Effect of the administration of recombinant activated factor VII (rFVIIa; NovoSeven) in the management of severe uncontrolled bleeding in patients undergoing heart valve replacement surgery.

Recombinant activated factor VII (rFVIIa; NovoSeven, Novo Nordisk A/S, Bagsvaerd, Denmark) is being increasingly used to secure haemostasis in difficult clinical situations. The role of rFVIIa in the treatment of patients undergoing open-heart surgery for valvular heart disease was evaluated in an open pilot study. Study objectives included evaluation of blood loss, haemostatic effect and safety and laboratory parameters following rFVIIa administration. To date, we have treated five patients (one child aged 2.5 years and four adults) undergoing surgical procedures including arterial switch, closure of atrial septal defect and De Vega's procedure (mitral valve replacement with tricuspid valve repair). Four patients received rFVIIa intraoperatively, while the fifth received it postoperatively. Satisfactory haemostasis was achieved with a single dose (30 microg/kg) of rFVIIa. Four hours after treatment mean blood loss was 262.5 ml for adults (220-334 ml) and 85 ml for the child. No significant adverse events were reported. Laboratory parameters indicated a mean 18.5-fold (range 3.7-42) increase in FVII levels at 30 min postinjection and a mean reduction of 12 s (range 3-39 s) in prothrombin time. In conclusion, rFVIIa represents an effective and well-tolerated treatment for serious bleeding episodes both during cardiac surgery and postoperatively.