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

Marieke Hoogewerf,1,2 Bart P Van Putte,2,3 David Stecher,4,5 Wilhelmina Bergmann,6 Patrick Klein,2,3 Pieter A Doevendans1,7,8 1Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands; 2Department of Cardiothoracic Surgery, St. Antonius Hospital, Utrecht, the Netherlands; 3Department of Cardiothoracic Surgery, Amsterdam University Medical Center, Amsterdam, Noord Holland, the Netherlands; 4Department of Cardiothoracic Surgery, University Medical Center Utrecht, Utrecht, the Netherlands; 5Department of Cardiothoracic Surgery, Medical Center Leeuwarden, Leeuwarden, Friesland, the Netherlands; 6Division of Pathology, Department of Biomolecular Health Sciences, Faculty of Veterinary Medicine, Utrecht University, Utrecht, the Netherlands; 7Netherlands Heart Institute, Utrecht, the Netherlands; 8Central Military Hospital, Utrecht, the NetherlandsCorrespondence: Marieke Hoogewerf, Department of Cardiology, University Medical Centre Utrecht, Heidelberglaan 100, 3584CX, Utrecht, the Netherlands, Tel +31 06 5134 0842, Email [email protected]: 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