李氏导管应用于心脏再同步化治疗的效果评价

Effect of Li′s catheter in the cardiac resynchronization therapy implantation

目的评价李氏导管应用于心脏再同步化治疗(CRT)的临床效果。方法该研究为回顾性队列研究。入选2016年1月1日至2022年1月1日于北京大学人民医院心内科就诊的具有CRT装置植入指征的患者。根据是否应用李氏导管将患者分为李氏导管组和对照组(采用传统方法进行CRT装置植入)。通过电子病历系统获得患者的一般临床资料。李氏导管是由李学斌医师自主研发的一种新型的冠状窦造影球囊导管(专利号:201320413174.1)。主要观察指标为CRT装置植入成功率,次要观察指标包括有效性指标和安全性指标。有效性指标包括手术时间、冠状窦造影时间、左心室电极植入时间、X线曝光时间、左心室电极阈值、膈肌刺激。安全性指标包括冠状窦夹层、心包填塞和心包积液发生率。结果研究共入选患者170例,其中李氏导管组90例,对照组80例。两组患者的年龄、男性占比,合并缺血性心肌病、高血压、糖尿病、慢性肾功能不全者占比,纽约心脏协会(NYHA)心功能Ⅰ、Ⅱ、Ⅲ级者占比,左心室射血分数、左心室舒张末期内径,左束支传导阻滞者占比,术前QRS波宽度,差异均无统计学意义(P均>0.05)。李氏导管组中植入CRT除颤器34例(37.8%),对照组为28例(35.0%),差异无统计学意义(P=0.710)。李氏导管组CRT装置植入成功率为100%(90/90),高于对照组的93.8%(75/80)(P=0.023)。李氏导管组的手术时间为57.0(52.0,62.3)min、完成冠状窦造影时间为8.0(6.0,9.0)min、左心室电极植入时间为8.0(7.0,9.0)min,对照组分别为91.3(86.3,97.0)、18.0(16.0,20.0)、25.0(22.0,27.7)min,李氏导管组均用时较短(P均<0.05)。李氏导管组患者X线曝光时间为15.0(14.0,17.0)min,亦短于对照组的32.5(29.0,36.0)min(P<0.001)。李氏导管组中无患者出现冠状窦夹层和心脏压塞,1例(1.1%)患者出现了膈肌反应,对照组中6例(6.7%)患者出现了冠状窦夹层,1例(1.1%)患者出现了心包积液,3例(3.3%)患者出现了膈肌反应,李氏导管组冠状窦夹层的发生率明显低于对照组(P=0.011)。李氏导管组和对照组患者术后左心室阈值分别为1.80(1.60,2.38)V/0.5 ms和1.80(1.60,2.40)V/0.5 ms,差异无统计学意义(P=0.120)。结论使用李氏导管进行CRT装置植入可提高手术成功率,缩短冠状窦造影和左心室电极植入时间,减少术中X线暴露,降低冠状静脉夹层的发生率,临床效果好。

Objective To evaluate the effect of Li′s catheter in cardiac resynchronization therapy(CRT)implantation.Methods This study was a retrospective cohort study.Patients with indications for CRT implantation who visited the Department of Cardiology,Peking University People′s Hospital from January 1,2016 to January 1,2022 were enrolled.Patients were divided into Li′s catheter group(CRT implantation with Li′s catheter)and control group(CRT implantation with the traditional method).The general clinical data of the patients were obtained through the electronic medical record system.Li′s catheter is a new type of coronary sinus angiography balloon catheter independently developed by Dr.Li Xuebin(patent number:201320413174.1).The primary outcome was the success rate of CRT device implantation,and the secondary outcomes included efficacy and safety parameters.Efficacy indicators included operation time,coronary sinus angiography time,left ventricular lead implantation time,X-ray exposure time,left ventricular lead threshold,and diaphragm stimulation.Safety outcomes included incidence of coronary sinus dissection,cardiac tamponade,and pericardial effusion.Results A total of 170 patients were enrolled in this study,including 90 in Li′s catheter group and 80 in control group.Age,male proportion of patients,proportion of patients with ischemic cardiomyopathy,hypertension,diabetes mellitus,chronic renal insufficiency,New York Heart Association(NYHA)functional classification,left ventricular ejection fraction,left ventricular end-diastolic diameter,proportion of left bundle branch block,and preoperative QRS wave width were similar between the two groups(all P>0.05).In Li′s catheter group,34 cases(37.8%)implanted with CRT defibrillators,and 28 cases(35.0%)implanted with CRT defibrillators in control group,the difference was not statistically significant(P=0.710).The success rate of CRT device implantation in Li′s catheter group was 100%(90/90),which was significantly higher than that in control group(93.8%,75/80,P=0.023).The operation time was 57.0(52.0,62.3)minutes,the time to complete coronary sinus angiography was 8.0(6.0,9.0)minutes,and the time of left ventricular electrode implantation was 8.0(7.0,9.0)minutes in Li′s catheter group,and was 91.3(86.3,97.0),18.0(16.0,20.0),25.0(22.0,27.7)minutes respectively in control group,all significantly shorter in Li′s catheter group(all P<0.05).The exposure time of X-ray was 15.0(14.0,17.0)minutes in Li′s catheter group,which was also significantly shorter than that in control group(32.5(29.0,36.0)minutes,P<0.001).There was no coronary sinus dissection and cardiac tamponade in Li′s catheter group,and 1 patient(1.1%)had diaphragmatic stimulation in Li′s catheter group.In control group,6 patients(6.7%)had coronary sinus dissection,and 1 patient(1.1%)developed pericardial effusion,and 3 patients(3.3%)had diaphragmatic stimulation.The incidence of coronary sinus dissection in Li′s catheter group was significantly lower than that in control group(P=0.011).The postoperative left ventricular thresholds in Li′s catheter group and control group were similar(1.80(1.60,2.38)V/0.5 ms vs.1.80(1.60,2.40)V/0.5 ms,P=0.120).Conclusions Use of Li′s catheter is associated with higher success rate of CRT implantation,short time of coronary sinus angiography and left ventricular electrode implantation,reduction of intraoperative X-ray exposure,and lower incidence of coronary vein dissection in this patient cohort.