Comparative analysis of antifibrinolytic medications in pediatric heart surgery

Sara K. Pasquali, Jennifer S. Li, Xia He, Marshall L. Jacobs, Sean M. O'Brien, Matthew Hall, Robert D B Jaquiss, Karl F. Welke, Eric D. Peterson, Samir S. Shah, Jeffrey P. Jacobs

Research output: Contribution to journalArticle

65 Citations (Scopus)

Abstract

Objectives: Recent studies suggest adverse events associated with aprotinin in adults may not occur in children, and there is interest in further pediatric study of aprotinin. However, there are limited contemporary data comparing aprotinin with other available antifibrinolytics (aminocaproic acid [ACA] and tranexamic acid [TXA]) to guide current practice and aid in potential trial design. We performed a comparative analysis in a large multicenter cohort. Methods: The Society of Thoracic Surgeons Congenital Heart Surgery Database (2004-2008) was linked to medication data from the Pediatric Health Information Systems Database. Efficacy and safety outcomes were evaluated in multivariable analysis adjusting for patient and center factors overall and in neonates and those undergoing redo sternotomy. Results: A total of 22,258 patients (25 centers) were included: median age, 7.6 months (interquartile range, 2.6-43.4 months). Aprotinin (vs no drug) was associated with a significant reduction in combined hospital mortality/bleeding requiring surgical intervention overall (odds ratio [OR], 0.81; 95% confidence intervals [CI], 0.68-0.91) and in the redo sternotomy subgroup (OR, 0.57; 95% CI, 0.40-0.80). There was no benefit in neonates and no difference in renal failure requiring dialysis in any group. In comparative analysis, there was no difference in outcome in aprotinin versus ACA recipients. TXA (vs aprotinin) was associated with significantly reduced mortality/bleeding requiring surgical intervention overall (OR, 0.47; 95% CI, 0.30-0.74) and in neonates (OR, 0.30; 95% CI, 0.15-0.58). Conclusions: These observational data suggest aprotinin is associated with reduced bleeding and mortality in children undergoing heart surgery with no increase in dialysis. Comparative analyses suggest similar efficacy of ACA and improved outcomes associated with TXA.

Original languageEnglish (US)
Pages (from-to)550-557
Number of pages8
JournalJournal of Thoracic and Cardiovascular Surgery
Volume143
Issue number3
DOIs
StatePublished - Mar 1 2012

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Antifibrinolytic Agents
Aprotinin
Thoracic Surgery
Pediatrics
Tranexamic Acid
Aminocaproic Acid
Odds Ratio
Confidence Intervals
Sternotomy
Newborn Infant
Hemorrhage
Dialysis
Databases
Health Information Systems
Child Mortality
Hospital Mortality
Renal Insufficiency
Safety
Mortality
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery
  • Pulmonary and Respiratory Medicine

Cite this

Pasquali, S. K., Li, J. S., He, X., Jacobs, M. L., O'Brien, S. M., Hall, M., ... Jacobs, J. P. (2012). Comparative analysis of antifibrinolytic medications in pediatric heart surgery. Journal of Thoracic and Cardiovascular Surgery, 143(3), 550-557. https://doi.org/10.1016/j.jtcvs.2011.06.048

Comparative analysis of antifibrinolytic medications in pediatric heart surgery. / Pasquali, Sara K.; Li, Jennifer S.; He, Xia; Jacobs, Marshall L.; O'Brien, Sean M.; Hall, Matthew; Jaquiss, Robert D B; Welke, Karl F.; Peterson, Eric D.; Shah, Samir S.; Jacobs, Jeffrey P.

In: Journal of Thoracic and Cardiovascular Surgery, Vol. 143, No. 3, 01.03.2012, p. 550-557.

