Comparing outcomes for infiltrative and restrictive cardiomyopathies under the new heart transplant allocation system.
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ABSTRACT:
SUBMITTER: Griffin JM
PROVIDER: S-EPMC7755228 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundPatients with restrictive or hypertrophic cardiomyopathy (RCM/HCM) and congenital heart disease (CHD) do not derive clinical benefit from inotropes and mechanical circulatory support. Concerns were expressed that the new heart allocation system implemented in October 2018 would disadvantage these patients. This paper aimed to examine the impact of the new adult heart allocation system on transplantation and outcomes among patients with RCM/HCM/CHD.MethodsWe identified adult patients with RCM/HCM/CHD in the United Network for Organ Sharing (UNOS) database who were listed for or received a cardiac transplant from April 2017-June 2020. The cohort was separated into those listed before and after allocation system changes. Demographics and recipient characteristics, donor characteristics, waitlist survival, and post-transplantation outcomes were analyzed.ResultsThe number of patients listed for RCM/HCM/CHD increased after the allocation system change from 429 to 517. Prior to the change, the majority RCM/HCM/CHD patients were Status 1A at time of transplantation; afterwards, most were Status 2. Wait times decreased significantly for all: RCM (41 days vs 27 days; P<0.05), HCM (55 days vs 38 days; P<0.05), CHD (81 days vs 49 days; P<0.05). Distance traveled increased for all: RCM (76 mi. vs 261 mi, P<0.001), HCM (88 mi. vs 231 mi. P<0.001), CHD (114 mi vs 199 mi, P<0.05). Rates of transplantation were higher for RCM and CHD (P<0.01), whereas post-transplant survival remained unchanged.ConclusionsThe new allocation system has had a positive impact on time to transplantation of patients with RCM, HCM, and CHD without negatively influencing survival.
| S-EPMC7924739 | biostudies-literature
Project description:BackgroundThis study evaluated the current clinical trends, risk factors, and temporal effects of post-transplant dialysis on outcomes following orthotopic heart transplantation after the 2018 United States adult heart allocation policy change.MethodsThe United Network for Organ Sharing (UNOS) registry was queried to analyze adult orthotopic heart transplant recipients after the October 18, 2018 heart allocation policy change. The cohort was stratified according to the need for post-transplant de novo dialysis. The primary outcome was survival. Propensity score-matching was performed to compare the outcomes between 2 similar cohorts with and without post-transplant de novo dialysis. The impact of post-transplant dialysis chronicity was evaluated. Multivariable logistic regression was performed to identify risk factors for post-transplant dialysis.ResultsA total of 7,223 patients were included in this study. Out of these, 968 patients (13.4%) developed post-transplant renal failure requiring de novo dialysis. Both 1-year (73.2% vs 94.8%) and 2-year (66.3% vs 90.6%) survival rates were lower in the dialysis cohort (p < 0.001), and the lower survival rates persisted in a propensity-matched comparison. Recipients requiring only temporary post-transplant dialysis had significantly improved 1-year (92.5% vs 71.6%) and 2-year (86.6 % vs 52.2%) survival rates compared to the chronic post-transplant dialysis group (p < 0.001). Multivariable analysis demonstrated low pretransplant estimated glomerular filtration (eGFR) and bridge with extracorporeal membrane oxygenation (ECMO) were strong predictors of post-transplant dialysis.ConclusionsThis study demonstrates that post-transplant dialysis is associated with significantly increased morbidity and mortality in the new allocation system. Post-transplant survival is affected by the chronicity of post-transplant dialysis. Low pretransplant eGFR and ECMO are strong risk factors for post-transplant dialysis.
