VitaFlowTM经导管瓣膜系统治疗重度主动脉瓣狭窄——多中心2年随访结果Vita Flow? transcatheter valve system in the treatment of severe aortic stenosis: Two-year results of a multicenter study
杨力凡,张晓春,张蕾,张源,陈莎莎,管丽华,潘文志,周达新,葛均波
摘要(Abstract):
目的报道VitaFlowTM经导管瓣膜系统治疗重度主动脉瓣狭窄的前瞻性、多中心、单臂上市前临床研究的2年随访结果。方法连续入选2014年9月至2016年11月在我国11家中心应用VitaFlowTM经导管瓣膜系统行经导管主动脉瓣置换术(TAVR)的110例不适合外科手术的重度主动脉瓣狭窄患者。观察结果包括术后2年的全因死亡率、并发症等,并对42例二叶式主动脉瓣(BAV)患者和68例三叶式主动脉瓣(TAV)患者进行比较。结果 110例患者平均年龄(77.7±4.8)岁,胸外科医师协会评分(8.8±5.6)%;术后2年全因死亡率为4.5%,卒中、主要血管并发症、大出血发生率和新的起搏器植入率分别为7.3%、2.7%、7.3%和19.1%。手术6个月后未见中度或重度瓣周漏发生,术后2年108例(98.2%)患者纽约心脏病协会心功能分级≤Ⅱ级。BAV患者与TAV患者的血流动力学及手术效果相似。结论术后2年的临床随访结果表明Vita Flow?经导管瓣膜系统治疗不适合外科手术的老年重度主动脉瓣狭窄患者具有较高的安全性和有效性。
关键词(KeyWords): VitaFlow?经导管瓣膜系统;主动脉瓣狭窄;经导管主动脉瓣置换术
基金项目(Foundation): 国家重点研发计划(2017YFC1104202-2)
作者(Author): 杨力凡,张晓春,张蕾,张源,陈莎莎,管丽华,潘文志,周达新,葛均波
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