Venus-A主动脉瓣膜介入治疗重度主动脉瓣狭窄的效果

Effect of transcatheter aortic valve replacement using Venus-A valve for treating patients with severe aortic stenosis

目的探讨应用国产主动脉瓣膜（Venus-A瓣膜）对重度主动脉狭窄患者行经导管主动脉瓣置换术（TAVR）的效果。 方法2012年9月至2015年1月，采用前瞻性研究方法在5家大型心脏病中心（包括阜外医院、浙江大学医学院附属第二医院、四川大学华西医院、南京医科大学第一附属医院、上海交通大学医学院附属瑞金医院）连续入选STS积分≥4%的外科手术中高危或手术禁忌重度主动脉狭窄患者101例，应用Venus-A瓣膜实施TAVR。主要研究终点为TAVR术后1年内的全因死亡或卒中；次要研究终点包括TAVR术后1年内的有效性和安全性。 结果98例（97.9%）患者成功行TAVR，其余3例患者转外科手术治疗。85例患者应用1个Venus-A瓣膜完成TAVR，13例患者采用瓣中瓣技术置入2个Venus-A瓣膜。术后7 d，发生卒中1例（1.0%），急性心肌梗死2例（2.0%），心包积液5例（5.0%），严重血管并发症6例（5.9%），死亡2例（2.0%）；超声心动图显示，主动脉瓣跨瓣压差低于术前[11（8，15） mmHg （1 mmHg＝0.133 kPa）比59（45，71）mmHg，P〈0.01]，未发现主动脉瓣瓣环破裂和瓣叶血栓。术后6个月，NYHA心功能分级≤Ⅱ级的比率高于术前[94.4%（84/89）比21.3%（21/89）, P〈0.01]。术后1年，主要研究终点发生率为7.9%（8/101），其中全因死亡发生率为5.9%（6/101），卒中发生率为2.0%（2/101）。Kaplan-Meier生存分析显示，术后1年累计生存率为94.1%。 结论使用Venus-A瓣膜对重度主动脉瓣狭窄患者行TAVR近中期疗效确切，且安全性良好。

ObjectiveTo evaluate the effect of transcatheter aortic valve replacement（TAVR） using Venus-A valve for treating patients with severe aortic stenosis. MethodsIn this prospective study, 101 consecutive severe aortic stenosis patients with high surgical risk（Society of Thoracic Surgeon（STS） score ≥4%） or at prohibitive surgical risk were enrolled from 5 academic cardiovascular centers in China（Fuwai hospital, the second affiliated hospital of Zhejiang university school of medicine, West China hospital of Sichuan university, the first affiliated hospital of Nanjing medical university, Ruijin hospital of Shanghai Jiaotong university school of medicine） from September 2012 to January 2015, and Venus-A valves were used in TAVR for these patients. The primary endpoints were death from any cause and major stroke in 1 year. The secondary endpoints included efficacy and safety of TAVR in 1 year. ResultsTAVR success rate was 97.9%（98/101）, and 3 patients were transferred to receive surgical AVR. There were 85 patients using 1 Venus-A valve, and 13 patients underwent valve-in-valve implantation using 2 Venus-A valves. There were 1 case（1.0%） of stroke, 2 cases（2.0%）of acute myocardial infarction, 5 cases（5.0%） of pericardial effusion, 6 cases（5.9%） of severe vascular complication, and 2 cases（2.0%） of death after 7 days of TAVR. Meanwhile, aortic pressure gradient derived from echocardiography was significantly reduced when compared with pre-procedure level（11（8, 15） mmHg （1 mmHg=0.133 kPa） vs. 59（45, 71）mmHg, P〈0.01）, and there was no aortic root rupture or leaflets thrombosis. Rate of NYHA functional class ≤Ⅱ improvements were observed at 6 months follow-up when compared with pre-procedure（94.4%（84/89）vs. 21.3%（21/89）, P〈0.01）. The primary endpoint was 7.9%（8/11）, and the incidence of all cause death and stroke was 5.9%（6/101） and 2.0%（2/101） respectively at 1 year after the procedure. Kaplan-Meier survival analysis showed that cumulative survival rate was 94.1% at 1 year after the procedure. ConclusionTAVR using Venus-A valve for treating patients with severe aortic stenosis is effective and safe in the early and medium term post procedure.