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Comparative analysis of antifibrinolytic medications in pediatric heart surgery.

Publication ,  Journal Article
Pasquali, SK; Li, JS; He, X; Jacobs, ML; O'Brien, SM; Hall, M; Jaquiss, RDB; Welke, KF; Peterson, ED; Shah, SS; Jacobs, JP
Published in: J Thorac Cardiovasc Surg
March 2012

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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Published In

J Thorac Cardiovasc Surg

DOI

EISSN

1097-685X

Publication Date

March 2012

Volume

143

Issue

3

Start / End Page

550 / 557

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Tranexamic Acid
  • Time Factors
  • Sternotomy
  • Risk Factors
  • Risk Assessment
  • Respiratory System
  • Reoperation
  • Renal Insufficiency
 

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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. J Thorac Cardiovasc Surg, 143(3), 550–557. https://doi.org/10.1016/j.jtcvs.2011.06.048
Pasquali, Sara K., Jennifer S. Li, Xia He, Marshall L. Jacobs, Sean M. O’Brien, Matthew Hall, Robert D. B. Jaquiss, et al. “Comparative analysis of antifibrinolytic medications in pediatric heart surgery.J Thorac Cardiovasc Surg 143, no. 3 (March 2012): 550–57. https://doi.org/10.1016/j.jtcvs.2011.06.048.
Pasquali SK, Li JS, He X, Jacobs ML, O’Brien SM, Hall M, et al. Comparative analysis of antifibrinolytic medications in pediatric heart surgery. J Thorac Cardiovasc Surg. 2012 Mar;143(3):550–7.
Pasquali, Sara K., et al. “Comparative analysis of antifibrinolytic medications in pediatric heart surgery.J Thorac Cardiovasc Surg, vol. 143, no. 3, Mar. 2012, pp. 550–57. Pubmed, doi:10.1016/j.jtcvs.2011.06.048.
Pasquali SK, Li JS, He X, Jacobs ML, O’Brien SM, Hall M, Jaquiss RDB, Welke KF, Peterson ED, Shah SS, Jacobs JP. Comparative analysis of antifibrinolytic medications in pediatric heart surgery. J Thorac Cardiovasc Surg. 2012 Mar;143(3):550–557.
Journal cover image

Published In

J Thorac Cardiovasc Surg

DOI

EISSN

1097-685X

Publication Date

March 2012

Volume

143

Issue

3

Start / End Page

550 / 557

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Tranexamic Acid
  • Time Factors
  • Sternotomy
  • Risk Factors
  • Risk Assessment
  • Respiratory System
  • Reoperation
  • Renal Insufficiency