Aprotinin is safe in pediatric patients undergoing cardiac surgery.

OBJECTIVE: Aprotinin, a serine protease inhibitor, decreases transfusion requirements and inflammatory response after cardiopulmonary bypass. This study was done to determine whether aprotinin is associated with adverse outcomes, particularly mortality and acute kidney failure, in pediatric patients (<18 years of age) undergoing cardiopulmonary bypass.
METHODS: We compared a cohort of all pediatric cardiopulmonary bypass operations from 1994-1999, when aprotinin was not used (n = 1230), with a cohort from 2000-2006, when all patients received high-dose aprotinin (n = 1251). Primary end points were operative and late mortality, acute kidney failure, need for dialysis, and neurologic complications. Association of aprotinin with primary end points was assessed by means of univariate analysis, multivariate logistic regression, and Cox regression analysis, where appropriate.
RESULTS: The aprotinin group was younger (mean age, 3.49 +/- 1.84 vs 3.64 +/- 4.75 years; P = .019) and had a higher Aristotle score (7.8 +/- 2.3 vs 7.2 +/- 2.6, P < .001). Univariate and multivariate analysis showed no significant difference between the no-aprotinin and aprotinin groups for operative mortality (55 [4.5%] vs 47 [3.8%], P = .508), acute kidney failure (68 [6.0%] vs 69 [5.7%], P = .77), need for temporary dialysis (6 [0.49%] vs 12 [0.96%], P = .17), or neurologic complications (14 [1.1%] vs 17 [1.4%], P = .62). By means of Cox regression analysis, aprotinin had no influence on late mortality (24 vs 10 deaths, P = .078).
CONCLUSION: In this retrospective cohort study of pediatric patients undergoing cardiopulmonary bypass, there was no association between the use of aprotinin and acute kidney failure, need for dialysis, neurologic complications, and operative or late mortality. We continue to use aprotinin for all pediatric patients undergoing cardiopulmonary bypass.