Due to their effect on aneurysm hemodynamics, flow diverters (FD) have become a routine endovascular therapy for intracranial aneurysms. Since over- and undersizing affect the device’s hemodynamic abilities, selecting the correct device diameter and accurately simulating FD placement can improve patient-specific outcomes. The purpose of this study was to validate the accuracy of virtual flow diverter deployments in the novel Derivo® 2 device. We retrospectively analyzed blood flows in ten FD placements for which 3D DSA datasets were available pre- and post-intervention. All patients were treated with a second-generation FD Derivo® 2 (Acandis GmbH, Pforzheim, Germany) and post-interventional datasets were compared to virtual FD deployment at the implanted position for implanted stent length, stent diameters, and curvature analysis using ANKYRAS (Galgo Medical, Barcelona, Spain). Image-based blood flow simulations of pre- and post-interventional configurations were conducted. The mean length of implanted FD was 32.61 (±11.18 mm). Overall, ANKYRAS prediction was good with an average deviation of 8.4% (±5.8%) with a mean absolute difference in stent length of 3.13 mm. There was a difference of 0.24 mm in stent diameter amplitude toward ANKYRAS simulation. In vessels exhibiting a high degree of curvature, however, relevant differences between simulated and real-patient data were observed. The intrasaccular blood flow activity represented by the wall shear stress was qualitatively reduced in all cases. Inflow velocity decreased and the pulsatility over the cardiac cycle was weakened. Virtual stenting is an accurate tool for FD positioning, which may help facilitate flow FDs’ individualization and assess their hemodynamic impact. Challenges posed by complex vessel anatomy and high curvatures must be addressed.

To introduce a computational tool for peri-interventional intracranial aneurysm treatment guidance that maps preoperative planning information from simulation onto real-time X-Ray imaging. Preoperatively, multiple flow diverter (FD) devices are simulated based on the 3D mesh of the vessel to treat, to choose the optimal size and location. In the peri-operative stage, this 3D information is aligned and mapped to the continuous 2D-X-Ray scan feed from the operating room. The current flow diverter position in the 3D model is estimated by automatically detecting the distal FD marker locations and mapping them to the treated vessel. This allows to visually assess the possible outcome of releasing the device at the current position, and compare it with the one chosen pre-operatively. The full pipeline was validated using retrospectively collected biplane images from four different patients (5 3D-DSA datasets in total). The distal FD marker detector obtained an average F1-score of 0.67 ( ± 0.224 ) in 412 2D-X-Ray scans. After aligning 3D-DSA + 2D-X-Ray datasets, the average difference between simulated and deployed positions was 0.832 mm ( ± 0.521 mm). Finally, we qualitatively show that the proposed approach is able to display the current location of the FD compared to their pre-operatively planned position. The proposed method allows to support the FD deployment procedure by merging and presenting preoperative simulation information to the interventionists, aiding them to make more accurate and less risky decisions.

Flow diverter implantation has emerged as a highly effective treatment for cerebral aneurysms. However, the variability in patient-specific vascular anatomy necessitates detailed pre-operative planning to mitigate potential complications arising from standard, one-size-fits-all devices. To address these challenges, robust predictive simulation tools are essential for optimizing flow diverter design and implantation strategies tailored to the unique characteristics of each patient's anatomy. This study focuses on developing an advanced numerical simulation tool for modeling the mechanical behavior of braided flow diverters during crimping and navigation through patient-specific vasculature. Using isogeometric analysis (IGA) with NURBS-based representations in LS-Dyna, the intricate deformations of the flow diverter wires during catheter crimping are captured with high accuracy. The patient-specific vessel geometries, derived from imaging data, are integrated into the model to account for variations in vascular structure, ensuring precise alignment and controlled navigation of the device. The navigation process relies on optimizing the central axis of the blood vessel to minimize torsional stress on the flow diverter, reducing the risk of device malfunction or failure during deployment. By incorporating patient-specific information, such as vessel curvature and tortuosity, the simulation tool enables the prediction of potential issues, thus allowing for intervention planning that is tailored to individual anatomy. This patient-specific approach enhances the safety and efficacy of flow diverter implantation and serves as a foundation for improved device design prior to prototype development.

Endovascular treatment of intracranial aneurysms with flow diverters (FD) has become one of the most promising interventions. Due to its woven high-density structure they are particularly applicable for challenging lesions. Although several studies have already conducted realistic hemodynamic quantification of the FD efficacy, a comparison with morphologic post-interventional data is still missing. This study analyses the hemodynamics of ten intracranial aneurysm patients treated with a novel FD device. Based on pre- and post-interventional 3D digital subtraction angiography image data, patient-specific 3D models of both treatment states are generated applying open source threshold-based segmentation methods. Using a fast virtual stenting approach, the real stent positions available in the post-interventional data are virtually replicated and both treatment scenarios were characterized using image-based blood flow simulations. The results show FD-induced flow reductions at the ostium by a decrease in mean neck flow rate (51%), inflow concentration index (56%) and mean inflow velocity (53%). Intraluminal reductions in flow activity for time-averaged wall shear stress (47%) and kinetic energy (71%) are present as well. However, an intra-aneurysmal increase in flow pulsatility (16%) for the post-interventional cases can be observed. Patient-specific FD simulations demonstrate the desired flow redirection and activity reduction inside the aneurysm beneficial for thrombosis formation. Differences in the magnitude of hemodynamic reduction exist over the cardiac cycle which may be addressed in a clinical setting by anti-hypertensive treatment in selected cases.

