Abstract 1933: Aprotinin is Not Associated With Renal Failure or Increased Mortality in Children Undergoing Congenital Heart Surgery
Background: Aprotinin was used frequently in children undergoing congenital heart surgery until it was taken off the market in 2007 following studies demonstrating increased mortality and renal failure in adults. Small case series suggest that aprotinin may not be associated with these adverse outcomes in children; thus there is interest in further study of aprotinin in this population. We evaluated the safety of aprotinin in a large cohort undergoing congenital heart surgery.
Methods: The Pediatric Health Information Systems Database was utilized to evaluate use of aprotinin in children (0 –18y) undergoing congenital heart surgery at 35 US children’s hospitals from 2003–2007. Those who received other antifibrinolytic agents during surgery were excluded. Propensity scores were constructed to account for potential confounding including age, sex, race, prematurity, genetic syndrome, type of surgery [using the Risk Adjustment in Congenital Heart Surgery (RACHS) method], center, and center volume. Multivariable analysis adjusting for propensity score, individual covariates, and within center clustering was performed to evaluate in-hospital mortality and post-operative morbidity, including renal failure requiring dialysis.
Results: A total of 38,150 patients were included: 56% male, median age 6m (interquartile range 36d - 2.9y). Overall, 62% of patients received aprotinin (range 0 –79% of patients/center). Aprotinin use was associated with older age, higher RACHS category, and smaller center volume. Unadjusted in-hospital mortality was 3.4%, and 1.1% of patients received post-operative dialysis. In multivariable analysis, there was no difference in in-hospital mortality (adjusted OR 1.0, 95% CI 0.99 –1.01) or post-operative dialysis (adjusted OR 1.0, 95% CI 0.99 –1.01) among aprotinin recipients and non-recipients.
Conclusions: Use of aprotinin in children undergoing congenital heart surgery varied widely by center. In contrast to adult studies, our analysis suggests that aprotinin is not associated with increased mortality or dialysis in children. These observational data suggest further study of the efficacy and safety of aprotinin in children undergoing congenital heart surgery may be warranted, and would not pose undue risk.