The Heartflo device for distal coronary anastomoses: clinical experiences in 60 patients.

Abstract

The Heartflo anastomotic device automates the suturing process with simultaneous delivery of 10 standard polypropylene sutures through the graft and the coronary vessel wall to construct the anastomosis. We performed clinical testing in 60 patients undergoing coronary artery bypass grafting. One automated distal coronary anastomosis was initially placed in each patient, the other anastomoses were created with standard running sutures. After a "flat foot"-shaped prototype was deployed in 30 patients (group I), the design of the foot was modified and deployment of the new device performed in the next 30 patients (group II). In group I, automated anastomoses were completed in 16 patients (53%) using 1.7 +/- 1 additional stitches. In 26 group II patients (86%), a hemostatic anastomosis using 1.2 +/- 1 additional stitches was achieved. Anastomoses were completed in 19.0 +/- 3 minutes in group I and in 15.6 +/- 2 minutes in group II. We have shown the feasability of coronary anastomoses using the Heartflo device. The modified version improved tissue capture, resulting in a higher rate of completed anastomoses. Because anastomotic time is still prolonged, an easier suture management is mandatory in the next developmental step.