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冠状动脉栓塞保护装置的并发症和失效模式:来自 MAUDE 数据库的见解。

Complications and failure modes of coronary embolic protection devices: Insights from the MAUDE database.

机构信息

Division of Cardiology, Banner University Medical Center/University of Arizona, Phoenix, Arizona, USA.

Division of Cardiology, Florida Atlantic University, Boca Raton, Florida, USA.

出版信息

Catheter Cardiovasc Interv. 2022 Feb;99(2):405-410. doi: 10.1002/ccd.29717. Epub 2021 Apr 20.

DOI:10.1002/ccd.29717
PMID:33876860
Abstract

BACKGROUND

There is limited data on complications associated with the use of coronary embolic protection devices (EPDs).

METHODS

We queried the Manufacturer and User Facility Device Experience database between November 2010 and November 2020 for reports on coronary EPDs: Spider FX (Medtronic, Minneapolis, MN) and Filterwire EZ (Boston Scientific, Natick, MA).

RESULTS

We retrieved 119 reports on coronary EPD failure (Spider FX n = 33 and Filterwire EZ n = 86), most of which (78.2%) occurred during saphenous vein graft interventions. The most common failure mode was inability to retrieve the EPD (49.6%), with the filter trapped against stent struts in 76.2% of the cases. Other device complications included filter fracture (28.6%), failure to cross (7.6%), failure to deploy (7.6%), and failure to recapture the filter (3.4%). Filter fracture (54.5 vs. 29.1%) and failure to recapture (9.1 vs. 2.1%) were more commonly reported, while failure to deploy the filter (0 vs. 10.5%) was less commonly reported with the Spider-FX.

CONCLUSIONS

The most common modes of failure of coronary EPDs are the failure of retrieval (49.6%), followed by the filter fracture (28.6%). When using EPDs, careful attention to the technique is essential to avoid failures and subsequent complications.

摘要

背景

关于使用冠状动脉栓塞保护装置(EPD)相关并发症的数据有限。

方法

我们在 2010 年 11 月至 2020 年 11 月期间查询了制造商和用户设施设备使用经验数据库,以获取关于冠状动脉 EPD 的报告:Spider FX(美敦力,明尼苏达州明尼阿波利斯)和 Filterwire EZ(波士顿科学,马萨诸塞州纳提克)。

结果

我们检索到 119 份冠状动脉 EPD 故障报告(Spider FX n=33,Filterwire EZ n=86),其中大部分(78.2%)发生在隐静脉桥血管介入术中。最常见的故障模式是无法取回 EPD(49.6%),其中 76.2%的情况下过滤器卡在支架支柱上。其他设备并发症包括过滤器断裂(28.6%)、无法通过(7.6%)、无法展开(7.6%)和无法重新捕获过滤器(3.4%)。Spider-FX 中更常报告过滤器断裂(54.5%比 29.1%)和无法重新捕获(9.1%比 2.1%),而无法展开过滤器(0%比 10.5%)的情况较少。

结论

冠状动脉 EPD 最常见的故障模式是无法取回(49.6%),其次是过滤器断裂(28.6%)。在使用 EPD 时,必须仔细注意技术,以避免故障和随后的并发症。

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Catheter Cardiovasc Interv. 2022 Feb;99(2):405-410. doi: 10.1002/ccd.29717. Epub 2021 Apr 20.
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