TY - JOUR
T1 - Safety of Aprotinin in Congenital Heart Operations
T2 - Results from a Large Multicenter Database
AU - Pasquali, Sara K.
AU - Hall, Matthew
AU - Li, Jennifer S.
AU - Peterson, Eric D.
AU - Jaggers, James
AU - Lodge, Andrew J.
AU - Jacobs, Jeffrey P.
AU - Jacobs, Marshall L.
AU - Shah, Samir S.
N1 - Funding Information:
Dr Pasquali receives support ( KL2 RR024127–02 ) from the National Center for Research Resources , a component of the National Institutes of Health, and from the American Heart Association Mid-Atlantic Affiliate Clinical Research Program . Dr Shah receives support from the National Institute of Allergy and Infectious Diseases ( K01 AI73729 ) and the Robert Wood Johnson Foundation Physician Faculty Scholar Program . The contents of this publication are solely the responsibility of the authors and do not necessarily represent the official view of National Center for Research Resources, National Institutes of Health, American Heart Association, or Robert Wood Johnson Foundation. The authors had full control of the design of the study, methods used, outcome parameters, analysis of data and production of the written report.
PY - 2010/7
Y1 - 2010/7
N2 - Background: Aprotinin was used frequently in children undergoing congenital heart operations with the aim of reducing bleeding, until it was taken off the market after adult studies reported increased renal failure and death. We evaluated the safety of aprotinin in a large multicenter cohort of children undergoing congenital heart operations. Methods: The Pediatric Health Information Systems Database was used to evaluate aprotinin in children (aged 0 to 18 years) undergoing congenital heart operations at 35 children's hospitals from 2003 to 2007. Propensity scores were constructed to account for potential confounders of age, sex, race, prematurity, genetic syndrome, type of operation (Risk Adjustment in Congenital Heart Surgery-1 category), center, and center volume. Multivariable analysis, adjusting for propensity score and individual covariates was performed to evaluate in-hospital mortality, postoperative renal failure requiring dialysis, and length of stay. Subanalysis was performed in the high-risk cohort undergoing reoperation. Results: The study included 30,372 patients (56% male) who were a median age of 7 months (interquartile range, 36 days to 3.2 years). Overall, 44% received aprotinin. Multivariable analysis found no difference in postoperative mortality (odds ratio, 1.00; 95% confidence interval [CI], 0.99 to 1.01), dialysis (odds ratio, 1.00; 95% CI, 0.99 to 1.01), or length of stay (least square mean difference, -0.44 days; 95% CI, -1.01 to 0.13) between aprotinin recipients and nonrecipients. No difference was found in mortality or dialysis in patients undergoing reoperation. Aprotinin recipients in the reoperation subgroup had significantly reduced length of stay (least square mean difference, -2.05 days; 95% CI -3.29 to -0.81),. Conclusions: These data suggest aprotinin is not associated with increased mortality or dialysis in children undergoing congenital heart operations and that further evaluation of aprotinin in this population could be undertaken without undue risk.
AB - Background: Aprotinin was used frequently in children undergoing congenital heart operations with the aim of reducing bleeding, until it was taken off the market after adult studies reported increased renal failure and death. We evaluated the safety of aprotinin in a large multicenter cohort of children undergoing congenital heart operations. Methods: The Pediatric Health Information Systems Database was used to evaluate aprotinin in children (aged 0 to 18 years) undergoing congenital heart operations at 35 children's hospitals from 2003 to 2007. Propensity scores were constructed to account for potential confounders of age, sex, race, prematurity, genetic syndrome, type of operation (Risk Adjustment in Congenital Heart Surgery-1 category), center, and center volume. Multivariable analysis, adjusting for propensity score and individual covariates was performed to evaluate in-hospital mortality, postoperative renal failure requiring dialysis, and length of stay. Subanalysis was performed in the high-risk cohort undergoing reoperation. Results: The study included 30,372 patients (56% male) who were a median age of 7 months (interquartile range, 36 days to 3.2 years). Overall, 44% received aprotinin. Multivariable analysis found no difference in postoperative mortality (odds ratio, 1.00; 95% confidence interval [CI], 0.99 to 1.01), dialysis (odds ratio, 1.00; 95% CI, 0.99 to 1.01), or length of stay (least square mean difference, -0.44 days; 95% CI, -1.01 to 0.13) between aprotinin recipients and nonrecipients. No difference was found in mortality or dialysis in patients undergoing reoperation. Aprotinin recipients in the reoperation subgroup had significantly reduced length of stay (least square mean difference, -2.05 days; 95% CI -3.29 to -0.81),. Conclusions: These data suggest aprotinin is not associated with increased mortality or dialysis in children undergoing congenital heart operations and that further evaluation of aprotinin in this population could be undertaken without undue risk.
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U2 - 10.1016/j.athoracsur.2010.02.073
DO - 10.1016/j.athoracsur.2010.02.073
M3 - Article
C2 - 20609740
AN - SCOPUS:77953709413
SN - 0003-4975
VL - 90
SP - 14
EP - 21
JO - Annals of Thoracic Surgery
JF - Annals of Thoracic Surgery
IS - 1
ER -