[The use of recombinant activated factor VIIa for major bleedings in open heart surgery].
BACKGROUND
We evaluated the efficacy of activated recombinant factor VIIa (rFVIIa) administration for critical bleeding during cardiothoracic surgery in Iceland.


METHODS
Over a 33 month period, 10 consecutive patients with major life-threatening bleeding during or right after open cardiac surgery that received rFVIIa in 11 operations. Clinical information was retrospectively collected from hospital charts.


RESULTS
The 10 patients were on average 66 year old, ranging 36-82 yrs. All patients were NYHA-class III or IV, there of three underwent emergency surgery. Complicated AVR+/-CABG was the most common type of operation (n=5), with average operation time 673 min. (range 475-932) and perfusion time 287 min. (range 198-615). After the administration of rFVIIa, haemostasis was acquired in 8 of 11 operations, with a significant improvement in coagulation parameters. Three patiens needed reoperation for bleeding. Transfusion of packed red cell (p=0.002) and plasma (p<0.02) decreased significantly after administration of rFVIIa and prothrombin time was shortened (p<0.004). Five patients succumbed, one of them with a cerebral infarction and pulmonary embolus, the latter confirmed at autopsy. Other causes of death were intractable bleeding, myocardial infarction, multiorgan failure and disseminated intravascular coagulopathy.


CONCLUSIONS
rFVIIa can be used effectively to stop intractable bleedings in open heart surgery, with 8 out of 11 patients in this small series achieving hemostasis after its administration. Mortality in this group of patients was high (50%), however, in all cases rFVIIa was used as an end-of-the-line treatment where other therapy had failed. One patient died from pulmonary embolism and cerebral infarct, raising the question of hypercoagulation. Further studies on the side effects and indications of rFVIIa treatment are necessary.
Ingimarsson
Johann Pall
JP
Onundarson
Pall T
PT
Valsson
Felix
F
Vidarsson
Brynjar
B
Gudbjartsson
Tomas
T
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use*; D016063:Blood Loss, Surgical / Q000401:mortality / Q000517:prevention & control*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects* / Q000401:mortality; D017707:Erythrocyte Transfusion; D015942:Factor VIIa / Q000627:therapeutic use*; D005260:Female; D006489:Hemostatic Techniques; D006801:Humans; D007055:Iceland; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000188:drug therapy* / Q000401:mortality; D011994:Recombinant Proteins / Q000627:therapeutic use; D012086:Reoperation; D012189:Retrospective Studies; D016896:Treatment Outcome
D000925:Anticoagulants; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa