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Long term angiographic monitoring reveals safety and efficacy of the Converge end-to-side anastomotic coupler.

Sutureless anastomotic systems promise to minimize surgical trauma during revascularization procedures. We evaluate graft patency following end-to-side coupling with the Converge device. Fifteen of 35 enrolled patients of a two-center, non-randomized clinical study underwent 2-year angiography and clinical follow up, after sutureless anastomotic coupling of one of the grafts, using the Converge system. Fifteen anastomoses with the Converge system and 38 'manual' anastomoses were performed. Mean patient age was 65.9+/-8.6 years (13 male, 1 female). Mean ejection fraction (EF) was 60.6+/-10.2%. Mean follow-up period was 1.8+/-0.4 years. Device-related adverse events, such as excessive hemorrhage, thromboembolic complications, perianastomotic leak, infarction and device failure, leading to explantation or death were followed clinically. One patient (1/15) displayed an occluded venous graft to an obtuse marginal branch. All other Converge anastomoses were patent. The challenging or laborious anastomoses and low anastomotic flow (at operation) did not correlate with morphological obstruction at angiography. No other adverse effects were noted. The Converge sutureless anastomotic coupler fashions safe graft-to-coronary anastomoses which exhibit adequate patency at the 2-year follow-up time point. This system might offer a favorable anastomotic option in the expanding fields of minimal invasive, off-pump and endoscopic surgery.