国产机械锁定及弹性自锁TEER器械在治疗功能性二尖瓣反流中的疗效对比

Comparison on the efficacy of Chinese-made novel-designed mechanical-locked and elastic self-locked transcatheter edge-to-edge repair system in the treatment of patients with functional mitral regurgitation

目的评价并比较国产机械锁定及弹性自锁经导管二尖瓣缘对缘介入修复(TEER)器械在治疗功能性二尖瓣反流中的短期疗效差异。方法采用回顾性非随机对照的方式纳入云南省阜外心血管病医院2022年5月—2023年4月因心力衰竭合并中重度或重度功能性二尖瓣反流行TEER手术的患者。根据使用的手术器械将患者分为Clip2Edge组和ValveClip组。收集并比较两组患者的基线资料、围手术期及术后30 d随访指标。主要终点指标为术后30 d器械成功率,次要终点指标包括术后即刻技术成功率以及术后30 d全因死亡率、急性心力衰竭再入院率及脑梗死、严重出血等严重不良事件发生率。结果共纳入60例功能性二尖瓣反流患者,其中ValveClip组26例,Clip2Edge组34例,年龄(63.8±9.3)岁,女性24例(40%)。两组患者年龄、心功能、合并症等基线指标,二尖瓣反流4+比例[19例(73%)比29例(85%)],左心室舒张末期容积[(220.8±91.2)ml比(210.8±71.7)ml],差异均无统计学意义(P均>0.05)。术后即刻技术成功率均为100%。完成术后30 d随访的患者无急性心力衰竭发作再入院,无全因死亡、脑梗死、严重出血等严重不良事件发生。器械成功率ValveClip组24例(100%),Clip2Edge组27例(96%),差异无统计学意义(P>0.05)。结论不同类型的国产TEER器械在治疗功能性二尖瓣反流中具有相同的安全性及有效性,短期随访结果满意。

Objective To evaluate and compare the short-term efficacy of domestic mechanical-locked(Clip2Edge)and elastic self-locked(ValveClip)transcranial mitral valve edge-to-edge interventional repair(TEER)devices in the treatment of functional mitral regurgitant valves.Methods In this retrospective non-randomized comparative study,patients underwent TEER procedure in Fuwai Yunnan Cardiovascular Disease Hospital from May 2022 to April 2023 for heart failure combined with moderate to severe or severe functional mitral valve were divided into Clip2Edge and ValveClip groups based on the TEER system used.Baseline,perioperative,and postoperative 30 d follow-up data were collected and compared between the two groups.The primary outcome was the success rate on the 30 d post operation,while secondary outcomes included immediate postoperative technical success rate and the incidence of all-cause mortality on the 30 d post operation,readmission rate of acute heart failure,cerebral infarction,severe bleeding,and other serious adverse events rates.Results A total of 60 patients were enrolled,34 patients were in the Clip2Edge group and 26 in the ValveClip group,mean age was(63.8±9.3)years,and 24 patients(40%)were female.There were no significant differences in baseline data of age,cardiac function,comorbidities,mitral regurgitation 4+(19(73%)vs.29(85%)),the end-diastolic volume of left ventricle((220.8±91.2)ml vs.(210.8±71.7)ml)between the two groups(all P>0.05).The technical success rate immediately after the procedure was 100%.There were no readmission of acute heart failure,death,cerebral infarction,severe bleeding,and other serious adverse events up to the 30 d follow-up.Device success rate was similar between the ValveClip group(24 cases(100%))and the Clip2Edge group(27 cases(96%))(P>0.05).Conclusion Both types of novel domestic TEER devices are safe and feasible in treating patients with functional mitral regurgitation.