The role of recombinant factor VIIa in on-pump cardiac surgery: proceedings of the Canadian Consensus Conference.
OBJECTIVE
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 microg.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.
Karkouti
Keyvan
K
University Health Network, Toronto General Hospital, Department of Anesthesia, Toronto, Ontario, Canada. keyvan.karkouti@uhn.on.ca
Beattie
W Scott
WS
Crowther
Mark A
MA
Callum
Jeannie L
JL
Chun
Rosaleen
R
Fremes
Stephen E
SE
Lemieux
Jérôme
J
McAlister
Vivian C
VC
Muirhead
Brian D
BD
Murkin
John M
JM
Nathan
Howard J
HJ
Wong
Bill I
BI
Yau
Terrence M
TM
Yeo
Erik L
EL
Hall
Richard I
RI
D016063:Blood Loss, Surgical / Q000517:prevention & control; D002170:Canada; D006348:Cardiac Surgical Procedures; D002986:Clinical Trials as Topic; D001026:Coronary Artery Bypass; D015942:Factor VIIa / Q000627:therapeutic use*; D006801:Humans; D011994:Recombinant Proteins / Q000627:therapeutic use
D011994:Recombinant Proteins; D015942:Factor VIIa