Evaluation of the enclose proximal anastomosis device in coronary artery bypass grafting.

PURPOSE: Minimal manipulation of the ascending aorta during coronary artery bypass grafting may reduce the incidence of adverse perioperative events related to atheroembolic events. The objective of this study was to evaluate a new proximal anastomotic device (Novare Enclose device [Novare Surgical Systems, Cupertino, CA]). DESCRIPTION: Over a 23-month period, a total of 76 proximal anastomoses were performed in 50 patients (40 males and 10 females; mean age, 74.36 years). In 45 patients, the proximal anastomosis was constructed before the distal (25 off-pump and 20 on-pump), and in 5 patients the proximal anastomosis was constructed on cardiopulmonary bypass because of diseased ascending aortas. EVALUATION: The average time per anastomosis was <8 minutes. There were no device related complications. There were no atheroembolic complications in this cohort of patients. One patient underwent cardiac catheterization postoperatively, and the proximal vein anastomosis in this patient was widely patent.
CONCLUSIONS: The Novare Enclose proximal anastomotic device (Novare Surgical Systems) appears to be safe and effective as a tool for proximal anastomosis within a reasonable time period and is comparable with accepted techniques.

RCT Entities:   Population Interventions Outcomes