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临时性下腔静脉滤器:我们该如何前行?

Temporary Inferior Vena Cava Filters: How Do We Move Forward?

作者信息

Arous Edward J, Messina Louis M

机构信息

Division of Vascular and Endovascular Surgery, University of Massachusetts Medical School, Worcester, MA.

Diabetes Center of Excellence and Division of Vascular and Endovascular Surgery, University of Massachusetts Medical School, Worcester, MA.

出版信息

Chest. 2016 May;149(5):1143-5. doi: 10.1016/j.chest.2016.03.015. Epub 2016 Mar 21.

Abstract

Despite their widespread use, the indications for the selective use of temporary inferior vena cava (IVC) filters remains uncertain with few trials supporting their use. Additionally, the risks of long-term temporary IVC filter insertion are being increasingly discussed amongst the mainstream media and through multiple class action lawsuits. Retrievable IVC filters were specifically designed to have a less secure implantation in order to facilitate retrieval. However, multiple reports have demonstrated significant filter-related complications, most commonly related to duration of implantation. Furthermore, the risk is not isolated to one manufacturer alone. The incidence of filter-related complications is linearly related to its duration of time on the market. Currently, the FDA recommends that IVC filters be removed within 25-54 days of their implantation. Unfortunately, little evidence exists to show that this recommendation is followed routinely. Recently, the PRESERVE Trial (NCT02381509) was initiated as a multicenter non-randomized open label study to determine the safety and effectiveness of commercially available IVC filters (both temporary and permanent) in individuals who require mechanical prophylaxis against pulmonary embolism. Until such evidence is developed, temporary IVC filters should be implanted based on best available evidence and routinely removed within the guidelines of the FDA of 25-54 days. A fair question at this point is whether the design features themselves that are required to manufacture a low profile removable IVC filter can achieve effective prophylaxis against pulmonary embolism at a low rate of short and long-term complications.

摘要

尽管临时下腔静脉(IVC)滤器被广泛使用,但其选择性使用的指征仍不明确,仅有少数试验支持其应用。此外,主流媒体以及多起集体诉讼越来越多地讨论了长期植入临时IVC滤器的风险。可回收IVC滤器专门设计为植入固定性较低,以便于取出。然而,多项报告显示了与滤器相关的严重并发症,最常见的与植入持续时间有关。此外,这种风险并非仅局限于某一个制造商。与滤器相关并发症的发生率与其上市时间呈线性相关。目前,美国食品药品监督管理局(FDA)建议在植入IVC滤器后的25 - 54天内将其取出。不幸的是,几乎没有证据表明这一建议得到了常规遵循。最近,PRESERVE试验(NCT02381509)启动,作为一项多中心非随机开放标签研究,以确定市售IVC滤器(临时和永久性)在需要机械预防肺栓塞的个体中的安全性和有效性。在得出此类证据之前,应根据现有最佳证据植入临时IVC滤器,并在FDA规定的25 - 54天指南内常规取出。此时一个合理的问题是,制造低轮廓可回收IVC滤器所需的设计特征本身能否在低短期和长期并发症发生率的情况下有效预防肺栓塞。

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