Thirty-day Outcomes of First-in-man Implantation of a Novel Transcatheter Edge-to-edge Mitral Repair System in Patients With Severe Mitral Regurgitation  

作　　者：Kai Xu Yan Wang Shaoliang Chen Xiangbin Pan Ben He Ruiyan Zhang Bin Wang Junjie Zhang Zhengbin Zhu Bin Wang Da Zhu Yaling Han 

机构地区：[1]Department of Cardiology,General Hospital of Northern Theater Command,Shenyang,Liaoning 110016,China [2]Department of Cardiology,Xiamen Cardiovascular Hospital Xiamen University,Xiamen,Fujan 361102,China [3]Department of Cardiology,Nanjing First Hospital,Nanjing,Jiangsu 210006,China [4]Department of Structure Heart Disease,Fuwai Yunnan Cardiovascular Hospital,Kunming,Yunnan 650102,China [5]Department of Cardiology,Shanghai Chest Hospital,Shanghai 200030,China [6]Department of Cardiology,Rujin Hospital Shanghai Jiaotong University School of Medicine,Shanghai 200025,China

出　　处：《Cardiology Discovery》2024年第2期142-147,共6页心血管病探索（英文）

基　　金：supported by the National Key Project of Research and Development Plan during the fourteenth Five-year Plan Period(2022YFC2503400).

摘　　要：Objectives:The aim of this multicenter,prospective,single-arm pilot study(ClinicalTrials.gov number:NCT05040074)was to observe the procedural and 30-day results of the novel transcatheter mitral valve repair system,SQ-Kyrin■-M Clip(Shenqi Medical,Shanghai,China),in patients with severe mitral regurgitation(MR).Methods:The heart team considered patients from 5 centers in China with clinically significant functional mitral regurgitation≥3+despite optimal medical therapy or degenerative mitral regurgitation≥3+with high surgical risk as candidates for transcatheter repair.All patients received transcatheter edge-to-edge mitral valve repair under general anesthesia.The primary outcome was technical success,which included all of the following measured at the exit from the catheterization laboratory:(1)absence of procedural mortality;(2)successful access,delivery,and retrieval of the device delivery system;(3)successful deployment and correct positioning of the frst intended device;and(4)no emergency surgery or reintervention related to the device or access procedure.The secondary outcomes included all-cause mortality,serious adverse events,device success,and procedural success 30 d after the intervention.Results:From June 2021 to December 2021,18 patients were enrolled in this study with age(75.7±7.4)years.Fifteen patients had MR 4+,while 3 had MR 3+.Technical success was achieved in all patients,including 6 degenerative mitral regurgitation and 12 functional mitral regurgitation patients.There was no all-cause mortality at 30 d.One patient had single leaflet device attachment within 30 d,which was regarded as a serious adverse event,and the patient was successfully treated with reintervention by implanting another clip.Another patient's transmitral gradient was 6 mmHg(>5 mmHg),with an effective orifice area of 2.57 cm^(2) after the procedure.Sixteen patients had device success and procedural success at 30 d postoperation.Fourteen patients had MR 1+,3 had MR 2+,and only 1 patient had MR 3+30 d after the procedur

关 键 词：Heart failure Mitral regurgitation Transcatheter mitral valve repair Transcatheter edge-to-edge repair 

分 类 号：R654.2[医药卫生—外科学]