Recombinant factor VIIa for intractable blood loss after cardiac surgery: a propensity score-matched case-control analysis.

BACKGROUND: Cardiac surgery is occasionally complicated by massive blood loss that is refractory to standard hemostatic interventions. Recombinant factor VIIa (rF-VIIa) is being increasingly used as rescue therapy in such cases, but little information is available on its safety and efficacy for this indication. STUDY DESIGN AND METHODS: The outcomes of the first 51 cardiac surgery patients who received rF-VIIa for intractable blood loss (from November 2002 to February 2004) at a single institution according to a standardized clinical guideline were compared to 51 matched control patients, with the control patients identified from a large database and matched based on the propensity for massive blood loss. RESULTS: Blood loss and blood product usage were significantly decreased after 2.4 to 4.8 mg of rF-VIIa. In those treated after sternal closure (n = 32), there was a significant reduction in blood loss from the hour before to the hour after treatment: 100 (70, 285) mL (median [25th, 75th percentiles]; p < 0.0001). Except for a slower postoperative recovery and higher incidence of acute renal dysfunction, the adverse event rates were similar between the rF-VIIa-treated patients and their matched controls. CONCLUSIONS: These results suggest that rF-VIIa may be an effective rescue therapy for patients with intractable hemorrhage after cardiac surgery. A clinically important risk of stroke or other major thrombotic complications could not be ruled out by our study. Controlled clinical trials with adequate power to detect the impact of rF-VIIa therapy on morbidity and mortality therefore are necessary before one can recommend its routine use in patients undergoing cardiac surgery who have excessive bleeding. assive blood loss is a serious complication of cardiac surgery that occurs when standard hemostatic interventions, which include surgical intervention, local hemostatic agents, and transfusion of blood products, fail to stop hemorrhage after surgery. There has recently been a great deal of interest in the use of recombinant factor VIIa (rF-VIIa)—a novel hemostatic agent that is currently approved only for patients with hemophilia with antibodies against specific coagulation factors (anti-FVIII or antiF IX)—for control of refractory hemorrhage after cardiac surgery. There are now multiple case reports and small case series that have described the successful use of rFVIIa in cardiac surgery. 1-10 Owing to their small sample sizes and lack of comparison groups, however, these reports can confirm neither the efficacy nor the safety of rF-VIIa for this indication. The high rate of serious adverse events in these reports has raised concerns about the safety of rF-VIIa in cardiac surgery.