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临床试验/NCT04306575
NCT04306575Unknown不适用

Challenges and Complications of a Stepwise Approach for Transvenous Lead Extraction, Single High-Volume Center Study

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Procedural related major complications

研究概览

简要总结

It is an observational study of predictors of complications and difficulty of trans-venous lead extraction procedure. This procedure is done for patient who had a previous cardiac pacemaker or defibrillator implantation which had a dysfunction or infection so needed to be extracted.

详细描述

The number of cardiac implantable electronic device (CIED) implantations has increased over recent years (1) with approximately 1.2-1.4 million CIEDs are being implanted annually worldwide.(2) Consequently this has been associated with increasing rates of infection and lead malfunctions, affecting approximately 1-2% of all CIED cases.(3)

Recently, it is estimated that between 10 000 and 15 000 leads are extracted worldwide each year.(4) Over the past few decades, transvenous lead extraction (TLE) has evolved as the preferred method for leads removal being less invasive compared to surgical removal by open heart surgery which is now reserved for cases with high risk procedures or a very large vegetation.

Most frequent indications for TLE are infection (accounting for 52.8%) and lead dysfunction (accounting for 38.1%) of all cases of TLE. (5)

There have been different approaches (superior and inferior approaches) and techniques for TLE. Current techniques employ mechanical and/or laser equipment with variable success rates. The locking stylet has been the principal tool in these techniques, while the telescoping (powered or non-powered) mechanical or laser sheaths serve as the most important ancillary tools.

Despite being a safe procedure with minor complications ranging from 0.06 to 6.2%, but serious complications may still arise in 0.2-1.8 % of cases in even the most experienced hands with mortality rates in several large registries amounting 0.2 - 1.2 %.(6) Although many studies have tried to identify risk factors for complications including patient/lead profile and centre/operator experience, major studies still have conflicting results.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •All consecutive patients referred for lead extraction with class I and IIa indications according to 2017 HRS expert consensus statement on CIED lead management and extraction.

排除标准

  • •Patients primarily requiring surgical extraction

结局指标

主要结局

Procedural related major complications

时间窗: one year

Complications includes pericardial effusion/tamponade, arrhythmia, hypotension, pulmonary embolism and death

次要结局

  • Clinical and radiological success(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Aboelhassan Abdelrady Mohamed

Assistant lecturer

Assiut University

研究点 (1)

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