应用国产NovoClasp系统的经导管二尖瓣缘对缘修复术治疗原发性中重度二尖瓣反流的疗效分析  

Effect of transcatheter mitral valve edge-to-edge repair using a domestic NovoClasp system for primary moderate-to-severe mitral regurgitation

作　　者：王硕 战吟戈 郑庆厚[2] 刘刚[2] 王乐[2] 李柳[2] WANG Shuo;ZHAN Yinge;ZHENG Qinghou;LIU Gang;WANG Le;LI Liu(Department of Cardiology,Shijiazhuang People’s Hospital,Shijiazhuang 050031,China;Department of Cardiology,The First Hospital of Hebei Medical University,Shijiazhuang 050011,China)

机构地区：[1]石家庄市人民医院心内科,石家庄050031 [2]河北医科大学第一医院心内科,石家庄050011

出　　处：《中国医科大学学报》2025年第2期127-132,共6页Journal of China Medical University

基　　金：河北省卫生健康委员会重点科技研究计划(20241849)。

摘　　要：目的 探讨应用国产NovoClasp系统的经导管二尖瓣缘对缘修复术治疗原发性中重度二尖瓣反流的疗效分析。方法 回顾分析2022年6月至2023年6月河北医科大学第一医院心脏中心应用国产NovoClasp系统进行经导管二尖瓣缘对缘修复术,治疗并完成6个月随访的19例原发性二尖瓣反流患者的临床资料。所有患者均完善术前检查,分析患者治疗的安全性和有效性。术后安全性相关指标包括二尖瓣夹即刻成功率,瓣夹移位、二尖瓣狭窄、心脏传导阻滞、急性心力衰竭、脑卒中、入径血管破裂、心脏压塞、术后二尖瓣反流≥2+、大出血及死亡发生情况。有效性指标包括术前及术后7 d、3个月、6个月的关键心功能指标[N末端B型利钠肽前体(NT-proBNP)、可溶性生长刺激表达基因2 (sST2)、左室射血分数、左心室舒张末期内径、二尖瓣反流程度、平均二尖瓣跨瓣压力阶差、二尖瓣开口面积、左心房前后径]。结果 治疗安全性分析结果显示,瓣膜植入即刻成功率100%。其中,1例应用了2枚二尖瓣夹;1例术后发生了急性脑卒中,为右侧顶叶及左侧顶枕叶急性脑梗死。患者均未出现瓣夹移位、二尖瓣狭窄、心脏传导阻滞、急性心力衰竭、入径血管破裂、心脏压塞、术后二尖瓣反流≥2+、大出血和死亡情况。治疗有效性分析结果显示,患者术后7 d较术前二尖瓣反流程度均显著改善(Z=5.466,P <0.001)。术后临床症状改善明显,术后7 d时,NYHAⅠ~Ⅱ级患者9例(47.4%),与术前(1例,5.3%)比较显著增多;术后第6个月时NYHAⅠ~Ⅱ级患者17例(89.5%),显示出良好的治疗效果。术后7 d时心功能指标NT-proBNP与术前比较明显下降(P=0.001),之后呈逐渐下降趋势;术后3个月时心肌纤维化指标sST2与术前比较显著下降(P=0.001),之后呈逐渐下降趋势。术后6个月时左心室舒张末期内径与术前比较差异有统计学意义(P=0.006)。术后7 d时平均二Objective To evaluate the efficacy of transcatheter mitral valve edge-to-edge repair using the domestic NovoClasp system in patients with primary moderate-to-severe mitral regurgitation(MR).Methods A retrospective analysis was conducted on 19 patients with primary MR who underwent transcatheter mitral valve edge-to-edge repair using the domestic NovoClasp system at the Cardiac Center,The First Hospital of Hebei Medical University,and completed a 6-month follow-up.All patients underwent a complete preoperative examination,and the safety and efficiency of surgery were evaluated.The safety indicators included immediate success rate of mitral valve clip,clip displacement,mitral stenosis,heart block,acute heart failure,stroke,access vessel rupture,cardiac tamponade,postoperative MR ≥2+,major bleeding,and death.The efficiency indicators included N-terminal pro-B-type natriuretic peptide(NT-proBNP),soluble growth stimulation expressed gene 2(sST2),left ventricular ejection fraction,left ventricular end diastolic diameter,degree of MR,mean mitral transvalvular pressure gradient,mitral valve opening area,and left atrial anteroposterior diameter at various time points(before surgery and at 7 days,3 months,and 6 months after surgery).Results Safety indicators after surgery showed that the immediate success rate of valve implantation was 100%,including in one patient who received two mitral valve clamps and one who suffered from acute stroke(acute cerebral infarction in the right parietal lobe and left parietal-occipital lobe) after surgery.There were no cases of clamps displacement,mitral stenosis,heart block,acute heart failure,access vessel rupture,cardiac tamponade,postoperative MR ≥2+,major bleeding,or death.The effectiveness indicators after surgery showed that the degree of MR significantly improved 7 days after surgery compared with that before surgery(Z = 5.466,P < 0.001).Clinical symptoms improved significantly after surgery,with proportion of NYHAⅠ-Ⅱ(9cases,47.4%) significantly higher than that before surg

关 键 词：经导管二尖瓣缘对缘修复术 原发性中重度二尖瓣反流 NovoClasp系统 

分 类 号：R541.4[医药卫生—心血管疾病]