Purpose:Given the inherent complexity of neurointerventional procedures and the associated risks of ionizing radiation exposure, it is crucial to prioritize ongoing training and improve safety protocols. The aim of this study is to assess a training and evaluation in-vitro environment using a vascular model of M1 stenosis, within a clinical angiography suite, without relying on animal models or X-ray radiation. Materials and methods:Using a transparent model replicating M1 stenosis, we conducted intracranial stenting procedures with four different setups (Gateway & Wingspan, Gateway & Enterprise, Neurospeed & Acclino, and Pharos Vitesse). A video camera was integrated with the angiography system's monitor for real-time visualization, while a foot switch was employed to simulate live fluoroscopy. Three neuroradiologists with varying levels of expertise performed each procedure for three times. The total duration of fluoroscopy as well as the time from passing the stenosis with the wire to completion of the procedure were recorded using a dedicated software designed for this experimental setup. Results:Compared to the Gateway & Wingspan procedure, the total fluoroscopy time reduced significantly with the Gateway & Enterprise, Neurospeed & Acclino, and Pharos Vitesse procedures by 51.56 s, 111.33 s, and 144.89 s, respectively (p < 0.001). Additionally, physicians with under 2 years and over 5 years of experience reduced FT by 62.83 s and 106.42 s, respectively, (p < 0.001), compared to a novice physician. Similar trends were noted for the time of wire distal to stenosis, with significant reductions for Neurospeed & Acclino and Pharos Vitesse compared to both Gateway & Wingspan as well as Gateway & Enterprise (all p < 0.001). Conclusion:Procedures requiring wire exchange maneuvers exhibited nearly twice the fluoroscopy time in comparison to balloon-mounted stenting or stent-placement via PTA balloon catheters. The more experienced neuroradiologist demonstrated significantly quicker performance in line with expectations in a real-life clinical setting, when compared to the less experienced interventionalist. This in-vitro setup allowed the evaluation of alternative technical approaches and differences in experience of operators without the use of animal models or X-ray. The setup combines advantages of simulators and silicone vessel models in a realistic working environment.

Personalized medical devices adapted to the anatomy of the individual promise greater treatment success for patients, thus increasing the individual value of the product. In order to cater to individual adaptations, however, medical device companies need to be able to handle a wide range of internal processes and components. These are here referred to collectively as the personalization workload. Consequently, support is required in order to evaluate how best to target product personalization. Since the approaches presented in the literature are not able to sufficiently meet this demand, this paper introduces a new method that can be used to define an appropriate variety level for a product family taking into account standardized, variant, and personalized attributes. The new method enables the identification and evaluation of personalizable attributes within an existing product family. The method is based on established steps and tools from the field of variant-oriented product design, and is applied using a flow diverter—an implant for the treatment of aneurysm diseases—as an example product. The personalization relevance and adaptation workload for the product characteristics that constitute the differentiating product properties were analyzed and compared in order to determine a tradeoff between customer value and personalization workload. This will consequently help companies to employ targeted, deliberate personalization when designing their product families by enabling them to factor variety-induced complexity and customer value into their thinking at an early stage, thus allowing them to critically evaluate a personalization project.

The d-xylose tolerance test was performed by measuring the excretion of d-xylose in urine during 24 hours after oral administration of 25 g of d-xylose in 500 ml of water.1. In the control series of 161 hospitalized patient with acid gastric secretion, the mean d-xylose excretion was 10.72 ± 0.28 g. The d-xylose values were highests in the age group 35-44 years, and after that there was a decreasing tendency with increasing age.2. In 101 patients with hypochromic anemia, the mean d-xylose excretion was 8.23 ± 0.37 g. The difference from the control series was highly significant. The excretion in cases with acid gastric secretion was slightly higher than in cases with no acid gastric secretion, though the difference was statistically insignificant.3. In 22 patients with hypochromic anemia, in whom a chronic hemorrhage was a contributory factor to the anemia the mean d-xylose excretion was 10.30 ± 0.60 g. The difference from the mean in the group with hypochromic anemia without notable hemorrhage is signifi...

