Longitudinal Stent Deformation in Undeployed Stents: A Case Series

Longitudinal stent deformation (LSD) is a recently reported problem with newer generation stents. The modification of stent materials and designs to make them more deliverable and conformable, as well as a focused approach in retaining their radial strength, has compromised longitudinal strength in currently available stents. Additionally, enhanced stent radiopacity, improved fluoroscopy, and heightened awareness have led to an increased incidence rate of the potentially under-recognized problem of LSD. Although originally described in deployed stents, LSD is being recognized in undeployed stents too. With available data to suggest an increased rate of adverse cardiac events like stent thrombosis and in-stent restenosis with LSD in deployed stents, an attempt to retrieve an undeployed deformed stent appears justified. We report 3 cases of LSD in undeployed stents and discuss its recognition. We also discuss the retrieval and visual inspection of retrieved stents and the simultaneous completion of coronary interventions via a double guide technique.

Efficient computational modelling of smooth muscle orientation and function in the aorta

Understanding the mechanical effects of smooth muscle cell (SMC) contraction on the initiation and the propagation of cardiovascular diseases such as aortic dissection is critical. Framed by elastic lamellar sheets in the lamellar unit, there are SMCs in the media with a distinct radial tilt, which indicates their contribution to the radial strength. However, the mechanical effects of this type of anisotropy have not been fully discussed. Therefore, in this study, we propose a constitutive framework that models the passive and active mechanics of the aorta, taking into account the dispersed nature of the aortic constituents by applying the discrete fibre dispersion method. We suggest an isoparametric approach by evaluating various numerical integration methods and introducing a non-uniform discretization of the unit hemisphere to increase its computational efficiency. Finally, the constitutive parameters are fitted to layer-specific experimental data and initial computational results are briefly presented. The radial tilt of SMCs is also analysed, which has a noticeable influence on the mechanical behaviour of the aorta. In the absence of sufficient experimental data, the results indicate that the active contribution of SMCs has a remarkable impact on the mechanics of the healthy aorta.

PDLLA-Zn-nitrided Fe bioresorbable scaffold with 53-μm-thick metallic struts and tunable multistage biodegradation function

Balancing the biodegradability and mechanical integrity of a bioresorbable scaffold (BRS) with time after implantation to match the remodeling of the scaffolded blood vessel is important, but a key challenge in doing so remains. This study presents a novel intercalated structure of a metallic BRS by introducing a nanoscale Zn sacrificial layer between the nitrided Fe platform and the sirolimus-carrying poly(d,l-lactide) drug coating. The PDLLA-Zn-FeN BRS shows a multistage biodegradation behavior, maintaining mechanical integrity at the initial stage and exhibiting accelerated biodegradation at the subsequent stage in both rabbit abdominal aortas and human coronary arteries, where complete biodegradation was observed about 2 years after implantation. The presence of the nanoscale Zn sacrificial layer with an adjustable thickness also contributes to the tunable biodegradation of BRS and allows the reduction of the metallic strut thickness to 53 μm, with radial strength as strong as that of the current permanent drug-eluting stents.

Design and Shape Optimization of a Biodegradable Polymeric Stent for Curved Arteries Using FEM

Stent treatment has revealed safe and efficient outcomes for straight arteries, while it is still challenging for curved coronary arteries. On the one hand, a stent should be flexible enough to take the artery’s curvature with the least stress to the artery wall. On the other hand, it has to be strong enough to prevent any artery diameter reduction after the implant. In this work, the genetic algorithm multi-objective optimization method is exploited to provide a Pareto set and to design a curvature stent. The design has been performed based on the appropriate flexibility and radial strength design, depending on the characteristics of a particular case study. In the optimization procedure, flexibility and radial strength have been evaluated based on ASTM standard mechanical tests. These tests have been parametrically simulated using the finite element method. The strut curvature is formed by the spline curvature, whose middle point coordinates are two of the optimization variables. The other optimization variable is the thickness of the stent. Based on the Pareto set achieved from the optimization, five different stent designs have been proposed. In these designs, the middle part of the stent is stiffer (in the plaque aggregated) and benefits more radial strength rather than flexibility. At the stent’s extremes, where more deformation takes place, flexibility is weighted more than radial strength. These five design sets differ in their objective weight ratios. At the end of this research, their implementation in a curved vessel is simulated in ABAQUS/CAE, and von Mises stress distribution, maximum von Mises stress, and stent recoil after imposing the stent have been analyzed. The obtained Pareto front can also be a useful guide for physicians to design and manufacture customized stents for each patient.