| S-EPMC10591214 | biostudies-literature
Project description:ObjectiveThe effects of recipient body mass index (BMI) on waitlist strategies, waitlist outcomes, and post-transplant outcomes among adult patients listed for heart transplantation under the updated 2018 allocation system have not been well characterized.MethodsThe United Network of Organ Sharing data set between October 2015 and March 2021 was analyzed, and patients were grouped based on recipient BMI and whether listing occurred in the old (pre-October 2018) or new allocation system.ResultsListing strategies differed by BMI group, but trends of increased use of temporary mechanical support and decreased use of durable support remained among all BMI groups, except those with BMI > 35 kg/m2 . Waitlist outcomes improved among all BMI cohorts in the new allocation system, including among patients with BMI 30-34.9 and >35 kg/m2 , although patients with higher BMIs continued to have longer waitlist times. Post-transplant outcomes in the new allocation system are worse for patients with BMI > 30 kg/m2 (hazard ratio: 1.47; confidence interval: 1.19-1.82; p < .001).ConclusionsThe 2018 change to the heart transplant allocation system was associated with similar changes in the use of mechanical support for listing strategy across BMI ranges, except in the most obese, and improved waitlist outcomes across all BMI ranges. Post-transplant outcomes in the new allocation system are worse for patients with BMI > 30 kg/m2 compared to patients with BMI < 30 kg/m2 . These findings have important clinical implications for our understanding of the ongoing influence of BMI on waitlist courses and post-transplant outcomes among patients listed for heart transplantation.
| S-EPMC9320797 | biostudies-literature
Project description:BACKGROUND:Patients with restrictive cardiomyopathy (RCM) and hypertrophic cardiomyopathy (HCM) generally are considered poor candidates for mechanical circulatory support devices (MCSDs) and often not able to be bridged mechanically to heart transplantation. This study characterized MCSD utilization and transplant waitlist outcomes in patients with RCM/HCM under the current allocation system and discusses changes in the era of the new donor allocation system. METHODS AND RESULTS:Patients waitlisted from 2006 to 2016 in the United Network for Organ Sharing registry were stratified by RCM/HCM versus other diagnoses. MCSD utilization and waitlist duration were analyzed by propensity score models. Waitlist outcomes were assessed by cumulative incidence functions with competing events. Predictors of waitlist mortality or delisting for worsening status in patients with RCM/HCM were identified by proportional hazards model. Of 30?608 patients on the waitlist, 5.1% had RCM/HCM. Patients with RCM/HCM had 31 fewer waitlist days (P<0.01) and were ?26% less likely to receive MCSD (P<0.01). Cumulative incidence of waitlist mortality was similar between cohorts; however, patients with RCM/HCM had higher incidence of heart transplantation. Predictors of waitlist mortality or delisting for worsening status in patients with RCM/HCM without MCSD support included estimated glomerular filtration rate <60 mL/min per 1.73 m2, pulmonary capillary wedge pressure >20 mm?Hg, inotrope use, and subjective frailty. CONCLUSIONS:Patients with RCM/HCM are less likely to receive MCSD but have similar waitlist mortality and slightly higher incidence of transplantation compared with other patients. The United Network for Organ Sharing RCM/HCM risk model can help identify patients who are at high risk for clinical deterioration and in need of expedited heart transplantation.
| S-EPMC5905429 | biostudies-literature
Project description:BackgroundAn early report of recipient heart transplantation outcomes under the new U.S. heart allocation system introduced in late 2018 found a lower post-transplant survival rate compared with that of the prior system.ObjectivesThe aim of this study was to examine recipient survival under the new system by using an updated dataset.MethodsThe 2015 to 2019 United Network for Organ Sharing registry was queried for adult heart transplant recipients, stratified according to whether the subjects were listed and underwent transplant before or after October 18, 2018, when the new allocation system was implemented. The association between allocation system and recipient mortality was analyzed by using the Kaplan-Meier method and multivariable Cox proportional hazards regression.ResultsA total of 7,119 recipients met inclusion criteria: 6,004 (84%) and 1,115 (16%) listed and undergoing transplant in the old and new allocation systems, respectively. This registry update included 576 new-system recipients, more than double the amount previously analyzed. Recipients from the new system were more likely to be bridged to transplant with temporary mechanical circulatory support devices instead of durable left ventricular assist devices and had longer graft ischemic times. After adjustment, the new system was not associated with poorer survival on Kaplan-Meier survival analysis (log-rank test; p = 0.075) or multivariable Cox proportional hazards modeling (adjusted hazard ratio: 1.18; 95% confidence interval: 0.90 to 1.55).ConclusionsThe short-term survival of recipients listed and receiving a transplant under the old and new allocation systems seems to be comparable. The modification to the allocation system has resulted in several changes to the clinical profiles of patients undergoing transplants that must be closely monitored in the coming years.
