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J Thorac Cardiovasc Surg 2005;130:1645-1652
© 2005 The American Association for Thoracic Surgery

Evolving Technology

The Cardica C-Port System: Clinical and angiographic evaluation of a new device for automated, compliant distal anastomoses in coronary artery bypass grafting surgery—A multicenter prospective clinical trial

^a Department of Cardiac Surgery, University of Technology Dresden, Dresden, Germany
^b Department of Cardiac Surgery, Heart Center, University of Leipzig, Leipzig, Germany
^c Department of Cardiac Surgery, Cardiocentro Ticino, Lugano, Switzerland
^d Department of Cardiovascular and Thoracic Surgery, Klinikum Braunschweig, Braunschweig, Germany
^e Department of Cardiovascular Medicine, Stanford University, Stanford, Calif
^f Department of Cardiac Surgery, Heart Center Hamburg, University of Hamburg, Hamburg, Germany

Read at the Eighty-fifth Annual Meeting of The American Association for Thoracic Surgery, San Francisco, Calif, April 10-13, 2005.

Received for publication March 31, 2005; revisions received August 10, 2005; accepted for publication August 17, 2005.

^_* Address for reprints: Klaus E. Matschke, MD, Department of Cardiac Surgery, Heart Center Dresden University Hospital, Fetscherstr 76, D-01307 Dresden, Germany (Email: k.matschke{at}herzzentrum-dresden.com).

OBJECTIVES: The C-Port System (Cardica, Inc, Redwood City, Calif) integrates in one tool all functions necessary to enable rapid automated distal coronary anastomoses. The goal of this prospective, nonrandomized, and multicenter study is to determine the safety and efficacy of this novel anastomotic system.

METHODS: Five centers enrolled 133 patients awaiting elective coronary artery bypass grafting surgery. Outcome variables were intraoperative device performance, incidence of device-related adverse events, predischarge and 6-month angiographic graft patency, and 12-month clinical outcome. Independent core laboratories performed qualitative and quantitative angiographic and computed tomographic assessments.

RESULTS: The C-Port was used to perform a vein-to-coronary anastomosis in 130 patients. Intraoperative conversion to a hand-sewn anastomosis was necessary in 11 patients because of inadequate target site preparation, inappropriate target vessel selection, or both. Inadequate blood flow related to poor runoff required conversion in 3 additional patients. Three patients died before discharge of causes unrelated to the device. At discharge, 113 patients had a C-Port implant in place, and 104 C-Port anastomoses were studied by means of angiography, resulting in 100 FitzGibbon A, 3 FitzGibbon B, and 1 FitzGibbon 0 classifications. At 6 months, one additional patient died of a device-unrelated cause, and 98 patients were evaluated by means of angiography (n = 89). Overall patency (FitzGibbon A) was 92.1%. Three C-Port anastomoses were rated FitzGibbon B, and 4 were rated FitzGibbon 0. At 12 months, 107 (98.2%) of 109 alive patients were followed up, without any reports of device-related major adverse cardiac events.

CONCLUSIONS: The C-Port System allows for a rapid, reliable, and compliant distal anastomosis and yields favorable 6-month angiographic and 12-month clinical results when compared with published studies.

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