Dataset Information

Comparing outcomes for infiltrative and restrictive cardiomyopathies under the new heart transplant allocation system.

ABSTRACT: The new heart transplantation (HT) allocation policy was introduced on 10/18/2018. Using the UNOS registry, we examined early outcomes following HT for restrictive cardiomyopathy, hypertrophic cardiomyopathy, cardiac sarcoidosis, or cardiac amyloidosis compared to the old system. Those listed who had an event (transplant, death, or waitlist removal) prior to 10/17/2018 were in Era 1, and those listed on or after 10/18/2018 were in Era 2. The primary endpoint was death on the waitlist or delisting due to clinical deterioration. A total of 1232 HT candidates were included, 855 (69.4%) in Era 1 and 377 (30.6%) in Era 2. In Era 2, there was a significant increase in the use of temporary mechanical circulatory support and a reduction in the primary endpoint, (20.9 events per 100 PY (Era 1) vs. 18.6 events per 100 PY (Era 2), OR 1.98, p = .005). Median waitlist time decreased (91 vs. 58 days, p < .001), and transplantation rate increased (119.0 to 204.7 transplants/100 PY for Era 1 vs Era 2). Under the new policy, there has been a decrease in waitlist time and waitlist mortality/delisting due to clinical deterioration, and an increase in transplantation rates for patients with infiltrative, hypertrophic, and restrictive cardiomyopathies without any effect on post-transplant 6-month survival.

SUBMITTER: Griffin JM

PROVIDER: S-EPMC7755228 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Comparing outcomes for infiltrative and restrictive cardiomyopathies under the new heart transplant allocation system.

Griffin Jan M JM DeFilippis Ersilia M EM Rosenblum Hannah H Topkara Veli K VK Fried Justin A JA Uriel Nir N Takeda Koji K Farr Maryjane A MA Maurer Mathew S MS Clerkin Kevin J KJ

Clinical transplantation 20201028 12

The new heart transplantation (HT) allocation policy was introduced on 10/18/2018. Using the UNOS registry, we examined early outcomes following HT for restrictive cardiomyopathy, hypertrophic cardiomyopathy, cardiac sarcoidosis, or cardiac amyloidosis compared to the old system. Those listed who had an event (transplant, death, or waitlist removal) prior to 10/17/2018 were in Era 1, and those listed on or after 10/18/2018 were in Era 2. The primary endpoint was death on the waitlist or delistin ...[more]

PMID: 33048376

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Project description:ImportanceThe US heart allocation policy was changed on October 18, 2018. The association of this change with recipient and donor selection and outcomes remains to be elucidated.ObjectiveTo evaluate changes in patient characteristics, wait list outcomes, and posttransplant outcomes after the recent allocation policy change in heart transplant.Design, setting, and participantsIn this cohort study, all 15 631 adults undergoing heart transplants, excluding multiorgan transplants, in the US as identified by the United Network for Organ Sharing multicenter, national registry were reviewed. Patients were stratified according to prepolicy change (October 1, 2015, to October 1, 2018) and postpolicy change (October 18, 2018 or after). Follow-up data were available through March 31, 2020.ExposuresHeart transplants after the policy change.Main outcomes and measuresCompeting risk regression for wait list outcomes was performed. Posttransplant survival was compared using the Kaplan-Meier method, and risk adjustment was performed using multivariable Cox proportional hazards regression analysis.ResultsIn this cohort study, of the 15 631 patients undergoing transplant, 10 671 (mean [SD] age, 53.1 [12.7] years; 7823 [73.3%] male) were wait listed before and 4960 (mean [SD] age, 52.7 [13.0] years; 3610 [72.8%] male) were wait listed after the policy change. Competing risk regression demonstrated reduced likelihood of mortality or deterioration (subhazard ratio [SHR], 0.60; 95% CI, 0.52-0.69; P < .001), increased likelihood of transplant (SHR, 1.38; 95% CI, 1.32-1.45; P < .001), and reduced likelihood of recovery (SHR, 0.54; 95% CI, 0.40-0.73; P < .001) for wait listed patients after the policy change. A total of 6078 patients underwent transplant before and 2801 after the policy change. Notable changes after the policy change included higher frequency of bridging with temporary mechanical circulatory support and lower frequency of bridging with durable left ventricular assist devices. Posttransplant survival was reduced after the policy change (1-year: 92.1% vs 87.5%; log-rank P < .001), a finding that persisted after risk adjustment (HR, 1.29; 95% CI, 1.07-1.55; P = .008).Conclusions and relevanceSubstantial changes have occurred in adult heart transplant in the US after the policy change in October 2018. Wait list outcomes have improved, although posttransplant survival has decreased. These data confirm findings from earlier preliminary analyses and demonstrate that these trends have persisted to 1-year follow-up, underscoring the importance of continued reevaluation of the new heart allocation policy.

