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Evaluation of the PAS-Port Proximal Anastomosis System in coronary artery bypass surgery (the EPIC trial)
John D Puskas1, Michael E Halkos, Husam Balkhy
1Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta, Georgia 30308, USA. john.puskas@emoryhealthcare.org
Insights
The PAS-Port device offers comparable graft patency to traditional hand-sewn anastomoses in coronary artery bypass grafting. This automated device reduces surgical time without compromising patient outcomes.
Area of Science:
- Cardiovascular Surgery
- Medical Devices
- Surgical Innovation
Background:
- Traditional coronary artery bypass grafting (CABG) often requires aortic clamping for proximal vein graft anastomosis.
- This clamping can be associated with potential complications and increased surgical time.
Purpose of the Study:
- To evaluate the efficacy of the PAS-Port device for automated proximal anastomosis in CABG.
- To compare the PAS-Port device to traditional hand-sewn anastomoses without aortic clamping.
Main Methods:
- A multicenter, prospective, randomized trial involving 220 patients undergoing CABG.
- Randomized assignment of either PAS-Port device or hand-sewn anastomosis for proximal vein grafts within each patient.
- Primary endpoint: angiographic graft patency at 9 months; Secondary endpoints: anastomotic time and major adverse cardiac events.
Main Results:
- 9-month graft patency was 80.3% for PAS-Port versus 82.0% for hand-sewn, demonstrating non-inferiority.
- Freedom from major adverse cardiac events at 9 months was high for both groups (97.7% PAS-Port, 98.2% hand-sewn).
- The PAS-Port device significantly reduced anastomotic time by an average of 4.6 minutes (P < .001).
Conclusions:
- The PAS-Port device provides an effective proximal anastomosis in CABG.
- It achieves comparable 9-month graft patency to hand-sewn anastomoses.
- The device enables anastomosis without aortic clamping, reducing surgical time.
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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