rFVIIa administered by continuous infusion during surgery in patients with severe congenital FVII deficiency

Abstract

The use of recombinant FVIIa (rFVIIa) to control bleed in individuals with FVII deficiency has been proven to be effective. The main problems associated with its use are that it requires frequent bolus injections to counteract its short half-life and high cost. Our study aimed to evaluate whether any advantage could be gained by providing rFVIIa by continuous infusion during surgery with regard to haemostatic efficacy, safety and cost. The prospective study included 10 patients with severe FVII deficiency, who underwent 25 surgical procedures (13 major and 12 minor procedures) and were treated with rFVIIa administered by continuous infusion. Tranexamic acid was given concomitantly every 8 h. Prothrombin time, FVII:C assay and thrombin generation assay were used to monitor the treatment. The mean total dose given was 10 mg during a major surgery and 4.4 mg during a minor surgery for a mean treatment duration of 7.5 and 4.0 days respectively. This corresponds to a reduction of 70-90% in drug usage and medication cost compared with bolus injections. Except for one major perioperative bleeding, excellent haemostasis was achieved in all procedures. One patient developed a transient inhibitory activity. None of these events affected the postoperative course or prolonged the hospital stay. Our study demonstrated that continuous infusion of rFVIIa during surgery is safe, effective and highly cost effective.

Surgery in patients with congenital factor VII deficiency: A single center experience

“…To maintain a constant concentration of FVII, continuous infusion can be more effective [17]. The use of continuous infusion as an alternative to administering rFVIIa has been investigated in hemophilia patients with inhibitors, whereas experience with continuous infusion in FVII-deficient patients seems very limited.…”

A rare combination

“…Surgery in such patients carries a risk of bleeding and the optimal treatment regimen for major surgeries has not still been defined. Continuous infusion or bolus of rFVIIa techniques have been tried [5].…”

Newly diagnosed congenital factor VII deficiency and utilization of recombinant activated factor VII (NovoSeven®)

“…These dosage recommendations vary dramatically from the dosing guidelines for patients with hemophilia, in which rFVIIa is currently recommended at 90 μg/kg every 2 hours until hemostasis is achieved 27. It has been suggested by Tran et al that continuous infusion of rFVIIa during surgery results in the desired hemostasis as well as requiring a significantly reduced amount of rFVIIa, when compared with bolus injections 31. Such infusional dosing has not become regarded as standard and therefore bolus dosing remains recommended.…”