Stent Design Research Articles

Feasibility assessment of polyvinyl alcohol-based bioresorbable cardiovascular stents manufactured via solvent-cast direct writing extrusion

BackgroundBioresorbable stents represent a promising approach in cardiovascular interventions compared to drug-eluting stents. Additive manufacturing, particularly ink deposition, offers customization and versatility. This study delves into the potential of solvent cast direct-write 3D printing to fabricate cardiovascular stents using environmentally friendly solvents. MethodologyPolyvinyl alcohol, a biocompatible synthetic polymer that dissolves in water, was investigated as a suitable material for stent fabrication. The polymer was deposited on a rotating mandrel and subsequently crosslinked to establish a pseudostable state. Test specimens and stents were fabricated for characterization of both the material and stent dynamics. ResultsThis outcome is potentially suitable for deployment in the human body environment and adaptable to various biomedical applications, such as drug delivery patches or implants. The research optimized the fabrication of various stent geometries using polyvinyl alcohol and evaluated the kinetics of the working environment of these stents. Specifically, the 8-cell diamond stent showed remarkable characteristics, such as a high overexpansion of more than 0.5 mm, a compression force of 0.02 N and an elastic recovery of 88.85 %, with a strut thickness of 50.25 μm. Additionally, the study discusses the possibility of sterilizing polyvinyl alcohol with different methods, ethanol and autoclave were selected. ConclusionsThe results indicate that autoclaving leads to an increase in crystallinity. This yields a decrease in water absorption and an increase in mechanical properties. These results suggest that polyvinyl alcohol-based stents fabricated by solvent-cast direct writing are potential candidates for bioresorbable stent design.

Percutaneous Balloon-Expandable Stent Implantation to Treat Transverse Aortic Arch Obstruction: Medium- to Long-Term Outcomes of a Retrospective Multicenter Study.

Transverse aortic arch obstruction is a challenging lesion for which stent implantation provides a potentially important alternate therapy. The objectives were to evaluate the technical, procedural, and medium-to-long-term clinical outcomes of percutaneous stent implantation of transverse aortic arch obstruction. This is a retrospective, multicenter study of transverse aortic arch stent implantation. Univariable and multivariable analyses were performed. Index catheterization included 187 stent implants in 146 patients. The median age is 14.3 years (interquartile range, 9.3-19), weight is 53 kg (30-69), and follow-up is 53 months (12-120). The most common stent design was open cell (n=90, 48%). Stents overlapped 142 arch vessels (37 carotid arteries) in 118 (81%) cases. Technical and procedural success rates were 100% and 88%, respectively. Lower weight (P=0.018), body surface area (P=0.013), and minimum-to-descending aortic diameter ratio (P<0.001) were associated with higher baseline aortic gradient. The residual gradient was inversely associated with implant and final dilation diameters (P<0.001). The combined incidence of aortic injury and stent-related complications was 14%. There were no reports of abnormal brain scans or stroke. Blood pressure cuff gradient, echocardiographic arch velocity, and hypertension rates improved within 1-year follow-up with increased antihypertensive medication use. Reintervention was reported in 60 (41%) patients at a median of 84 (22-148) months to first reintervention. On multivariable logistic regression, residual aortic gradient >10 mm Hg was associated with increased odds of reintervention at all time points when controlling for each final dilation diameter, weight, and minimum-to-descending aortic diameter ratio. Transverse aortic arch stent implantation has high rates of technical, procedural, and medium-to-long-term clinical success. Aortic gradient >10 mm Hg is associated with increased odds of reintervention at 1-year and most recent follow-ups. Open cell stent design was frequently used for its advantages in conformability, perfusion of arch vessels, low fracture rate, and the ability to perform effective angioplasty of side cells.

FRED X flow diverter for the treatment of intracranial aneurysms: Two-center experience and mini-review of the literature.

