Recombinant activated factor VII in the treatment of intractable non-surgical bleeding following major vascular procedures

Recombinant form of activated factor VII (rFVIIa) has been approved for use in haemophiliacs with antibodies to factor VIII or factor IX. Recent studies and clinical experiences have showed that rFVIIa gives extreme haemostatic effects in patients with severe "nonhaemophilic" bleeding produced after trauma and major surgery. We present our preliminary experience of the use of rFVIIa in vascular surgery where conventional haemostatic measures were inadequate. There were 17 patients divided into three groups: Group I--6 patients with ruptured abdominal aortic aneurysms; Group II--7 patients with thoracoabdominal aortic aneurysms and 1 patient with acute complicated dissection of thoracic aorta type III; Group III--3 patients with retroperitoneal tumours involving great abdominal vessels. Clinical improvement was reported following the treatment in 14 of 17 patients in our study. Bleeding was successfully controlled as evidenced by improved haemodynamic parameters and decreased inotrope and transfusion requirement. More liberal use of rFVIIa in vascular patients is limited, because there is no randomized controlled trial proving efficacy and safety in vascular patients. We recommend the use of rFVIIa in vascular surgery only during and after operative treatment of thoracoabdominal aortic aneurysms, ruptured abdominal aortic aneurysms and retroperitoneal tumours involving aorta and/or inferior vena cava complicated with "non-surgical" massive uncontrolled bleeding.