Current flow diverter (FD) designs limit the possibilities to achieve ideal functional parameters for intra-aneurysmal flow alteration in the implanted state. In this work, we evaluate the technical feasibility of a new patient-specific FD concept and the impact on intra-aneurysmal flow reduction compared to standard FD. Based on a literature review, we defined functional requirements, followed by the design and manufacturing of two different prototypes, which we implanted in a patient-specific phantom model. Functional porosity distributions and contour parameters were evaluated in the implanted state and compared to standard FD. Subsequently, we carried out a series of particle image velocimetry (PIV) measurements, in order to assess the impact on intra-aneurysmal flow. With both patient-specific prototypes, it was possible to achieve stronger intra-aneurysmal flow reductions in terms of maximum and mean velocity and vorticity than a standard FD; however, one design showed a strong sensitivity against malpositioning. Overall, fluid dynamics parameters correlated with geometrical aspects such as the porosity and its grade of homogeneity. Beyond that, we found influences by the FD contour projection within the aneurysm, especially connected to the formation of in-jets. Our results show that there is a technically feasible concept, which enables a more specific adjustment of functional FD parameters and more effective intra-aneurysmal flow reduction. This could potentially lead to improvements in the efficacy of aneurysm occlusion in cases with challenging fluid dynamics.

For testing new designs of braided stents, an animal free anatomical model is needed, in which different Flow Diverter (FD) designs can be implanted and evaluated. The geometric replication of vessels by additively manufactured (AM) models has already been proven for aneurysm coiling within the neurointerventional training model HANNES. Nevertheless, since FDs closely interact with the vessel wall, AM vessel model materials need to be qualificated for the use case. Therefore, this paper presents an appropriate test bench for AM material tests and characterizes AM impact factors. As an outlook, different AM materials are tested and compared. Additionally, the impact of the postprocessing is investigated for one material. The paper shows the qualification of AM models for animal free design tests of a medical devices, where an objective test environment gives the opportunity to qualify AM materials for the medical use case.

PURPOSE:It has been hypothesized that microstents which are used to prevent coil protrusion in the treatment of cerebral aneurysms may have flow diverting and therefore occlusive effects. In a rabbit elastase aneurysm model, we investigated the aneurysm occlusion rate and vessel reaction of a braided Accero stent prototype with porosity in the lower range of other available (non-flow-diverter) microstents. METHODS:Ten aneurysms were induced the right subclavian artery in New Zealand white rabbits and treated with the Accero stent prototype. In each subject, a second stent was implanted in the abdominal aorta to cover the origins of branch arteries. Angiographic follow-up and explantation of the devices and aneurysms for histological analysis were performed after 3 months (n = 5) and 6 months (n = 5). RESULTS:Grades I (< 50%) and II (> 50%) occlusion rates were observed in 9 (90%) and 1 (10%) of ten aneurysms treated with the stent device. The mean reduction in contrast filling at 6 months was 42.1% (p = .02). Neointima thickness was significantly higher in the subclavian artery than in the abdominal aorta after 3 (p = .03), whereas not after 6 months (p = .1). No cases of inadequate wall apposition, branch artery occlusion or stent thrombosis were observed. CONCLUSION:The present study showed flow remodelling properties of the device prototype with progredient aneurysm occlusion. A larger in vivo study with induced aneurysm should be done to confirm these results.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Particle image velocimetry (PIV) is a commonly used method for in vitro investigation of fluid dynamics in biomedical devices, such as flow diverters for intracranial aneurysm treatment. Since it is limited to transparent blood substituting fluids like water-glycerol mixture, the influence of coagulation and platelet aggregation is neglected. We aimed at the development and the application of a modified platelet rich plasma as a new PIV fluid with blood-like rheological and coagulation properties. In standardized intracranial aneurysm silicone models, the effect of this new PIV plasma on the fluid dynamics before and after flow diverter implantation was evaluated and compared with water-glycerol measurements. The flow diverting effect was strongly dependent on the used fluid, with considerably lower velocities achieved using PIV plasma, despite the same starting viscosity of both fluids. Moreover, triggering coagulation of PIV plasma allowed for intra-aneurysmal clot formation. We presented the first in vitro PIV investigation using a non-Newtonian, clottable PIV plasma, demonstrating a mismatch to a standard PIV fluid and allowing for thrombus formation.

Treatment of intracranial aneurysm with flow-diverting devices has become widespread in recent years. Despite that, intra-aneurysmal flow changes are yet not fully understood and can lead to different complications. Our aim was an in vitro contrast-based evaluation of the influence of flow diverter size and position on intra-aneurysmal flow dynamics.

Flow diverters are widely extended in clinical practice for intracraneal aneurysms treatment. They are formed by a dense mesh of braided wires that partially occludes the aneurysm neck and restores the blood flow into the parent vessel. The occlusion degree is highly dependant on the distribution of the wires under the aneurysm, which is affected by the vessel geometry. Nowadays, there are no clinical indicators of the covering ratio once the flow diverter is deployed. We propose a novel method for the simulation of the flow diverter local porosity before its deployment into the parent vessel. We validate the method on curved silicon models, obtaining a correlation of 0.9 between the simulated values and the measured porosity on the deployed flow diverter.