The flow re-direction endoluminal device (FRED) is a safe and effective treatment option for intracranial aneurysms. The novel FRED X features an antithrombotic surface coating ("X Technology") on an otherwise unmodified stent design. This two-center study evaluates the clinical safety and efficacy of FRED X and compares it to the literature. Consecutive patients treated between 2020 and 2023 were retrospectively reviewed for aneurysm characteristics, procedural details and complications, and angiographic outcomes. A mini-review of the literature for FRED X clinical trials was performed and results were pooled using a random effects model. Thirty-four patients (mean age 56 years) were treated for 34 aneurysms. The mean aneurysm size was 7.7 ± 5.0 mm, 7 (21%) were ruptured, 6 (18%) were recurrent after previous treatment, 11 (32.3%) were located in the posterior circulation, and 4 (12.5%) had non-saccular morphology. All procedures were technically successful and no balloon angioplasty was required. There was 1 (2.9%) symptomatic complication (a transient ischemic attack) and no procedural morbidity or mortality. Technical asymptomatic events included 1 procedural stent occlusion that was reopened with thrombectomy and 3 cases of vasospasm. Complete and adequate occlusion rates were 68% (19/28) and 89% (25/28) at a mean follow-up time of 6 months, respectively. The results of this study are comparable to previous FRED X studies. The results demonstrate a high feasibility and procedural safety of the FRED X with adequate mid-term occlusion rates. Long-term and comparative studies are needed to evaluate the full potential of the FRED X.

Pivotal Evaluation of Novel Dedicated Venous Stent for Iliofemoral Venous Obstruction: A Prospective Cohort Study.

The purpose was to evaluate the clinical outcomes of a dedicated venous stent with the tripartite composite segments for the treatment of iliofemoral venous obstruction (IVO) in a mixed cohort of nonthrombotic iliac vein lesion (NIVL) and post-thrombotic syndrome (PTS) over a period of 12 months. The Grency Trial is a prospective, multicenter, single-arm, open-label, pivotal study, which was conducted at 18 large tertiary hospitals in China from August 2019 to October 2020. A total of 133 hospitalized patients were screened and 110 patients with clinical, etiology, anatomical, and pathophysiology clinical class (CEAP) clinical grade C>3 and iliac vein stenosis >50% or occlusion, including 72 patients with NIVL and 38 patients with PTS, were implanted with Grency venous stents. Primary endpoint was stent patency at 12 months follow-up, and secondary outcomes were technical success; improvement in venous clinical severity score (VCSS) at 3, 6, and 12 month follow-up; and rates of clinical adverse events. Among 110 patients who were implanted with Grency venous stents, 107 patients completed the 12 month follow-up. All 129 stents were successfully implanted in 110 limbs. Twelve-month primary patency rate was 94.39% [95% confidence interval [CI]=88.19%-97.91%] overall, and 100% [94.94%-100%] and 83.33% [67.19%-93.63%] in the NIVL and PTS subgroups, respectively. Venous clinical severity score after iliac vein stenting improved significantly up to 12 months follow-up. There were 3 early major adverse events (1 intracerebral hemorrhage and 2 stent thrombosis events related to anticoagulation therapy), and 7 late major adverse events (1 cardiovascular death, 1 intracranial hemorrhage with uncontrolled hypertension, and 5 in-stent restenosis cases without stent fractures or migration). The Grency venous stent system appeared excellent preliminary safe and effective for IVO treatment. Further large-scale studies with longer-term follow-up are needed to evaluate long-term patency and durability of stent. The design of venous stents for iliofemoral venous obstruction (IVO) must address engineering challenges distinct from those encountered in arterial stenting. The Grency venous stent, a nitinol self-expanding stent specifically tailored for IVO, features a composite structure designed to meet the stent requirements of various iliac vein segments. The Grency Trial is a prospective, multicenter, single-arm, open-label pivotal study aimed at evaluating the efficacy and safety of the Grency stent system. Following a 12-month follow-up period, the Grency venous stent system has demonstrated both safety and efficacy in treating iliofemoral venous outflow obstruction.

Mechanical behaviors of a new elliptical valve stent in bicuspid aortic valve

Background and ObjectiveThe conventional valve stents that are cylindrical in shape will become elliptical when implanted in bicuspid aortic valve, thereby reducing the durability of the artificial valve. In this study, a new design of valve stent is presented where valve stents have elliptical cross-section at the annulus and it is expected to have better expandability and circle shape during the interaction between the stent and bicuspid aortic valve, thereby extending the durability of artificial valve. MethodsFinite element method (FEM) is used to study the mechanical behavior of the novel valve stent in the bicuspid aortic valve. The effects of three matching relationship between the ellipticity of the stents and the ellipticity of the annulus (i.e., the ellipticity of the stent is greater than, equal to and less than the annulus ellipticity, respectively) on the mechanical behavior of stent expansion are studied. In addition, the expansion mechanical behavior of the novel valve stent at different implantation depths is also compared. ResultsResults indicate that novel valve stent implantation with elliptical features is superior to conventional circular valve stent. When the novel valve stent ellipticity is less than the annulus ellipticity, the ellipticity of the novel valve stent after implantation is smaller than that of the conventional circular valve stent. This indicated that the novel valve stent has better expandability and post-expansion shape, making artificial valve to have better durability. The risk of paravalvular leak after implantation is lowest when the novel valve stent ellipticity is less than annulus ellipticity. When the novel valve stent ellipticity coincides with annulus ellipticity, the aortic wall is subjected to greatest stress. With the increase of implantation depth, the stress on the novel valve stent decrease. ConclusionsThis study might provide insights for improving stent design for bicuspid aortic valve.

3D printing of personalised stents using new advanced photopolymerizable resins and Ti-6Al-4V alloy

PurposeThe development of new advanced materials, such as photopolymerizable resins for use in stereolithography (SLA) and Ti6Al4V manufacture via selective laser melting (SLM) processes, have gained significant attention in recent years. Their accuracy, multi-material capability and application in novel fields, such as implantology, biomedical, aviation and energy industries, underscore the growing importance of these materials. The purpose of this study is oriented toward the application of new advanced materials in stent manufacturing realized by 3D printing technologies.Design/methodology/approachThe methodology for designing personalized medical devices, implies computed tomography (CT) or magnetic resonance (MR) techniques. By realizing segmentation, reverse engineering and deriving a 3D model of a blood vessel, a subsequent stent design is achieved. The tessellation process and 3D printing methods can then be used to produce these parts. In this context, the SLA technology, in close correlation with the new types of developed resins, has brought significant evolution, as demonstrated through the analyses that are realized in the research presented in this study. This study undertakes a comprehensive approach, establishing experimentally the characteristics of two new types of photopolymerizable resins (both undoped and doped with micro-ceramic powders), remarking their great accuracy for 3D modeling in die-casting techniques, especially in the production process of customized stents.FindingsA series of analyses were conducted, including scanning electron microscopy, energy-dispersive X-ray spectroscopy, mapping and roughness tests. Additionally, the structural integrity and molecular bonding of these resins were assessed by Fourier-transform infrared spectroscopy–attenuated total reflectance analysis. The research also explored the possibilities of using metallic alloys for producing the stents, comparing the direct manufacturing methods of stents’ struts by SLM technology using Ti6Al4V with stent models made from photopolymerizable resins using SLA. Furthermore, computer-aided engineering (CAE) simulations for two different stent struts were carried out, providing insights into the potential of using these materials and methods for realizing the production of stents.Originality/valueThis study covers advancements in materials and additive manufacturing methods but also approaches the use of CAE analysis, introducing in this way novel elements to the domain of customized stent manufacturing. The emerging applications of these resins, along with metallic alloys and 3D printing technologies, have brought significant contributions to the biomedical domain, as emphasized in this study. This study concludes by highlighting the current challenges and future research directions in the use of photopolymerizable resins and biocompatible metallic alloys, while also emphasizing the integration of artificial intelligence in the design process of customized stents by taking into consideration the 3D printing technologies that are used for producing these stents.

Multi-objective structural optimization and degradation model of magnesium alloy ureteral stent

BackgroundMg alloys have attractive properties, including biocompatibility, biodegradability, and ideal mechanical properties. Moreover, Mg alloys are regarded as one of the promising candidates for manufacturing ureteral stents. This study proposed a multi-objective optimization method based on the Kriging surrogate model, NSGA-Ⅲ, and finite element analysis to improve the degradation performance of Mg alloy ureteral stents. MethodsThe finite element model for the degradation of Mg alloy ureteral stents has been established to compare the degradation performance of the stents under different parameters. Latin hypercube sampling was adopted to generate train sample points in the design space. Meanwhile, the Kriging surrogate model was constructed between strut parameters and stent degradation behavior. The NSGA-Ⅲ was utilized to determine the optimal solution in the global design space. ResultsThe optimized stent achieved 5.52 ​× ​degradation uniformity (M), 10 ​× ​degradation time (DT), and 4 ​× ​work time (FT). The errors between the Kriging surrogate model and the finite element calculation results were less than 6%. ConclusionThe optimized stent achieved better degradation performance. The degradation behavior of stents was dependent on the design parameters. The multi-objective optimization method based on the Kriging surrogate model and finite element analysis was effective in stent design optimization problems.

Shape-Setting of Self-Expanding Nickel–Titanium Laser-Cut and Wire-Braided Stents to Introduce a Helical Ridge

PurposeAltered hemodynamics caused by the presence of an endovascular device may undermine the success of peripheral stenting procedures. Flow-enhanced stent designs are under investigation to recover physiological blood flow patterns in the treated artery and reduce long-term complications. However, flow-enhanced designs require the development of customised manufacturing processes that consider the complex behaviour of Nickel-Titanium (Ni-Ti). While the manufacturing routes of traditional self-expanding Ni–Ti stents are well-established, the process to introduce alternative stent designs is rarely reported in the literature, with much of this information (especially related to shape-setting step) being commercially sensitive and not reaching the public domain, as yet.MethodsA reliable manufacturing method was developed and improved to induce a helical ridge onto laser-cut and wire-braided Nickel–Titanium self-expanding stents. The process consisted of fastening the stent into a custom-built fixture that provided the helical shape, which was followed by a shape-setting in air furnace and rapid quenching in cold water. The parameters employed for the shape-setting in air furnace were thoroughly explored, and their effects assessed in terms of the mechanical performance of the device, material transformation temperatures and surface finishing.ResultsBoth stents were successfully imparted with a helical ridge and the optimal heat treatment parameters combination was found. The settings of 500 °C/30 min provided mechanical properties comparable with the original design, and transformation temperatures suitable for stenting applications (Af = 23.5 °C). Microscopy analysis confirmed that the manufacturing process did not alter the surface finishing. Deliverability testing showed the helical device could be loaded onto a catheter delivery system and deployed with full recovery of the expanded helical configuration.ConclusionThis demonstrates the feasibility of an additional heat treatment regime to allow for helical shape-setting of laser-cut and wire-braided devices that may be applied to further designs.

Impact of stent strut link location in proximal balloon edge dilation technique for bifurcation percutaneous coronary intervention.

The single-stent strategy has generally been accepted as the default approach to bifurcation percutaneous coronary intervention. We have proposed the proximal balloon edge dilation (PBED) technique to prevent stent deformation during side branch (SB) dilation. This bench study aimed to evaluate the impact of stent link location and stent design on stent deformation, obstruction by stent struts at a jailed SB ostium, and incomplete stent apposition in the proximal optimization technique (POT)-PBED procedure. A coronary bifurcation model was used. We intentionally set the absence or presence of stent link on the carina (link-free or link-connect) under videoscope observation and compared stent parameters between 3- and 2-link stents (n = 5 each, n = 20 total). In the link-free group, the SB jailing rate of 3-link stents was significantly higher than that of 2-link stents (15.5 ± 5.1% vs. 6.6 ± 1.2%, p = 0.009). In the link-connect group, the SB jailing rate of 3-link stents was significantly lower than that of 2-link stents (30.0 ± 4.5% vs. 39.0 ± 2.6%, p = 0.009). In the bifurcation segment, the rate of incomplete stent apposition was significantly lower for 3-link stents of the link-connect group than for 2-link stents of the link-connect group (3.3 ± 4.2% vs. 19.0 ± 7.8%, p = 0.009). For both stent designs, ellipticity ratio was higher for link-connect group than link-free group. Link location as well as stent cell design greatly impacted stent deformation during the POT-PBED procedure.

