Philippon François, Liu Lili, Fung Jeffrey Wing-Hong, Deharo Jean-Claude, Anselme Frederic, Delnoy Peter Paul, Crijns Harry, Morillo Carlos A, Krahn Andrew D, Gutleben Klaus, Delumeau Julien, Molin Franck
Electrophysiology Division, Institut universitaire de cardiologie et de pneumologie de Québec, Québec, Canada.
Pacing Clin Electrophysiol. 2015 Apr;38(4):438-47. doi: 10.1111/pace.12584. Epub 2015 Jan 28.
This multicenter acute clinical study was designed to verify novel three-dimensional (3D) quadripolar lead designs that can achieve ≤2.5 V average pacing capture threshold (PCT) not only at the apex, but also at the base of the left ventricle with phrenic nerve stimulation (PNS) avoidance for cardiac resynchronization.
During the implant procedure, up to two different left ventricular investigational leads were introduced and tested in the same target coronary vein based on the coronary sinus venogram in a wedged and unwedged position. Adverse events were collected in 30 days following the procedure.
Eighty-seven leads were tested in 50 patients. When the best performing spiral electrode was chosen from each lead testing, the average of the best PCT on spiral in a wedged position was similar to the unwedged position (1.7 ± 1.5 V vs 1.9 ± 1.5 V, P = ns) and was similar to the wedged tip electrode average PCT (1.7 ± 1.5 V vs 1.6 ± 1.6 V, P = ns). In the majority of patients (89-96%), pacing was achievable in a mid-basal ventricular location without PNS.
This acute study demonstrated that a 3D quadripolar spiral lead design can achieve acceptable PCTs and avoid PNS without repositioning the lead at implant in the vast majority of patients. It also demonstrated that this lead design can achieve mid-basal ventricular stimulation with low PCT and good acute stability.
本多中心急性临床研究旨在验证新型三维（3D）四极导线设计，该设计不仅能在左心室心尖部，还能在左心室基底部实现平均起搏夺获阈值（PCT）≤2.5V，同时避免膈神经刺激（PNS）以进行心脏再同步治疗。
在植入过程中，根据冠状静脉窦造影，在同一目标冠状静脉中，以楔入和非楔入位置引入并测试多达两种不同的左心室研究导线。术后30天收集不良事件。
对50例患者测试了87根导线。当从每次导线测试中选择性能最佳的螺旋电极时，楔入位置螺旋电极上最佳PCT的平均值与非楔入位置相似（1.7±1.5V对1.9±1.5V，P=无显著差异），且与楔入尖端电极的平均PCT相似（1.7±1.5V对1.6±1.6V，P=无显著差异）。在大多数患者（89%-96%）中，无需膈神经刺激即可在心室中基底部位实现起搏。
这项急性研究表明，三维四极螺旋导线设计在绝大多数患者植入时无需重新定位导线即可实现可接受的PCT并避免膈神经刺激。它还表明，这种导线设计可以通过低PCT和良好的急性稳定性实现心室中基底部位刺激。
