PEDIATRIC AND CONGENITAL HEART DISEASE Original Studies Percutaneous Atrial Septal Occluder Devices and Cardiac Erosion: A Review of the Literature

PEDIATRIC AND CONGENITAL HEART DISEASE Original Studies Percutaneous Atrial Septal Occluder Devices and Cardiac Erosion: A Review of the Literature
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小儿和先天性心脏病原创研究经皮房间隔封堵器装置和心脏糜烂:文献综述

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发表时间:
2012
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通讯作者:
John D. Carroll
John D. Carroll
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作者:
Geoffrey B. Crawford;R. Brindis;Mitchell W. Krucoff;Benjamin P. Mansalis;John D. Carroll

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目的:系统回顾文献中与房间隔缺损 (ASD) 封堵器相关的所有糜烂病例。背景:主动脉或心房壁的延迟侵蚀是使用 ASD 装置经皮间隔缺损封堵术的一种罕见但可能致命的并发症。人们对流行病学知之甚少。方法:在 MEDLINE 数据库中搜索 ASD 封堵器相关侵蚀的病例。结果:25 篇文章介绍了与 AMPLATZER 鼻中隔封堵器 (ASO) 装置相关的糜烂事件(2002 年 3 月至 2011 年 6 月),记录了 21 例独立的手术确诊病例。案例系列和评论文章中报道了另外 79 起不同的事件。在所有已确定的独立病例中,有 73 例发生在美国。没有文章将 HELEX 中隔封堵器与糜烂联系起来。报告了与 FDA 未经批准的经皮缺损闭合装置相关的其他事件 (n 5 16)。 ASO 侵蚀发生率的估计不可靠,因为分子(侵蚀事件数量)和分母(植入装置的患者数量)未知;估计范围为 0.1% 至 0.3%。结论:心脏糜烂是 ASO 装置罕见但严重的并发症。侵蚀事件最常归因于装置尺寸过大或主动脉后边缘缺陷;然而,缺乏令人信服的风险因素的共识和证据。需要进一步评估侵蚀的根本原因以及该并发症的真实发生率;使用对照患者和/或设备注册建立进行的分析代表了合乎逻辑的后续步骤。 VC 2012 Wiley 期刊公司
Objective: To systematically review all cases in the literature of erosion associated with Atrial Septal Defect (ASD) occluder devices. Background: Delayed erosion of the aortic or atrial wall is an infrequent but potentially lethal complication of percutaneous septal defect closure using an ASD device. The epidemiology is poorly understood. Methods: The MEDLINE database was searched for cases of ASD occluder deviceassociated erosion. Results: Twenty-five articles present erosion events associated with the AMPLATZER Septal Occluder (ASO) device (March 2002–June 2011), documenting 21 independent, surgically confirmed cases. Another 79 distinct events are reported in case series and review articles. Of all identified independent cases, 73 were reported in the United States. No articles associate the HELEX Septal occluder and erosions. Additional events are reported in association with FDA-unapproved percutaneous defect closure devices (n 5 16). Estimation of ASO erosion incidence is unreliable because the numerator (number of erosion events) and denominator (number of patients with an implanted device) are unknown; estimates range from 0.1 to 0.3%. Conclusion: Cardiac erosion is a rare but serious complication of the ASO device. Erosion events are most often ascribed to device over-sizing or deficient retro-aortic rims; however, both consensus and evidence for a cogent risk factor(s) is lacking. Further assessment of the root cause of erosion and true incidence of this complication is required; analyses using control patients and/or device registry establishment represent logical next steps. VC 2012 Wiley Periodicals, Inc.