Evaluation of embedded modular branched stent graft in treating aortic arch aneurysm using imaging-based computational flow analysis

Embedded modular branched stent graft (EMBSG) was a new option for aortic arch aneurysm. However, the therapeutic effect of this innovative stenting technique has not been fully assessed. Computational fluid dynamics and three-dimensional structural analyses were performed on three patients (Patient I, Patient II and Patient III) with aortic arch aneurysm, both before and after EMBSG implantation. Patient-specific alterations from preoperative to postoperative were analyzed via morphological and functional metrics. Patient I and Patient II showed notable curvature changes and area reduction after intervention procedure. Three patients showed an increase in flow velocity after EMBSG implantation, while the pressure drop from ascending aorta to the aortic arch was remarkable in Patient I and Patient II with the value of 7.09 ​mmHg, and 10.95 ​mmHg, respectively. Patient I and Patient II also showed elevated time-averaged wall shear stress (TAWSS) in the stenting region, while Patient III showed a trivial change in TAWSS after intervention procedure. Three patients showed low relative residence time after EMBSG insertion. The short-term results of EMBSG in treating aortic arch aneurysm were promising. Hemodynamic parameters have the potential to assist in the outcome evaluation and might be used to guide the stent graft design and wise selection, thereby improving the long-term therapeutic effect in managing complex vascular disease.

Design of novel poly(L-lactide)-based shape memory multiblock copolymers for biodegradable esophageal stent application

Esophageal cancer is a globally prevalent malignancy known for its extremely aggressive nature and high fatality rates. However, the conventional stents used in its treatment pose limitations including rigidity, non-degradability, and a lack of anti-inflammatory action. Shape memory multiblock copolymer stents (SMBS) have attracted considerable attention because of their distinctive characteristics. Nonetheless, achieving a variety of key functionalities, such as biocompatibility, biodegradability, thermoresponsiveness (body temperature, 37 °C), water responsiveness (biofluid), flexibility, and robustness, in a simple polymer system for practical applications still presents a significant problem. Herein, a versatile SMBS that is capable of delivering all the aforementioned key functionalities is proposed. This SMBS can efficiently be prepared via a rapid two-step strategy, leveraging the shape memory effect (SME) of a poly(L-lactide) (PLA)-based physical crosslinking network programmed into specific shapes. The proposed stent design incorporates bio-based PLA with flexible and hydrophilic polyethylene glycol (PEG), resulting in PEG-PLA multiblock copolymers with tunable transition temperatures (31.90–54.60 °C), effectively covering the body temperature (37 °C). Additionally, PEG-PLA exhibited a wide range of water uptake ratio of 41 % to 328 % and satisfactory elongation at break (142.8 % to 1920.6 %), and desired pH-dependent and simulated gastrointestinal biodegradability. Specifically, PEG4000PLA1500 displayed excellent body temperature-triggered (with a recovery rate of 99.5 %) and water-triggered dual SME, which allowed it to potentially be fabricated into on-demand synchronous shape memory and drug-release functional SMBS for esophageal stenosis therapy. The results of this study indicate that the proposed SMBS holds substantial potential for biomedical applications.

In-Stent Restenosis: Achilles’ Heel of Post-PCI Era

Despite advancements in stent design and polymer coatings over the past two decades, 1% to 2% of patients annually still experience instent restenosis (ISR). ISR reduces myocardial perfusion, may develop symptoms of myocardial ischemia, and thus leads to a high risk of myocardial infarction and cardiac death. Given that millions of drug-eluting stents (DES) are implanted globally every year, ISR remains a prevalent clinical issue with significant public health implications. Coronary intravascular imaging, includes intravascular ultrasound (IVUS) and optical coherence tomography (OCT), can help physicians gain deeper insights into the potential mechanisms of ISR. The preferred treatment strategy hinges on an accurate diagnosis and better understanding of etiology. The mechanism of ISR is multifaceted, and its treatment is challenging. Although the risk of ISR continues to decrease with advancements in DES application, further research is still needed to enrich the treatment options for ISR.

