Mazzone Patrizio, Melillo Francesco, Radinovic Andrea, Marzi Alessandra, Paglino Gabriele, Della Bella Paolo, Mascioli Giosuè
Arrhythmia Unit and Electrophysiology Laboratories Department of Cardiology and Cardiothoracic Surgery Ospedale San Raffaele Milan Italy.
Electrophysiology Unit Cardiovascular Department Humanitas Gavazzeni Hospital Bergamo Italy.
J Arrhythm. 2020 Feb 14;36(2):343-350. doi: 10.1002/joa3.12310. eCollection 2020 Apr.
The aim of this study is to assess the safety and efficacy of the new bidirectional rotational mechanical sheath TightRail™ (Spectranetics) for lead extraction.
This is a bicentric prospective study that included patients who underwent a transvenous lead extraction (TLE) in two Italian centers (San Raffaele Hospital and Humanitas Gavazzeni Hospital). From November 2016 to December 2018, 26 patients underwent a TLE procedure in which the TightRail™ was used. The new TightRail Sub-C was used in 20 (76%) patients to overcome the fibrosis between the vessel and the first rib. Median age was 69 (IQR 60.7-79.5) years. The indication for TLE were infection (57.7%) or lead dysfunction (42.3%). A total of 57 leads (range 1-4), 40 of which using the TightRail (range 1-4), were extracted. Overall mean implant duration was 98.2.0 ± 66.5 months. Mean age of the lead extracted with the TightRail sheath was 99.1 ± 70.2 months and was higher compared to that of the leads extracted manually (84.4 ± 60.3 months, = .001). The overall clinical success was 100% and complete procedural success without the use of a snare was achieved in 98.3%. There were no cases of death or major complications and only two minor complications occurred. All patients were event-free at 6-month follow-up.
This initial experience using the TightRail™ suggests a high safety and efficacy profile for extractions in a wide range of lead age.
本研究旨在评估新型双向旋转机械鞘管TightRail™（斯贝克特拉尼克斯公司）用于导线拔除的安全性和有效性。
这是一项双中心前瞻性研究，纳入了在意大利两个中心（圣拉斐尔医院和加瓦泽尼人文医院）接受经静脉导线拔除（TLE）的患者。2016年11月至2018年12月，26例患者接受了使用TightRail™的TLE手术。20例（76%）患者使用了新型TightRail Sub-C以克服血管与第一肋骨之间的纤维化。中位年龄为69岁（四分位间距60.7 - 79.5岁）。TLE的适应证为感染（57.7%）或导线功能障碍（42.3%）。共拔除57根导线（范围1 - 4根），其中40根使用TightRail（范围1 - 4根）。总体平均植入时间为98.2±66.5个月。使用TightRail鞘管拔除的导线平均使用年限为99.1±70.2个月，高于手动拔除的导线（84.4±60.3个月，P = 0.001）。总体临床成功率为100%，98.3%的患者在未使用圈套器的情况下实现了完全手术成功。无死亡或重大并发症病例，仅发生两例轻微并发症。所有患者在6个月随访时均无事件发生。
使用TightRail™的这一初步经验表明，在广泛的导线使用年限范围内进行拔除时，其具有较高的安全性和有效性。
