Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
ARTORG Center for Biomedical Engineering Research, University of Bern, Bern, Switzerland.
Pacing Clin Electrophysiol. 2023 May;46(5):365-375. doi: 10.1111/pace.14686. Epub 2023 Apr 5.
The implantation procedure of left ventricular (LV) leads and the management of cardiac resynchronization therapy (CRT) patients can be challenging. The IS-4 standard for CRT offers additional pacing vectors compared to bipolar leads (IS-1). IS-4 leads improve procedural outcome and may also result in lower adverse events during follow-up (FU) and improve clinical outcome in CRT patients. Further long-term FU data comparing the two lead designs are necessary.
In this retrospective, single-center study we included adult patients implanted with a CRT-Defibrillator (CRT-D) or CRT-Pacemaker (CRT-P) with a quadripolar (IS-4 group) or bipolar (IS-1 group) LV lead and with available ≥3 years clinical FU. The combined primary endpoint was a combination of predefined, lead-related adverse events. Secondary endpoints were all single components of the primary endpoint.
Overall, 133 patients (IS-4 n = 66; IS-1 n = 67) with a mean FU of 4.03 ± 1.93 years were included. Lead-related adverse events were less frequent in patients with an IS-4 lead than with an IS-1 lead (n = 8, 12.1% vs. n = 23, 34.3%; p = .002). The secondary outcomes showed a lower rate of LV lead deactivation/explantation and LV lead dislodgement/dysfunction (4.5% vs. 22.4%; p = .003; 4.5% vs. 17.9%; p = .015, respectively) in the IS-4 patient group. Less patients suffered from unresolved phrenic nerve stimulation with an IS-4 lead (3.0% vs. 13.4%; p = .029). LV lead-related re-interventions were fewer in case of an IS-4 lead (6.1% vs. 17.9%; p = .036).
In this retrospective analysis, the IS-4 LV lead is associated with lower lead-related complication rates than the IS-1 lead at long-term FU.
左心室（LV）导线的植入程序和心脏再同步治疗（CRT）患者的管理可能具有挑战性。与双极导线（IS-1）相比，IS-4 标准为 CRT 提供了额外的起搏向量。IS-4 导线可改善手术结果，并可能在随访（FU）期间导致更低的不良事件发生率，并改善 CRT 患者的临床结局。需要进一步进行比较两种导线设计的长期 FU 数据。
在这项回顾性、单中心研究中，我们纳入了植入具有四极（IS-4 组）或双极（IS-1 组）LV 导线的成年 CRT-除颤器（CRT-D）或 CRT-起搏器（CRT-P）患者，并具有≥3 年的临床 FU。主要复合终点是预先设定的与导线相关的不良事件的组合。次要终点是主要终点的所有单一组成部分。
总体而言，纳入了 133 名患者（IS-4 组 n = 66；IS-1 组 n = 67），平均 FU 为 4.03 ± 1.93 年。IS-4 导线患者的与导线相关的不良事件发生率低于 IS-1 导线患者（n = 8，12.1% vs. n = 23，34.3%；p =.002）。次要结局显示，IS-4 患者组 LV 导线失活/拔出和 LV 导线脱位/功能障碍的发生率较低（4.5% vs. 22.4%；p =.003；4.5% vs. 17.9%；p =.015）。使用 IS-4 导线的患者中，未解决的膈神经刺激的发生率较低（3.0% vs. 13.4%；p =.029）。如果使用 IS-4 导线，LV 导线相关的再介入较少（6.1% vs. 17.9%；p =.036）。
在这项回顾性分析中，与 IS-1 导线相比，IS-4 LV 导线在长期 FU 时与较低的导线相关并发症发生率相关。
