A Novel Aortic End-to-End Anastomotic Stapler Device—Results of a Human Cadaver Study

OBJECTIVES: To evaluate a novel aortic anastomotic device designed for end-to-end anastomosis between a vascular prosthesis and the native aorta, aiming to facilitate aortic replacement and shorten circulatory arrest times. METHODS: Ascending aortic replacements with Dacron grafts and external Teflon felt strips were performed in 10 fresh human cadavers. Five procedures were performed using a continuous 4-0 polypropylene running suture, and 5 with the aortic anastomotic device. The device deploys single straight needle pins through the aortic wall and felt, securing them externally with a cap. Explanted graft-aorta specimens were connected to a pressure pump filled with glycerol/H2O solution (170/90 mm Hg, 5 minutes). The primary end-point was anastomotic time; secondary end-points were fluid loss and tissue trauma assessed macroscopically and microscopically. RESULTS: Median time for end-to-end anastomosis was significantly shorter with the aortic anastomotic device (05:39 [interquartile range, IQR 04:22-06:30] minutes:seconds) compared to conventional suture (09:17 [IQR 06:53-10:34]; P = .016). The number of pins per anastomosis was lower than the number of stitches (17 [15-18] vs 22 [21-24]; P = .008). Fluid loss was comparable between groups (100 [52.5-174.5] mL vs 45 [21.8-104.0] mL; P = .310). Microscopy revealed intimal tears in all sutured specimens but in none of the device group, P = .008. CONCLUSIONS: In this preliminary human cadaver study, the novel aortic anastomotic device proved to be technically feasible, significantly faster than conventional suturing, and produced less tissue trauma while maintaining comparable sealing. The device may shorten circulatory arrest times and improve anastomotic quality in aortic surgery. Further in vivo studies are warranted. CLINICAL TRIAL REGISTRATION: This was a prospective experimental cadaver study, not eligible for registration in a public registry for clinical trials.