Carl L. Backer1, Angela M. Kelle1, Robert D. Stewart1, Sunitha C. Suresh1, Farah N. Ali2, Constantine Mavroudis1; 1Division of Cardiovascular-Thoracic Surgery, Department of Surgery, Northwestern University Feinberg School of Medicine, Children's Memorial Hospital, Chicago, IL; 2Division of Nephrology, Department of Pediatrics, Northwestern University Feinberg School of Medicine, Children's Memorial Hospital, Chicago, IL
Objective: Aprotinin is a serine protease inhibitor that has been shown to decrease transfusion requirements and the inflammatory response following cardiopulmonary bypass (CPB). The purpose of this study was to determine if aprotinin is associated with adverse outcomes, particularly mortality and renal impairment, in pediatric patients (<18 years of age) undergoing CPB.Methods: Since 1999 we have used high dose aprotinin for all CPB cases. Using our Congenital Cardiac Surgery database we compared a cohort of all pediatric patients from the prior 6 years who did not receive aprotinin (n=1226) to a 6-year cohort since 1999 who received aprotinin (n=1249). Primary endpoints were operative mortality, biochemical renal dysfunction, and need for dialysis. Biochemical renal dysfunction was defined as postoperative (within 72 hours) creatinine level = twice the preoperative level. The association of aprotinin with the primary endpoints was assessed by multivariate logistic regression.
Results: The aprotinin group was younger (mean age 3.2 vs. 3.7 years, p<0.01) and had a higher Aristotle score (7.80 vs. 7.23, p<0.0001). CPB time was slightly shorter in the aprotinin group (119 vs. 124 min, p<0.05) although aortic cross-clamp time was similar (59.3 vs. 58.9 min, p=0.8). By univariate analysis there was no significant difference between aprotinin and no aprotinin groups for operative mortality (50/1249, 4.0% vs. 54/1226, 4.4%, p=0.7), renal dysfunction (64/1238, 5.2% vs. 74/1197, 6.2%, p=0.3), or need for temporary dialysis (12/1249, 1.0% vs. 6/1226, 0.5%, p=0.24). No patient in either group required permanent dialysis, however temporary dialysis was associated with a 61% mortality (11/18). After controlling for age, Aristotle score, and CPB time, there was no association between aprotinin use and operative mortality (Odds ratio 95% CI = 0.8 to 2.0), renal dysfunction (Odds ratio 95% CI = 0.5 to 1.1), or need for dialysis (Odds ratio 95% CI = 0.12 to 1.1)
Conclusion: In this retrospective cohort study of pediatric patients undergoing CPB, there was no association between the use of aprotinin and biochemical renal dysfunction, need for dialysis, or operative mortality. We continue to use aprotinin for all pediatric patients undergoing CPB.
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