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Multicenter Trial of a Novel Vascular Sealant

Objective
Suture line bleeding from synthetic grafts increases operating time and expense. Numerous sealants are available; however, prophylactic control of suture line bleeding has not been successfully demonstrated. Arterx Vascular Sealant is a glutaraldehyde-based agent designed for prophylactic use. The purpose of this study was to evaluate the safety and prophylactic efficacy of this new generation sealant.
Methods
A single-armed multi-institutional study from Europe utilizing the Arterx Vascular Sealant for open vascular reconstructions with prosthetic materials was undertaken. Sealant was applied prophylactically to the suture line after completion of the sutured anastomosis. The primary endpoint was immediate hemostasis without clinically significant bleeding. Secondary endpoints were timed hemostasis.
Results
53 arterial anastomosis with prosthetic graft were performed in 31 patients. 34 (64%) of these were performed with Dacron graft and 19 (36%) were performed with PTFE. The femoral artery was the most common site of anastomosis (23), with aortic (10), iliac (7), popliteal (4), tibial (4), carotid (2), brachial (2) and subclavian (1) arteries also utilized. Immediate hemostasis was achieved in 53 of 53 cases (100%). No clinically significant suture line bleeding occurred following operation. Two patients had minor oozing following application of the sealant, but neither required further intervention. The sealant was easy to apply, quickly formed into a soft gel, which was easily removed from instruments and surrounding tissue if needed.
Conclusion
The Arterx Vascular Sealant is effective in achieving prophylactic hemostasis following prosthetic arterial anastomosis. It appears safe with no clinically significant adverse events related to the sealant. A full prospective controlled trial of this product for prophylaxis is warranted, but the results of this preliminary trial appear promising.