新型Memoclip经心尖二尖瓣夹系统单中心临床试验结果分析  

Analysis of single-center clinical trial results for the novel Memoclip transapical mitral valve clip system

作　　者：黄健兵[1] 曾凡强 汤敏[1] 姜兆磊[1] 周长平 刘海霞 张丽[1] 丁芳宝[1] 梅举[1] HUANG Jian-bing;ZENG Fan-qiang;TANG Min;JIANG Zhao-lei;ZHOU Chang-ping;LIU Hai-xia;ZHANG Li;DING Fang-bao;MEI Ju(Department of Cardiothoracic Surgery,Xinhua Hospital,School of Medicine,Shanghai Jiaotong University,Shanghai 200092,China;Department of Cardiothoracic Surgery,Hefei High-tech Cardiovascular Hospital,Hefei 230038,China)

机构地区：[1]上海交通大学医学院附属新华医院心胸外科,上海市200092 [2]合肥高新心血管病医院心胸外科

出　　处：《中国心血管病研究》2025年第4期304-309,共6页Chinese Journal of Cardiovascular Research

基　　金：上海市科委科研计划项目(22QC1401100);上海市经济和信息化委员会创新医疗器械应用示范项目(23SHS02400);上海交通大学“交大之星”计划医工交叉研究基金(YG2022ZD008)。

摘　　要：目的 总结本中心使用新型Memoclip经心尖二尖瓣夹系统治疗的二尖瓣反流患者的临床数据,分析该二尖瓣夹系统的设计特点,探讨其治疗二尖瓣反流的安全性及有效性。方法 总结2021年12月至2023年8月本中心完成的使用新型Memoclip经心尖二尖瓣夹系统治疗的49例二尖瓣反流患者,其中男性24例(49.0%),年龄(68±12.8)岁。术前经食道超声心动图(TEE)确认所有患者均为重度二尖瓣反流(反流程度3+以上),其中Ⅰ型30例(61.2%),Ⅱ型11例(22.4%),Ⅲb型4例(8.2%),Ⅳ型4例(8.2%),所有患者均使用新型Memoclip经心尖二尖瓣夹系统行二尖瓣缘对缘夹合治疗,手术在超声引导下完成,术中即刻评估二尖瓣反流情况。术后1月、3月、6月、1年随访复查心脏彩超,评估患者心功能状态、6分钟步行距离、生活质量评分情况。结果 全组患者围术期无死亡病例。术中TEE提示二尖瓣成形效果满意,1例残余反流为2+,其余均为1+以下。术后随访患者二尖瓣反流有12例增加至2+,1例增加至3+,1例增加至3+但经药物治疗后又减少至1+。1例患者术后6 min步距离、生活质量评分下降,心功能无明显改善;其余患者6 min步距离、生活质量评分均有不同程度改善,心功能均明显改善。结论 新型Memoclip经心尖二尖瓣夹系统可安全有效的治疗解剖合适的二尖瓣反流患者,显著改善二尖瓣反流,治疗效果满意。Objective To summarize the clinical data of patients with mitral regurgitation treated by the novel Memoclip transapical mitral valve clip system.And to explore the design features,safety and efficacy of the Memoclip system.Methods A total of 49 mitral regurgitation patients [24(49.0%) males,25(51%) females;age(68 ± 12.8) years] treated by the novel Memoclip system from December 2021 to August 2023 were included.Preoperative transesophageal echocardiography(TEE) confirmed severe mitral regurgitation(grade 3+ or higher)in all patients,classified as Type Ⅰ(n=30,61.2%),Type Ⅱ(n=11,22.4%),Type Ⅲb(n=4,8.2%),and Type Ⅳ(n=4,8.2%).All patients underwent transapical edge-to-edge mitral valve clipping under ultrasound guidance.Transesophageal echocardiography would assess the mitral regurgitation grade immediately after surgery.Postoperative follow-up at 1,3,6,and 12 months included echocardiography,cardiac function status,6-minute walking distance,and quality of life scores.Results No perioperative deaths occurred.Intraoperative TEE showed satisfactory results of mitral valve repair,with residual mitral regurgitation≤1 + in 48 cases and 2 + in 1 case.During follow-up,mitral regurgitation increased to 2+ in 12 patients,3+ in 1 patient,and transient 3+(reduced to1+ after medical therapy) in 1 patient.One patient showed worsened 6-minute walking distance and quality of life scores without functional improvement,while others exhibited significant improvements in 6-minute walking distance,quality of life,and cardiac function.Conclusion The novel Memoclip transapical mitral valve clip system is safe and effective for anatomically suitable mitral regurgitation patients,achieving significant regurgitation reduction and satisfactory therapeutic outcomes.

关 键 词：二尖瓣反流 二尖瓣夹合术 Memoclip二尖瓣夹 

分 类 号：R654.7[医药卫生—外科学]