摘要
To assess the hemodynamic performance and biocompatibility of China-made solid pyrolytic carbon bileaflet valve prosthesis so as to provide evidences for clinical trial,fifteen sheep aged 5-6 months underwent mitral replacement with 21-mm JiuLing valve under cardiopulmonary bypass. The first ten sheep underwent preliminary study to establish the trial methods and the matching of animal weight and prosthesis size, other five underwent formal experiment. The hemodynamic parameters of the prosthesis were determined by means of open cardiac catheterization and echocardiography intraoperatively and 2.5 years after operation respectively. The biocompatibility was evaluated by observing animal survival and valve thrombosis or thromboembolism.In result,all of the five sheep undergoing formal experiment survived well. There were no any prosthesis-related complications including mechanical valve failures, endocarditis, thrombosis, thromboembolism, and paravalvular leak. The transvalvular gradients were 5.2±1.7mmHg, 6.1±0.3mmHg and 6.8±0.4mmHg, the former was measured by catheterization intraoperatively, the two later were achieved by catheterization and echocardiography respectively 2.5 years after operation. The gradients increased mildly with the marked increase in cardiac output under dobutamine stress.The results of this study demonstrated that the JiuLing valve prosthesis has good biocompatibility and excellent hemodynamic performance.
To assess the hemodynamic performance and biocompatibility of China-made solid pyrolytic carbon bileaflet valve prosthesis so as to provide evidences for clinical trial,fifteen sheep aged 5-6 months underwent mitral replacement with 21-mm JiuLing valve under cardiopulmonary bypass. The first ten sheep underwent preliminary study to establish the trial methods and the matching of animal weight and prosthesis size, other five underwent formal experiment. The hemodynamic parameters of the prosthesis were determined by means of open cardiac catheterization and echocardiography intraoperatively and 2.5 years after operation respectively. The biocompatibility was evaluated by observing animal survival and valve thrombosis or thromboembolism.In result,all of the five sheep undergoing formal experiment survived well. There were no any prosthesis-related complications including mechanical valve failures, endocarditis, thrombosis, thromboembolism, and paravalvular leak. The transvalvular gradients were 5.2±1.7mmHg, 6.1±0.3mmHg and 6.8±0.4mmHg, the former was measured by catheterization intraoperatively, the two later were achieved by catheterization and echocardiography respectively 2.5 years after operation. The gradients increased mildly with the marked increase in cardiac output under dobutamine stress.The results of this study demonstrated that the JiuLing valve prosthesis has good biocompatibility and excellent hemodynamic performance.