| S-EPMC7335324 | biostudies-literature
Project description:Lung transplantation is a specialized procedure used to treat chronic end-stage respiratory diseases. Due to the scarcity of lung donors, constructing fair and equitable lung transplant allocation methods is an issue that has been addressed with different strategies worldwide. This work aims to describe how Italy's "national protocol for the management of surplus organs in all transplant programs" functions through an online app to allocate lung transplants. We have developed two probability models to describe the allocation process among the various transplant centers. An online app was then created. The first model considers conditional probabilities based on a protocol flowchart to compute the probability for each area and transplant center to receive each n-th organ in the period considered. The second probability model is based on the generalization of the binomial distribution to correlated binary variables, which is based on Bahadur's representation, to compute the cumulative probability for each transplant center to receive at least nth organs. Our results show that the impact of the allocation of a surplus organ depends mostly on the region where the organ was donated. The discrepancies shown by our model may be explained by a discrepancy between the northern and southern regions in relation to the number of organs donated.
| S-EPMC8296876 | biostudies-literature
Project description:BackgroundIn October 2018, the U.S. heart allocation system expanded the number of priority "status" tiers from 3 to 6 and added cardiogenic shock requirements for some heart transplant candidates listed with specific types of treatments.ObjectivesThis study sought to determine the impact of the new policy on the treatment practices of transplant centers.MethodsInitial listing data on all adult heart candidates listed from December 1, 2017 to April 30, 2019 were collected from the Scientific Registry of Transplant Recipients. The status-qualifying treatments (or exception requests) and hemodynamic values at listing of a post-policy cohort (December 2018 to April 2019) were compared with a seasonally matched pre-policy cohort (December 2017 to April 2018). Candidates in the pre-policy cohort were reclassified into the new priority system statuses by using treatment, diagnosis, and hemodynamics.ResultsComparing the post-policy cohort (N = 1,567) with the pre-policy cohort (N = 1,606), there were significant increases in listings with extracorporeal membrane oxygenation (+1.2%), intra-aortic balloon pumps (+ 4 %), and exceptions (+ 12%). Listings with low-dose inotropes (-18%) and high-dose inotropes (-3%) significantly decreased. The new priority status distribution had more status 2 (+14%) candidates than expected and fewer status 3 (-5%), status 4 (- 4%) and status 6 (-8%) candidates than expected (p values <0.01 for all comparisons).ConclusionsAfter implementation of the new heart allocation policy, transplant centers listed more candidates with extracorporeal membrane oxygenation, intra-aortic balloon pumps, and exception requests and fewer candidates with inotrope therapy than expected, thus leading to significantly more high-priority status listings than anticipated. If these early trends persist, the new allocation system may not function as intended.
