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


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Department of Cardiac Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Jin-Miao
JM
Chen
Department of Cardiac Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Yu
Y
Ding
Department of Cardiac Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Shu-Yang
SY
Lu
Department of Cardiac Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Sun
S
Pan
Department of Cardiac Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Mieradilijiang
M
Abudupataer
Department of Cardiac Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Tao
T
Hong
Department of Cardiac Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Chun-Sheng
CS
Wang
Carpentier-Edwards PerimountTM valve; SCBC valve; bovine pericardial valve; noninferiority