Stapled coronary anastomosis with minimal intraluminal artifact: The S 2 Anastomotic System in the off-pump porcine model

Abstract

Objective A reliable, easy-to-use, 1-shot anastomotic device will significantly push the barrier for less invasive coronary bypass surgery. The current study was designed to test the safety, efficacy, and early patency of a novel distal anastomotic device. Methods The S 2 Anastomotic System (iiTech BV, Amsterdam, The Netherlands) was used in 10 consecutive pigs (73 kg) on a mild antiplatelet regimen. In each animal, the device was used to create an internal thoracic artery to left anterior descending bypass on the beating heart. The anastomoses were evaluated intraoperatively (n = 10), at 2 days (n = 2), and at 5 weeks (n = 8) by functional flow measurements, postmortem angiography, and histomorphologic examination. Results In all pigs, the S 2Anastomic System rapidly created successful anastomoses at the first attempt (graft loading and coronary ischemia time: 1.2 ± 0.3 minutes and 3.0 ± 0.6 minutes) on target vessels of 1.6 to 2 mm inner diameter. There were no technical failures or anastomotic leaks requiring additional sutures. Both intraoperatively and at the time of death, ischemically induced peak hyperemic flow responses demonstrated widely patent bypasses, which were confirmed by postmortem angiography (FitzGibbon grade A, n = 10) and macroscopic evaluation (anastomotic orifice: 2 mm). Histomorphologic evaluation showed a normal healing response with negligible neointima covering the connector and limited streamlining repair tissue formation between the staple-like elements of the connector. Conclusions The S 2 Anastomotic System consistently created automated, fast, and reliable internal thoracic to coronary artery anastomoses on the porcine beating heart with excellent graft patency and healing characteristics at the 5-week follow-up.