Chen Jinmiao, Lv Minzhi, Lu Yuntao, Fu Jiahui, Guo Yingqiang, Tao Liang, Zhou Xinmin, Gu Tianxiang, Wei Lai, Hong Tao, Wang Chunsheng
Department of Cardiovascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
Department of Biostatistics, Zhongshan Hospital, Fudan University, Shanghai, China.
Front Cardiovasc Med. 2021 Dec 13;8:736877. doi: 10.3389/fcvm.2021.736877. eCollection 2021.
To evaluate the 2-year clinical safety and hemodynamic outcomes of the Cingular bovine pericardial bioprosthesis. A prospective, multicenter, single-arm trial was conducted in patients who required aortic or mitral valve replacement. From March 2016 to October 2017, 197 patients were implanted with the Cingular bovine pericardial valve at five sites in China. The clinical outcomes and hemodynamic performance were assessed through a 2-year follow-up. Clinical safety events were reviewed by an independent clinical events committee, and echocardiographic data were assessed by an independent core laboratory. The mean age was 66.9 ± 4.9 years. The 2-year survival rate was 96.4%. A complete 2-year clinical follow-up was achieved in 189 of 190 survivors. No case of structural valve deterioration, major perivalvular leak, prosthetic valve endocarditis, or valve-related reoperation was seen. For the aortic valve, the mean pressure gradient observed was 12.5 ± 4.0 mm Hg, and the effective orifice area (EOA) was 2.0 ± 0.3 cm. For the smaller size aortic valves, 19 mm and 21 mm, respective mean EOA values of 1.7 ± 0.2 cm and 1.8 ± 0.2 cm were found. The values for mean pressure gradient and mean EOA for mitral bioprostheses were 4.0 ± 1.4 mm Hg and 2.2 ± 0.3 cm, respectively. There was no significant change between 1-year and 2-year hemodynamic performance. The Cingular bovine pericardial valve showed favorable clinical safety and hemodynamic outcomes over a 2-year follow-up. Further follow-up is required to validate the long-term durability.
评估Cingular牛心包生物瓣膜的2年临床安全性和血流动力学结果。对需要进行主动脉或二尖瓣置换的患者进行了一项前瞻性、多中心、单臂试验。2016年3月至2017年10月，197例患者在中国的五个地点植入了Cingular牛心包瓣膜。通过2年的随访评估临床结果和血流动力学性能。临床安全事件由独立的临床事件委员会审查，超声心动图数据由独立的核心实验室评估。平均年龄为66.9±4.9岁。2年生存率为96.4%。190名幸存者中有189名完成了完整的2年临床随访。未发现结构性瓣膜退变、严重瓣周漏、人工瓣膜心内膜炎或瓣膜相关再次手术的病例。对于主动脉瓣，观察到的平均压力阶差为12.5±4.0 mmHg，有效瓣口面积（EOA）为2.0±0.3 cm²。对于较小尺寸的主动脉瓣，19 mm和21 mm的平均EOA值分别为1.7±0.2 cm²和1.8±0.2 cm²。二尖瓣生物瓣膜的平均压力阶差和平均EOA值分别为4.0±1.4 mmHg和2.2±0.3 cm²。1年和2年的血流动力学性能之间没有显著变化。Cingular牛心包瓣膜在2年的随访中显示出良好的临床安全性和血流动力学结果。需要进一步随访以验证其长期耐久性。
