Edward’s SAPIEN 3瓣膜系统在接受经房间隔二尖瓣瓣中瓣置换术的外科手术高危患者中的效应评估:一项中国多中心研究  

Outcomes of transcatheter transseptal mitral valve-in-valve replacement using Edward’s SAPIEN 3 in high surgical risk patients-a multicenter study in China

作　　者：陈翔 王斌 许翌炜 彭小平[2] 乔帆 梁祥文[4] 韩克[5] 姜小飞 马翔[7] 杨文艺[8] 傅国胜[9] 苏茂龙 王焱 CHEN Xiang;WANG Bin;XU Yi-wei;PENG Xiao-ping;QIAO Fan;LIANG Xiang-wen;HAN Ke;JIANG Xiao-fei;MA Xiang;YANG Wen-yi;FU Guo-sheng;SU Mao-long;WANG Yan(Department 2of Cardiology,Xiamen Cardiovascular Hospital of Xiamen University,Xiamen 361000,China;Department of Cardiology,the First Affiliated Hospital of Nanchang University,Nanchang 330006,China;Department of Cardiac Surgery,the First Affiliated Hospital of the Second Military Medical University,Shanghai 200433,China;Department of Cardiology,Yulin First People’s Hospital,Yulin 537099,China;Department of Cardiology,the First Affi liated Hospital of Xi’an Jiao Tong University,Xi’an 710061,China;Department of Cardiology,Zhuhai People’s Hospital,Zhuhai 519099,China;Department of Cardiology,the First Affiliated Hospital of Xinjiang Medical University,Urumqi 830013,China;Department of Cardiology,Shanghai General Hospital,Shanghai 200080,China;Department of Cardiology,Sir Run Run Shaw Hospital,Hangzhou 310016,China)

机构地区：[1]厦门大学附属心血管病医院心血管内科,福建厦门361000 [2]南昌大学第一附属医院心血管内科,江西南昌330006 [3]中国人民解放军海军军医大学第一附属医院心血管外科,上海200433 [4]玉林市第一人民医院心血管内科,广西玉林537099 [5]西安交通大学第一附属医院心血管内科,陕西西安710061 [6]珠海市人民医院心血管内科,广东珠海519099 [7]新疆医科大学第一附属医院心血管内科,新疆乌鲁木齐830013 [8]上海市第一人民医院心血管内科,上海200080 [9]浙江大学医学院附属邵逸夫医院心血管内科,浙江杭州310016

出　　处：《中国介入心脏病学杂志》2025年第2期79-86,共8页Chinese Journal of Interventional Cardiology

摘　　要：目的 评估使用瓣中瓣(ViV)技术进行经导管二尖瓣置换术(TMVR)在二尖瓣外科生物瓣膜置换术后发生瓣膜退化且外科手术高危患者中的安全性和有效性。方法 本研究为多中心的回顾性队列研究,连续纳入2021年2月至2022年10月于9家医疗中心,应用Edward’s SAPIEN 3瓣膜系统(Edward’s SAPIEN 3 transcatheter heart valve,Edward’s SAPIEN 3 THV)进行ViVTMVR的患者。研究的主要效应终点为二尖瓣学术研究联盟(MVARC)标准定义的技术成功和手术成功率、死亡率,以及根据纽约心脏病协会(NYHA)心功能分级评估的心功能变化情况。临床随访节点包括术后30 d及6个月。结果 经过评估后共20例在外科生物瓣膜置换术后并发瓣膜退化后接受ViV-TMVR的患者被纳入本研究。入选患者的平均年龄为(73.5±5.5)岁,其中女17例(85.0%),14例(70.0%)患者基线NYHA心功能分级为Ⅲ/Ⅳ级。与基线数据相比,患者术后平均跨瓣压差[(6.75±2.27)mmHg比(13.05±5.05)mmHg,P<0.001]和血流峰速[(2.05±0.36)m/s比(2.58±0.42)m/s,P<0.001]均得到显著改善。经过6个月的临床随访,共有2例(10.0%)患者因心力衰竭再入院,其中1例(5.0%)患者发生死亡,但在术后30 d内未发生任何不良心血管事件。此外,在整个随访期内未出现任何与ViV-TMVR相关的不良事件。因此在本研究中,ViV-TMVR术后即刻的技术成功率为100.0%,总手术成功率可达90.0%。此外,随访6个月后NYHA心功能分级与基线相比得到显著改善(P=0.0004)。结论 经房间隔的ViV-TMVR手术具有高度的技术成功率,并可显著改善此类患者的心功能。这一技术对于外科生物瓣膜置换术后出现瓣膜退化的高危患者而言,可成为一种安全、高效的治疗选择。Objective To evaluate the safety and efficacy of valve-in-valve transcatheter mitral valve replacement(ViV-TMVR)in patients with bioprosthetic valve degeneration who are at high surgical risk.Methods This study is a multi-center,retrospective cohort analysis of 20 consecutive patients who underwent transseptal ViV-TMVR using the Edwards SAPIEN 3 transcatheter heart valve(THV).The primary endpoints include technical success and procedural success,both defined according to the Mitral Valve Academic Research Consortium(MVARC)criteria,as well as mortality and functional change assessed based on New York Heart Association(NYHA)classification at 30-days and six months post-procedure.Clinical follow-up assessments are conducted at 30-days and six months.Results From February 2021 to October 2022,a total of 20 patients with symptoms of bioprosthetic valve degeneration were enrolled across nine sites in China.The patients had a mean age of(73.5±5.5)years,with 85.0%being females and 70.0%classified as NYHA classⅢ/Ⅳ.The study achieved a 100.0%technical success rate and a 90.0%procedural success rate finally.All patients remained alive during the 30-day follow-up period.However,six months post-intervention,two patients(10.0%)were re-hospitalized due to heart failure,and sadly,one of them(5.0%)died.None of the patients reported any adverse events related to ViV-TMVR during the follow-up period.Notably,there was a significant improvement in NYHA class compared to baseline(P=0.0004)at six-month follow-ups.Conclusions The transseptal ViV-TMVR technique proved to be highly successful and was associated with significant improvement in NYHA class function.These findings strongly suggest that it serves as a safe and efficient treatment alternative for high-risk patients suffering from bioprosthetic valve degeneration.

关 键 词：经导管二尖瓣置换术 瓣中瓣 生物瓣退行性变 高危 

分 类 号：R54[医药卫生—心血管疾病]