing with tetralogy of Fallot). Five patients presented with symptoms [chest pain (1), dyspnoea on exertion (2) or history of syncope (2)]; while the remaining 19 patients were referred for evaluation of either murmur or co-existing CHD. There was no in-hospital mortality after the surgical repair. Fourteen patients had sufficient identifiers for NDI/OPTN linkage; among them, only one death occurred from unrelated non-cardiac causes within a median period of 19.4 years of follow-up (IQR: 18-24.6). Outcomes were excellent after reimplantation up to 25 years later and further longitudinal monitoring is important to understand the interaction of pre-existing coronary pathology with the effects of ageing.

Donor-derived tuberculosis among solid organ transplant recipients in the United States-2008 to 2018.

Mycobacterium tuberculosis can be transmitted via organ donation and result in severe outcomes. To better understand donor-derived tuberculosis (DDTB), all potential transmissions reported to the Organ Procurement and Transplantation Network (OPTN) Ad Hoc Disease Transmission Advisory Committee between 2008 and 2018 were analyzed. Among 51 total reports, nine (17%) (9 donors/35 recipients) had≥1 recipient with proven/probable disease transmission. Of these, eight were reported due to recipient disease, and one was reported due to a positive donor result. Proven/probable DDTB transmissions were reported in six lung and five nonlung recipients. The median time to diagnosis was 104 days posttransplant (range 0-165 days). Pulmonary TB, extrapulmonary TB, pulmonary plus extrapulmonary TB, and asymptomatic TB infection with positive interferon-gamma release assay were present in five, three, one, and two recipients, respectively. All recipients received treatment and survived except for one whose death was not attributed to TB. All donors associated with proven/probable DDTB had≥1TB risk factor. Six were born in a TB-endemic country, five had traveled to a TB-endemic country, three had been incarcerated, and three had latent TB infection. These cases highlight the importance of evaluating donors for TB based on risk factors. Early posttransplant TB in organ recipients of donors with TB risk factors requires prompt reporting to OPTN to identify other potential affected recipients and implement timely treatment interventions.

Life expectancy without a transplant for status 1A liver transplant candidates

Status 1A liver transplant candidates are given the highest medical priority for the allocation of deceased donor livers. Organ Procurement and Transplantation Network (OPTN) policy requires physicians to certify that a candidate has a life expectancy without a transplant of less than 7days for that candidate to be given status 1A. Additionally, candidates receiving status 1A must have one of six medical conditions listed in policy. Using Scientific Registry of Transplant Recipients data from all prevalent liver transplant candidates from 2010 to 2020, we used a bias-corrected Kaplan-Meier model to calculate the survival of status 1A candidates and to determine their life expectancy without a transplant. We found that status 1A candidates have a life expectancy without a transplant of 24 (95% CI 20-46) days-over three times longer than what policy requires for status 1A designation. We repeated the analysis for subgroups of status 1A candidates based on the medical conditions that grant status 1A. We found that none of these subgroups met the life expectancy requirement. Harmonizing OPTN policy with observed data would sustain the integrity of the allocation process.

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 1year 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.

Misplaced emphasis, misunderstood risk: a cultural history of Public Health Service infectious disease guidelines.

To review and summarize the evolution of the Public Health Service (PHS) guidelines and Organ Procurement and Transplantation Network (OPTN) regulations for the prevention of blood borne virus transmission in solid organ transplant through the lens of popular culture, scientific evolution, patient and practitioner bias and outcomes research. The most recent set of guidelines and regulations were released in 2020 and represent a culmination of decades of opinion, research and debate within the scientific and lay communities. The guidelines were created to address public concern, and the risk of undiagnosed disease transmission in the context of the novel public health crisis of AIDS. We reviewed milestone publications from the scientific and lay press from the first description of AIDS in 1981 to the present to help illustrate the context in which the guidelines were created, the way they changed with subsequent editions, and offer critical consideration of issues with the current set of guidelines and a potential way forward. Further consideration should be given to the way in which the current guidelines identify donors with risk criteria for infectious disease transmission and mandate explanation of donor-specific risk factors to potential recipients, in our era of universal donor screening and recipient surveillance.

Kidney transplant program specific reporting and transplant metrics.

