Recombinant factor VIIa in the treatment of postoperative hemorrhage after cardiac surgery.
BACKGROUND
A generalized coagulation disorder after cardiac surgery that is associated with massive postoperative hemorrhage is not completely understood. Recombinant factor VIIa (rFVIIa) has emerged as a possible "salvage" medication. Limited experience reported in the literature and fears of possible thromboembolic complications make the use of rFVIIa in the treatment of bleeding after cardiac surgery controversial.


METHODS
We analyzed retrospectively all consecutive cardiac surgical patients who have received rFVIIa in the Helsinki University Hospital in order to evaluate the safety and efficacy of rFVIIa after cardiac surgery in our institution. Altogether, 16 patients were identified from operating room and intensive care unit (ICU) databases. Patient records and operating room and ICU databases were reviewed.


RESULTS
In this series of high risk patients hospital mortality was high (25%). A definite hemostatic effect was seen after rFVIIa administration in all but three patients (82%). Mean amount of bleeding and amount of platelet and fresh frozen plasma transfusions decreased significantly after rFVIIa administration. Four patients had serious postoperative thromboembolic complications.


CONCLUSIONS
Recombinant factor VIIa was effective in restoring hemostasis, but thromboembolic complications occurred after rFVIIa use. They may be related to the underlying pathologies and surgery performed. It is possible, however, that rFVIIa treatment contributed to their occurrence.
Raivio
Peter
P
Department of Cardiothoracic Surgery, Helsinki University Hospital, Helsinki, Finland. peter.raivio@hus.fi
Suojaranta-Ylinen
Raili
R
Kuitunen
Anne H
AH
D000328:Adult; D000368:Aged; D013504:Cardiovascular Surgical Procedures / Q000009:adverse effects*; D005167:Factor VII / Q000009:adverse effects / Q000627:therapeutic use*; D015942:Factor VIIa; D005260:Female; D006487:Hemostasis; D006490:Hemostatics / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000188:drug therapy* / Q000209:etiology; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012189:Retrospective Studies; D013923:Thromboembolism / Q000139:chemically induced; D016896:Treatment Outcome
D006490:Hemostatics; D011994:Recombinant Proteins; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa