First clinical results with a 30° end-to-side coronary anastomosis coupler

Objectives: The purpose of this study is to evaluate the safety and efficacy of a novel coronary anastomotic Coupler (Converge Medical, Inc., Sunnyvale, CA) that facilitates a non-penetrating, sutureless vein graft to coronary artery anastomosis.

Material and Methods: The Coupler utilizes a set of concentric mating frames approximating adjacent vessel tissue allowing for biological healing of the anastomosis. The frames are manufactured from Nitinol, a nickel titanium super-elastic metal alloy. The Nitinol frames attach the bypass graft to the coronary artery in a 30° end-to-side configuration. Between November 2002 and March 2003 a total of 46 patients (44 male) with a mean age of 66 years±8yrs. were admitted for coronary artery revascularization and included in the study. The mean LVEF was 61%±12%.

Results: Thirty-three patients were successfully treated with the Coupler. Ten patients did not meet the intraoperative inclusion criteria, and were excluded from the study due to small (≤ 2.0mm) or severely calcified coronary vessels, or small vein grafts. Hemostasis could not be achieved with the Coupler in 3 patients, and in these instances the Coupler was removed and the anastomosis was sutured without complication. Average mean flow rate using transit time method through the Coupler attached bypasses was 60ml/min±26ml/min. In a control angiography 2 months after surgery, 29 of the 30 connector grafts were patent. One stenosis of 50–75% occured in a connector anastomosis. Angiographic patency assessments for hand sewn CABG showed 62 (89,9%) patent and 7 (10,1%) occluded grafts.

Conclusions: Initial results indicate that the Converge Coupler can be used to create a safe and effective 30° vein graft to coronary artery anastomosis under suitable conditions.