Objective To design an original transcatheter mitral valve mono-leaflet mitral valve replacement system,validate the safety and efficacy of the device and optimize the implantation procedure before clinical application.Methods The initial validity of implantation was verified by in vitro fluidics simulations,and a porcine model without regurgitation(n=3)as well as a porcine model with mitral regurgitation(n=4)were established to verify the maneuverability and effectiveness of the device implantation.Results In vitro fluidics simulations showed a reduction in regurgitation after the device implantation.In all porcine animal models,the replacement devices were successfully implanted without intraoperative adverse events,and postoperative autopsy showed the valve device in place without significant damage to the surrounding tissues.In the regurgitation animal model,immediate postoperative ultrasound suggested a significant reduction or disappearance of regurgitation and a significant increase in the height of mitral valve alignment(P=0.007),and suggested no significant regurgitation with perivalvular leakage and no significant perivalvular Thrombosis at 1 month postoperatively.Conclusion This original transcatheter mitral valve mono-leaflet replacement system can effectively alleviate mitral regurgitation and would be expected to be a new treatment option for the patients at high risk for surgery.
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