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Ann Thorac Surg 2005;80:3-5
© 2005 The Society of Thoracic Surgeons

Editorial

Off-Label Use of Recombinant Factor VIIA Concentrates After Cardiac Surgery

George Despotis, MDa,b,*, Michael Avidan, MDa,c, Douglas M. Lublin, MD, PhDb

a Department of Anesthesiology, St. Louis, Missouri, USA
b Department of Pathology and Immunology, St. Louis, Missouri, USA
c Department of Surgery, Washington University School of Medicine, St. Louis, Missouri

* Address reprint requests to Dr Despotis, Department of Anesthesiology, Box 8054, Washington University School of Medicine, 660 S Euclid Ave, St. Louis, MO63110 (Email: despotig@notes.wustl.edu).

The first 300 words of the full text of this article appear below.

Recombinant activated factor VIIa (rFVIIa) is currently FDA approved for the management of bleeding related to hemophilia in patients with factor inhibitors. Although the off-label use of this agent has been reported to be successful in reversing life-threatening bleeding in a number of clinical scenarios [1], the body of literature for off-label use predominately consists of case reports and anecdotal experience with limited data from randomized clinical trials.

The mechanism of action of activated factor VII involves generation of thrombin by initial binding to tissue factor and subsequent activation of factor X on the platelet surface; activated factor X in combination with factor V (ie, prothrombinase complex) leads to localized thrombin formation. This occurs in the absence of factor VIII or factor IX. The extent of thrombin activation relates to the concentration of activated factor VII achieved. Partial thrombin activation occurs at rFVIIa concentrations approximating 50 nM, whereas full activation of thrombin, referred to as a "thrombin burst," is achieved with higher levels (100 to 150 nM) [1]. This pronounced thrombin activity on thrombin-activated platelet surfaces leads to a stabilized thrombin plug and tight fibrin structure resistant to lysis. One of the reasons postulated for the potential safety of rFVIIa is that it should be effective predominately at the sites of vessel injury where there is localized expression of tissue factor by subendothelial cells. However, the risks of thrombosis associated with rFVIIa may be theoretically increased when there is systemic (eg, disseminated intravascular coagulation) or localized, pathologic expression of tissue factor (eg, atherosclerotic coronary artery disease).

Because recombinant FVIIa usage has been steadily increasing in non-approved settings, significant concerns have arisen about its safety, efficacy, and costs. Dosing of rFVIIa for non-approved settings is not standardized and is evolving in part based on cost considerations and . . . [Full Text of this Article]


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