Stent induced hemodynamic changes in the coronary arteries are associated with higher risk of adverse clinical outcome. The purpose of this study was to evaluate the impact of stent design on wall shear stress (WSS), time average WSS, and WSS gradient (WSSG), in idealized stent geometries using computational fluid dynamics. Strut spacing, thickness, luminal protrusion, and malapposition were systematically investigated and a comparison made between two commercially available stents (Omega and Biomatrix). Narrower strut spacing led to larger areas of adverse low WSS and high WSSG but these effects were mitigated when strut size was reduced, particularly for WSSG. Local hemodynamics worsened with luminal protrusion of the stent and with stent malapposition, adverse high WSS and WSSG were identified around peak flow and throughout the cardiac cycle respectively. For the Biomatrix stent, the adverse effect of thicker struts was mitigated by greater strut spacing, radial cell offset and flow-aligned struts. In conclusion, adverse hemodynamic effects of specific design features (such as strut size and narrow spacing) can be mitigated when combined with other hemodynamically beneficial design features but increased luminal protrusion can worsen the stent’s hemodynamic profile significantly.

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A computational atlas of normal coronary artery anatomy provides distributions of diameter, lengths and bifurcation angles as well as more complex shape analysis. These data define normal anatomical variation, facilitating stent design, selection and optimal treatment strategy. These population models are necessary for accurate computational flow dynamics, can be 3D printed for bench testing bifurcation stents and deployment strategies, and can aid in the discussion of different approaches to the treatment of coronary bifurcations.

This is a consensus document from the European Bifurcation Club concerning bench testing in coronary artery bifurcations. It is intended to provide guidelines for bench assessment of stents and other strategies in coronary bifurcation treatment where the United States Food and Drug Administration (FDA) or International Organization for Standardization (ISO) guidelines are limited or absent. These recommendations provide guidelines rather than a step-by-step manual. We provide data on the anatomy of bifurcations and elastic response of coronary arteries to aid model construction. We discuss testing apparatus, bench testing endpoints and bifurcation nomenclature.

Implanting stents is the most efficient and minimally invasive technique for treating coronary artery diseases, but the risks of stent thrombosis (ST) and in-stent restenosis (IRS) hamper the healing process. There have been a variety of stents in market but dominated by ad hoc design motifs. A systematic design method that can enhance deliverability, safety and efficacy is still in demand. Most existing designs are focused on patient and biological factors, while the mechanical failures related to stenting architectures, e.g., inadequate stent expansion, stent fracture, stent malapposition and foreshortening, are often underestimated. With regard to these issues, the selfexpanding (SE) stents may perform better than balloon-expandable (BE) stents, but the SE stents are not popular in clinic practice due to poor deliverability, placement accuracy, and precise match of the stent size and shape to the vessel. This paper addresses the importance between stent structures and clinic outcomes in the treatment of coronary artery disease. First, a concurrent topological optimization method will be developed to systematically find the best material distribution within the design domain. An extended parametric level set method with shell elements is proposed in the topology optimization to ensure the accuracy and efficiency of computations. Second, the auxetic metamaterial with negative Poisson's ratio is introduced into the self-expanding stents. Auxetics can enhance mechanical properties of structures, e.g., fracture toughness, indentation and shear resistance and vibration energy absorption, which will help resolve the drawbacks due to the mechanical failures. Final, the optimized SE stent is numerically validated with the commercial software ANSYS and then prototyped using additive manufacturing techniques. Topological optimization gives a rare opportunity to exploiting the unique advantages of additive manufacturing. Hence, the topologically optimized auxetic architectures will provide a new solution for developing novel stenting structures, especially conductive to self-expanding SE stents. The new design will overcome the limitations of conventional SE stents associated with mechanical structures while maintain their valuable features, to help reduce the occurrence of ST and ISR and benefit the clinic practice in treating coronary heart disease.