Design strategy of poly (L‐lactic acid) mixed braided stent: The influence of braiding ratio of thick and thin monofilaments

AbstractFor the design of polymer stents, supportability and flexibility are two important indexes, but they are often difficult to balance. The mixed braiding of monofilaments with different diameters provides a potential solution to balance these two indices. In this study, the influence of mixed braiding on the mechanical properties of the stent was further explored by adjusting the knitting ratio of thick and thin monofilaments. By replacing the monofilaments in the stent with monofilaments with smaller diameters in turn, the changing trend of supportability and flexibility is obtained. The results show that, when the number of thick monofilaments is greater than or equal to that of thin monofilaments, the supportability of the stent can not only be maintained but also the flexibility can be greatly improved. Therefore, mixed braiding has the function of adjusting supportability and flexibility.

Polish Society of Biomechanics Morecki&Fidelus Award Winner: Comparison of two polymers PDO and PLLA/PCL in application of urological stent for the treatment of male urethral stenosis.

Purpose: The primary objective of the conducted research was to develop an urological stent design for the treatment of male ure-thral stenosis. Given the variable loading conditions inside the urethra, the proposed stent should maintain normal tissue kinetics and obstruct the narrowed lumen. The suitable selection for the stent material significantly influences the regeneration and proper remodeling of the urethral tissues. Methods: In this work, the mechanical characteristics of some polymer materials were studied, including: polydi-oxanone (PDO) and poly(L-lactide) (PLLA)/polycaprolactone (PCL) composite. The obtained mechanical properties for static tensile testing of the materials, allowed the determination of such parameters as Young's modulus (E), tensile strength (R m) and yield strength (R e). Subsequently, the design of a urological stent was developed, for which a numerical analysis was carried out to check the behaviour of the stent during varying loads prevailing in the urethra. Result: The research indicated that PDO has better mechanical properties than the proposed PLLA/PCL composite. The numerical analysis results suggested that the developed stent design can be successfully used in the treatment of male urethral stenosis. The obtained stress and strain distributions in the numerical analysis confirm that the PDO material can be used as a material for an urological stent. Conclusions: The biodegradable polymers can be successfully used in urology. Their advantages over solid materials are their physicochemical properties, the ability to manipulate the rate and time of degradation and the easy availability of materials and manufacturing technology.

ANALYSIS AND OPTIMIZATION OF WIND RESISTANCE PARAMETERS FOR LATTICE-TYPE HIGH-MODULUS SUPPORTS BASED ON THE OPTIMAL CRITERIA METHOD

Lattice high-molded support can generally be used for cast-in-place support for bridges, but for more than 50 meters of lattice high support, due to the wind, load and other factors, due to the support length and slenderness of the relatively large, relatively light and flexible structure and other characteristics of the role of the wind load is very sensitive. When the lattice high-molded stent construction is used in the typhoon area, it is easy to be damaged by the typhoon, and the structural design of the lattice high-molded stent and the construction of that technology are facing great challenges. In this paper, based on the new construction of a special bridge in Fujian, finite element analysis of four-legged and six-legged lattice bracing is carried out by ANSYS, and the effects of steel pipe diameter, number of columns, longitudinal and transversal spacing of bracing, and diagonal bracing structural parameters on structural performance are analyzed by using the coefficients of buckling stability and the coefficients of critical loading. The results of the study show that the main design variable for displacement sensitivity is the diameter of vertical rod; the main design variable for stress sensitivity is the diameter of diagonal rod; the main design variable for overall stability sensitivity is the diameter of diagonal rod; and the main design variable for overall stability sensitivity of total volume is the diameter of diagonal rod. And the optimal wind resistance parameters are: 4 lattice high-braced columns are selected, the section length should be controlled within 15m, and the total height should not be more than 70m, and the spacing of the columns is controlled between 7m and 8m. This study proposes a set of optimized design process method for wind-resistant lattice structure under the constraints of stiffness, strength and critical load factor, which improves the economy and ensures the reasonableness of the design, and can be used for the design of high-modular lattice bracket in typhoon area.

