title: Clinical experience with the Novare Enclose II manual proximal anastomotic device during off-pump coronary artery surgery.
abstract: OBJECTIVE
  The aim of this study was to assess the feasibility and safety of a new proximal anastomotic device during off-pump coronary surgery.
  
  
  METHODS
  The Novare Enclose II is a manual proximal anastomotic device that enables the surgeon to perform proximal anastomoses without side-biting clamps in a fully pressurized aorta. The device was used in 30 off-pump coronary artery bypass graft (CABG) patients (Group A) for performing 25 vein, 10 free right internal thoracic artery and 14 radial artery anastomoses to the aorta. The number of proximal anastomoses varied between 1 and 3 per patient. Intraoperative transcranial Doppler measurements were performed to detect cerebral microemboli during the use of the device and were compared with transcranial Doppler measurements of 30 off-pump patients where a partial side clamp was used for proximal anastomoses (Group B). The aorta was evaluated using transesophageal echocardiography (TEE) and epiaortic echocardiography (EAE) in both groups before the procedure and patients with a calcified aorta were excluded.
  
  
  RESULTS
  In Group A, 49 proximal anostomoses were performed as planned with the device using conventional hand-sewn methods. Twenty-four of these were arterial conduits. In Group B, 32 proximal anastomoses were performed using 25 veins and 7 arterial grafts. There were no procedure related to adverse events or complications in both groups. The median number of microemboli was 15 (range 5-48) in Group A and 68 (range 35-290) in Group B (P<0.05).
  
  
  CONCLUSIONS
  The Enclose II device can be a valuable tool to perform venous or arterial proximal anastomoses during off-pump CABG. Transcranial Doppler results suggest that the device seems to be less traumatizing than side clamping and may reduce clamp-associated complications during off-pump coronary artery surgery.
authors.affiliation: Department of Cardiac Surgery and Cardiology, Florence Nightingale Hospital, Abide'i Hürriyet Cad No. 290, 80220 Sisli-Istanbul, Turkey.
authors.forename: Belhhan
authors.initials: B
authors.lastname: Akpinar
authors.forename: Mustafa
authors.initials: M
authors.lastname: Guden
authors.forename: Ertan
authors.initials: E
authors.lastname: Sagbas
authors.forename: Ilhan
authors.initials: I
authors.lastname: Sanisoglu
authors.forename: Mehmet U
authors.initials: MU
authors.lastname: Ergenoğlu
authors.forename: Cavlan
authors.initials: C
authors.lastname: Turkoglu
mesh_terms: D000714:Anastomosis, Surgical / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D047549:Coronary Artery Bypass, Off-Pump / Q000379:methods*; D003327:Coronary Disease / Q000150:complications / Q000000981:diagnostic imaging / Q000601:surgery*; D017548:Echocardiography, Transesophageal; D004617:Embolism / Q000209:etiology; D004867:Equipment Design; D005240:Feasibility Studies; D006801:Humans; D018709:Statistics, Nonparametric; D016896:Treatment Outcome