The Role of Recombinant, Activated Factor VII in Hemorrhage Following Cardiac Surgical Procedures

SUMMARY While the usage of aprotinin and other antifibrinolytics has significantly decreased bleeding and transfusion requirements in cardiac surgical patients in general, certain patients still experience massive hemorrhage despite such therapy. Reexploration for bleeding has been identified as a strong independent risk factor for operative mortality, renal failure, prolonged mechanical ventilation, adult respiratory distress syndrome, sepsis, and atrial arrhythmias. Consequently, therapies to effectively limit otherwise uncontrolled hemorrhage have an important role in the clinical management of cardiac surgical patients. The hemostatic efficacy of recombinant factor VIIa (rFVIIa) appears to lie in its ability to activate FX directly to produce thrombin, independent of the presence and/or activity of co‐factors FVIII, FIX or FXI. There is also some evidence for the efficacy of rFVIIa in patients with platelet dysfunction which may also be relevant to its usage in cardiac surgical patients. This review considers the most recent clinical reports of the usage of rFVIIa for the control of massive blood loss and potentially fatal hemorrhage following cardiac surgery, with a view to assessing efficacy and dosing strategies. In addition, concern has been raised that patients undergoing cardiac surgery may have vulnerable plaques in coronary arteries or aorta, thus the risk of intracoronary activation of hemostasis with consequent potential for ischemic and thrombotic events may exist. Controlled clinical trials of rFVIIa assessing dose‐ranging and with adequate power to detect the impact of therapy on morbidity and mortality are necessary before it can be recommended for routine use in patients who present excessive bleeding following cardiac surgery.