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J Thorac Cardiovasc Surg 2009;138:125-132
© 2009 The American Association for Thoracic Surgery
Evolving Technology/Basic Science |
a Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, Georgia
b Department of Cardiothoracic and Cardiovascular Surgery, the Wisconsin Heart Hospital, Milwaukee, Wis
c Scottsdale Healthcare Medical Center, Scottsdale, Ariz
d Division of Cardiovascular and Thoracic Surgery, St Michael's Medical Center, Newark, NJ
e Department of Cardiovascular and Thoracic Surgery, St Luke's Medical Center, Milwaukee, Wis
f Department of Cardiac Surgery, Rhönklinik Bad Neustadt, Bad Neustadt, Germany
g Department of Cardiac and Thoracic Surgery, Herzzentrum Jena University, Jena, Germany
h Department of Cardiac, Thoracic, and Vascular Surgery, Klinik für Herz-, Thorax- und Gefäßchirurgie, Städtisches Klinikum Braunschweig GmbH, Hannover, Germany
i Department of Cardiothoracic Surgery, Lenox Hill Hospital, New York, NY
j Department of Cardiovascular and Thoracic Surgery, Mainline Heart Health Center, Wynnewood, Pa
k Department of Cardiac Surgery, Herzzentrum Dresden, Dresden, Germany
Received for publication November 2, 2008; revisions received January 10, 2009; accepted for publication February 2, 2009. * Address for reprints: John D. Puskas, MD, Division of Cardiothoracic Surgery, Emory University School of Medicine, 550 Peachtree St, Crawford Long Hospital, 6th Floor, Medical Office Tower, Atlanta, GA 30308. (Email: john.puskas{at}emoryhealthcare.org).
Objective: During coronary surgery, proximal vein graft anastomoses have been performed by using an aortic partial occlusion clamp to allow for a hand-sewn anastomosis. The purpose of this multicenter, prospective, randomized trial was to evaluate the efficacy of the PAS-Port device (Cardica, Inc, Redwood City, Calif), which allows an automated proximal anastomosis to be performed without aortic clamping.
Methods: Between June 22, 2006, and March 22, 2007, 220 patients requiring coronary artery bypass grafting with at least 2 vein grafts were enrolled. Within each patient, 1 graft was randomly assigned to receive a PAS-Port device, and the other was assigned to receive a hand-sewn anastomosis to the ascending aorta. The primary end point was angiographic patency (<50% stenosis) 9 months after surgical intervention. Secondary end points included average time to complete each anastomosis and 9-month freedom from major adverse cardiac events.
Results: One hundred eighty-three patients received matched grafts that were angiographically assessed at 9 months. The 9-month graft patency was 82.0% (150/183) for hand-sewn and 80.3% (147/183) for PAS-Port grafts. The patency rate of PAS-Port anastomoses was statistically noninferior to that of hand-sewn anastomoses (95% lower confidence limit for difference, –7.95%). The freedom from major adverse cardiac events at 9 months was 97.7% for PAS-Port (95% confidence interval, 94.5%–99.0%) and 98.2% for hand-sewn (95% confidence interval, 95.1%–99.3%) grafts. The PAS-port device was associated with a 4.6 ± 3.9–minute reduction in anastomotic time compared with that seen with a hand-sewn anastomosis (P < .001).
Conclusions: The PAS-Port proximal anastomotic device produces an effective anastomosis with a 9-month patency rate that is comparable with that of a hand-sewn anastomosis. It allows for construction of a proximal anastomosis without aortic clamping and requires less time than a hand-sewn anastomosis.
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