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

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

¹ Departments of Anesthesia and Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario
² Department of Anesthesia, University of Toronto, Toronto, Ontario
³ Department of Medicine, Division of Hematology, McMaster University, Hamilton, Ontario
⁴ Department of Clinical Pathology, University of Toronto, Toronto, Ontario
⁵ Department of Anesthesia, University of Calgary, Calgary, Alberta
⁶ Department of Surgery, Division of Cardiac and Vascular Surgery, University of Toronto, Toronto, Ontario
⁷ Department of Anesthesia, Laval University, Quebec City, Quebec
⁸ Department of Surgery, University of Western Ontario, London, Ontario
⁹ Department of Anesthesia, University of Manitoba, Winnipeg, Manitoba
¹⁰ Department of Anesthesia, University of Western Ontario, London, Ontario
¹¹ Department of Anesthesia, University of Ottawa, Ottawa, Ontario
¹² Department of Anesthesia, University of Toronto, Toronto, Ontario
¹³ Department of Surgery, Division of Cardiac Surgery, University of Toronto, Toronto, Ontario
¹⁴ Department of Medicine, Division of Hematology, University of Toronto, Toronto, Ontario
¹⁵ Department of Anesthesia, Dalhousie University, Halifax, Nova Scotia

Address correspondence to: Dr. Keyvan Karkouti, University Health Network, Toronto General Hospital, Department of Anesthesia, EN 3- 402, 200 Elizabeth Street, Toronto, Ontario M5G 2C4, Canada. Phone: 416-340-5164; Fax: 416-340-3698; E-mail: keyvan.karkouti{at}uhn.on.ca

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. Recommendations were based on evidence from the literature 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 riskbenefit profile in cardiac surgery patients.

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