高建斌,马米尔,史青,唐永研,杨宏波,潘家华,张戈军,骆志玲,朱达,潘湘斌

• 1:云南省阜外心血管病医院结构性心脏病病区
• 2:国家心血管病中心北京协和医学院中国医学科学院阜外医院结构性心脏病中心
• 3:云南省阜外心血管病医院超声科

摘要(Abstract)：

目的 分析新一代国产自锁式经导管二尖瓣缘对缘修复系统KokaclipTM首次临床应用的效果。方法 本研究为前瞻性、单中心、单组观察的可行性临床研究，纳入2021年10月至2022年2月于云南省阜外心血管病医院行经导管二尖瓣缘对缘介入修复治疗的患者12例。患者经超声心动图确认为二尖瓣反流（MR）≥3+。手术采用股静脉路径，使用经导管二尖瓣缘对缘修复系统KokaclipTM完成二尖瓣介入修复，并记录围术期超声心动图指标、心功能分级、肾及各器官功能等指标与并发症发生情况。主要终点指标为术后30 d手术成功率。结果 12例患者平均年龄（67.00±8.55）岁，男7例。其中退行性二尖瓣反流（DMR）患者1例，功能性二尖瓣反流（FMR）患者11例，MR 4+与MR 3+的患者各6例，MR平均缩流颈宽度（7.68±2.73） mm，平均左心室射血分数（39.1±10.7）%，所有患者纽约心脏病协会（NYHA）心功能分级均为Ⅲ/Ⅳ级。患者围术期恢复顺利，术后30 d随访手术成功率100%；无严重心血管临床并发症及器械相关并发症发生；超声心动图提示MR显著改善，3例MR 0+,8例MR 1+,1例MR 2+；平均左心室舒张末期内径（57.08±12.62）mm,8例（67%）患者NYHA心功能分级为Ⅰ～Ⅱ级。结论 新一代国产自锁式经导管二尖瓣缘对缘修复系统KokaclipTM在首次临床应用中展现了良好的可靠性、安全性及有效性。

关键词(KeyWords)： 二尖瓣反流;自锁式经导管二尖瓣缘对缘修复系统;经股静脉路径

Abstract:

Keywords:

基金项目(Foundation): 云南省心血管病临床医学中心项目（FZX2019-06-01）

作者(Author): 高建斌,马米尔,史青,唐永研,杨宏波,潘家华,张戈军,骆志玲,朱达,潘湘斌

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