A Sutureless Vascular Closure Device for Emergent Bovine Xenograft Implantation

A novel vascular staple (C-staple) was developed that does not enter the vasculature lumen during anastomoses. The objective of this study was to demonstrate C-staple safety when used with a bovine xenograft and compare efficacy of the C-staple procedure with Anastoclip surgical clips or suturing when used with a bovine xenograft. Eight sheep had an acute comparison between suturing and C-staples using both common carotid arteries. Sixteen sheep had xenograft placement in the left carotid artery, eight with C-staples and eight with Anastoclips in a chronic study. Over 6 months, Doppler ultrasound interrogation of the common carotid arteries was performed. After 6 months, arteries were evaluated histopathologically. Cross-clamp and surgical times were longer in the C-staple group than the suture group, and xenograft implantation times were statistically longer with C-staples than with Anastoclips. After 6 months, C-staple biocompatibility was similar to Anastoclips. Patency and hemodynamics of the bovine xenograft were not statistically different between the two groups. C-staples performed as well as the Anastoclips except for implant times, likely due to delivery system differences. Histological findings and clinical outcomes were no different with the two devices. Further refinements of the C-staple delivery system are necessary before proceeding to clinical trials.