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Prospective Randomized Study of Fibrin Sealant Versus Manual Compression for Treatment of Suture Line Bleeding in Expanded Polytetrafluoroethylene (ePTFE) Graft Placement
SIBU P. SAHA, MD, MBA1, SATISH MULUK, MD2, WORTHINGTON SCHENK, III, MD3, JAMES W. DENNIS, MD4, BETTINA PLODER, MS5, ANI GRIGORIAN, MFA6, ISABELLA PRESCH, MD, MBA5, ANDREAS GOPPELT, PHD5.
1DIVISION OF CARDIOVASCULAR AND THORACIC SURGERY, DEPARTMENT OF SURGERY, UNIVERSITY OF KENTUCKY, LEXINGTON, KY, USA, 2ALLEGHENY GENERAL HOSPITAL, DIVISION OF VASCULAR SURGERY WEST PENN, PITTSBURGH, PA, USA, 3UNIVERSITY OF VIRGINIA, THE SURGICAL THERAPEUTIC ADVANCEMENT CENTER, DEPARTMENT OF SURGERY, CHARLOTTESVILLE, VA, USA, 4UNIVERSITY OF FLORIDA HEALTH SCIENCE CENTER OF JACKSONVILLE, DEPARTMENT OF SURGERY, JACKSONVILLE, FL, USA, 5BAXTER INNOVATIONS GMBH, VIENNA, Austria, 6BAXTER HEALTHCARE CORP., WESTLAKE VILLAGE, CA, USA.
Objectives: This study evaluated whether the use of a fibrin sealant containing 500 IU/mL thrombin and synthetic aprotinin (FS) is beneficial for treatment of challenging suture-line bleeding at vascular anastomoses of ePTFE grafts, including those further complicated by concomitant antiplatelet therapies.
Methods: Over a 1-year period ending in 2010, ePTFE graft prostheses including arterio-arterial bypasses and AV shunts were placed in 140 patients who experienced suture-line bleeding that required treatment after surgical hemostasis. Across 24 US centers, 70 subjects were randomized and treated with FS and 70 with manual compression (control). The primary endpoint was the proportion of subjects who achieved hemostasis at the study suture line at 4 minutes after start of application of FS or positioning of surgical gauze pads onto the study suture line.
Results: There was a statistically significant difference in the comparison of hemostasis rates at the study suture line at 4 minutes between FS (62.9%) and control (31.4%) subjects (P<0.0001), which was the primary endpoint. Similarly, hemostasis rates in the subgroup of subjects on antiplatelet therapies were 64.7% (FS group) and 28.2% (control group). When analyzed by bleeding severity, the hemostatic advantage of FS over control at 4 minutes was similar (27.8% absolute improvement for moderate bleeding vs. 32.8% for severe bleeding). Logistic regression analysis---accounting for gender, age, intervention type, bleeding severity, blood pressure, heparin coating of ePTFE graft, and antiplatelet therapies---found a statistically significant treatment effect in the odds ratio (OR) of meeting the primary endpoint between treatment groups (OR=6.73, P<0.0001), as well as statistically significant effects for intervention type (OR = 0.25, P=0.0055) and bleeding severity (OR = 2.59, P=0.0209). The safety profile of FS was excellent as indicated by the lack of any related serious adverse events.
Conclusions: Data from this prospective, controlled, randomized, subject-blinded, multicenter study confirmed that FS is safe and its efficacy is superior to manual compression for hemostasis in patients with peripheral vascular ePTFE grafts. The data also suggest that FS can achieve hemostasis independently of the patient’s own coagulation system, as shown in a representative population of vascular disease patients under single or dual antiplatelet therapies.
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