Initial experience with the enclose proximal aortic anastomosis device during off-pump coronary artery bypass: an alternative to aortic side clamping.

BACKGROUND The utilization of off-pump coronary artery bypass surgery (OPCAB) has resulted in the development of new technology to facilitate the creation of aorto-coronary graft anastomoses. Proximal aortic devices (PADs) enable the construction of a proximal aortic anastomosis without the use of a side-biting aortic clamp, thus reducing the risk of neurologic injury from particulate embolization. METHODS One hundred ninety-seven patients underwent OPCAB at our institution between January 2003 and December 2004. Sixty (30.5%) patients had proximal aorto-coronary graft anastomoses constructed with the Novare Enclose PAD. The remaining 137 (69.5%) patients had graft construction with a standard aortic side-clamp technique. We compared the outcomes of these 2 cohorts to evaluate the safety and efficacy of the Novare Enclose PAD. RESULTS One hundred seven proximal anastomoses were constructed in the PAD group, and 199 proximal were constructed in the side-clamp group. Three patients (1.5%), all in the side-clamp group, sustained permanent neurologic deficits after OPCAB. There were 2 cases of device malfunctions. There were no anastomotic thromboses, no reoperations for anastomotic hemorrhage, and no patients required anastomotic revision. Of the 197 patients in the series, there were 4 deaths, 2 in each group, resulting in an overall mortality rate of 2%. CONCLUSION The Novare Enclose PAD is a safe device that facilitates suture construction of proximal aorto-coronary graft anastomosis. In a select group of patients, the use of this device may reduce the risk of neurologic injury when compared to the application of an aortic side-biting clamp for coronary bypass surgery.