Recombinant activated factor VII for refractory bleeding after acute aortic dissection surgery: a propensity score analysis.
OBJECTIVE
The aim of this study was to assess safety and effectiveness of recombinant activated factor VII (rFVIIa) in patients with refractory bleeding undergoing acute aortic dissection surgery with deep hypothermic circulatory arrest.


METHODS
Propensity score-matched analysis.


METHODS
University hospital.


METHODS
Twenty-three cardiac surgery patients receiving rFVIIa compared with 23 matched controls.


METHODS
An intravenous bolus of rFVIIa (70 microg/kg) was administered at the end of a complete transfusion protocol. Five patients received rFVIIa in the operating room, and 18 patients received rFVIIa in the intensive care unit. Four of the intensive care unit patients required a second dose.


RESULTS
Blood loss and transfusion requirements were significantly reduced in the period after rFVIIa administration. A highly significant reduction in hourly blood loss was found at -1 hr vs. 0 hrs and 0 hrs vs. 1 hr (-194 and -77.5 mL, respectively; both adjusted p < .001). In addition, significant improvements of international normalized ratio (p < .001), partial thromboplastin time (p < .001), platelet count (p < .001), fibrinogen (p < .001), and antithrombin (p < .001) were detected after rFVIIa administration. The two groups did not differ regarding adverse events.


CONCLUSIONS
rFVIIa was successfully used as an additional therapy both during and after acute aortic dissection surgery with deep hypothermic circulatory arrest, when bleeding was refractory to conventional methods. Randomized studies are necessary to confirm the safety and efficacy of rFVIIa in this setting.
Tritapepe
Luigi
L
Department of Anesthesiology and Intensive Care, University of Rome La Sapienza, Rome, Italy.
De Santis
Vincenzo
V
Vitale
Domenico
D
Nencini
Cecilia
C
Pellegrini
Fabio
F
Landoni
Giovanni
G
Toscano
Federico
F
Miraldi
Fabio
F
Pietropaoli
Paolo
P
D000784:Aortic Dissection / Q000601:surgery*; D001014:Aortic Aneurysm / Q000601:surgery*; D002315:Cardiopulmonary Bypass / Q000009:adverse effects; D003029:Coagulants / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D015942:Factor VIIa / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007036:Hypothermia, Induced / Q000009:adverse effects; D016015:Logistic Models; D008297:Male; D016555:Matched-Pair Analysis; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000188:drug therapy* / Q000209:etiology; D011994:Recombinant Proteins; D016019:Survival Analysis; D013923:Thromboembolism / Q000139:chemically induced
D003029:Coagulants; D011994:Recombinant Proteins; D015942:Factor VIIa