Chen Jinmiao, Lv Minzhi, Fu Jiahui, He Chen, Guo Yingqiang, Tao Liang, Zhou Xinmin, Gu Tianxiang, Bartus Krzysztof, 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.
Interdiscip Cardiovasc Thorac Surg. 2024 Jan 2;38(1). doi: 10.1093/icvts/ivad209.
The short-term performance of the Cingular bovine pericardial aortic valve was proven. This study evaluated its 5-year safety and haemodynamic outcomes.
It enrolled 148 patients who underwent surgical aortic valve replacement with the Cingular bovine pericardial aortic valve between March 2016 and October 2017 in 5 clinical centres in China. Safety and haemodynamic outcomes were followed up to 5 years. The incidence of all-cause mortality, structural valve deterioration and reintervention was estimated by Kaplan-Meier analysis.
The mean age of patients was 67.7 [standard deviation (SD) 5.1] years, and 36.5% of patients were female. The mean follow-up was 5.3 (SD 1.2) years. Five-year freedom from all-cause mortality, structural valve deterioration and all-cause reintervention were 91.2%, 100% and 99.3%, respectively. At 5 years, the mean gradient and effective orifice area of all sizes combined were 14.0 (SD 5.5) mmHg and 1.9 (SD 0.3) cm2, respectively. For 19- and 21-mm sizes of aortic prostheses, the mean gradients and effective orifice area at 5 years were 17.5 (SD 7.0) mmHg and 1.6 (SD 0.2) cm2 and 13.7 (SD 6.7) mmHg and 1.8 (SD 0.3) cm2, respectively. The incidence of moderate or severe patient-prosthesis mismatch was 4.1% and 0.0% patients at 5 years, respectively.
The 5-year safety and haemodynamic outcomes of Cingular bovine pericardial aortic valve are encouraging. Longer-term follow-up is warranted to assess its true durability.
已证实Cingular牛心包主动脉瓣的短期性能。本研究评估了其5年安全性和血流动力学结果。
纳入2016年3月至2017年10月在中国5个临床中心接受Cingular牛心包主动脉瓣置换术的148例患者。对安全性和血流动力学结果进行了长达5年的随访。采用Kaplan-Meier分析估计全因死亡率、瓣膜结构恶化和再次干预的发生率。
患者的平均年龄为67.7岁[标准差（SD）5.1]，36.5%为女性。平均随访时间为5.3年（SD 1.2）。全因死亡率、瓣膜结构恶化和全因再次干预的5年无事件生存率分别为91.2%、100%和99.3%。5年时，所有尺寸组合的平均压差和有效瓣口面积分别为14.0（SD 5.5）mmHg和1.9（SD 0.3）cm²。对于19毫米和21毫米尺寸的主动脉假体，5年时的平均压差和有效瓣口面积分别为17.5（SD 7.0）mmHg和1.6（SD 0.2）cm²以及13.7（SD 6.7）mmHg和1.8（SD 0.3）cm²。5年时中度或重度人工瓣膜-患者不匹配的发生率分别为4.1%和0.0%。
Cingular牛心包主动脉瓣的5年安全性和血流动力学结果令人鼓舞。有必要进行长期随访以评估其真正的耐久性。
