Perioperative use of recombinant factor VII to prevent intraoperative aneurysm rupture in high risk patients: a preliminary safety evaluation.

OBJECT: The authors present a safety evaluation of the perioperative use of recombinant activated factor VII (rFVIIa) in a series of subarachnoid hemorrhage patients undergoing microsurgical aneurysm clipping.
METHODS: We performed a retrospective chart review of the records of 18 consecutive subarachnoid hemorrhage patients who underwent craniotomy for aneurysm clipping and received an intraoperative dose of rFVIIa. In each case, the aneurysm was felt to be a "high risk" lesion for intraoperative rupture either because it had bled multiple times prior to surgery or based on anatomical considerations. All complications were recorded whether or not they were attributed to the use of rFVIIa.
RESULTS: Eighteen patients, 7 men and 11 women, ranging in age from 42 to 85 years were included in this review. Nine patients (50%) were either Hunt/Hess Grades IV or V. Six patients developed clinically significant cerebral vasospasm. Fifteen patients required ventricular drainage on admission, and seven patients ultimately required a ventriculoperitoneal shunt. One lower extremity deep venous thrombosis and seven upper extremity venous thromboses in association with peripherally inserted central catheter (PICC) lines were identified on screening Doppler evaluations. There were no associated pulmonary emboli. No aneurysm ruptured intraoperatively.
CONCLUSION: We describe our experience with the use of a single dose of rFVIIa administered perioperatively in an attempt to decrease the rate of intraoperative aneurysm rupture in patients undergoing microsurgical aneurysm clipping. There were no significant immediate or long-term adverse effects attributable to the use of rFVIIa in this group, and we encountered no intraoperative ruptures in this relatively small series.