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Jan F. Gummert
Stefanos Demertzis
Klaus Matschke
Utz Kappert
Marcel Anssar
Francesco Siclari
Volkmar Falk
Wolfgang Harringer
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Right arrow Coronary disease

Ann Thorac Surg 2006;81:90-96
© 2006 The Society of Thoracic Surgeons

Original article: Cardiovascular

Six-Month Angiographic Follow-Up of the PAS-Port II Clinical Trial

Jan F. Gummert, MD a , * , Stefanos Demertzis, MD b , Klaus Matschke, MD c , Utz Kappert, MD c , Marcel Anssar, MD d , Francesco Siclari, MD b , Volkmar Falk, MD a , Edwin L. Alderman, MD e , Wolfgang Harringer, MD d

a Department of Cardiac Surgery, Heartcenter, University of Leipzig, Leipzig, Germany
b Department of Cardiac Surgery, Cardiocentro Ticino, Lugano, Switzerland
c Department of Cardiac Surgery, Heart Center Dresden, Dresden, Germany
d Department of Cardiovascular and Thoracic Surgery, Klinikum Braunschweig, Braunschweig, Germany
e Department of Cardiovascular Medicine, Stanford University, Palo Alto, California

Accepted for publication June 8, 2005.

* Address correspondence to Dr Gummert, University of Leipzig, Heartcenter, Department of Cardiac Surgery, Strümpellstr 39, D-04289 Leipzig, Germany (Email: gumj{at}medizin.uni-leipzig.de).

Presented at the Poster Session of the Forty-first Annual Meeting of The Society of Thoracic Surgeons, Tampa, FL, Jan 24–26, 2005.

BACKGROUND: The PAS-Port device (Cardica, Redwood City, CA) allows the rapid deployment of a clampless proximal anastomosis between a vein graft and the aorta.

METHODS: Fifty-four patients awaiting elective coronary artery bypass graft surgery were enrolled. Outcome variables were intraoperative device performance, early and 6- month angiographic graft patency, and 12-month clinical follow-up.

RESULTS: Sixty-three PAS-Port devices were deployed in 54 patients. Two deployments were unsuccessful. There were no reoperations for bleeding. Two patients died of causes unrelated to the device. Patency evaluation at discharge was performed by angiogram on 49 implants and computed tomography in 2 implants (86% follow-up). At discharge, all evaluated grafts were patent (100%) and rated Fitzgibbon A. At 6-month follow-up, there was no additional mortality; 47 implants (88% follow-up) were evaluated by angiography (Fitzgibbon O [n = 1], Fitzgibbon B [n = 1], and Fitzgibbon A [n = 45]) and 5 by computed tomography. All grafts but 1 were patent (98.1%). At 12 months, 2 additional patients died of causes unrelated to the PAS-Port implant. Forty-six of 50 alive patients (95.8%) were followed up without any reports of device-related major adverse cardiac events.

CONCLUSIONS: Discharge (100%) and 6-month patency (98%) are excellent; patency and 12 months' clinical follow-up compares favorably with data from historical hand-sewn controls. The PAS-Port system safely allows the clampless creation of a proximal anastomosis.




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