BACKGROUND: The use of aortic connector devices for proximal vein graft anastomosis has been shown to be associated with a relevant rate of early graft complications. Cardica PAS-Port is a new aortic connector whose preliminary clinical results seem promising. The safety and efficacy of this aortic connector device have been evaluated in this prospective, randomized study. MATERIAL AND METHODS: Twenty-four patients were randomized to receive proximal aorta-vein graft anastomosis with either the Cardica PAS-port aortic connector or by the hand-sewn technique. Twenty-three patients underwent multidetector computed tomographic scan (MDCT) of the chest 6 months after surgery to evaluate graft patency. RESULTS: All aortic connector devices (18) were successfully deployed and 31 proximal anastomoses were performed by the hand-sewn technique. MDCT showed that 6-month freedom from vein graft complication was 22.2% in the PAS-Port group and 58.1% in the hand-sewn group (P = .04). Four vein grafts (22.2%) anastomosed with the PAS-Port and 2 hand-sewn vein grafts (6.5%) were occluded (P = .10). The use of the PAS-Port aortic connector was also predictive of any vein graft complication when adjusted for vein graft flow (P = .01; OR 8.64, 95% CI 1.66-45.00) and for peripheral resistance units (P = .02; OR 6.14, 95% CI 1.33-28.43). CONCLUSIONS: The results of this prematurely stopped, prospective, randomized study suggest that the use of PAS-Port aortic connector device is associated with a higher rate of early vein graft complications than the hand-sewn technique.
RCT Entities:
BACKGROUND: The use of aortic connector devices for proximal vein graft anastomosis has been shown to be associated with a relevant rate of early graft complications. Cardica PAS-Port is a new aortic connector whose preliminary clinical results seem promising. The safety and efficacy of this aortic connector device have been evaluated in this prospective, randomized study. MATERIAL AND METHODS: Twenty-four patients were randomized to receive proximal aorta-vein graft anastomosis with either the Cardica PAS-port aortic connector or by the hand-sewn technique. Twenty-three patients underwent multidetector computed tomographic scan (MDCT) of the chest 6 months after surgery to evaluate graft patency. RESULTS: All aortic connector devices (18) were successfully deployed and 31 proximal anastomoses were performed by the hand-sewn technique. MDCT showed that 6-month freedom from vein graft complication was 22.2% in the PAS-Port group and 58.1% in the hand-sewn group (P = .04). Four vein grafts (22.2%) anastomosed with the PAS-Port and 2 hand-sewn vein grafts (6.5%) were occluded (P = .10). The use of the PAS-Port aortic connector was also predictive of any vein graft complication when adjusted for vein graft flow (P = .01; OR 8.64, 95% CI 1.66-45.00) and for peripheral resistance units (P = .02; OR 6.14, 95% CI 1.33-28.43). CONCLUSIONS: The results of this prematurely stopped, prospective, randomized study suggest that the use of PAS-Port aortic connector device is associated with a higher rate of early vein graft complications than the hand-sewn technique.