Computational and experimental mechanical performance of a new everolimus-eluting stent purpose-built for left main interventions

Left main (LM) coronary artery bifurcation stenting is a challenging topic due to the distinct anatomy and wall structure of LM. In this work, we investigated computationally and experimentally the mechanical performance of a novel everolimus-eluting stent (SYNERGY MEGATRON) purpose-built for interventions to large proximal coronary segments, including LM. MEGATRON stent has been purposefully designed to sustain its structural integrity at higher expansion diameters and to provide optimal lumen coverage. Four patient-specific LM geometries were 3D reconstructed and stented computationally with finite element analysis in a well-validated computational stent simulation platform under different homogeneous and heterogeneous plaque conditions. Four different everolimus-eluting stent designs (9-peak prototype MEGATRON, 10-peak prototype MEGATRON, 12-peak MEGATRON, and SYNERGY) were deployed computationally in all bifurcation geometries at three different diameters (i.e., 3.5, 4.5, and 5.0 mm). The stent designs were also expanded experimentally from 3.5 to 5.0 mm (blind analysis). Stent morphometric and biomechanical indices were calculated in the computational and experimental studies. In the computational studies the 12-peak MEGATRON exhibited significantly greater expansion, better scaffolding, smaller vessel prolapse, and greater radial strength (expressed as normalized hoop force) than the 9-peak MEGATRON, 10-peak MEGATRON, or SYNERGY (p < 0.05). Larger stent expansion diameters had significantly better radial strength and worse scaffolding than smaller stent diameters (p < 0.001). Computational stenting showed comparable scaffolding and radial strength with experimental stenting. 12-peak MEGATRON exhibited better mechanical performance than the 9-peak MEGATRON, 10-peak MEGATRON, or SYNERGY. Patient-specific computational LM stenting simulations can accurately reproduce experimental stent testing, providing an attractive framework for cost- and time-effective stent research and development.

The DESolve® novolimus bioresorbable scaffold

A longtime aspiration of interventional cardiologists remains to improve the long-term impact of stent permanence in coronaries to restore original vessel patency and physiological endothelium response. Bioresorbable vascular scaffolds were considered revolutionary in coronary devices, but several trials were disappointing; thus, the challenge in this field remains. DESolve is a novolimus-eluting poly-L lactide-based polymer scaffold that dissolves through a bio-reabsorption mechanism, vanishing completely in 2 years. Its ability to supply the necessary radial strength to support the vessel for the critical early months after delivery is an important feature showing a unique self-correction property, which reduces incomplete stent apposition. Overexpansion has a good, safe margin with DESolve. This review aims to provide an overview of this controversial topic.

Braided composite stent for peripheral vascular applications

Braided composite stent (BCS), woven with nitinol wires and polyethylene terephthalate (PET) strips, provides a hybrid design of stent. The mechanical performance of this novel stent has not been fully investigated yet. In this work, the influence of five main design factors (number of nitinol wires, braiding angle, diameter of nitinol wire, thickness and stiffness of the PET strip) on the surface coverage, radial strength, and flexibility of the BCS were systematically studied using computational models. The orthogonal experimental design was adopted to quantitatively analyze the sensitivity of multiple factors using the minimal number of study cases. Results have shown that the nitinol wire diameter and the braiding angle are two most important factors determining the mechanical performance of the BCS. A larger nitinol wire diameter led to a larger radial strength and less flexibility of the BCS. A larger braiding angle could provide a larger radial strength and better flexibility. In addition, the impact of the braiding angle decreased when the stent underwent a large deformation. At the same time, the impact of the PET strips increased due to the interaction with nitinol wires. Moreover, the number of PET strips played an important role in the surface coverage. This study could help understand the mechanical performance of BCS stent and provides guidance on the optimal design of the stent targeting less complications.