CorLink sutureless aortic anastomotic device: results of an animal study

The CorLink Automated Anastomotic Device (AD) was developed to create a sutureless vein-to-aorta anastomosis without the need to clamp the aorta. This study examined the effectiveness and safety of this device in an animal model.

Forty-seven vein-to-aorta anastomoses using the AD and 27 control hand-sutured anastomoses were constructed in 28 sheep. The distal part of these grafts were connected either to the main pulmonary artery (40 AD, 20 control), or to the sheep's brachiocephalic trunk (7 AD, 7 control). Procedural details focusing on deployment, leakage, and early patency rates were examined. Sheep were sacrificed after periods ranging from 1 to 180 days. Specimens were examined grossly and histologically.

All but three attempts to construct an anastomosis were successful (2 AD, 1 control). All anastomoses were patent immediately after their construction. There was no difference between control and AD anastomoses in respect to flow rates at the end of operation and before sacrifice. No metal breaks were detected. Fourteen of the 47 AD anastomoses and 6 of the control anastomoses (29.8% versus 22.2% P = ns) were occluded at autopsy. Histological findings characteristic of the healing process, were evenly distributed between AD and control anastomoses in both models. Intimal thickening was found in a notable number of anastomoses, but without any significant difference between the AD and control sutured (44.7% versus 40.7% P = ns).

The AD proved safe and effective for the construction of proximal vein-to-aorta anastomoses as compared to control hand-sutured anastomoses.