The role of recombinant factor VIIa in on-pump cardiac surgery: Proceedings of the Canadian Consensus Conference

  • Keyvan Karkouti
  • W. Scott Beattie
  • Mark A. Crowther
  • Jeannie L. Callum
  • Rosaleen Chun
  • Stephen E. Fremes
  • Jérôme Lemieux
  • Vivian C. McAlister
  • Brian D. Muirhead
  • John M. Murkin
  • Howard J. Nathan
  • Bill I. Wong
  • Terrence M. Yau
  • Erik L. Yeo
  • Richard I. Hall
Special Article

Abstract

Purpose

Recombinant activated factor VII (rFVIIa) is currently not approved by Health Canada or the Food and Drug Administration for treating excessive blood loss in nonhemophiliac patients undergoing on-pump cardiac surgery, but is increasingly being used “off-label” for this indication. A Canadian Consensus Conference was convened to generate recommendations for rFVIIa use in on-pump cardiac surgery.

Methods: The panel undertook a literature review of the use of rFVIIa in both cardiac and non-cardiac surgery. Appropriateness, timing, and dosage considerations were addressed for three cardiac surgery indications: prophylactic, routine, and rescue uses. Recommendationswere based on evidencefromtheliterature and derived by consensus following recognized grading procedures.

Results

The panel recommended against prophylactic or routine use of rFVIIa, as there is no evidence at this time that the benefits of rFVIIa outweigh its potential risks compared with standard hemostatic therapies. On the other hand, the panel made a weak recommendation (grade 2C) for the use of rFVIIa (one to two doses of 35–70 μg·kg-1) as rescue therapy for blood loss that is refractory to standard hemostatic therapies, despite the lack of randomized controlled trial data for this indication.

Conclusions

In cardiac surgery, the risks and benefits of rFVIIa are unclear, but current evidence suggests that its benefits may outweigh its risks for rescue therapy in selected patients. Methodologically rigorous studies are needed to clarify its risk-benefit profile in cardiac surgery patients.

Objectif

Le facteur VII activé recombinant (rFVIIa) n’est actuellement approuvé ni par Santé Canada ni par la Food and Drug Administration (FDA) pour le traitement du saignement excessif chez les patients non-hémophiles subissant une chirurgie cardiaque avec circulation extra-corporelle (CEC); néanmoins, il est de plus en plus utilisé de manière ‘non conforme’ pour cette indication. Une Conférence canadienne de consensus s’est réunie afin de rédiger des recommandations quant à l’utilisation du rFVIIa lors de la chirurgie cardiaque avec CEC.

Méthode

Le panel a entrepris une revue de la littérature traitant de l’utilisation du rFVIIa en chirurgies cardiaque et non cardiaque. Des considérations quant à la justification, au moment de l’administration et à la posologie ont été évaluées pour trois indications en chirurgie cardiaque: les utilisations prophylactique, de routine ou de sauvetage. Les recommandations, basées sur des données probantes tirées de la littérature, ont été interprétées par un consensus suivant des procédures de gradation reconnues.

Résultats

Le panel s’est prononcé contre une utilisation prophylactique ou de routine du rFVIIa, étant donné qu’il n’existe actuellement pas de preuve que les bienfaits du rFVIIa l’emportent sur les risques potentiels encourus en comparaison des thérapies hémostatiques standard. En revanche, le panel a énoncé une recommandation faible (note 2C) en faveur de l’utilisation du rFVIIa (une à deux doses de 35–70 μg·kg-1) comme thérapie de sauvetage en cas de saignement réfractaire aux thérapies hémostatiques standard et ce, malgré le manque de données d’études randomisées contrôlées concernant cette indication.

Conclusion

En chirurgie cardiaque, les risques et bienfaits du rFVIIa ne sont pas clairs; toutefois, les données actuelles suggèrent que ses bienfaits pourraient contrebalancer ses risques dans les cas de thérapie de sauvetage chez certains patients. Des études méthodologiquement rigoureuses sont nécessaires afin de clarifier le profil risque/bénéfice du rFVIIa pour les patients de chirurgie cardiaque.

[Le rôle du facteur VIIa recombinant dans la chirurgie cardiaque avec circulation extra-corporelle: Rapport de la Conférence canadienne de consensus]

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Copyright information

© Canadian Anesthesiologists 2007

Authors and Affiliations

  • Keyvan Karkouti
    • 1
  • W. Scott Beattie
    • 1
  • Mark A. Crowther
    • 1
  • Jeannie L. Callum
    • 1
  • Rosaleen Chun
    • 1
  • Stephen E. Fremes
    • 1
  • Jérôme Lemieux
    • 1
  • Vivian C. McAlister
    • 1
  • Brian D. Muirhead
    • 1
  • John M. Murkin
    • 1
  • Howard J. Nathan
    • 1
  • Bill I. Wong
    • 1
  • Terrence M. Yau
    • 1
  • Erik L. Yeo
    • 1
  • Richard I. Hall
    • 1
  1. 1.Department of AnesthesiaUniversity Health Network, Toronto General HospitalTorontoCanada

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