Abstract:Objective: This study aimed to evaluate the Biocompatibility, anti-calcification, and long-term stability of a novel balloon-expandable transcatheter aortic valve in vivo. Method: 27 healthy white pigs weighing about 45 kg were selected as experimental animals. Preoperative physical examination and appropriate pre-treatment, including drug treatment and disinfection, were performed. Under aseptic surgical conditions, the valve loaded on the balloon catheter delivery system was implanted into the porcine aortic valve position through the femoral artery vascular access. After the operation, the vital signs, diet and activity of the animals were closely observed, and give continuous drug treatment. At immediate, 30D, 90D, 180D, etc. , echocardiography and Digital Subtraction Angiography (DSA) were performed to assess the Hemodynamics of the implanted valve, the location of the valve, and the impact on the surrounding cardiac structures, at the corresponding follow-up points, the animal heart and major organ tissues were sampled, and the tissue inflammatory response, thrombus score, calcification degree and endothelialization degree were analyzed by histopathology staining. X-ray and Micro-CT were used to evaluate the structural integrity of the valve stent and the calcification of the valve leaflets. Results: Finally, 23 animals were included in the valid analysis. The animals with successful valve implantation recovered well and had stable vital signs. The follow-up examination showed that the aortic valve blood flow velocity, transvalvular pressure difference and leaflet motion were normal or gradually improved, the stent position was stable, and the vessel remained unobstructed. Histological analysis showed that the tissue at the implantation site had mild inflammatory cell infiltration, no thrombosis, low calcification area, good stent integrity, and low calcification of the valve leaflets. The results of statistical analysis showed that all the indicators were in line with expectations, and the differences were statistically significant(P<0.05). Conclusion: The new balloon-expandable transcatheter aortic valve system has shown good Biocompatibility, anti-calcification and implant stability in animal experiments, laying a solid foundation for subsequent clinical trials, it is expected to improve the therapeutic effect of Transcatheter Aortic Valve Implantation (TAVI) on Chinese patients and promote the technological progress of domestic TAVI devices, to bring new breakthroughs and development opportunities in the field of cardiovascular disease treatment.