(In)comparability of Carotid Artery Stent Characteristics: A Systematic Review on Assessment and Comparison with Manufac
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REVIEW
ARTERIAL INTERVENTIONS
(In)comparability of Carotid Artery Stent Characteristics: A Systematic Review on Assessment and Comparison with Manufacturer Data Evelien E. de Vries1 • Mert Ko¨k1 • Astrid M. Hoving1,2 • Cornelis H. Slump2 Raechel J. Toorop1 • Gert J. de Borst1
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Received: 5 January 2020 / Accepted: 17 April 2020 The Author(s) 2020
Abstract Purpose 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. Methods 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.
Results 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. Conclusion 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.
Evelien E. de Vries and Mert Ko¨k have contributed equally.
Introduction
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00270-020-02499-1) contains supplementary material, which is available to authorized users.
Carotid artery stenting is a minimally invasive alternative to carotid endarterectomy for treatment of significant carotid artery stenosis. However, as the 30-day (minor) stroke rate as well as the rate of subclinical ischemic events is currently to the detriment of carotid stenting, this treatment is reserved for the patients at deemed high surgical risk [1]. Since the majority of 30-day strokes occur on the day of the procedure [2], it is likely that short-term outcomes of carotid stenting can be improved by improving the procedural aspects, including the stent, itself.
& Gert J. de Borst [email protected] 1
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