| Objective: To design and trial-manufacture a new kind of regulative sutureless aortic prosthesis which can accomplish the aortic anastomosis rapidly, simply and safely. Methods: After reviewing and analysing the advantages and disadvanges of present aortic prostheses in clinical use, we designed a new kind of sutureless aortic prosthesis with its diameter can be regulated. The prosthesis could accomplish aortic anastomosis by external ligature without any conventional suture. The new devices were tested in "ex vivo" as well as "in vivo" swine descending aorta substitution experiments. We also carried out a comparison study on the differences between the conventional and sutureless anastomosis on descending aorta substitution surgery. Results: The ex vivo test indicated that the new regulative sutureless aortic prosthesis had satisfied ability to vary its vascular ends diameter, to endure the external ligation without lumen distortion, and to suffer enough intraluminal pressure without blood leaking. The in vivo swine experiments proved that the prosthesis could fulfill the descending aorta substitution quickly and safely, and the new device showed satisfied biocompatibility after mid-term observation. Compared with normal Dacron grafts, the new sutureless protheses were much better to reduce the operative durations, complications, cross-clamping time, blood loss, and postoperative drainage (P<0.01). And there was no significant difference on operative mortality, mid-term(3 months) follow-up, biological healing and tissue compatibility. Conclusions: The new regulative sutureless aortic prosthesis has strong practicality and favorable clinical prospects. |