Efficacy and safety of activated recombinant factor VII in cardiac surgical patients.
OBJECTIVE
Excessive bleeding is a common and morbid problem after cardiac surgery. There is no doubt a need for an effective and safe hemostatic agent in order to minimize transfusions and avoid surgical reintervention for hemostasis. Recombinant activated factor VII (rFVIIa) is being used (off-label) increasingly after cardiac surgery to prevent or to control hemorrhage, but its efficacy and safety remain unclear.


RESULTS
Several case reports, case series and registries would tend to support the use of activated recombinant factor VII to control excessive bleeding after cardiac operations. On the contrary, two randomized controlled trials have produced negative results whereas a third has not been published yet. Adverse thrombotic events are reported with increasing frequency.


CONCLUSIONS
At present, the generalized use of rFVIIa to prevent or to control excessive bleeding after cardiac surgery cannot be recommended. The decision to administer a potent hemostatic such as rFVIIa outside its recognized prescribing indications should be made with caution by well informed physicians and discussed with the patient. Patients should be informed about knowledge gaps and pertinent risks, which are both important in the case of rFVIIa.
Hardy
Jean-François
JF
Department of Anesthesiology, University of Montreal, Montreal, Quebec, Canada. francois.hardy@umontreal.ca
Bélisle
Sylvain
S
Van der Linden
Philippe
P
D016063:Blood Loss, Surgical / Q000517:prevention & control; D006348:Cardiac Surgical Procedures; D015942:Factor VIIa / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D007431:Intraoperative Complications / Q000188:drug therapy; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins
D011994:Recombinant Proteins; D015942:Factor VIIa