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移植血管和血管内移植物分析:我们的立场是什么,我们应该怎么做?

Explanted Vascular and Endovascular Graft Analysis: Where Do We Stand and What Should We Do?

机构信息

Groupe Européen de Recherche sur les Prothèses appliquées à la Chirurgie Vasculaire (GEPROVAS), Strasbourg, France; Department of Vascular Surgery and Kidney Transplantation, University of Strasbourg, Strasbourg, France.

Division of Vascular Surgery, Department of Surgery, Stanford University, Stanford, CA, USA.

出版信息

Eur J Vasc Endovasc Surg. 2018 Apr;55(4):567-576. doi: 10.1016/j.ejvs.2018.01.022. Epub 2018 Feb 23.

Abstract

OBJECTIVE/BACKGROUND: Since the late 1950s, major advances in vascular surgical practice have been closely associated with the introduction of novel vascular implants. These devices have been constructed from a variety of materials and have been designed to be implanted in several different ways. Despite a rigorous regulatory process, regular failures continue to be observed. A systematic review of the literature and of the Geprovas registry was performed in order to improve understanding of the failures.

METHODS

A systematic review was performed via a search of the MEDLINE and Embase databases. Full text, English, German, or French language studies without any chronological limit were included. The reference lists of included studies, as well as the first 20 related items, were scanned for other potentially relevant studies.

RESULTS

Data extraction allowed the evaluation of 184 publications; 72 publications met the inclusion criteria. Only 12 publications reported sufficient data for structural, histopathological, and epidemiological analysis. However, explant analysis allowed the understanding of degenerative phenomena: "warp knitted" replaced "weft knitted" polyethylene terephthalate grafts, decreasing the risk of dilatation or rupture; inter-nodal distance was modified in order to improve polytetrafluoroethylene graft incorporation capacities; and index of saturation, endograft fabric/stent interactions, and stent fatigue phenomena have been extensively studied in an attempt to improve endovascular device durability.

CONCLUSION

A general lack of depth of reporting of explants remains. Dedicated systematic explant analysis programs are the key to improving the performance of future generations of devices.

摘要

目的/背景:自 20 世纪 50 年代末以来,血管外科学实践的重大进展与新型血管植入物的引入密切相关。这些设备由各种材料制成,并设计为以多种不同方式植入。尽管经过严格的监管程序,但仍不断观察到设备的常规故障。为了更好地了解故障,对文献和 Geprovas 登记处进行了系统回顾。

方法

通过对 MEDLINE 和 Embase 数据库进行检索,进行了系统回顾。纳入了没有时间限制的全文、英文、德文或法文的研究。纳入研究的参考文献列表以及前 20 个相关项也被扫描,以寻找其他可能相关的研究。

结果

数据提取允许评估 184 篇出版物;72 篇出版物符合纳入标准。只有 12 篇出版物报告了足够的数据进行结构、组织病理学和流行病学分析。然而,通过对植入物的分析,可以了解退行性病变:“经编”取代“纬编”聚对苯二甲酸乙二醇酯移植物,降低扩张或破裂的风险;节点间距离被修改,以提高聚四氟乙烯移植物的结合能力;并广泛研究了饱和度指数、血管内移植物的织物/支架相互作用以及支架疲劳现象,以提高血管内设备的耐用性。

结论

植入物的报告深度普遍不足。专门的系统植入物分析程序是提高下一代设备性能的关键。

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