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). CONCLUSION: 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.
RCT Entities:
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). CONCLUSION: 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.