Commentary on the Article "(In)comparability of Carotid Artery Stent Characteristics: A Systematic Review on Assessment
- PDF / 174,506 Bytes
- 2 Pages / 595.276 x 790.866 pts Page_size
- 87 Downloads / 188 Views
COMMENTARY
COMMENTARY
Commentary on the Article ‘‘(In)comparability of Carotid Artery Stent Characteristics: A Systematic Review on Assessment and Comparison with Manufacturer Data’’ Stefan Mu¨ller-Hu¨lsbeck1
Received: 20 May 2020 / Accepted: 28 May 2020 Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2020
First of all, one has to congratulate the authors for their approach comparing carotid artery stent characteristics based on the literature research and provided the manufacturer’s information in an un-biased and neutral manner [1]. The reader’s first impression might be clouded by the lack of any break-through results, but this lack is the result itself. Sufficient and comparable data on carotid stents currently in use are not available! The lack of such data illustrates the author’s main message—the lack of data, or data being far too heterogeneous to provide and any quantitative comparisons are hampered by the differing testing methods [2]. As stated by the authors, and confirmed with their article, there is a strong need to homogenize testing technologies and define clear and transparent reporting standards on carotid stent properties, meaning companies should be obliged to describe their product according to globally standardized reporting forms, such as EUDAMED (European database on medical devices). Before these requirements on standardized reporting are fulfilled, a universal definition for stent characteristics, such as scaffolding, is also required. The technical term scaffolding reflects a kind of marketing wording introduced by medical product companies to simply rate the stent as good and perhaps even better than a potential competitor. There should be a clear and accepted definition of what that term really means: open or closed cell stent design refers to scaffolding properties of the stent, as it relates to the free
& Stefan Mu¨ller-Hu¨lsbeck [email protected] 1
Department of Diagnostic and Interventional Radiology / Neuroradiology, Academic Hospitals Flensburg, Flensburg, Germany
cell area of the strut (smaller free cell area result in greater wall coverage [3]). In order to compare scaffolding properties of a stent, exact data of the free cell area and the resulting vessel wall coverage needs to be provided. However, good scaffolding properties currently used to present the stent in a positive light don’t give any information on this. This information is at the moment relevant with respect to the discussion about potential advantages and disadvantages of so-called micromesh or dual-layer stents. In order to take into account all device characteristics, as part of the condition for a technical successful procedure, the system of delivery and the crossing profile also need to be taken into account, as there is roughly a 30% difference when comparing 6F and 5F crossing profile of the stent delivery system, which might have a certain impact. As we know, the clinical outcome of carotid artery stentin
Data Loading...
