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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.

Background: Certain heart manipulations carried out to access anastomotic sites during beating heart coronary artery bypass (OPCAB) compromise hemodynamics, and these risks can affect end-organ perfusion and limit patient selection. Evidence suggests that right heart support (RHS) augments left ventricular preload and provides hemodynamic stability. This study evaluated hemodynamic measures in OPCAB with RHS with respect to individual target vessels and general target distribution groups., Methods: Beating heart surgery was performed on 52 patients with left ventricular preload managed with RHS. The average patient age was 69.9 years, and the average ejection fraction was 42.9% +/- 10.9%. Measurements of cardiac output, stroke volume, mean arterial pressure (MAP), heart rate, and cardiac index (CI) were taken at baseline, during each anastomosis with the optimal heart position, and when the RHS was momentarily interrupted prior to heart release. Anastomoses were categorized individually and into posterior/lateral (n = 91) or anterior/right (n = 90) groups and divided into the following output groups based on CI with optimal heart positioning without RHS: group 1 (low output; CI < 1.8), group 2 (marginal output; 1.8 < or = CI < 2.2), group 3 (acceptable output; CI > or = 2.2), and group 4 (output unchanged or increased)., Results: One hundred eighty-one vessels were grafted with an average of 3.5 per patient. Significant reductions in CI, MAP, and stroke volume were observed for all target vessels when RHS was briefly off, especially for posterior and lateral target vessels (12%-26% decrease). In both posterior/lateral and anterior/right target vessel groups, RHS improved CI and MAP in > or = 90% of the anastomoses (groups 1-3). Without RHS, 60% of posterior/lateral and 54% of anterior/right target positions resulted in critically low or marginal output (groups 1 and 2). There was one bypass conversion and no surgical interruptions, intraoperative intra-aortic balloon pump placements, or deaths., Conclusion: Augmenting left ventricular preload with RHS improves hemodynamic measures during OPCAB for all target vessel positions and provides critical support in a large number of anastomoses.