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

Matschke, Klaus E; Gummert, Jan F; Demertzis, Stefanos; Kappert, Utz; Anssar, Marcel B; Siclari, Francesco; Falk, Volkmar; Alderman, Edwin L; Detter, Christian; Reichenspurner, Hermann; Harringer, Wolfgang (2005). 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. Journal of thoracic and cardiovascular surgery, 6(130), pp. 1645-52. St. Louis, Mo.: Mosby 10.1016/j.jtcvs.2005.08.033

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Faculty Institutions > Teaching Staff, Faculty of Medicine

UniBE Contributor:

Demertzis, Stefanos

ISSN:

0022-5223

ISBN:

16308011

Publisher:

Mosby

Language:

English

Submitter:

Factscience Import

Date Deposited:

04 Oct 2013 15:08

Last Modified:

04 May 2014 23:21

Publisher DOI:

10.1016/j.jtcvs.2005.08.033

PubMed ID:

16308011

Web of Science ID:

000233896300026

URI:

https://boris.unibe.ch/id/eprint/29667 (FactScience: 157797)

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