Design a Novel Polymeric Heart Valve PHV-SH and Test the Feasibility Using in Vivo Pre-Clinical Non-inferiority Trial
Wei Wang
Department of Cardiovascular Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 100 Haining Road, Hongkou District, Shanghai, 200080 China
Search for more papers by this authorJingyi Cao
Department of Cardiovascular Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 100 Haining Road, Hongkou District, Shanghai, 200080 China
Search for more papers by this authorXiaoshen Yan
Suzhou Hearthill Medical Technology Co., Ltd, Suzhou, Jiangsu, 215123 China
Search for more papers by this authorCorresponding Author
Yu Zhuang
Department of Cardiovascular Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 100 Haining Road, Hongkou District, Shanghai, 200080 China
E-mail: [email protected]; [email protected]; [email protected]
Search for more papers by this authorFan Qiao
Department of Cardiovascular Surgery, Changhai hospital affiliated to the Naval Medical University, Shanghai, 200433 China
Search for more papers by this authorXiaoping Ning
Department of Cardiovascular Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 100 Haining Road, Hongkou District, Shanghai, 200080 China
Department of Cardiovascular Surgery, Changhai hospital affiliated to the Naval Medical University, Shanghai, 200433 China
Search for more papers by this authorMin Yu
Department of Cardiovascular Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 100 Haining Road, Hongkou District, Shanghai, 200080 China
Search for more papers by this authorSheng Shi
Department of Cardiovascular Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 100 Haining Road, Hongkou District, Shanghai, 200080 China
Search for more papers by this authorDicheng Yang
Department of Cardiovascular Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 100 Haining Road, Hongkou District, Shanghai, 200080 China
Search for more papers by this authorCorresponding Author
Feng Shen
Department of Cardiovascular Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 100 Haining Road, Hongkou District, Shanghai, 200080 China
E-mail: [email protected]; [email protected]; [email protected]
Search for more papers by this authorCorresponding Author
Fanglin Lu
Department of Cardiovascular Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 100 Haining Road, Hongkou District, Shanghai, 200080 China
E-mail: [email protected]; [email protected]; [email protected]
Search for more papers by this authorWei Wang
Department of Cardiovascular Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 100 Haining Road, Hongkou District, Shanghai, 200080 China
Search for more papers by this authorJingyi Cao
Department of Cardiovascular Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 100 Haining Road, Hongkou District, Shanghai, 200080 China
Search for more papers by this authorXiaoshen Yan
Suzhou Hearthill Medical Technology Co., Ltd, Suzhou, Jiangsu, 215123 China
Search for more papers by this authorCorresponding Author
Yu Zhuang
Department of Cardiovascular Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 100 Haining Road, Hongkou District, Shanghai, 200080 China
E-mail: [email protected]; [email protected]; [email protected]
Search for more papers by this authorFan Qiao
Department of Cardiovascular Surgery, Changhai hospital affiliated to the Naval Medical University, Shanghai, 200433 China
Search for more papers by this authorXiaoping Ning
Department of Cardiovascular Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 100 Haining Road, Hongkou District, Shanghai, 200080 China
Department of Cardiovascular Surgery, Changhai hospital affiliated to the Naval Medical University, Shanghai, 200433 China
Search for more papers by this authorMin Yu
Department of Cardiovascular Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 100 Haining Road, Hongkou District, Shanghai, 200080 China
Search for more papers by this authorSheng Shi
Department of Cardiovascular Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 100 Haining Road, Hongkou District, Shanghai, 200080 China
Search for more papers by this authorDicheng Yang
Department of Cardiovascular Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 100 Haining Road, Hongkou District, Shanghai, 200080 China
Search for more papers by this authorCorresponding Author
Feng Shen
Department of Cardiovascular Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 100 Haining Road, Hongkou District, Shanghai, 200080 China
E-mail: [email protected]; [email protected]; [email protected]
Search for more papers by this authorCorresponding Author
Fanglin Lu
Department of Cardiovascular Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, 100 Haining Road, Hongkou District, Shanghai, 200080 China
E-mail: [email protected]; [email protected]; [email protected]
Search for more papers by this authorAbstract
Polymeric heart valves (PHVs) present a promising alternative to mechanical and bio-prosthetic valves, addressing critical issues such as durability and calcification. This study investigates poly(styrene-block-ethylene/butylene-block-styrene) (SEBS) block copolymers for PHV applications, focusing on material characterization, valve fabrication, in vitro durability testing, and in vivo bio-compatibility evaluation. Mechanical tests, including thermogravimetric analysis (TGA), dynamic mechanical analysis (DMA), differential scanning calorimetry (DSC), and hydrodynamic performance analysis demonstrated that SEBS offers excellent thermal stability, flexibility, and fatigue resistance. Bio-compatibility assessments conducted per ISO 10993 standards revealed minimal cytotoxicity, hemolysis, and adverse immune responses. The hydrodynamic performance tests showed favorable hemodynamics, with low transvalvular pressure gradients and effective orifice areas within acceptable limits. In vivo trials on animal models confirmed that SEBS valves maintained competent valve function, without significant structural degeneration or calcification, over the 140-day study period. Mild regurgitation, observed in a subset of models, is attributed to anatomical variations and surgical technique. These results suggest that SEBS-based PHVs are a durable, biocompatible alternative to traditional heart valves and hold promise for overcoming limitations associated with current mechanical and bioprosthetic designs.
Conflict of Interest
The authors declare no conflict of interest.
Open Research
Data Availability Statement
The data that support the findings of this study are available from the cor-responding author upon reasonable request.
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