Minneapolis Heart Institute Foundation, 920 East 28th Street, Suite 300, Minneapolis, MN 55407, USA.
Europace. 2010 Mar;12(3):395-401. doi: 10.1093/europace/eup375. Epub 2009 Nov 27.
An estimated 10,000-15,000 pacemaker and implantable cardioverter-defibrillator (ICD) leads are extracted annually worldwide using specialized tools that disrupt encapsulating fibrous tissue. Additional information is needed regarding the safety of the devices that have been approved for lead extraction. The aim of this study was to determine whether complications due to device-assisted lead extraction might be more hazardous than published data suggest, and whether procedural safety precautions are effective.
We searched the US Food and Drug Administration's (FDA) Manufacturers and User Defined Experience (MAUDE) database from 1995 to 2008 using the search terms 'lead extraction and death' and 'lead extraction and injury'. Additional product specific searches were performed for the terms 'death' and 'injury'. Between 1995 and 2008, 57 deaths and 48 serious cardiovascular injuries associated with device-assisted lead extraction were reported to the FDA. Owing to underreporting, the FDA database does not contain all adverse events that occurred during this period. Of the 105 events, 27 deaths and 13 injuries occurred in 2007-2008. During these 2 years, 23 deaths were linked with excimer laser or mechanical dilator sheath extractions. The majority of deaths and injuries involved ICD leads, and most were caused by lacerations of the right atrium, superior vena cava, or innominate vein. Overall, 62 patients underwent emergency surgical repair of myocardial perforations and venous lacerations and 35 (56%) survived.
These findings suggest that device-assisted lead extraction is a high-risk procedure and that serious complications including death may not be mitigated by emergency surgery. However, skilled standby cardiothoracic surgery is essential when performing pacemaker and ICD lead extractions. Although the incidence of these complications is unknown, the results of our study imply that device-assisted lead extractions should be performed by highly qualified physicians and their teams in specialized centres.
据估计，全世界每年使用专门工具提取 10000-15000 根起搏器和植入式心脏复律除颤器（ICD）导线，这些工具会破坏包裹的纤维组织。需要更多关于已批准用于导线提取的设备安全性的信息。本研究旨在确定由于设备辅助的导线提取而导致的并发症是否比已发表的数据所表明的更为危险，以及程序安全预防措施是否有效。
我们使用搜索词“导线提取和死亡”和“导线提取和损伤”，从 1995 年到 2008 年，在美国食品和药物管理局（FDA）的制造商和用户定义的经验（MAUDE）数据库中进行了搜索。对于术语“死亡”和“损伤”，还进行了额外的产品特定搜索。在 1995 年至 2008 年期间，FDA 共报告了 57 例与设备辅助的导线提取相关的死亡和 48 例严重心血管损伤事件。由于报告不足，FDA 数据库并未包含在此期间发生的所有不良事件。在 105 例事件中，27 例死亡和 13 例损伤发生在 2007-2008 年。在这两年中，有 23 例死亡与准分子激光或机械扩张鞘提取有关。大多数死亡和损伤涉及 ICD 导线，且大部分是由于右心房、上腔静脉或无名静脉的撕裂引起的。总体而言，有 62 例患者接受了心肌穿孔和静脉撕裂的紧急外科修复，其中 35 例（56%）存活。
这些发现表明，设备辅助的导线提取是一种高风险的程序，即使进行紧急手术，严重并发症包括死亡也可能无法得到缓解。然而，在进行起搏器和 ICD 导线提取时，熟练的备用心胸外科医生待命是必不可少的。尽管这些并发症的发生率尚不清楚，但我们的研究结果表明，设备辅助的导线提取应由高素质的医生及其团队在专门中心进行。
