Recombinant Factor VIIa Treatment of Severe Bleeding in Cardiac Surgery Patients: A Retrospective Analysis of Dosing, Efficacy, and Safety Outcomes

Objective

To describe rFVIIa dosing and clinical outcomes in cardiovascular surgery patients with refractory bleeding.

Design

Retrospective chart review of patients receiving rFVIIa from January 1, 2004 to September 30, 2005, in the cardiovascular surgery setting.

Setting

Tertiary care, private teaching hospital.

Participants

Ninety-three patients who received rFVIIa after cardiovascular surgery for the management of refractory bleeding.

Interventions

None.

Measures and Main Results

Patients received an average of 7.6 ± 6.8 units of red blood cells (RBCs) before rFVIIa dosing (mean dose, 56.2 ± 26.5 μg/kg). Median and 25th and 75th quartile blood product consumption was significantly reduced 6 hours after rFVIIa versus 6 hours before (RBCs, −3 units, [−1, −7]; cryoprecipitate, −7.5 units [0, −20]; platelet, −3 units [−1, −4]; fresh frozen plasma, −4 units [−2, −7]). Repeated rFVIIa dosing occurred in 10% of patients, with 8 (8.6%) and 2 (2.25%) patients receiving second and third doses, respectively. Subgroup analysis of each rFVIIa dosing quartile >30 μg/kg showed a significant reduction in RBCs; however, no significant differences were found in the magnitude of RBC reduction or percent of patients requiring massive transfusion among the quartiles. No adverse thrombotic episodes were noted, and the observed mortality (22.6%) was not attributed to rFVIIa therapy.

Conclusions

rFVIIa effectively reduces blood product use in cardiovascular surgery patients having massive blood loss. Although the optimal dose of rFVIIa for use in cardiovascular surgery remains undetermined, these data provide evidence that dosing regimens using <90 μg/kg are effective in this population and may provide guidance for centers establishing standardized protocols for rFVIIa use in cardiovascular surgery patients.

Key Words: factor VIIa, dosing, NovoSeven, cardiac surgery, hemorrhage, hemostasis