Animal Study of a Novel Device for Clampless Proximal Anastomosis in Coronary Bypass Surgery.

Abstract

Limitations of existing techniques for clampless proximal anastomosis (CPA) in coronary artery bypass grafting include air emboli and excessive bleeding. This study evaluated the safety and performance of a new device for performing CPA. The device includes a temporary adjustable sealing element that is connected by a catheter to a handle that controls its opening and closure. An aortic punch is mounted on the catheter and activated by a detachable handle. Six adult female swine underwent partial coronary artery bypass grafting that included construction of a CPA using autologous arterial or venous conduits. During anastomosis construction, good sealing was achieved in all cases, and a blower was not needed in 4 of 6 animals. In the first 2 cases, the blower was intermittently used in 14 % of the entire anastomosis construction time. A mean flow rate of 140.0 ± 52.9 mL/min was measured for the arterial grafts and 666.7 ± 230.9 mL/min for the venous grafts. The VIOLA device (Vascular Graft Solutions, Tel Aviv, Israel) is safe and associated with good hemostasis and minimal use of a blower during CPA construction in a swine model.