OBJECTIVE: The use of recombinant factor VIIa (rFVIIa) (NovoSeven RT(®)) to establish hemostasis during massive perioperative bleeding in cardiac surgery has been explored in several retrospective studies. While early results are promising, a paucity of data leaves many questions about its safety profile. We sought to further define its use and associated outcomes in a large cohort study at a single institution. METHODS: A retrospective cohort study design was used, in which 236 patients received rFVIIa for bleeding after cardiac surgery. These patients were matched with a cohort of 213 subjects, who had similar operations during the same period of time. Primary end points included thrombo-embolic events, mortality, incidence of re-operation, use of blood products, and patient disposition at 30 days. Statistical significance was assessed at p < 0.05. RESULTS: There was no statistically significant difference in the incidence of stroke (3.4%, 1.9%; p = 0.32), renal failure (8.5%, 7.0%; p = 0.57), or 30-day mortality (7.7%, 4.3%; p = 0.14) between the rFVIIa and the control groups, respectively. The rFVIIa group did experience a higher rate of re-operation for bleeding (11.0%, 1.9%; p = 0.0001) and had a two-fold increase in the use of each of the following: cryoprecipitate, fresh-frozen plasma, platelets, and packed red blood cells, relative to the control group (p < 0.00001). CONCLUSIONS: rFVIIa is an effective hemostatic agent for intractable bleeding in high-risk cardiac surgery with an acceptable safety profile. rFVIIa does not appear to be associated with increased postoperative complications, including thrombo-embolic events and death.
OBJECTIVE: The use of recombinant factor VIIa (rFVIIa) (NovoSeven RT(®)) to establish hemostasis during massive perioperative bleeding in cardiac surgery has been explored in several retrospective studies. While early results are promising, a paucity of data leaves many questions about its safety profile. We sought to further define its use and associated outcomes in a large cohort study at a single institution. METHODS: A retrospective cohort study design was used, in which 236 patients received rFVIIa for bleeding after cardiac surgery. These patients were matched with a cohort of 213 subjects, who had similar operations during the same period of time. Primary end points included thrombo-embolic events, mortality, incidence of re-operation, use of blood products, and patient disposition at 30 days. Statistical significance was assessed at p < 0.05. RESULTS: There was no statistically significant difference in the incidence of stroke (3.4%, 1.9%; p = 0.32), renal failure (8.5%, 7.0%; p = 0.57), or 30-day mortality (7.7%, 4.3%; p = 0.14) between the rFVIIa and the control groups, respectively. The rFVIIa group did experience a higher rate of re-operation for bleeding (11.0%, 1.9%; p = 0.0001) and had a two-fold increase in the use of each of the following: cryoprecipitate, fresh-frozen plasma, platelets, and packed red blood cells, relative to the control group (p < 0.00001). CONCLUSIONS: rFVIIa is an effective hemostatic agent for intractable bleeding in high-risk cardiac surgery with an acceptable safety profile. rFVIIa does not appear to be associated with increased postoperative complications, including thrombo-embolic events and death.
Authors: Nicholas D Andersen; Syamal D Bhattacharya; Judson B Williams; Emil L Fosbol; Evelyn L Lockhart; Mayur B Patel; Jeffrey G Gaca; Ian J Welsby; G Chad Hughes Journal: Ann Thorac Surg Date: 2012-05-01 Impact factor: 4.330
Authors: Christian O'Donnell; Alexander J Rodriguez; Jai Madhok; Husham Sharifi; Hanjay Wang; Connor G O'Brien; Jack Boyd; William Hiesinger; Joe Hsu; Charles C Hill Journal: J Cardiothorac Vasc Anesth Date: 2021-04-25 Impact factor: 2.628
Authors: Charles L Percy; Rudolf Hartmann; Rhidian M Jones; Subramaniam Balachandran; Dheeraj Mehta; Michael Dockal; Friedrich Scheiflinger; Valerie B O'Donnell; Judith E Hall; Peter W Collins Journal: Blood Coagul Fibrinolysis Date: 2015-06 Impact factor: 1.276