Recombinant activated factor VII in cardiac surgery: Is it effective in reducing postoperative bleeding?

ABSTRACT

The FDA approved recombinant factor Vila [rFVIIa][Novo Nordisk, Bagsvaerd, Denmark] in 1999 for treatment of spontaneous or surgical bleeding episodes in patients with hemophilia A or B. rFVIIa was rapidly used in the treatment or prophylaxis of bleeding in other conditions including cardiac surgery. The question addressed was whether use of rFVIIa could help Hemostasis, and decrease blood or blood product requirements in cardiac surgery patients and its safety as regards thrombosis risk. This is a retrospective comparative study conducted in King Fahad Cardiac Center [KFCC], King Saud University [KSU] Riyadh, KSA. Discharge data of 250 patients who had cardiac surgery through August 2010 to July 2011 were reviewed, 14 patients without hemophilia received Recombinant Activated Factor VII were included in the study as rFVIIa group. Another 15 patient were randomly assigned to the control group. Data analyzed are patient's age, sex, procedure done, CPB time, blood loss, blood or blood products transfusion, intensive care unit [ICU] stay, dose of rFVIIa, and any reported thrombotic adverse effect. A single dose of 1.2 rFVIIa was given to rFVIIa group patients, Demographic data were comparable in both groups without significance. Cardiopulmonary bypass time was 114.91 +/- 654 minutes in rFVIIa group and 119.44 +/- 139 in control group [p=0.6229]. Post operative drain was 598.33 +/- 153.68 and 945.75 +/- 946.8 in rFVIIa and control group respectively [p=0.395]. Blood and product transfusion showed no statistical difference between the groups as well as ICU stay and hospital stay. One patient in the control group was re-explored due to a surgical cause. No reported thrombo embolic complications among study patients. Small dose rFVIIa cannot be considered effective for bleeding after cardiac surgery. Further larger randomized trials will better provide evidence of the effective value of rFVIIa in this setting. Further investigation is warranted in order to design guidelines on the use of rVIIa in cardiac surgery and to determine its safety and efficacy profile