Distal anastomotic patency of the Cardica C-PORT(R) xA system versus the hand-sewn technique: a prospective randomized controlled study in patients undergoing coronary artery bypass grafting.

OBJECTIVES The C-Port® Distal Anastomosis Systems (Cardica, Inc., Redwood City, CA, USA) demonstrated favourable results in feasibility trials. However, distal vein anastomoses created with the C-Port® or C-Port xA® system have never been compared with hand-sewn distal vein anastomoses. The objective of this study was to compare distal end-to-side anastomoses facilitated with the C-Port xA® System with the traditional hand-sewn method. METHODS This single-centre prospective randomized controlled study comprised 71 patients (device group n = 35, control group n = 36) who underwent primary elective coronary artery bypass grafting between June 2008 and April 2011. The primary study end-point was 12-month distal anastomotic patency, which was assessed with prospective ECG-gated 256-multislice computed tomographic coronary angiography using a step-and-shoot scanning protocol. For the primary end-point, a per-protocol analysis was used. RESULTS In the device group, four (11%) anastomoses were converted to hand-sewn anastomoses, and additional stitches to achieve haemostasis were necessary in 22 (76%) patients. There was no hospital mortality in either group. During the 12-month follow-up, a single death occurred in the Device group and was unrelated to the device. Twenty-nine patients in the device group and 32 in the control group completed 12-month CT coronary angiography. The overall patency of 160 studied distal vein graft anastomoses was 93%. Comparison of the end-to-side target anastomosis showed 12-month patencies of 86 and 88% in the device group and the control group, respectively. CONCLUSIONS According to these preliminary results and despite the limited number of patients, the use of the C-Port xA® System is safe enough to perform distal end-to-side vein graft anastomosis, with respect to 12-month end-to-side distal venous anastomotic patency. Although there are some technical challenges with this device, the incidence of complications is comparable to the traditional hand-sewn technique.