Recombinant factor VIIa (NovoSeven RT) use in high risk cardiac surgery

Document Type

Article

Abstract

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.

Medical Subject Headings

Aged; Blood Component Transfusion; Cardiac Surgical Procedures (adverse effects); Coagulants (administration & dosage, adverse effects, therapeutic use); Dose-Response Relationship, Drug; Drug Evaluation (methods); Factor VIIa (administration & dosage, adverse effects, therapeutic use); Female; Hemostasis, Surgical (adverse effects, methods); Humans; Male; Middle Aged; Postoperative Care (methods); Postoperative Hemorrhage (drug therapy, etiology, surgery); Recombinant Proteins (administration & dosage, adverse effects, therapeutic use); Reoperation; Retrospective Studies; Thromboembolism (etiology); Treatment Outcome

Publication Date

12-1-2011

Publication Title

European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery

E-ISSN

1873-734X

Volume

40

Issue

6

First Page

1314

Last Page

8; discussion 1318

PubMed ID

21601468

Digital Object Identifier (DOI)

10.1016/j.ejcts.2011.03.048

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