国产经导管缘对缘修复系统Neonova^(TM)治疗二尖瓣反流短期临床结局及超声评估  

Short-term clinical and echocardiographic outcomes of the novel domestic transcatheter edge-to-edge repair Neonova^(TM) system in patients with mitral regurgitation

作　　者：杨芸 李贺[1] 吴文谦 尚小珂[2] 陈澍[2] 钟禹成[2] 刘曼薇[1] 贺林[1] 孙振兴[1] 章子铭[1] 周羿 张鑫 董念国[2] 方凌云[1] 谢明星[1] Yang Yun;Li He;Wu Wenqian;Shang Xiaoke;Chen Shu;Zhong Yucheng;Liu Manwei;He Lin;Sun Zhenxing;Zhang Ziming;Zhou Yi;Zhang Xin;Dong Nianguo;Fang Lingyun;Xie Mingxing(Department of Ultrasound Medicine,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Clinical Research Center for Medical Imaging in Hubei Province,Hubei Province Key Laboratory of Molecular Imaging,Wuhan 430022,China;Department of Cardiovascular Surgery,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430022,China)

机构地区：[1]华中科技大学同济医学院附属协和医院超声医学科、湖北省影像医学临床医学研究中心分子影像湖北省重点实验室,武汉430022 [2]华中科技大学同济医学院附属协和医院心脏大血管外科,武汉430022

出　　处：《中华超声影像学杂志》2023年第1期51-59,共9页Chinese Journal of Ultrasonography

基　　金：国家自然科学基金(82001852,82001854,82230066);湖北省自然科学基金(2020CFB781)。

摘　　要：目的评估国产经导管二尖瓣夹合器及输送系统Neonova^(TM)治疗中重度及以上二尖瓣反流的短期安全性、有效性及技术特点,并探讨超声心动图在其围术期的应用。方法前瞻性纳入2021年6月至2022年3月在华中科技大学同济医学院附属协和医院就诊的10例外科手术高危且符合入组标准的中重度及以上二尖瓣反流患者,在经食管超声心动图及数字剪影血管造影引导下植入Neonova^(TM)系统二尖瓣夹合器,于术后即刻、术后7 d、术后1个月及术后3个月随访,评估该系统治疗中重度及以上二尖瓣反流的短期临床结局、超声心动图指标变化及手术技术学习曲线。结果①Neonova^(TM)系统治疗二尖瓣反流成功率为100%,术后即刻反流程度显著减轻(P=0.003)。随访期间,装置成功率和手术成功率均为90.0%,1例患者反流程度加重,于术后37 d行外科二尖瓣置换术,其余9例患者术后3个月反流程度改善为轻度(8/9)或中度(1/9)。患者纽约心脏病学会心功能分级和堪萨斯城心肌病患者生活质量问卷得分明显改善(均P<0.001)。②与术前相比,患者术后3个月时未出现二尖瓣狭窄,二尖瓣平均跨瓣压差无显著增加(P=0.324)。随访期间左室舒张末内径显著减小(P=0.008)。③手术时长60~300(175.8±75.2)min,手术时长与手术台次拟合的简单线性回归模型显示随着手术例数的增加,手术时间显著减少(F=15.857,P=0.004)。结论Neonova^(TM)介入治疗能安全、有效地改善外科高危患者的二尖瓣反流程度及临床症状。经胸及经食管超声心动图是国产经导管缘对缘修复系统治疗二尖瓣反流围术期管理的重要评估方式。Objective To investigate short-term safety,efficacy and the learning curve of this self-developed novel transcatheter valve repair system(Neonova^(TM)) in patients with mitral regurgitation,and explore the role of perioperative echocardiography.Methods Ten patients who visited the Union Hospital of Tongji Medical College,Huazhong University of Science and Technology from June 2021 to March 2022 and met the inclusive criteria were prospectively enrolled.All the patients were at high risk of surgery with moderate to severe or severe mitral regurgitation(MR).Clamps of Neonova^(TM) were implanted under guidance of transesophageal echocardiography and digital subtraction angiography.Clinical outcomes,echocardiography indexes and learning curves of this technique were evaluated immediately after intervention,7 d,1 month and 3 months post-intervention.Results The technical success rate was 100%with MR relieved in all patients immediately after intervention.The device and procedural success rates were both 90.0%with 1 patient received surgical replacement at 37 days post-intervention while the others′reduced to mild(8/9)and moderate(1/9)MR.New York Heart Association class and the Kansas City Cardiomyopathy Questionnaire improved significantly(all P<0.001).Mean mitral valve pressure gradient didn′t increase significantly after intervention when compared with that before intervention(P=0.324),and no mitral stenosis was observed.Left ventricular end-diastolic diameter decreased significantly(P=0.008)during follow up.Procedure duration ranged from 60 to 300(175.8±75.2)minutes.The simple linear regression model between procedure volume and duration showed that procedure duration decreased significantly with the increase of procedure volume(F=15.857,P=0.004).Conclusions Neonova^(TM) implantation can improve MR severity and clinical symptoms safely and effectively.Transthoracic echocardiography and transesophageal echocardiography are essential for perioperative management of transcatheter mitral valve repair.

关 键 词：超声心动描记术 二尖瓣反流 经导管缘对缘修复 

分 类 号：R654.2[医药卫生—外科学] R445.1[医药卫生—临床医学]