(In)comparability of Carotid Artery Stent Characteristics: A Systematic Review on Assessment and Comparison with Manufacturer Data

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.