Division of Cardiology, Internal Medicine III, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ward, Hamamatsu 431-3192, Japan.
Department of Cardiology, Chutoen General Medical Center, 1-1 Shobugaike, Kakegawa, 436-0040, Japan.
Europace. 2023 Apr 15;25(4):1451-1457. doi: 10.1093/europace/euad027.
Although the delivery catheter system for pacemaker-lead implantation is a new alternative to the stylet system, no randomized controlled trial has addressed the difference in right ventricular (RV) lead placement accuracy to the septum between the stylet and the delivery catheter systems. This multicentre prospective randomized controlled trial aimed to prove the efficacy of the delivery catheter system for accurate delivery of RV lead to the septum.
In this trial, 70 patients (mean age 78 ± 11 years; 30 men) with pacemaker indications of atrioventricular block were randomized to the delivery catheter or the stylet groups. Right ventricular lead tip positions were assessed using cardiac computed tomography within 4 weeks of pacemaker implantation. Lead tip positions were classified into RV septum, anterior/posterior edge of the RV septal wall, and RV free wall. The primary endpoint was the success rate of RV lead tip placement to the RV septum.
Right ventricular leads were implanted as per allocation in all patients. The delivery catheter group had higher success rate of RV lead deployment to the septum (78 vs. 50%; P = 0.024) and narrower paced QRS width (130 ± 19 vs. 142 ± 15 ms P = 0.004) than those in the stylet group. However, there was no significant difference in procedure time [91 (IQR 68-119) vs. 85 (59-118) min; P = 0.488] or the incidence of RV lead dislodgment (0 vs. 3%; P = 0.486).
The delivery catheter system can achieve a higher success rate of RV lead placement to the RV septum and narrower paced QRS width than the stylet system.
jRCTs042200014 (https://jrct.niph.go.jp/en-latest-detail/jRCTs042200014).
尽管起搏器导线植入的输送导管系统是一种替代钢针系统的新方法，但尚无随机对照试验研究过钢针系统与输送导管系统在右心室（RV）导线准确植入间隔部的差异。本多中心前瞻性随机对照试验旨在证明输送导管系统在准确将 RV 导线递送至间隔部的有效性。
本试验纳入了 70 名（平均年龄 78±11 岁；30 名男性）具有房室传导阻滞起搏适应证的患者，按随机数字表法分为输送导管组或钢针组。在起搏器植入后 4 周内，通过心脏计算机断层扫描评估右心室导线尖端位置。将导线尖端位置分为 RV 间隔部、RV 间隔壁的前/后缘和 RV 游离壁。主要终点是 RV 导线尖端植入 RV 间隔部的成功率。
所有患者均按分配植入了右心室导线。输送导管组 RV 导线植入间隔部的成功率更高（78% vs. 50%；P=0.024），起搏 QRS 波宽度更窄（130±19 比 142±15 ms；P=0.004），而钢针组则更低。然而，两组的手术时间[91（IQR 68-119）比 85（59-118）min；P=0.488]或 RV 导线脱位的发生率（0% vs. 3%；P=0.486）均无显著差异。
与钢针系统相比，输送导管系统可提高 RV 导线植入 RV 间隔部的成功率，使起搏 QRS 波宽度更窄。
jRCTs042200014（https://jrct.niph.go.jp/en-latest-detail/jRCTs042200014）。