Kidney transplantation is a heavily regulated medical procedure with the Secretary of HHS ultimately responsible for oversight and authority derived from the NOTA and the Final Rule. Transplant Programs undergo publicly reported evaluations every 6 months based on outcomes from a 2-and-a-half-year period. The current Bayesian metrics for kidney transplant programs were created such that over ten percentage of programs are deemed underperformers, or 'flag', every 6 months. Newly suggested transplant metrics have been released for public comment in Summer 2021. In addition to graft outcomes, waiting list mortality and organ acceptance rate ratios are proposed. Under the newly proposed kidney transplant metrics, over 10% of programs are expected to be deemed underperformers or 'flagged'. Transplant Center flagging is well correlated with decreased transplantation due to the transplant centres move to more conservative organ and patient acceptance. Death on the waiting list is a proposed metric over which transplant centres have little influence. In the USA, the harsh regulation continued by Health Resources and Services Administration (HRSA) through the national organ procurement and transplant network (OPTN) and Scientific Registry for Transplant Recipients (SRTR) leads directly to high organ discard rates and limitations to transplanting patients with perceived unadjusted risks. Instead of loosening regulation in a highly functioning industry that achieves remarkable outcomes in end stage kidney patients, the OPTN with the SRTR persist in increasing potential penalties through more proposed metrics that continue to deem 10% of US kidney transplant programs as underperformers. HRSA must establish a reasonable regulatory environment that allows for innovation and increased transplant opportunities for US end-stage renal disease patients.

Transplant surgery departmental leaders do not represent workforce demographics especially among women and underrepresented minorities — A retrospective analysis

IntroductionThe diversity among surgical directors for liver, kidney, and pancreas transplant departments has not been previously evaluated. We aim to quantify the sex and racial demographics of transplant department leaders and assess the impact on patient outcomes. MethodsDemographics were collected for 116 liver, 192 kidney, and 113 pancreas transplant directors using Organ Procurement and Transplantation Network (OPTN) directory and program websites. Scientific Registry of Transplant Recipients (SRTR) 5-tier program outcomes rankings were obtained for each program and matched to leader demographics. A retrospective analysis of transplant recipients from 2010 to 2019 was performed using the United Network for Organ Sharing (UNOS) database. Results91.5% of transplant surgical directors were male. 55% of departments had a Non-Hispanic White leader. Asian, Hispanic and Black transplant chiefs were at the helm of 23.3%, 9%, and 5% of divisions respectively. Multivariate cox regression analysis did not identify any differences in patient outcomes by transplant director demographics. ConclusionThere is a paucity of female and URM leaders in transplant surgery. Initiatives to promote research, mentorship, and career advancement opportunities for women and URM are necessary to address the current leadership disparity.

Opportunity to increase deceased donation for United States veterans

Recent changes to organ procurement organization (OPO) performance metrics have highlighted the need to identify opportunities to increase organ donation in the United States. Using data from the Organ Procurement and Transplantation Network (OPTN), Scientific Registry of Transplant Recipients (SRTR), and Veteran Health Administration Informatics and Computing Infrastructure Clinical Data Warehouse (VINCI CDW), we sought to describe historical donation performance at Veteran Administration Medical Centers (VAMCs). We found that over the period 2010-2019, there were only 33 donors recovered from the 115VAMCs with donor potential nationwide. VA donors had similar age-matched organ transplant yields to non-VA donors. Review of VAMC records showed a total of 8474 decedents with causes of death compatible with donation, of whom 5281had no infectious or neoplastic comorbidities preclusive to donation. Relative to a single state comparison of adult non-VA inpatient deaths, VAMC deaths were 20 times less likely to be characterized as an eligible death by SRTR. The rate of conversion of inpatient donation-consistent deaths without preclusive comorbidities to actual donors at VAMCs was 5.9% that of adult inpatients at non-VA hospitals. Overall, these findings suggest significant opportunities for growth in donation at VAMCs.

Kidney transplant outcomes in children and adolescents with systemic lupus erythematosus.

Literature supports equivalent kidney transplant outcomes in adults with systemic lupus erythematosus (SLE) compared with those without SLE. However, there are conflicting and scant data on kidney transplant outcomes, as well as controversy over optimal timing of transplantation, in children and adolescents with SLE. Analysis included kidney-only transplant recipients aged 2-21years from 2000 to 2017 enrolled in the Organ Procurement and Transplant Network (OPTN). The relationship between diagnosis (SLE n = 457, non-SLE glomerular disease n = 4492, and non-SLE non-glomerular disease n = 5605) and transplant outcomes was evaluated. The association between dialysis time and outcomes was analyzed in the SLE group only. In adjusted models, SLE had higher mortality compared with non-SLE glomerular recipients (HR 1.24 CI 1.07-1.44) and non-glomerular recipients (HR 1.42 CI 1.20-1.70). SLE was associated with higher graft failure compared with non-SLE glomerular (HR 1.42 CI 1.20-1.69) and non-glomerular disease (HR 1.67 CI 1.22-2.28). SLE had a higher risk of acute rejection at 1year compared with non-glomerular disease (HR 1.39 CI 1.03-1.88). There was a decreased risk of delayed graft function compared with non-SLE glomerular disease (HR 0.54, CI 0.36-0.82). There were no significant associations between dialysis time and transplant outcomes in the SLE group. SLE in children and adolescents is associated with worse patient and graft survival compared with non-SLE diagnoses. Outcomes in children and adolescents with SLE are not associated with dialysis time. Further studies are needed to assess implications of potential earlier transplantation and shorter time on dialysis prior to transplantation.