Development and Future Trends of Protective Strategies for Magnesium Alloy Vascular Stents.

Magnesium alloy stents have been extensively studied in the field of biodegradable metal stents due to their exceptional biocompatibility, biodegradability and excellent biomechanical properties. Nevertheless, the specific in vivo service environment causes magnesium alloy stents to degrade rapidly and fail to provide sufficient support for a certain time. Compared to previous reviews, this paper focuses on presenting an overview of the development history, the key issues, mechanistic analysis, traditional protection strategies and new directions and protection strategies for magnesium alloy stents. Alloying, optimizing stent design and preparing coatings have improved the corrosion resistance of magnesium alloy stents. Based on the corrosion mechanism of magnesium alloy stents, as well as their deformation during use and environmental characteristics, we present some novel strategies aimed at reducing the degradation rate of magnesium alloys and enhancing the comprehensive performance of magnesium alloy stents. These strategies include adapting coatings for the deformation of the stents, preparing rapid endothelialization coatings to enhance the service environment of the stents, and constructing coatings with self-healing functions. It is hoped that this review can help readers understand the development of magnesium alloy cardiovascular stents and solve the problems related to magnesium alloy stents in clinical applications at the early implantation stage.

NUMERICAL INVESTIGATION OF THE INFLUENCE OF THE LINK POSITIONING IN THE CORONARY STENT INSIDE THE NORMAL ARTERY: A COMPARATIVE STUDY OF TWO COMMERCIAL STENT DESIGNS

This paper investigates the performance of two commercial stent designs inside the normal artery for induced Von Mises Stress and radial displacement pattern. Investigation focuses on identifying the key design feature of the stent structure responsible for varied stress and displacement pattern. Two commercial stent designs, Supraflex (Stent S) and Yukon Choice (Stent T),are modeled using micro CT images and MIMICS® while idealized models are used for investigation. ANSYS Workbench is used to numerically expand the stent inside an idealized normal artery with inflation pressure. The stent and the artery are modeled using elastic-plastic and hyperelastic material models, respectively. The results suggest crucial influence of the link positioning in inducing an area of higher Von Mises Stress and stress gradient. The locations of a higher stress gradient are those in line with unbound stent crowns. Also, higher and uniform arterial displacement can be observed in the locations in line with the bound crown. Results also suggested a considerable difference in arterial distortion induced by two designs, causes for which can also be attributed to the differences in the link placement. The study suggests that the link connections play a crucial role in setting up stress field/radial displacement. Suitable modification of the link positioning can reduce the higher stress gradient and arterial distortion, which probably can reduce arterial injury.

Shortened Duration of Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention: A Contemporary Clinical Review

Percutaneous coronary intervention with stent implantation is an integral aspect of minimally interventional cardiac procedures. The technology and techniques behind stent design and implantation have evolved rapidly over several decades. However, continued discourse remains around optimal peri- and post-interventional management with dual antiplatelet therapy to minimise both major cardiovascular or cerebrovascular events and iatrogenic bleeding risk. Standard guidelines around dual antiplatelet therapy historically recommended long-term dual antiplatelet therapy for 12 months (with consideration for &gt;12 months in certain patients); however, emerging data and generational improvements in the safety of drug-eluting stents have ushered in a new era of short-term therapy to reduce the incidence of major bleeding events. This case review will provide an overview of the current state of guidelines around duration of dual antiplatelet therapy and examine recent updates and continued gaps in existing research.

