Abstract
The great success of stents in treating cardiovascular disease is actually undermined by their long-term fatigue failure. The high variability of stent failure incidence suggests that it is due to several correlated aspects, such as loading conditions, material properties, component design, surgical procedure, and patient functional anatomy. Numerical and experimental non-clinical assessments are included in the recommendations and requirements of several regulatory bodies and they are thus exploited in the analysis of stent fatigue performance. Optimization-based simulation methodologies have been developed as well, to improve the fatigue endurance of novel designs. This paper presents a review on the fatigue issue in metallic stents, starting from a description of clinical evidence about stent fracture up to the analysis of computational approaches available from the literature. The reported discussion on both the experimental and numerical framework aims at providing a general insight into stent lifetime prediction as well as at understanding the factors which affect stent fatigue performance for the design of novel components.
Highlights
Stents are medical devices used to restore the lumen patency of stenotic arteries, i.e., arteries narrowed by atherosclerosis, a degenerative disease of the vessel wall
Stent failure can be caused by the mechanical loading, either monotonic or cyclic loading during deployment or service, respectively
Other factors can contribute to stent failure, such as material properties, stent design, physiological environment, surgical procedure, patient functional anatomy and lifestyle.[67]
Summary
Stents are medical devices used to restore the lumen patency of stenotic arteries, i.e., arteries narrowed by atherosclerosis, a degenerative disease of the vessel wall. As an example, accelerated pulsatile testing at 65 Hz takes about 72 days to complete 4 9 108 cycles.[53] computer-based design modeling represents an assessment tool for the prediction of stent performance and lifetime.[25,47] Such a tool allows for the improvement of Both clinical procedures and stent design and it is accepted by regulatory bodies.[45,84]. The present paper aims at providing an overview on the fatigue issue in metallic stents manufactured from stainless steel, cobalt chromium, and Nitinol-based shape memory alloys The paper covers both the clinical evidence of stent fractures and the computational design approaches for lifetime assessment. The goal of the work is to resume and to critically discuss the existing framework available from the literature and to open up new questions and future perspectives for the optimization of stent design, materials, and clinical procedures
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