| S-EPMC7304520 | biostudies-literature
Project description:BackgroundThe purpose of the study was to characterize changes in waitlist and post-transplant outcomes of extracorporeal membrane oxygenation (ECMO) patients bridged to heart transplantation under the 2018 adult heart allocation policy.MethodsAll adult patients listed for isolated heart transplantation from August 2016 to December 2020 were identified using the United Network for Organ Sharing database. Patients were stratified into Eras (Era 1 and Era 2) centered around the policy change on October 18, 2018. Competing risk regression was used to evaluate waitlist death or deterioration across Eras. Cox proportional hazards models were used to determine associations between use of ECMO and 1-year post-transplant mortality within each Era.ResultsOf 8,902 heart transplants included in analysis, 339 (3.8%) were bridged with ECMO (Era 2: 6.1% vs Era 1: 1.2%, P<0.001). Patients bridged with ECMO in Era 2 were less frequently female (26.0% vs 42.0%, P = 0.02) and experienced shorter waitlist times (5 vs 11 days, P<0.001) along with a lower likelihood of waitlist death or deterioration (subdistribution hazard ratio, 0.45, 95% confidence interval, CI, 0.30-0.68, P<0.001) compared to those in Era 1. Use of ECMO was associated with increased post-transplant mortality at 1-year compared to all other transplants in Era 1 (hazard ratio 3.78, 95% CI 1.88-7.61, P < 0.001) but not Era 2.ConclusionsPatients bridged with ECMO in Era 2 experience improved waitlist and post-transplant outcomes compared to Era 1, giving credence to the increased use of ECMO under the new allocation policy.
| S-EPMC9122227 | biostudies-literature
Project description:BackgroundPatients with blood group O have historically been disadvantaged in the United Network for Organ Sharing (UNOS) heart transplant allocation system. We sought to determine whether the new UNOS allocation system implemented in 2018 had an impact on waitlist and post-transplant outcomes among blood groups.MethodsUsing the UNOS database we included all adult patients listed and transplanted with first-time single-organ heart transplant between 10/17/15 and 10/1/21. For post-transplant outcomes, we separately evaluated all adult patients transplanted with the same time-frame. We used exclusion criteria and censoring to limit biases from changing clinical practices around the allocation change (10/18/2018), and from unequal or inadequate follow-up. We compared clinical characteristics and outcomes before and after the allocation change among each blood group. Fine-Gray and Cox regression models were used to estimate the effect of the new allocation system on competing waitlist outcomes- transplantation, death-or-removal from waitlist- and post-transplant survival, respectively.ResultsOf the 21,565 patients listed for transplantation 14,000 met criteria for waitlist analysis (7,035 in the old system vs. 6,965 in the new), and 7,657 met criteria for post-transplant analysis (3,519 in the old system vs. 4,138 in the new). Among each blood group, new allocation change was associated with higher transplantation rates lower waitlist days and lower waitlist mortality (except Group AB). However, despite improvements, Group O was still associated with worse waitlist outcomes for each metric compared to non-O Groups. The new allocation system did not have a significant impact on post-transplant survival among any blood groups.ConclusionChanges in heart transplant allocation have attenuated but not eliminated blood group O disadvantage in access to donor hearts.
| S-EPMC9285771 | biostudies-literature
Project description:BackgroundThe opioid crisis has led to an increase in available donor hearts, although questions remain about the long-term outcomes associated with the use of these organs. Prior studies have relied on historical information without examining the toxicology results at the time of organ offer. The objectives of this study were to examine the long-term survival of heart transplants in the recent era, stratified by results of toxicological testing at the time of organ offer as well as comparing the toxicology at the time of donation with variables based on reported history.MethodsThe United Network for Organ Sharing database was requested as well as the donor toxicology field. Between 2007 and 2017, 23 748 adult heart transplants were performed. United Network for Organ Sharing historical variables formed a United Network for Organ Sharing Toxicology Score and the measured toxicology results formed a Measured Toxicology Score. Survival was examined by the United Network for Organ Sharing Toxicology Score and Measured Toxicology Score, as well as Cox proportional hazards models incorporating a variety of risk factors.ResultsThe number and percent of donors with drug use has significantly increased over the study period (P<0.0001). Cox proportional hazards modeling of survival including toxicological and historical data did not demonstrate differences in post-transplant mortality. Combinations of drugs identified by toxicology were not associated with differences in survival. Lower donor age and ischemic time were significantly positively associated with survival (P<0.0001).ConclusionsAmong donors accepted for transplantation, neither history nor toxicological evidence of drug use was associated with significant differences in survival. Increasing use of such donors may help alleviate the chronic donor shortage.
| S-EPMC8366767 | biostudies-literature