Clinical and angiographic results after mechanical connection for distal anastomosis in coronary surgery

Background: Sutureless anastomotic devices are of increasing interest in cardiovascular surgery. We investigated the stainless steel clip system of St Jude Medical/Anastomotic Technology Group (Maple Grove, Minn) to connect saphenous vein grafts with coronary arteries. Methods: Forty-five patients were enrolled in this feasibility study performed on patients who had on-pump coronary artery bypass grafting, but 32 patients only received I distal anastomosis with this investigational device (2.5 mm [n = 14] and 2.0 mm [n = 18]). Thirteen were excluded because target vessels were too small, calcified, or tortuous. The system consists of an expandable clip mounted on a balloon catheter; delivery is obtained during balloon inflation. The main differences between the 2.5-mm and 2.0-mm devices are different loading and deployment in smaller coronary arteries for the 2.0-mm device. Results: A connecting device was deployed on the right coronary artery in 14 patients, the posterior descending branch in 12 patients, the obtuse marginal in 5 patients, and the posterolateral branch in I patient. Perfect hemostasis of the sutureless connector anastomosis was obtained in 28 patients. Three connectors were removed because of minor leakage at the connection site, and I connector was removed because of mismanipulation after successful deployment. Hand-sewn anastomosis was performed at the same arteriotomy site. Intraoperative flow was assessed by the transit time method and averaged 71 +/- 24 mL/min. One patient died of neurologic injury; the connector was patent at autopsy. One patient had a perioperative myocardial infarction. There was no adverse cardiac event in the remaining patients. All patients underwent clinical follow-up after 6 and 12 months and 35 angiograms were available in 21 patients: after 3 and 6 months, 17 anastomoses were patent and the saphenous vein graft was occluded in 4 patients. Conclusions: The coronary connector system from St Jude Medical/Anastomotic Technology Group allows consistently uniform sutureless connection between the saphenous vein graft and coronary artery. Loading and deployment require careful training. This technology is under constant development and may give a significant boost to less invasive coronary revascularization techniques.