Preclinical Feasibility of the ELANA End-to-End Anastomotic Technique in a Porcine Pilot Study

Purpose: To advance minimally invasive surgical techniques, we developed the sutureless ELANA ® End-to-End anastomotic technique. This preclinical study aimed to evaluate the technical feasibility, hemostatic performance, and short-term patency of the new approach in a porcine model. Methods: Six pigs underwent implantation of the ELANA End-to-End device in a divided in situ right internal mammary artery (RIMA) via partial sternotomy. The pigs were followed-up for either 35 days (N=3) or 90 (N=3) days. Feasibility was evaluated based on technical success, achievement of hemostasis, and anastomotic construction time. Patency was assessed at the end of follow-up through angiography and histological analysis. Results: The anastomosis was successfully constructed in four of six animals. Among these, hemostasis was achieved in three cases without additional intervention; one required a single hemostatic stitch. The median anastomotic construction time was 18 (15– 45) minutes. Technical failure in two animals was due to difficulty maintaining vessel alignment during deployment. All four successfully constructed anastomoses were patent at the end of follow-up (N=2, 35 days; N=2, 90 days), with no evidence of stenosis on angiography or histology. Conclusion: The ELANA End-to-End technique demonstrated promising patency outcomes. However, the current procedure is technically demanding. Design improvements aimed at stabilizing vessel positioning are warranted to enhance feasibility and reduce construction time. Keywords: coronary artery bypass grafting, sutureless, anastomosis, minimal invasive, ELANA