Abstract 15504: A New Coronary Anastomotic Connector in a Preclinical Safety Study

Abstract

Introduction: A facilitated construction of a distal coronary anastomosis is the key towards less invasive coronary bypass surgery, ideally in an endoscopic hybrid approach. This study evaluates a new laser-assisted, zero ischemia coronary anastomotic connector in comparison to the hand-sutured anastomotic technique, in a long-term follow-up porcine off-pump bypass model. The initial results of this preclinical comparative safety study are presented. Hypothesis: We assessed the hypothesis that the coronary connector is not inferior to the hand-sutured technique, in terms of patency, healing, and hemodynamic function. Methods: In 22 pigs (3 months follow-up, n=10; 6 months follow-up, n=12), the so-called Trinity Clip connector facilitated a LITA-to-LAD anastomosis, and in 14 pigs (3 months follow-up, n=6; 6 months follow-up, n=8) the anastomosis was hand-sutured. All anastomoses (n=36) were evaluated intraoperatively by means of graft flow measurements and at follow-up by angiography and histology. Results: After construction, complete hemostasis was obtained in 95% (21/22) of the connector facilitated anastomoses and in 86% (12/14) of the hand-sutured. Both groups had a mean coronary outer diameter of 1.8 ± 0.1 mm. The mean peak hyperemic flow response (peak [following 30-second graft occlusion]/base flow) was 4.1 ± 1.0 in the connector group versus 4.2 ± 1.1 in the hand-sutured group. The patency in both groups was 100% (connector group: at 6 months [n=3/3] and 3 months [n=5/5]; hand-sutured group: at 6 months [n=1/1] and 3 months [n=4/4]). Conclusions: The initial data of this preclinical study demonstrates similar anastomosis success rate in both groups. The connector is easy-to-use and seems to be safe and reliable in the long-term porcine off-pump bypass model. Complete data on the long-term will be expected soon and the resulting histological and angiographic data will further elucidate the future relevance of this new coronary anastomotic device. In conclusion, albeit the preliminary study status, the connector has potential to facilitate minimally invasive or endoscopic CABG.