Investigation of outcomes following recombinant activated FVII use for refractory bleeding during abdominal aortic aneurysm repair

Objective: To evaluate the outcomes following recombinant activated Factor VII (rFVIIa) use during abdominal aortic aneurysms (AAA) repair. Design: AAA patients were selected from the Australian and New Zealand Haemostasis Registry (ANZHR) who received off-licence rFVIIa to control critical bleeding. Methods: Patient characteristics and outcomes were compared between responders (bleeding stopped/attenuated) and non-responders (bleeding continued) to rFVIIa, stratified by aneurysm status (ruptured (r-AAA) vs. non-ruptured (nr-AAA)). Patients were also scored using POSSUM (Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity) and Hardman Index mortality predictive models. Results: In total, 77 AAA patients were included in the analysis. Approximately 73 (n = 56) of them had ruptured aneurysms and about 50 (n = 35/70 with known data) responded positively to rFVIIa. Eleven incidents of thromboembolic adverse events were reported in 9 patients (6 r-AAA and 3 nr-AAA). Responders in both ruptured and non-ruptured groups had significantly lower 28-day mortality than non-responders (r-AAA: 40 (10/25) vs. 92 (24/26); P <0.001; nr-AAA: 30 (3/10) vs. 67 (6/9); P <0.01). Mortality predictive models did not show any difference between overall observed and expected mortality in ANZHR patients. Conclusion: Patients who responded to rFVIIa had a lower mortality than those who did not respond to the treatment.