Prospective randomized study evaluating an absorbable cyanoacrylate for use in vascular reconstructions.

Abstract

BACKGROUND: An easy-to-use vascular sealant with good safety and efficacy is needed to prevent anastomotic bleeding in vascular surgery. This study evaluated the safety and efficacy of cyanoacrylate surgical sealant in establishing hemostasis of expanded polytetrafluoroethylene to arterial vascular anastomoses in arteriovenous (AV) grafts and femoral bypass grafts. METHODS: This multicenter, randomized, controlled, open-label study was conducted in a hospital setting at 12 sites: 10 in the United States and 2 in Europe. A total of 151 patients undergoing femoral bypass procedures or AV shunt procedures for hemodialysis access using expanded polytetrafluoroethylene grafts were randomized 2:1 to receive cyanoacrylate surgical sealant or the control (oxidized cellulose) between April 26, 2004, and January 18, 2005. Randomization was stratified by clinical site and type of procedure. After the anastomosis, cyanoacrylate surgical sealant or the control was applied to all anastomosis sites for patients undergoing femoral bypass procedures and to only the arterial anastomosis sites for patients undergoing AV shunt procedures. The primary end point was the elapsed time from clamp release to hemostasis. Secondary end points were the proportion of patients achieving hemostasis at t = 0 (immediate), 1, 5, or 10 minutes after clamp release, use of additional adjunctive measures to achieve hemostasis, and occurrence of adverse events. RESULTS: Baseline demographics and clinical characteristics showed that the two treatment groups were similar at baseline. The mean time from clamp release to hemostasis was 119.3 seconds with cyanoacrylate surgical sealant vs 403.8 seconds with the control (P < .001). Immediate hemostasis was achieved in 54.5% of patients receiving cyanoacrylate surgical sealant and in 10% of those receiving the control. The proportion of patients requiring additional adjunctive measures was lower with cyanoacrylate surgical sealant, and the occurrence of adverse events was similar in both groups. CONCLUSIONS: This study demonstrates that cyanoacrylate surgical sealant is effective at reducing the time to hemostasis and achieving immediate hemostasis in AV shunt and femoral bypass procedures and that it is safe for internal use. Cyanoacrylate surgical sealant is an easy-to-use vascular sealant with good safety and efficacy that significantly decreases anastomotic bleeding in vascular surgery.