Forleo Giovanni B, Di Biase Luigi, Panattoni Germana, Mantica Massimo, Parisi Quintino, Martino Annamaria, Pappalardo Augusto, Sergi Domenico, Tesauro Manfredi, Papavasileiou Lida P, Santini Luca, Calò Leonardo, Tondo Claudio, Natale Andrea, Romeo Francesco
Department of Cardiology, University of Rome "Tor Vergata", Rome, Italy,
J Interv Card Electrophysiol. 2015 Jan;42(1):59-66. doi: 10.1007/s10840-014-9956-1. Epub 2014 Dec 13.
Small single-center comparative studies suggest improved outcomes in cardiac resynchronization therapy (CRT) patients implanted with a quadripolar left ventricular (LV) lead in comparison with non-quadripolar (bipolar) leads. This study represents the first large multicenter prospective registry comparing implant and 6-month postoperative lead performance following CRT-defibrillator (CRT-D) implantation with quadripolar vs. bipolar leads.
During a 39-month period, 418 consecutive patients having CRT-D implantation attempts with either a quadripolar (n = 230) or bipolar LV lead (n = 188) were enrolled in the registry. The primary outcome of the study was LV lead failure defined as any abnormality, excluding infection, resulting in surgical lead revision or CRT termination. Additionally, operative and follow-up data were analyzed for significant difference between groups.
Baseline characteristics of both groups were similar. In 72.9 % of quadripolar leads versus 65.0 % of bipolar leads, the LV lead successfully engaged the predefined ideal target side branch (p = 0.47). Implant duration and fluoroscopy times were significantly shorter when a quadripolar lead was used (p = 0.007 and p = 0.001, respectively). The primary end point occurred in six patients (2.7 %) in the quadripolar group and in 14 patients (8.0 %) in the bipolar group (p = 0.02). Clinically significant phrenic nerve stimulation (PNS) occurred in 4.6 vs. 14.2 % of quadripolar vs. bipolar patients, respectively (p = 0.002); all PNS were resolved noninvasively through programming in the quadripolar group vs. 84 % in bipolar group (p = 0.75). The use of a bipolar lead was associated with a higher risk of surgical LV lead revision (6.3 vs. 2.3 %; p = 0.057) and a higher incidence of dislodgment (5.7 vs. 2.7 %; p = 0.16).
This multicenter study demonstrates that the use of a quadripolar LV lead results in significantly lower rates of lead-related problems and reduced procedural and fluoroscopic times for biventricular system implantation. This has important implications for LV pacing lead choice.
小型单中心比较研究表明，与非四极（双极）导线相比，植入四极左心室（LV）导线的心脏再同步治疗（CRT）患者预后更佳。本研究是第一项大型多中心前瞻性注册研究，比较了植入四极与双极导线的心脏再同步除颤器（CRT-D）植入术后的植入情况及术后6个月导线性能。
在39个月期间，418例连续尝试植入CRT-D的患者被纳入注册研究，其中230例植入四极LV导线，188例植入双极LV导线。研究的主要结局是LV导线故障，定义为导致手术更换导线或终止CRT的任何异常情况（不包括感染）。此外，分析手术和随访数据，以比较两组之间的显著差异。
两组的基线特征相似。72.9%的四极导线与65.0%的双极导线成功连接到预定义的理想目标侧支（p = 0.47）。使用四极导线时，植入时间和透视时间显著缩短（分别为p = 0.007和p = 0.001）。四极组有6例患者（2.7%）达到主要终点，双极组有14例患者（8.0%）达到主要终点（p = 0.02）。临床上显著的膈神经刺激（PNS）分别发生在4.6%的四极导线患者和14.2%的双极导线患者中（p = 0.
