Recombinant factor VIIa (NovoSeven RT) use in high risk cardiac surgery.

OBJECTIVE

The use of recombinant factor VIIa (rFVIIa) (NovoSeven RT(®)) to establish hemostasis during massive perioperative bleeding in cardiac surgery has been explored in several retrospective studies. While early results are promising, a paucity of data leaves many questions about its safety profile. We sought to further define its use and associated outcomes in a large cohort study at a single institution.

METHODS

A retrospective cohort study design was used, in which 236 patients received rFVIIa for bleeding after cardiac surgery. These patients were matched with a cohort of 213 subjects, who had similar operations during the same period of time. Primary end points included thrombo-embolic events, mortality, incidence of re-operation, use of blood products, and patient disposition at 30 days. Statistical significance was assessed at p < 0.05.

RESULTS

There was no statistically significant difference in the incidence of stroke (3.4%, 1.9%; p = 0.32), renal failure (8.5%, 7.0%; p = 0.57), or 30-day mortality (7.7%, 4.3%; p = 0.14) between the rFVIIa and the control groups, respectively. The rFVIIa group did experience a higher rate of re-operation for bleeding (11.0%, 1.9%; p = 0.0001) and had a two-fold increase in the use of each of the following: cryoprecipitate, fresh-frozen plasma, platelets, and packed red blood cells, relative to the control group (p < 0.00001).

CONCLUSIONS

rFVIIa is an effective hemostatic agent for intractable bleeding in high-risk cardiac surgery with an acceptable safety profile. rFVIIa does not appear to be associated with increased postoperative complications, including thrombo-embolic events and death.