Department of Cardiology and Cardiothoracic Surgery, Arrhythmia Unit and Electrophysiology Laboratories, Ospedale San Raffaele, Milan, Italy.
Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Via N. Giustiniani 2, 35121 Padova, Italy.
Europace. 2018 May 1;20(5):829-834. doi: 10.1093/europace/eux020.
The aim of this prospective multicentre study is to evaluate safety and efficacy of the new bidirectional rotational mechanical lead extraction (LE) sheath (Evolution RL, Cook Medical, USA) in chronically implanted leads (>1-year-old leads).
Between September 2013 and June 2016, a total of 238 leads in 124 consecutive patients were removed by using the new Evolution RL rotational mechanical sheath. Indications for LE were cardiac device infection in 63 (50.8%) cases, lead malfunction in 41 (33.1%), upgrade in 1 (0.8%) case and for other reasons in the remaining 19 cases (15.3%). Ninety-one leads (38.2%) were implantable cardioverter defibrillator leads (81 dual coil vs. 10 single coil), 38 (16%) right ventricular leads, 86 (36.1%) right atrial leads, and 23 (9.7%) coronary sinus leads. The mean implant duration was 92.2 ± 52.9 months (range 12-336). 91.6% of the leads (218/238) were extracted completely with the Evolution RL alone, with the complete success rate rising to 98.7% (235/238 leads) with combined use of a snare. Overall clinical success rate was 100%. No Evolution sheath-related complications were noted. There were no deaths or major complications. Five minor complications (4%) were encountered. In cases of companion leads no wrapping or lead damage were observed.
On the basis of our prospective multicentre study, the new hand-powered bidirectional rotational mechanical LE sheath is an effective and safe tool for the extraction of chronically implanted leads without major complications and lead wrapping or lead damage.
本前瞻性多中心研究旨在评估新型双向旋转机械导丝提取（LE）鞘（美国库克医疗的 Evolution RL）在慢性植入导丝（>1 年的导丝）中的安全性和有效性。
2013 年 9 月至 2016 年 6 月，使用新型 Evolution RL 旋转机械鞘共取出 124 例连续患者的 238 根导丝。LE 的适应证为心脏器械感染 63 例（50.8%）、导丝故障 41 例（33.1%）、升级 1 例（0.8%）和其余 19 例（15.3%）的其他原因。91 根导丝（38.2%）为植入式心脏复律除颤器导丝（81 根双线圈 vs. 10 根单线圈）、38 根（16%）右心室导丝、86 根（36.1%）右心房导丝和 23 根（9.7%）冠状窦导丝。平均植入时间为 92.2±52.9 个月（范围 12-336）。91.6%（218/238）的导丝仅用 Evolution RL 完全取出，完全成功率上升至 98.7%（235/238 导丝），联合使用圈套器。总临床成功率为 100%。未观察到与 Evolution 鞘相关的并发症。无死亡或重大并发症。发生 5 例轻微并发症（4%）。在伴发导丝的情况下，未观察到导丝缠绕或损伤。
根据我们的前瞻性多中心研究，新型手动双向旋转机械 LE 鞘是一种有效且安全的工具，可用于提取慢性植入导丝，无重大并发症、导丝缠绕或导丝损伤。
