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Treatment of refractory bleeding after cardiac operations with low-dose recombinant activated factor VII (NovoSeven^®): a propensity score analysis

^a Experimental Surgery Unit, Department of Heart and Vessels, Careggi Hospital, Florence, Italy
^b Cardiac Surgery Unit, Civic Hospital, Brescia, Italy
^c Cardiac Surgery Unit, Department of Heart and Vessels, Careggi Hospital, Florence, Italy
^d University of Florence, Florence, Italy

Received 19 July 2007; received in revised form 6 October 2007; accepted 9 October 2007.

^_* Corresponding author. Address: Experimental Surgery Unit, Department of Heart and Vessels, Careggi Hospital, Viale Morgagni 85, 50134 Florence, Italy. Tel.: +39 055 794 7467; fax: +39 055 794 7628. (Email: sandro.gelsomino{at}libero.it).

Background: Recombinant activated factor VII (rFVIIa) has been increasingly used to stop life-threatening bleeding following cardiac operations. Nonetheless, the issue of dosing, given the expense and potential for thrombotic complications, is still of major concern. We report our experience with small-dose rFVIIa in patients with refractory bleeding after cardiac surgery. Methods and results: From September 2005 to June 2007, 40 patients (mean age 70.1 ± 9.2 years, 52.5 males) received a low dose of rFVIIa (median: 18 µg/kg, interquartile range: 9–16 µg/kg) for refractory bleeding after cardiac surgery. Forty propensity score-based greedy matched controls were compared to the study group. Low dose of rFVIIa significantly reduced the 24-h blood loss: 1610 ml [ 1285–1800 ml] versus 3171 ml [2725–3760 ml] in the study and control groups, respectively (p < 0.001). Thus, hourly bleeding was 51.1 ml [34.7–65.4 ml] in patients receiving rFVIIa and 196.2 ml/h [142.1–202.9 ml] in controls (p < 0.001). Furthermore, patients receiving rFVIIa showed a lower length of stay in the intensive care unit (p < 0.001) and shorter mechanical ventilation time (p < 0.001). In addition, the use of rFVIIa was associated with reduction of transfusion requirements of red blood cells, fresh frozen plasma and platelets (all, p < 0.001). Finally, treated patients showed improved hemostasis with rapid normalization of coagulation variables (partial thromboplastin time, international normalized ratio, platelet count, p < 0.001). In contrast, activated prothrombin time and fibrinogen did not differ between groups (p = ns). No thromboembolic-related event was detected in our cohort. Conclusions: In our experience low-dose rFVIIa was associated with reduced blood loss, improvement of coagulation variables and decreased need for transfusions. Our findings need to be confirmed by further larger studies.

Key Words: Hemorrhage • Plasma • Platelet-derived factors • Platelets