RESUMEN
OBJECTIVES: The present study sought to investigate the safety and efficacy of a new fibrin sealant using percutaneous delivery techniques. BACKGROUND: The femoral approach has become the preferred means of access for percutaneous diagnostic and interventional procedures. Control of access site bleeding following catheterization, however, remains a significant problem in interventional cardiology. METHODS: Adult mongrel dogs were used in this study. Series 1 compared the effectiveness of fibrin sealant vs. manual compression alone in the presence of anticoagulants, thrombolytic, and antiplatelet agents. Series 2 assessed fibrin sealant safety. Series 3 examined fibrin sealant performance under elevated blood pressure levels. RESULTS: Series 1: Hemostasis was achieved in all fibrin sealant sites in significantly less time (8.5 +/- 4.3 min) with no major complications compared to manual compression sites (65.2 +/- 19.3 min) accompanied by serious complications. For all adjunctive agents employed, hemostasis was achieved in fibrin sealant sites in significantly less time (warfarin 9.9 +/-.2, urokinase 11.2 +/- 5.6, ReoProª 10.5 +/- 6.3 min) than for manual compression sites (warfarin 86.5 +/- 21.4, urokinase 89.8 +/- 36.3, ReoPro 77.9 +/- 26.5 min). Series 2: I25 iodine-labeled fibrinogen sealant was applied to puncture sites with no traces of circulating radioactivity observed over a one-hour period. Series 3: hemostasis was achieved under elevated blood pressure conditions in all animals. Histologic studies showed complete re-absorption of fibrin sealant 28 days post-procedure with no evidence of foreign body reaction. CONCLUSIONS: Percutaneous application of fibrin sealant to achieve hemostasis following catheterization appears to be a simple, safe, and highly effective procedure in a canine model.
