Prospective, randomized study on the use of the cardica PAS-port aortic connector system in off-pump coronary artery bypass surgery.
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.


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.
Lahtinen
Jarmo
J
Division of Cardiothoracic and Vascular Surgery, Department of Surgery, Oulu University Hospital, Oulu, Finland.
Biancari
Fausto
F
Ojala
Risto
R
Mosorin
Martti
M
Cresti
Riccardo
R
Rainio
Pekka
P
Anttila
Vesa
V
Lepojärvi
Martti
M
Juvonen
Tatu
T
D000368:Aged; D000714:Anastomosis, Surgical / Q000295:instrumentation* / Q000379:methods; D001011:Aorta / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D047549:Coronary Artery Bypass, Off-Pump / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013536:Suture Techniques / Q000295:instrumentation*; D016896:Treatment Outcome