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J Thorac Cardiovasc Surg 2001;121:859-870
© 2001 The American Association for Thoracic Surgery

Evolving Technology

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

From the University of California, San Francisco, Calif, the Medical College of Virginia, Richmond, Va, and the Armed Forces Institute of Pathology, Washington, DC.

Received for publication May 4, 2000. Revisions requested Aug 15, 2000; revisions received Nov 3, 2000. Accepted for publication Nov 9, 2000. Address for reprints: Arthur C. Hill, MD, Department of Surgery, University of California at San Francisco, San Francisco General Hospital, 1001 Potrero Ave, Box 0807, San Francisco, CA 94143-0807.

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.

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