Biocompatibility and patency of a novel titanium vascular anastomotic device in a pig jugular vein

Abstract

This study aimed to evaluate the biocompatibility and patency of our newly developed titanium vascular anastomotic device (TVAD) in a pig jugular vein. TVAD was made of commercially pure grade 2 titanium. The patency and anastomotic time were simultaneously confirmed in an ex-vivo system developed by the authors and in vivo using pig jugular veins. Five 8-month-old pigs, with body weights of 50–60 kg, underwent anastomosis of both jugular veins using the device. Graft patency was evaluated for 12 weeks by biplane angiography and sonography. All tissue biopsy samples were analysed by histology. In all 10 cases, the anastomosis was completed in < 5 min. The vessel lumen was not damaged, and the inner vessel wall was completely endothelialised at the anastomotic site. No foreign body reactions were observed at the vessel lumen, vessels, and outer vessel walls by histopathologic analysis. Patency and absence of leakage at the anastomotic site of the follow-up period were confirmed clearly by angiography and sonography. This preliminary animal study proved that our newly developed device is a very promising tool for intima-to-intima contact anastomosis. TVAD can be used as a feasible and safe medical tool for vessel anastomosis.