Noninferiority of Shanghai Cingular biotech's bovine pericardial valve preclinical study in juvenile ovine model.

Abstract

This study introduces a newly Chinese domestic-designed/manufactured bovine pericardial valve, the SCBC valve (Shanghai Cingular Biotech Corporation, Shanghai, China), and evaluates its hemodynamic performance and calcification potential compared with the Carpentier-Edwards (CE) Perimount(TM) valve (Edwards Lifesciences, Irvine, CA, USA) in juvenile sheep for preclinical study. Five SCBC valves in study group and three CE Perimount(TM) valves (6900P with TFX) in control group were implanted in the mitral position of juvenile sheep and followed up for five months. Transthoracic echocardiography (TTE) for hemodynamic measurement was performed ten days, three months and five months postoperatively. Valve calcification was assessed by X-ray after euthanasia. Other collected data included macroscopic examination, blood analysis, microorganism culture and histological assessment. All sheep in two groups lived to sacrifice without evidence of valvular dysfunction. The SCBC valve had similar hemodynamic performance and susceptibility of calcification compared with the CE Perimount(TM) valve in juvenile ovine model. In all other parameters, the SCBC valve also exhibited no significant difference compared with the CE Perimount(TM) valve. Our study demonstrated that the SCBC valve can exhibit similar mid-term satisfactory safety and efficacy compared with the CE Perimount(TM) valve in the mitral position of juvenile sheep model.