Activated recombinant factor VII (rFVIIa) has been used to treat cardiac surgical bleeding in an off-label manner. Due to the high risk of mortality with ongoing hemorrhage, assessing the risk of potential thrombotic effects of rFVIIa administration is important. This report analyzes the characteristics associated with mortality in patients who received very-low-dose rFVIIa for nonsurgical bleeding.

A retrospective cohort study.

A tertiary care hospital.

There were 7,724 patients who had cardiac surgery from January 2012 to January 2025 with 623 receiving rFVIIa. The average dose of rFVIIa given was 18 μg/kg (min-max, 6-55 μg/kg).

rFVIIa was administered perioperatively in doses of 0.5- to 1-mg aliquots.

Of the 623 patients, 66 died and 557 survived. The median dose of rFVIIa given was not different in survivors versus nonsurvivors (2.17 v 2.79 mg, respectively; p = 0.001). Procedure type was associated with mortality (p = 0.004) as patients receiving rFVIIa for heart transplant, ventricular assist device, or other complex procedure had a mortality rate of 29.5%. with the majority of these being in ventricular assist device patients. Those who underwent aortic procedures (n = 250) had a mortality rate of 12.4%. Of the 103 patients undergoing coronary artery bypass grafting who received rFVIIa, all but one patient survived. Mortality was higher in patients who had emergent or urgent surgical procedures (p < 0.001), preoperative cardiogenic shock (p = 0.021), longer cardiopulmonary bypass time (p = 0.005), postoperative cardiac arrest (p = 0.001), and received more blood products (p < 0.001). There were no associations between mortality and stroke (p = 0.071) or infections (p = 1.00).

rFVIIa can be administered to cardiac surgical patients with characteristics associated with mortality that are similar to cardiac surgical patients who did not receive rFVIIa.