Very low-dose recombinant Factor VIIa administration for cardiac surgical bleeding reduces red blood cell transfusions and renal risk: a matched cohort study

Abstract

Outcomes following administration of very-low-dose recombinant activated factor VIIa (vld-rFVIIa) for cardiac surgical bleeding remain debatable. We sought to determine the association of vld-rFVIIa and adverse surgical outcomes. Retrospective, cohort matching of patients undergoing cardiac surgery who received vld-rFVIIa (median 13.02 μg/kg) for perioperative bleeding were matched to cardiac surgical patients who had bleeding and received standard of care for bleeding without Factor VIIa administration. Of the 362 matched patients (182 in each group), patients who received rFVIIa required significantly less red blood cell transfusions [median 3 units (range 0--60, IQR = 4 units) versus 4 units (range 2-34, IQR = 4 units); P = 0.0004], decreased length of hospital stay (median 8 versus 9 days; P = 0.0158) and decreased renal risk (P < 0.0001). Incidence of renal failure, postoperative infection, postoperative thrombosis, prolonged ventilation, total ICU hours and 30-day mortality were not different between the two groups. Vld-rFVIIa for cardiac surgical bleeding was associated with decreased red blood cell transfusion, renal risk and length of hospital stay without increased thromboembolism or mortality when compared to patients who had cardiac surgical bleeding and received standard of care without Factor VIIa.

Off-label Use of Recombinant Activated Factor VII for Cardiac Surgical Bleeding

“…In fact, two reports focusing on timing of administration of very-low-dose recombinant activated factor VII evaluated patients who received recombinant activated factor VII before receiving any or less than one hemostatic product (platelets or clotting factors) and compared outcomes with patients who received standard of care for post-CPB bleeding. 52,54 One of these studies included 51 matched pairs and focused on safety and found no differences in mortality, acute kidney injury, thromboembolic events, or other adverse outcomes when very-low-dose recombinant activated factor VII was administered as first- or second-line hemostatic therapy. 52 The other study analyzed 182 matched pairs in patients who received early recombinant activated factor VII (first or second line hemostatic agent) and found decreased erythrocyte transfusion, renal risk, and length of hospital stay.…”

“…52 The other study analyzed 182 matched pairs in patients who received early recombinant activated factor VII (first or second line hemostatic agent) and found decreased erythrocyte transfusion, renal risk, and length of hospital stay. 54…”

“…Recent reports of recombinant activated factor VII administration for cardiac surgical bleeding have utilized the term "very-low-dose" recombinant activated factor VII, meant to reflect doses of recombinant activated factor VII less than 20 mcg/kg [52][53][54][55] compared with the hemophilia dosing of 90 mcg/kg initially used in both pediatric and adult patients. Furthermore, most recent reports describe modifying the indications for recombinant activated factor VII and administering earlier in the course of bleeding rather than the classic indications of "intractable bleeding" or as "salvage therapy.…”

“…52 The other study analyzed 182 matched pairs in patients who received early recombinant activated factor VII (first or second line hemostatic agent) and found decreased erythrocyte transfusion, renal risk, and length of hospital stay. 54 Another study analyzing timing of recombinant activated factor VII administration provided a retrospective three-way match analysis in 214 patients who received recombinant activated factor VII for cardiac surgical bleeding based on timing of administration of very-lowdose recombinant activated factor VII. 53 In this study, patients were grouped based on receiving recombinant activated factor VII after 0 to 1 hemostatic product, 2 to 4 hemostatic products, or more than 5 products.…”