Role of recombinant factor VIIa in the treatment of intractable bleeding in vascular surgery

Abstract

Most recent publications have shown that the recombinant form of activated factor VII (rFVIIa; NovoSeven, Novo Nordisk A/S, Bagsværd, Denmark) induces excellent hemostasis in patients with severe intractable bleeding caused by trauma and major surgery. The purpose of this study was to determine the influence of rFVIIa on the treatment of intractable perioperative bleeding in vascular surgery when conventional hemostatic measures are inadequate. There were two groups of patients: the NovoSeven group (group N), 10 patients with ruptured abdominal aortic aneurysms (RAAAs) and 14 patients operated on due to thoracoabdominal aortic aneurysms (TAAAs); the control group (group C), 14 patients with RAAAs and 17 patients with TAAAs. All patients suffered intractable hemorrhage refractory to conventional hemostatic measures, while patients from group N were additionally treated with rFVIIa. Postoperative blood loss was significantly lower in group N treated with rFVII (P < .0001). Postoperative administration of packed red blood cells, fresh frozen plasma, and platelets was lower in patients from group N, (P < .0001). Successful hemorrhage arrest was reported in 21 patients (87.5%) treated with rFVIIa, and in 9 patients (29.03%) in group C (P < .001). Thirty-day mortality in these two groups significantly differed. The mortality rate was 12.5% (3 patients) in group N and 80.65% (25 patients) in group C (P < .0001). Our findings suggest that rFVIIa may play a role in controlling the intractable perioperative and postoperative bleeding in surgical patients undergoing a repair of RAAAs and TAAAs. Certainly, prospective randomized trials are necessary to further confirm the efficacy and cost-effectiveness of rFVIIa in these patients.