Abstract:Objective To investigate the safety of XcorTM，a novel transcatheter heart valve system，in healthy white pigs.Methods A total of 20 healthy experimental white pigs were selected and implanted with XcorTM biological valves through transapical transcatheter aortic valve replacement. All subjects were randomly divided into three groups，and cardiac color Doppler echocardiography（CDE），aortic root angiography，laboratory examinations,and anatomic pathologypost?euthanasia were performed in animals immediately（group A，2），3 months（group B，9）and 6 months（group C，9）after surgery to evaluate the effect of XcorTM valve replacement. Results All average weight of white pigs was（43.1±3.2）kg. The XcorTM valve system was successfully implanted in all 20 white pigs，with a 100% success rate for immediateinstrumentation. There were no adverse events and no deaths among the 20 white pigs. Six months after operation，CDE showed the positions of XcorTM valves were satisfactory and the opening and closing were good. Compared with preoperative，the peak transvalvular pressure difference，the effective opening area of the valve，the peak flow velocity and aortic annular diameter were improved（P<0.05）；while the left ventricular ejection fraction did not change significantly（P=0.733）. Laboratory tests showed no significant abnormalities. Gross pathology showed no significant pathologic changes in the important organs of the white pigs，and histopathology showed no severe pathologic changes in the valve leaflets. The calcium content in the aortic valve leaflets of groups A，B，C was（0.32 ± 0.22）μg/mg，（0.41±0.27）μg/mg，and（0.56 ± 0.14）μg/mg，respectively. There was no statistically significant difference（P>0.05）.Conclusion This animal study demonstrated that transapical transcatheter aortic valve replacement using the XcorTM bioprosthesis is safe and feasible，with no complications associated with the procedure，and that it can effectively replace the native aortic valve in normal operation.