Abstract

Objectives: To compare the clinical outcome of cardiac resynchronization therapy (CRT) in patients receiving a bipolar left ventricular (LV) lead with a side helix for active fixation to the outcome in patients receiving a quadripolar passive fixation LV lead.

Design: Sixty-two patients (mean age 72 ± 11 years) were blindly and randomly assigned to the active fixation bipolar lead group (n = 31) or to the quadripolar lead group (n= 31). The LV leads were targeted to the basal LV segment in a vein concordant to the LV segment with the latest mechanical contraction chosen on the basis of preoperative radial strain (RS) echocardiography.

Results: At the 6-month follow-up (FU), the reduction in LV end-systolic volume and LV reverse remodelling responder rate, defined as LV end-systolic volume reduction >15%, was 77% in the active fixation group and 83% in the quadripolar group, which was not significantly different. At the 12-month FU, the LV ejection fraction (LVEF) did not differ between the groups. There were no significant differences between the two groups in changes in New York Heart Association (NYHA) functional class or Minnesota Living with Heart Failure Questionnaire score. The occurrence of phrenic nerve stimulation (PNS) was 19% in the active fixation group versus 10% in the quadripolar group (p=.30), and all cases were resolved by reprogramming the device. All patients were alive at the 12-month FU. There was no device infection.

Conclusions: There were no significant differences between the active fixation group of patients and the quadripolar group of patients concerning improvement in echocardiographic parameters or clinical symptoms.

ClinicalTrials.gov number, NCT04632472

摘要

目的：比较接受双极左心室（LV）导联和侧螺旋主动固定的患者的心脏再同步治疗（CRT）的临床结果与接受四极被动固定LV导联的患者的结果。

设计： 62例患者（平均年龄72±11岁）被盲目随机分配到主动固定双极导线组（ n  = 31）或四极导线组（ n = 31）。左心室导线针对与左心室段一致的静脉中的基底左心室段，并根据术前放射状应变（RS）超声心动图选择最新的机械收缩。

结果：在6个月的随访（FU）中，主动固定组的LV收缩末期容积和LV逆重塑反应率降低（定义为LV收缩末期容积减少> 15％）为77％四极组中83％，差异无统计学意义。在FU的12个月时，两组之间的LV射血分数（LVEF）没有差异。两组之间在纽约心脏协会（NYHA）功能类别或明尼苏达州心衰患者问卷调查得分的变化方面无显着差异。活动固定组group神经刺激（PNS）的发生率为19％，而四极组为10％（ p= .30），并且通过重新编程设备解决了所有情况。所有患者在12个月的FU时都还活着。没有设备感染。

结论：活动固定组和四极组患者在超声心动图参数或临床症状改善方面无显着差异。

ClinicalTrials.gov编号，NCT04632472