Project description:In October 2018, the allocation policy for adult orthotopic heart transplant (OHTx) in the United States was changed, with the goal of reducing waitlist mortality and providing broader sharing of donor organs within the United States. This study aimed to assess the association of this policy change with changes in access to OHTx versus left ventricular assist devices (LVADs), overall and in key sociodemographic subgroups, in the United States from 2016 to 2019. We identified all patients receiving OHTx or LVAD between 2016 and 2019 using the National Inpatient Sample. Controlling for medical co-morbidities, prepolicy trends, and within-hospital-year effects, we fit a dynamic logistic regression model to evaluate patient and hospital factors associated with receiving OHTx versus LVAD before versus after policy change. We also examined the frequency of temporary mechanical circulatory support in the same fashion. We identified 2,264 patients who received OHTx and 3,157 who received LVADs during the study period. In its first year of implementation, the United Network for Organ Sharing policy change of 2018 was associated with no overall change utilization of OHTx versus LVAD. In OHTx recipients, the frequency of use of temporary mechanical circulatory support changed from 15.6% in the before period to 42.6% in the after period (p <0.001). Although the policy change was associated with differences in the odds of receiving an OHTx versus LVAD between different regions of the country, there were no significant changes based on age, gender, race/ethnicity, insurance status, or rurality. In conclusion, the United Network for Organ Sharing policy change on access to OHTx was associated with no overall change in OHTx versus LVAD use in its first year of implementation although we observed small changes in relative odds of transplant based on rurality. Shifts in regional allocation were not significant overall, although certain regions appeared to have a relative increase in their use of OHTx.

Project description:ImportanceWide state-level variability in waiting list outcomes have been noted for patients listed for heart transplant in the US, but little is known regarding center-level transplant rates since the heart allocation policy change.ObjectiveTo evaluate center-level transplant rates following the recent allocation policy change for heart transplant.Design, setting, and participantsThis cohort study used data from the United Network for Organ Sharing database from October 18, 2015, to March 1, 2020, for a nationwide analysis of transplant centers in the US. Transplant candidates were stratified into 2 time cohorts, with era 1 denoting the 3-year period before the policy change (October 18, 2018), and era 2 representing the 500-day period after the policy change but before the beginning of the COVID-19 pandemic. Data were analyzed from May to June 2021.ExposureThe heart allocation policy change enacted on October 18, 2018.Main outcomes and measuresCompeting risk regression for waiting list outcomes was performed to calculate adjusted era 1 and era 2 center-level transplant rates. Rates were compared across regions and states, as well as within organ procurement organizations. Pearson correlation coefficient was used to assess center-level factors associated with era 2 transplant rates.ResultsOf 15 940 transplant candidates included for analysis, 5063 (median [IQR] age, 56 [45-63] years; 1385 women [27.4%]) comprised the era 2 cohort. The proportion of patients with temporary mechanical circulatory support increased between era 1 and era 2 (extracorporeal membrane oxygenation, 2.00% vs 3.42%; percutaneous ventricular assist device, 0.66% vs 1.86%; intra-aortic balloon pump, 5.21% vs 13.10%). The adjusted mean center-level likelihood of transplant increased after the rule change (from 48.1% in era 1 to 78.0% in era 2). Significant variation in transplant rates was observed across regions and states even among centers with shared organ procurement organizations. The largest absolute difference in transplant rates was 27.1% for 2 centers belonging to the same organ procurement organization. Centers with higher transplant volumes in era 2 and with a greater proportion of candidates with intra-aortic balloon pump were observed to have higher transplant rates.Conclusions and relevanceDespite sharing organ supply and having a small geographical distance, these findings suggest that intercenter disparities in the likelihood of transplant have persisted following the heart allocation policy change. Further work is necessary to ensure equitable allocation of organs in heart transplant.

Dataset Information

Comparing outcomes for infiltrative and restrictive cardiomyopathies under the new heart transplant allocation system.

Publications

Comparing outcomes for infiltrative and restrictive cardiomyopathies under the new heart transplant allocation system.

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