新一代国产自锁式经导管二尖瓣缘对缘修复系统Kokaclip^(TM)首次临床应用的研究结果

First in man implantation of a novel designed transcatheter edge to edge mitral repair system-Kokaclip^(TM)in treating high risk patient with severe mitral regurgitation

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。

Objective We reported the first in man(FIM)study of a novel designed self-locked transcatheter edge to edge mitral repair system in treating high risk patient with severe mitral regurgitation(MR).Methods Patients had clinically significant MR≥3+admitted in Yunnan Fuwai hospital between October 2021 and February 2022 were enrolled.Transcatheter edge to edge mitral valve repair using KokaclipTM were performed.All outcomes were assessed through 30 days post-procedure.Major adverse events and echocardiographic parameters were assessed.The primary safety endpoint was procedure success rate at 30 days.Results A total of 12 patients with 3+/4+MR were enrolled in this study with a mean age of(67.00±8.55)years,including 7 males.All patients had New York Heart Association(NYHA)ⅢorⅣgrade including 11 FMR and 1 DMR.Procedure success rate was achieved in 100%patients at 30 days.There was no mortality,major adverse complications,as well as emergency surgery or re-intervention at 30 days follow-up.The echocardiography indicated that 11(92%)subjects had MR 0-1+.The patients were in good condition 30 days after operation,8(67%)subjects had NYHAⅠ/Ⅱgrade.Left ventricular end diastolic dimension was(57.08±12.62)mm 30-day follow-up.Conclusions This FIM study shows the efficacy and safety of KokaclipTM device in Chinese population with severe mitral regurgitation.