目的:报道国产经导管瓣膜系统（VitaFlowTM）治疗重度主动脉瓣狭窄（AS）的5年随访预后，并分析其影响因素。方法:本研究为前瞻性、多中心、单臂上市前临床研究。纳入2014年9月至2016年11月11家中心应用经导管瓣膜系统（VitaFlowTM）行经导管主动脉瓣置换术（TAVR）的外科手术禁忌的重度AS患者，排除因手术失败转外科手术的3例患者后，共纳入107例患者。所有患者均在术后30 d、6个月、12个月、2年、3年、4年及5年进行随访。随访内容包括心电图、纽约心脏病协会（NYHA）心功能分级及整个研究过程中发生的不良事件。主要复合终点为全因死亡和致残性卒中，次要终点为新的永久起搏器植入等。用Kaplan-Meier方法作生存曲线，Cox分析确定与术后全因死亡及致残性卒中相关的危险因素。结果:107例患者年龄（77.2±4.8）岁，男占53.3%（57/107），胸外科协会风险（STS）评分为（8.63 ±4.2）%。随访5年生存率为83.2%（89/107），死亡和致残性卒中复合发生率为19.6%（19/107），新发永久起搏器植入率为20.6%（22/107）。多因素Cox回归分析显示，糖尿病（HR=2.63，95% CI 1.04~6.69，P=0.042）是术后全因死亡和致残性卒中发生的独立预测因素。结论:术后5年的临床随访结果表明国产经导管瓣膜系统（VitaFlow™）治疗外科手术禁忌或高危的重度AS患者具有良好长期预后。糖尿病是长期预后的独立预测因素。
Chinese domestic transcatheter valve system in the treatment of severe aortic stenosis: analysis of long-term outcomes and predictors
Objective:To report the 5-year clinical outcomes of transcatheter aortic valve replacement with VitaFlow™ system in the treatment of severe aortic stenosis and to analyze the influence factors.Methods:From September 2014 to November 2016, 110 patients in 11 centers in China, who were not appropriate for surgical operation were consequently enrolled and underwent transcatheter aortic valve replacement with VitaFlow™ system.After excluding three patients who underwent transcatheter aortic valve replacement (TAVR) surgery but experienced complications, 107 patients remained. The primary endpoints were all-cause death and disabling stroke, and the secondary endpoints were new permanent pacemaker implantation and so on. The Kaplan-Meier method was used to create survival curves, Cox analysis was employed to pinpoint risk factors related to the endpoint events.Results:The age of the 107 patients [men 53.3% (57/107)] was (77.2±4.8) years old and the Society of Thoracic Surgeons (STS)score was (8.63 ±4.2) %. The 5-year survival rate at follow-up was 83.2%(89/107), the composite incidence of death and disabling stroke was 19.6%(19/107), the rate of new permanent pacemaker implantation was 20.0%(22/107). Multivariate Cox regression showed that diabetes mellitus (HR=2.63,95% CI 1.04-6.69,P=0.042) were independent predictors of all-cause death and disabling stroke occurrence.Conclusion:Clinical follow-up at 5 years postoperatively demonstrates the good long-term prognosis of the VitaFlow™ in the treatment of patients with severe aortic stenosis who are inappropriate for surgery or at high risk. Diabetes mellitus were independent predictors of long-term prognosis.
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