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

Abstract

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.