title: Prospective, randomized study on the use of the cardica PAS-port aortic connector system in off-pump coronary artery bypass surgery.
abstract: 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.
authors.affiliation: Division of Cardiothoracic and Vascular Surgery, Department of Surgery, Oulu University Hospital, Oulu, Finland.
authors.forename: Jarmo
authors.initials: J
authors.lastname: Lahtinen
authors.forename: Fausto
authors.initials: F
authors.lastname: Biancari
authors.forename: Risto
authors.initials: R
authors.lastname: Ojala
authors.forename: Martti
authors.initials: M
authors.lastname: Mosorin
authors.forename: Riccardo
authors.initials: R
authors.lastname: Cresti
authors.forename: Pekka
authors.initials: P
authors.lastname: Rainio
authors.forename: Vesa
authors.initials: V
authors.lastname: Anttila
authors.forename: Martti
authors.initials: M
authors.lastname: Lepojärvi
authors.forename: Tatu
authors.initials: T
authors.lastname: Juvonen
mesh_terms: 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