Department of Vascular Surgery, University Medical Center Utrecht, Room G04.129, PO Box 85500, 3508 GA, Utrecht, The Netherlands.
Department of Robotics and Mechatronics (EEMCS), University of Twente, PO Box 217, Enschede, The Netherlands.
Cardiovasc Intervent Radiol. 2020 Oct;43(10):1430-1437. doi: 10.1007/s00270-020-02499-1. Epub 2020 May 14.
Carotid stent (CS) characteristics, such as radial force, scaffolding and flexibility, are continuously modified by stent manufacturers aiming to improve stent performance. Since manufacturers' definitions and assessment methods are not disclosed, it is unknown how characteristics of different CSs relate to each other or to published literature. We examined in vitro methodological techniques used to measure CS characteristics and assessed comparability between published papers and outcomes as provided by the manufacturers.
A systematic review was conducted in MEDLINE, Embase, Cochrane, and Scopus databases. Studies reporting on in vitro investigations of predefined characteristics of CS used in current everyday clinical practice were included. The predefined characteristics were radial force, scaffolding, flexibility, foreshortening, side-branch preservation and visibility. Eight manufacturers of 10 currently used CS were contacted and data on the predefined device characteristics was requested.
12 published articles were included and six stent manufacturers provided data on six stents (two refused to share data). Used methodologies to measure stent characteristics in published literature and manufacturer data varied greatly for all included characteristics except foreshortening. The number of different units of measurement to express outcomes ranged from two for foreshortening to six for radial force.
A variety of methodologies and outcome measures is used to quantify CS characteristics, which hampers comparisons between published studies and manufacturer data. Future studies are encouraged to synchronize methodologies and outcome measures. Manufacturers are encouraged up to increase transparency of applied testing methodologies and outcomes.
颈动脉支架（CS）的特性，如径向力、支架结构和柔韧性，不断被支架制造商修改，旨在提高支架性能。由于制造商的定义和评估方法并未公开，因此我们并不清楚不同 CS 的特性之间如何相互关联，或者与已发表的文献有何关联。我们研究了体外测量 CS 特性的方法学技术，并评估了已发表文献和制造商提供的结果之间的可比性。
在 MEDLINE、Embase、Cochrane 和 Scopus 数据库中进行了系统评价。纳入了报告目前日常临床实践中使用的 CS 预先定义特性的体外研究。预先定义的特性包括径向力、支架结构、柔韧性、缩短、分支侧支保存和可视性。联系了 10 个目前使用的 CS 的 8 个制造商，并要求提供有关预先定义设备特性的数据。
纳入了 12 篇已发表的文章，其中 6 家支架制造商提供了 6 个支架的数据（2 家拒绝提供数据）。在已发表文献和制造商数据中，用于测量支架特性的方法学差异很大，除了缩短外，所有纳入的特性均如此。表达结果的不同测量单位数量从缩短的两个到径向力的六个不等。
用于量化 CS 特性的方法学和结果测量指标多种多样，这阻碍了已发表研究和制造商数据之间的比较。鼓励未来的研究协调方法学和结果测量指标。鼓励制造商提高测试方法学和结果的透明度。
