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

Abstract

<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.