ELECTRa (European Lead Extraction ConTRolled) Registry--shedding light on transvenous lead extraction real-world practice in Europe.
ELECTRa (European Lead Extraction ConTRolled) Registry--shedding light on transvenous lead extraction real-world practice in Europe.
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DOI：
10.1007/s00399-013-0279-1
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发表时间：
2013-09-01
期刊：
影响因子：
--
通讯作者：
Auricchio, Angelo
中科院分区：
文献类型：
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作者：
Bongiorni, Maria Grazia;Romano, Simone L;Auricchio, Angelo
随着对心血管植入式电子器械（CIED）的临床需求和更广泛适应症的日益认识，植入手术的数量大幅增加。因此，与这些器械相关的并发症发生率也有所增加。经静脉电极导线拔除术（TLE）是治疗CIED相关感染性并发症的金标准，通常需要用于电极导线故障的管理。目前，越来越多的临床试验机构开展TLE手术。ELECTRa（欧洲电极导线拔除控制）登记研究是欧洲首个针对TLE连续患者的大型前瞻性多中心登记研究，由欧洲心律协会（EHRA）进行，并由欧洲心脏病学会（ESC）欧洲观察研究部管理。该登记研究的主要目的是评价TLE的急性和长期安全性;次要目的是描述患者特征、电极导线、TLE适应症以及目前用于TLE的工具和技术。将从欧洲国家自愿入组约100家中心;这些中心是匿名的，并根据其活动量分为高容量中心（>30例患者/年）和低容量中心：（≤30例患者/年）。每家参与研究的临床试验机构必须入组并随访1年，连续评估2012年11月至2014年1月期间接受TLE的患者。目标是达到至少3，500例患者的样本量进行统计分析。将使用基于网络的系统收集数据，并在随机选择的中心进行稽查。正式开始于11月6日。到目前为止，已有89个中心加入，65个中心目前正在活动，这些中心已经获得了自己的伦理委员会的批准，截至2013年6月底，共有1,099名患者入组。登记研究的独立性、患者入组的连续性和研究监查是本登记研究的特征，有助于实现目标的科学有效性。
With the growing recognition of the clinical need and wider indications for cardiovascular implantable electronic devices (CIED), the number of implant procedures has increased considerably. Consequently, the rate of complications related to these devices has also increased. Transvenous lead extraction (TLE) is the gold standard in the treatment of CIED-related infective complications and is often required in the management of lead malfunction. An increasing number of centers currently perform TLE procedures. The ELECTRa (European Lead Extraction ConTRolled) Registry is the first large prospective multicenter registry of consecutive patients undergoing TLE in Europe, conducted by the European Heart Rhythm Association (EHRA) and managed by the European Society of Cardiology (ESC) EURObservational Research Department. The primary objective of the registry is to evaluate the acute and long-term safety of TLE; the secondary objective is to describe the characteristics of the patients, the leads, the indications for TLE, and the tools and techniques currently used for TLE. About 100 centers will be enrolled on a voluntary basis from European countries; they are anonymous and stratified on the basis of their volume of activity into high-volume centers (>30 patients/year) and low-volume centers: (≤30 patients/year). Each participating center will have to enroll and follow up for 1 year consecutively assessed patients undergoing TLE from November 2012 to January 2014. The target is to achieve a sample size of at least 3,500 patients for statistical analysis. Data will be collected using a Web-based system and will be audited at randomly selected centers. The official start was on 6 November. Eighty-nine centers have joined so far, 65 centers are currently active, those who have already obtained the approval of their own ethics committee, and 1,099 patients were enrolled at the end of June 2013. The independence of the registry, the consecutiveness of the patient enrolment, and the monitoring of the study are characteristics of this registry that will contribute to the scientific validity of the objectives to be achieved.