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Percutaneous Application of Fibrin Sealant to Achieve Hemostasis Following Arterial Catheterization
1Medical College of Wisconsin, Division of Cardiovascular Medicine, Froedtert East, 9200 West Wisconsin Avenue, Milwaukee, WI, 53226, USA.
Insights
This study demonstrates that percutaneous fibrin sealant effectively and safely achieves hemostasis after catheterization in dogs. It significantly reduces bleeding time compared to manual compression, even with anticoagulants.
Area of Science:
- Cardiology
- Biomaterials
Background:
- Femoral artery access is standard for percutaneous procedures.
- Controlling bleeding at the access site post-catheterization is a clinical challenge.
Purpose of the Study:
- To evaluate the safety and efficacy of a novel fibrin sealant for percutaneous hemostasis.
- To assess fibrin sealant performance in a canine model.
Main Methods:
- Compared fibrin sealant to manual compression in dogs receiving anticoagulants, thrombolytics, and antiplatelet agents.
- Assessed sealant safety using radiolabeled fibrinogen.
- Evaluated sealant performance under induced hypertension.
Main Results:
- Fibrin sealant achieved hemostasis significantly faster (8.5 min) than manual compression (65.2 min) with fewer complications.
- Hemostasis was rapid with fibrin sealant even with anticoagulants (warfarin, urokinase, ReoPro).
- No circulating radioactivity was detected, and histology confirmed sealant reabsorption without foreign body reaction.
Conclusions:
- Percutaneous fibrin sealant is a safe and effective method for achieving hemostasis after catheterization.
- The procedure is simple and well-tolerated in a canine model.
- Fibrin sealant offers a significant advantage over manual compression for managing access site bleeding.
Abstract:
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.