Effect of patient factors, center, and era on Fontan timing: An observational study using the Pediatric Health Information Systems Database

Abstract

BackgroundThere are no consensus guidelines defining optimal timing for the Fontan operation, the last planned surgery in staged palliation for single-ventricle heart disease. ObjectivesIdentify patient-level characteristics, center-level variation, and secular trends driving Fontan timing. MethodsA retrospective observational study of subjects who underwent Fontan from 2007-2021 at centers in the Pediatric Health Information Systems database was performed using linear mixed-effects modeling in which age at Fontan was regressed on patient characteristics and date of operation with center as random effect. ResultsWe included 10,305 subjects (40.4% female, 44% non-white) at 47 centers. Median age at Fontan was 3.4 years (IQR 2.6-4.4). Hypoplastic left heart syndrome (-4.4 months, 95% CI -5.5 to -3.3) and concomitant conditions (-2.6 months, 95% CI -4.1 to -1.1) were associated with younger age at Fontan. Subjects with technology-dependence (+4.6 months, 95% CI 3.1 to 6.1) were older at Fontan. Black (+4.1 months, 95% CI 2.5 to 5.7) and Asian (+8.3 months, 95% CI 5.4 to 11.2) race were associated with older age at Fontan. There was significant variation in Fontan timing between centers. Center accounted for 10% of variation (ICC 0.10, 95% CI 0.07 to 0.14). Center surgical volume was not associated with Fontan timing (p=0.21). Operation year was associated with age at Fontan, with a 3.1 month increase in age for every 5 years (+0.61 months, 95% CI 0.48 to 0.75). ConclusionsAfter adjusting for patient-level characteristics there remains significant inter-center variation in Fontan timing. Age at Fontan has increased. Future studies addressing optimal Fontan timing are warranted.