Impact of the Share 35 Policy on Perioperative Management and Mortality in Liver Transplantation Recipients.

BackgroundThe Share 35 policy was introduced in 2013 by the Organ Procurement and Transplantation Network (OPTN) to increase opportunities of sicker patients to access liver transplantation. However, it has the disadvantage of higher MELD score associated with adverse postoperative transplant outcomes. Early data after implementation of the Share 35 policy showed significantly poorer post-transplantation survival in some UNOS regions. We aimed to analyze the impact of Share 35 on demographics of patients, perioperative management, and perioperative mortality.Material/MethodsA retrospective analysis of data was performed from an institutional liver transplantation cohort from 1 January 2008 to 31 December 2017. Adult patients who underwent liver transplantation before 2013 were defined as the pre-Share 35 group and the other group was defined as the post-Share 35 group. The MELD score of each patient was calculated at the time of transplantation. Perioperative mortality was defined as death within 30 days after the operation.ResultsA total of 1596 patients underwent liver transplantation. Of those, 895 recipients underwent OLT in the pre-Share 35 era and 737 in the post-Share 35 era. The median MELD score was significantly higher in the post-Share 35 group (30 vs 26, P<0.001) and 45.7% of the post-Share 35 group had MELD scores ≥35. In intraoperative management, patients required significantly more blood component transfusion, intraoperative vasopressor, and fluid replacement. Veno-venous bypass (VVB) usage was significantly higher in the post-Share 35 era (47.2% vs 38.1%, P<0.001). In the subgroup of patients with MELD scores ≥35, the median waiting time was significantly shorter (18.5 vs 14.5 days, P=0.045). Overall perioperative mortality was not significantly difference between groups (P=0.435).ConclusionsAfter implementation of the Share 35 policy, we performed liver transplantation in significantly higher medical acuity patients, which required more medical resources to obtain a result comparable to that of the pre-Share 35 era.

In with the new and, mostly better: Considering the OPTN blood-borne virus policy updates

The Organ Procurement and Transplantation Network (OPTN) has recently updated their policies1 related to donors with risk criteria for blood-borne viruses (BBV) and their organ recipients to align with the 2020 U.S. Public Health Service (PHS) guidelines2 . Some of the new policies are anticipated to offer benefits, such as mandating hepatitis B virus vaccination in transplant candidates. Other new policies raise challenges with transplant candidate BBV screening, nomenclature, and the consent process. We would like to highlight some of these issues and discuss potential solutions.

Machine Learning Prediction of Liver Allograft Utilization From Deceased Organ Donors Using the National Donor Management Goals Registry.

Several machine learning classifiers were trained to predict transplantation of a liver graft. We utilized 127 variables available in the DMG dataset. We included data from potential deceased organ donors between April 2012 and January 2019. The outcome was defined as liver recovery for transplantation in the operating room. The prediction was made based on data available 12-18 h after the time of authorization for transplantation. The data were randomly separated into training (60%), validation (20%), and test sets (20%). We compared the performance of our models to the Liver Discard Risk Index. Of 13 629 donors in the dataset, 9255 (68%) livers were recovered and transplanted, 1519 recovered but used for research or discarded, 2855 were not recovered. The optimized gradient boosting machine classifier achieved an area under the curve of the receiver operator characteristic of 0.84 on the test set, outperforming all other classifiers. This model predicts successful liver recovery for transplantation in the operating room, using data available early during donor management. It performs favorably when compared to existing models. It may provide real-time decision support during organ donor management and transplant logistics.

The Dark Side of Chasing the Perfect Donor. Is it Time for Us to Change Cardiac Transplant Program Performance Metrics?

The Dark Side of Chasing the Perfect Donor. Is it Time for Us to Change Cardiac Transplant Program Performance Metrics?