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Recombinant activated factor VII in cardiac surgery: a meta-analysis.

Alberto Zangrillo1, Anna Mizzi, Giuseppe Biondi-Zoccai

  • 1Department of Cardiothoracic Anesthesia and Intensive Care, Università Vita-Salute San Raffaele, Milano, Italia.

Journal of Cardiothoracic and Vascular Anesthesia
|December 17, 2008
PubMed
Summary

Recombinant activated factor VII (rFVIIa) may reduce surgical re-exploration after cardiac surgery but could increase stroke risk. Further research in large trials is needed to confirm these findings.

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Area of Science:

  • Cardiovascular Surgery
  • Hematology
  • Pharmacology

Background:

  • Perioperative bleeding increases patient morbidity and mortality.
  • Recombinant activated factor VII (rFVIIa) is a hemostatic agent with potential to reduce bleeding.
  • Previous trials on rFVIIa efficacy were underpowered.

Purpose of the Study:

  • To meta-analyze the efficacy and safety of rFVIIa in reducing perioperative bleeding.
  • To assess the impact of rFVIIa on surgical re-exploration, transfusion, thromboembolic events, and mortality.

Main Methods:

  • Meta-analysis of 5 clinical trials including 298 patients.
  • Studies involved patients with refractory blood loss, with rFVIIa doses ranging from 17-90 microg/kg.
  • Outcomes included survival, thromboembolic events, and surgical re-exploration.

Main Results:

  • A nonsignificant reduction in surgical re-exploration was observed (OR=0.25, p=0.42).
  • A trend towards increased perioperative stroke risk was noted (OR=3.17, p=0.09).
  • No significant effect on mortality was found (OR=0.96, p=0.90).

Conclusions:

  • rFVIIa may reduce surgical re-exploration in cardiac surgery.
  • Potential increased risk of adverse events like perioperative stroke requires further investigation.
  • Large randomized controlled trials are necessary to confirm these findings and guide clinical practice.