Fibrin Sealant as a Hemostatic Agent in Vascular Surgery

Abstract

Until recently, the only commercially available products in the United States for topical hemostasis during surgery were those made from various preparations of animal collagen, gelatin, and cellulose. Although these products have become widely used, they lack any significant intrinsic coagulation mechanism, and basically serve as scaffolds upon which endogenous clot forms. Fibrin sealant, which has been commercially available in Europe since 1978 as an adjunctive hemostatic agent, has undergone preclinical and clinical studies as a topical hemostatic agent. These products were withdrawn from the U.S. market in 1978 when the Food and Drug Administration (FDA) revoked the license for commercial fibrinogen concentrates because of viral infectivity. Since then, a number of viral inactivation processes have been developed and have essentially eliminated the risk of transmission of HIV, hepatitis B, and hepatitis C. Viral inactivation is now used in all commercial fibrin sealant products, although the methods vary with the manufacturer (Table I). On May 1, 1998, the FDA approved one of these products for use in the United States (Tisseel; Baxter-Immuno, Vienna, Austria, and Glendale, CA). There are other manufacturers involved in the development of additional fibrin sealant prod ucts, and it is likely that many of these will become available in the future.