Facilitated coronary anastomosis using a nitinol U-Clip device: Bovine model

Abstract

Objective: The coronary anastomosis is the most difficult part of the coronary bypass procedure, particularly when using a minimally invasive technique. Methods to facilitate coronary anastomosis will make the minimally invasive approach to coronary bypass feasible. We sought preclinical validation and testing of the design and efficacy of a self-closing penetrating clip that can be used to facilitate the creation of graft-to-coronary end-to-side anastomosis. Methods: The nitinol U-Clip device (Coalescent Surgical, Inc, Sunnyvale, Calif) was used in 13 consecutive calves (63-118 kg). In each animal, the device was (1) used to create an anastomosis of the right internal thoracic artery to a coronary artery with the heart beating and (2) compared to polypropylene suture when used to repair two carotid arteriotomies. Intraoperative, 1-week, 8-week, and 26-week postoperative angiograms and detailed histopathologic examinations were used to evaluate anastomotic patency and healing characteristics. Results: The nitinol U-Clip device successfully created right internal thoracic artery-coronary artery anastomoses and repaired carotid arteriotomy sites in 13 consecutive calves. The clip was precisely placed by means of the integrated suture and needle in a fashion similar to that used for conventional suture. The clip met design specifications by reliable release and automatic closure, thereby eliminating knot tying and assisted suture management. At the time of harvest, angiography showed widely patent coronary anastomoses (FitzGibbon grade A criteria, n = 13) and carotid arteriotomy repair sites (n = 13). Histopathologic evaluation confirmed normal healing with smooth circumferential neointimal resurfacing at the anastomotic and repair sites. Conclusions: The nitinol U-Clip design and function was validated in the formation of bovine coronary anastomoses on the beating bovine heart with excellent graft patency and healing characteristics. The nitinol U-Clip device tests favorably when compared with conventional sutures in carotid artery repair.