Research output: Contribution to journalArticle

Pasquali, SK, Li, JS, He, X, Jacobs, ML, O'Brien, SM, Hall, M, Jaquiss, RDB, Welke, KF, Peterson, ED, Shah, SS & Jacobs, JP 2012, 'Comparative analysis of antifibrinolytic medications in pediatric heart surgery', Journal of Thoracic and Cardiovascular Surgery, vol. 143, no. 3, pp. 550-557. https://doi.org/10.1016/j.jtcvs.2011.06.048
Pasquali, Sara K. ; Li, Jennifer S. ; He, Xia ; Jacobs, Marshall L. ; O'Brien, Sean M. ; Hall, Matthew ; Jaquiss, Robert D B ; Welke, Karl F. ; Peterson, Eric D. ; Shah, Samir S. ; Jacobs, Jeffrey P. / Comparative analysis of antifibrinolytic medications in pediatric heart surgery. In: Journal of Thoracic and Cardiovascular Surgery. 2012 ; Vol. 143, No. 3. pp. 550-557.
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abstract = "Objectives: Recent studies suggest adverse events associated with aprotinin in adults may not occur in children, and there is interest in further pediatric study of aprotinin. However, there are limited contemporary data comparing aprotinin with other available antifibrinolytics (aminocaproic acid [ACA] and tranexamic acid [TXA]) to guide current practice and aid in potential trial design. We performed a comparative analysis in a large multicenter cohort. Methods: The Society of Thoracic Surgeons Congenital Heart Surgery Database (2004-2008) was linked to medication data from the Pediatric Health Information Systems Database. Efficacy and safety outcomes were evaluated in multivariable analysis adjusting for patient and center factors overall and in neonates and those undergoing redo sternotomy. Results: A total of 22,258 patients (25 centers) were included: median age, 7.6 months (interquartile range, 2.6-43.4 months). Aprotinin (vs no drug) was associated with a significant reduction in combined hospital mortality/bleeding requiring surgical intervention overall (odds ratio [OR], 0.81; 95{\%} confidence intervals [CI], 0.68-0.91) and in the redo sternotomy subgroup (OR, 0.57; 95{\%} CI, 0.40-0.80). There was no benefit in neonates and no difference in renal failure requiring dialysis in any group. In comparative analysis, there was no difference in outcome in aprotinin versus ACA recipients. TXA (vs aprotinin) was associated with significantly reduced mortality/bleeding requiring surgical intervention overall (OR, 0.47; 95{\%} CI, 0.30-0.74) and in neonates (OR, 0.30; 95{\%} CI, 0.15-0.58). Conclusions: These observational data suggest aprotinin is associated with reduced bleeding and mortality in children undergoing heart surgery with no increase in dialysis. Comparative analyses suggest similar efficacy of ACA and improved outcomes associated with TXA.",
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AU - Pasquali, Sara K.

AU - Li, Jennifer S.

AU - He, Xia

AU - Jacobs, Marshall L.

AU - O'Brien, Sean M.

AU - Hall, Matthew

AU - Jaquiss, Robert D B

AU - Welke, Karl F.

AU - Peterson, Eric D.

AU - Shah, Samir S.

AU - Jacobs, Jeffrey P.

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N2 - Objectives: Recent studies suggest adverse events associated with aprotinin in adults may not occur in children, and there is interest in further pediatric study of aprotinin. However, there are limited contemporary data comparing aprotinin with other available antifibrinolytics (aminocaproic acid [ACA] and tranexamic acid [TXA]) to guide current practice and aid in potential trial design. We performed a comparative analysis in a large multicenter cohort. Methods: The Society of Thoracic Surgeons Congenital Heart Surgery Database (2004-2008) was linked to medication data from the Pediatric Health Information Systems Database. Efficacy and safety outcomes were evaluated in multivariable analysis adjusting for patient and center factors overall and in neonates and those undergoing redo sternotomy. Results: A total of 22,258 patients (25 centers) were included: median age, 7.6 months (interquartile range, 2.6-43.4 months). Aprotinin (vs no drug) was associated with a significant reduction in combined hospital mortality/bleeding requiring surgical intervention overall (odds ratio [OR], 0.81; 95% confidence intervals [CI], 0.68-0.91) and in the redo sternotomy subgroup (OR, 0.57; 95% CI, 0.40-0.80). There was no benefit in neonates and no difference in renal failure requiring dialysis in any group. In comparative analysis, there was no difference in outcome in aprotinin versus ACA recipients. TXA (vs aprotinin) was associated with significantly reduced mortality/bleeding requiring surgical intervention overall (OR, 0.47; 95% CI, 0.30-0.74) and in neonates (OR, 0.30; 95% CI, 0.15-0.58). Conclusions: These observational data suggest aprotinin is associated with reduced bleeding and mortality in children undergoing heart surgery with no increase in dialysis. Comparative analyses suggest similar efficacy of ACA and improved outcomes associated with TXA.

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