Risk factors for peri-procedural stroke or death in internal carotid artery stenting: A neurology team experience

Background and Objectives: Suitable cases of extracranial internal carotid artery (ICA) stenosis can be treated with carotid artery stenting (CAS) or carotid endarterectomy. However, major complications in the peri-procedural period, like stroke and death, are more common with CAS. We therefore investigated the risk factors for stroke and death during the peri-procedural period following CAS. Methods: In this study, the files of patients who were treated with CAS by a neurology team during 2020–2022 were retrospectively analyzed. Patient age, gender, vascular risk factors, use of antiplatelet therapy, type of carotid artery stenosis (symptomatic or asymptomatic), measured stenosis degrees, contralateral carotid stenosis, types of aortic arch, balloon angioplasty, use of a filter-type embolism protection device, stent cell design (open or closed), and peri-procedural death, stroke, or myocardial infarction (MI) were recorded. All patients were followed up for the first 30 days after CAS. Results: The mean age of 219 patients included in our study was 67.8 ± 8.38 years and 68.5% were male. The most common comorbid diseases in the patients were hypertension (76.7%), hyperlipidemia (53.4%) and diabetes mellitus (DM) (43.4%). Stroke or death occurred in the peri-procedural period in 15 (6.85%) of the patients, but MI did not occur. No statistically significant difference was observed in terms of age or gender when comparing with the cases without stroke or death. Of the patients suffering stroke or death, ischemic stroke developed in 13 (86.67%), cerebral hemorrhage in two (13.33%) and two patients (13.33%) died. Two-thirds of the strokes were either minor (n=7, 46.67%) or moderate (n=4, 26.67%); 13 (86.67%) were ipsilateral, and 14 (93.33%) were in the anterior circulation. The complication risk was found to be significantly higher in patients with prior stroke (OR=3.865; 95% CI 1.282 to 11.652 p=.016), DM (OR=3.634; 95% CI 1.102 to 11.992 p=.034) and pre-dilation angioplasty (OR=13.100; 95% CI 1.762 to 97.422 p=.012). Conclusion: Prior stroke, DM and pre-dilation angioplasty increase peri-procedural stroke and death in CAS. However, even if a stroke complication develops after CAS, it is often not severe.

Comparison of endothelial shear stress between ultrathin strut bioresorbable polymer drug-eluting stent vs durable-polymer drug-eluting stent post-stent implantation: An optical coherence tomography substudy from BIOFLOW II

BackgroundRecent clinical data indicate a different performance of biodegradable polymer (BP)-drug eluting stent (DES) compared to durable polymer (DP)-DES. Whether this can be explained by a beneficial impact of BP-DES stent design on the local hemodynamic forces distribution remains unclear. ObjectivesTo compare endothelial shear stress (ESS) distribution after implantation of ultrathin (us) BP-DES and DP-DES and examine the association between ESS and neointimal thickness (NIT) distribution in the two devices at 9 months follow up. Methods and resultsWe retrospectively identified patients from the BIOFLOW II trial that had undergone OCT imaging. OCT data were utilized to reconstruct the surface of the stented segment at baseline and 9 months follow-up, simulate blood flow, and measure ESS and NIT in the stented segment. The patients were divided into 3 groups depending on whether DP-DES (N = 8, n = 56,160 sectors), BP-DES with a stent diameter of >3 mm (strut thickness of 80 μm, N = 6, n = 36,504 sectors), or BP-DES with a stent diameter of ≤3 mm (strut thickness of 60 μm, N = 8, n = 50,040 sectors) were used for treatment. The ESS, and NIT distribution and the association of these two variables were estimated and compared among the 3 groups. ResultsIn the DP-DES group mean NIT was 0.18 ± 0.17 mm and ESS 1.68 ± 1.66 Pa; for the BP-DES ≤3 mm group the NIT was 0.17 ± 0.11 mm and ESS 1.49 ± 1.24 Pa and for the BP-DES >3 mm group 0.20 ± 0.23 mm and 1.42 ± 1.24 Pa respectively (p < 0.001 for both NIT and ESS comparisons across groups). A negative correlation between NIT and baseline ESS was found, the correlation coefficient for all the stented segments was −0.33, p < 0.001. ConclusionIn this OCT sub-study of the BIOFLOW II trial, the NIT was statistically different between groups of patients treated with BP-DES and DP-DES. In addition, regions of low ESS were associated with increased NIT in all studied devices.