Erosion by the Amplatzer Septal Occluder: Experienced Operator Opinions at Odds With Manufacturer Recommendations?
Erosion by the Amplatzer Septal Occluder: Experienced Operator Opinions at Odds With Manufacturer Recommendations?
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DOI：
10.1002/ccd.21931
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发表时间：
2009-06-01
影响因子：
2.3
通讯作者：
Moore, John W.
中科院分区：
文献类型：
--
作者：
El-Said, Howaida G.;Moore, John W.
背景：装置侵蚀是 Amplatzer 房间隔封堵器 (ASO) 封堵 ASD 的一种非常罕见但可能致命的并发症。在审查了装置侵蚀案例后，一小群“专家”对 ASD 尺寸和装置选择的建议进行了修订，并于 2004 年被装置制造商采纳。这些修订建议使用不跨主动脉的较小装置，但仍然存在争议。目的：我们研究的目的是帮助就侵蚀的原因和预防策略达成广泛的专家共识。方法：我们报告了一个设备侵蚀案例，其中仔细遵循了 2004 年的修订；对先天性心血管介入研究联盟 (CCISC) 成员进行的一项调查，征求有关装置侵蚀的经验和意见。结果：在我们的案例中，装置盘似乎突出到主动脉根部，但没有跨过，并且具有独立于心脏运动的运动。 57 名调查受访者总共经历了 12,006 次 ASO 植入，其中 12 名成员报告了 3,010 次植入中的 14 次侵蚀。百分之九十的糜烂发生在主动脉边缘缺损的患者中。在 53 名患者中，有 38 名 (71.7%) 回答说，尺寸过小的且不跨过主动脉的装置发生侵蚀的风险最高。在 52 名患者中，44 名 (84%) 回应称装置相对于心脏的运动可能会导致侵蚀。结论：调查结果和我们的单个案例经验都表明，运营商的意见（或许还有设备尺寸调整实践）与 2004 年的修订不一致。需要进一步研究和关注这个问题。 (C) 2009 Wiley-Liss, Inc.
Background: Device erosion is a very rare but potentially fatal complication of ASD occlusion by the Amplatzer Septal Occluder (ASO). After reviewing cases of device erosion, recommendations for ASD sizing and device selection were revised by a small group of "experts" and adopted by the device manufacturer in 2004. These revisions, which recommend use of smaller devices, which do not straddle the aorta, remain controversial. Objective: The aim of our study is to help define an expanded expert consensus with respect to the causes and preventive strategies for erosions. Methods: We report a case of device erosion in which the 2004 revisions were carefully followed; and a survey of the members of the Congenital Cardiovascular Interventional Study Consortium (CCISC) soliciting experiences with and opinions about device erosion. Results: In our case, the device disk appeared to protrude into the aortic root but not straddle, and had motion independent of cardiac movement. Of 57 survey responders having a total experience of 12,006 ASO implants, 12 members reported 14 erosions among 3,010 implants. Ninety percent of erosions occurred in patients with deficit aortic rim. Of 53 patients, 38 (71.7%) responded that devices, which are undersized and do not straddle the aorta are at highest risk of erosion. Of 52 patients, 44 (84%) responded that motion of the device relative to the heart may cause erosion. Conclusion: Both the survey results and our single case experience suggest that operator opinions (and perhaps also device sizing practices) are at odds with the 2004 revisions. Further study and focus on this issue is needed. (C) 2009 Wiley-Liss, Inc.