Thrombotic events with use of recombinant activated factor VII in high-risk cardiac surgery

Introduction: Bleeding complications are common during high-risk cardiac surgeries, which necessitate the use of pro-thrombotic agents such as recombinant activated factor VII (rVIIa). However, large doses of rVIIa can increase the risk of thrombotic events, such as stroke or venous thromboembolism. Objectives: Investigate the adverse outcomes of 2 patient cohorts receiving rFVIIa during cardiac surgery, particularly the primary endpoint of a thrombotic event. Study Design: Retrospective cohort study Methods: Patients who were 18 years or older who were undergoing cardiac surgery from July 2011 to August 2014 at Banner Boswell Medical Center (BBWMC) and Banner University Medical Center Phoenix (BUMCP) were included. Key exclusion criteria were patients admitted for Transcatheter Aortic Valve Replacement or Left Ventricular Assist Device implant. Main outcome measures that will be collected include thrombotic events, dose of rVIIa, and concomitant agents used for control of bleeding. Results: The BBWMC cohort (n=34) demographics were 56% males and 44% females, with median age of 75 years. The mean dose of rFVIIa was 1.65mg. The most common cardiac surgery was aortic valve replacement (50%) followed by mitral valve replacement (32%). Thrombotic events were identified in one (2.94%) patient. The BUMCP cohort (n=17) data is currently in the collection stage. Preliminary data show that three (17.65%) patients had a thrombotic event, 23.5% died and 5.9% were discharged to hospice. The mean dose of rFVIIa administered was 5.64mg. Conclusions: We predict the outcomes of this study will show an association between the dose of rFVIIa administered and incidence of a thrombotic event in cardiac surgery patients. The results of this study may be used to demonstrate an association between adverse outcomes related to rFVIIa dose during cardiac surgery, providing additional information regarding safe utilization of rFVIIa for postoperative bleeding in cardiac surgery patients.