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BackgroundIn patients with unresectable hilar malignant biliary obstruction (MBO), bilateral metal stent placement is recommended. However, treatment selection between partially stent-in-stent (SIS) and side-by-side (SBS) methods is still controversial.StudyClinical outcomes of bilateral metal stent placement by SBS and SIS methods for hilar MBO were retrospectively studied in four Japanese centers. While large-cell-type uncovered metal stents were placed above the papilla in SIS, braided-type uncovered metal stents were placed across the papilla in SBS.ResultsA total of 64 patients with hilar MBO (40 SIS and 24 SBS) were included in the analysis. Technical success rate was 100% in SIS and 96% in SBS. Functional success rate was 93% in SIS and 96% in SBS. Early adverse event rates were higher in SBS (46%) than in SIS (23%), though not statistically significant (P = 0.09). Post-procedure pancreatitis was exclusively observed in SBS group (29%). Recurrent biliary obstruction rates were 48% and 43%, and the median time to recurrent biliary obstruction was 169 and 205 days in SIS and SBS, respectively.ConclusionsOther than a trend to higher adverse event rates including post-procedure pancreatitis in SBS, clinical outcomes of SIS and SBS methods were comparable in patients with unresectable hilar MBO.

Crimping and deployment of bioresorbable polymeric scaffold, Absorb, were modelled using a finite element method, in direct comparison with Co–Cr alloy drug eluting stent, Xience V. Absorb scaffold has an expansion rate lower than Xience V stent, with a less outer diameter achieved after balloon deflation. Due to the difference in design and material properties, Absorb also shows a higher recoiling than Xience V, which suggests that additional post-dilatation is required to achieve effective treatment for patients with calcified plaques and stiff vessels. However, Absorb scaffold induces significantly lower stresses on the artery–plaque system, which can be clinically beneficial. Eccentric plaque causes complications to stent deployment, especially non-uniform vessel expansion. Also the stress levels in the media and adventitia layers are considerably higher for the plaque with high eccentricity, for which the choice of stents, in terms of materials and designs, will be of paramount importance. Our results imply that the benefits of Absorb scaffolds are amplified in these cases.

To investigate the long-term outcomes of stent deployment in the treatment of refractory central venous occlusive disease (CVOD) in patients undergoing maintenance hemodialysis (MHD). MHD patients who were successfully treated with stenting for symptomatic CVOD that was resistant to balloon angioplasty alone were consecutively included in this retrospective study. The primary (PPR) and assisted (APR) patency rates of the central vein and hemodialysis vascular access (VA), reintervention, and survival rates after stenting were followed. Multivariate logistic regression analyses were conducted to determine the factors influencing VA abandonment and mortality. The cohort comprised 65 patients (52.3% male) aged 61.5 ± 13.5 years, with a mean dialysis vintage of 54.7 ± 39.1 months. During 40 (20-54) months of follow-up, symptomatic CVOD recurred in 32 (49.2%) patients, accounting for 51 secondary angioplasties, including 34 stenting procedures. The PPR and APR at 12, 24, 36, 48, and 60 months were 81%, 52%, 47%, 41%, and 41% and 98%, 98%, 82%, 82%, and 82%, respectively. VA abandonment was noted in 10 (15.4%) patients. Six (9.2%) and 17 (26.2%) patients died due to cardiovascular conditions and all causes, respectively. The number of secondary stenting procedures was significantly associated with decreased VA abandonment [odds ratio (OR) = 0.089, 95% confidence interval (CI): 0.008-0.992,  = 0.049] and all-cause mortality (OR = 0.104, 95% CI: 0.011-0.947,  = 0.045). Angioplasty with stenting is an effective and promising strategy for MHD patients with refractory CVOD.

The conventional methods of silicon stent insertion recommend usage of external loading devices, where the stent is folded into the loading device and pushed in to the tracheobronchial tree using an external pusher which is blind, and leads to placement of stent either distally or proximally needing repositioning or is done with fluoroscopy that involves radiation exposure. We demonstrate our experience in 16 cases of successful silicon stent placement using this technique, wherein an Ultrathin flexible bronchoscope or Hopkins Rigid telescope is pushed alongside the forceps that hold upper end of the folded silicon stent allowing stent placement under direct vision with control over the stent. The Proximal end of the stent can be pulled under vision before deployment for appropriate positioning while pulling the rigid barrel. The stent is always under the operator's control providing excellent control over placement, simplifies the procedure and is safe with no reported complications. We present a novel technique for silicon stent insertion under direct visualization, improving accuracy and safety while eliminating the need for external loading devices and fluoroscopy. This method demonstrated in 16 cases, simplifies the procedure, ensure precise placement and avoid radiation exposure while placing silicon stent.

To investigate the effect and safety of percutaneous endovascular angioplasty (PEA) with optional stenting for the treatment of severe stenosis or occlusion of subclavian artery, patients with severe stenosis ≥ 70% or occlusion of subclavian artery treated with PEA were retrospectively enrolled. The clinical data were analyzed. A total of 222 patients were retrospectively enrolled, including 151 males (68.0%) and 71 females (32.0%) aged 48–86 (mean 63.9 ± 9.0) years. Forty-seven (21.2%) patients had comorbidities. Subclavian artery stenosis ≥ 70% was present in 201 (90.5%) patients and complete subclavian occlusion in 21 (9.5%) cases. Angioplasty was successfully performed in all (100%) patients. Balloon-expandable stents were used in 190 (85.6%) cases, and self-expandable stents in 20 (9.0%) cases. Only 12 (5.4%) cases were treated with balloon dilation only. Among 210 patients treated with stent angioplasty, 71 (33.8% or 71/210) cases underwent balloon pre-dilation, 139 (66.2% or 139/210) had direct deployment of balloon-expandable stents, and 2 (1.0% or 2/210) experienced balloon post-dilation. Distal embolization protection devices were used in 5 (2.3% or 5/222) cases. Periprocedural complications occurred in 3 (1.4%) patients, including aortic dissection in 2 (0.9%) cases and right middle cerebral artery embolism in 1 (0.5%). No hemorrhage occurred. Among 182 (82.0%) patients with 6-month follow-up, restenosis > 70% occurred in 1 (0.5%) patient, and among 68 (30.6%) patients with 12-month follow-up, restenosis > 70% took place in 11 (16.2%) patients. Percutaneous endovascular angioplasty can be safely and efficiently performed for the treatment of severe stenosis ≥ 70% or occlusion of subclavian artery.

A flow diverter (FD) is a flexible, densely braided stent-mesh device placed endoluminally across an intracranial aneurysm to induce its thrombotic occlusion. FD treatment planning using computational virtual stenting and flow simulation requires accurate representation of the expanded FD geometry. We have recently developed a high fidelity virtual stenting (HiFiVS) technique based on finite element analysis to simulate detailed FD deployment processes in patient-specific aneurysms (Ma et al. J. Biomech. 45:2256–2263, 2012 ). This study tests if HiFiVS simulation can recapitulate real-life FD implantation. We deployed two identical FDs (Pipeline Embolization Device) into phantoms of a wide-necked segmental aneurysm using a clinical push–pull technique with different delivery wire advancements. We then simulated these deployment processes using HiFiVS and compared results against experimental recording. Stepwise comparison shows that the simulations precisely reproduced the FD deployment processes recorded in vitro . The local metal coverage rate and pore density quantifications demonstrated that simulations reproduced detailed FD mesh geometry. These results provide validation of the HiFiVS technique, highlighting its unique capability of accurately representing stent intervention in silico .

Considering the field of application involving stent deployment simulations, the exploitation of a digital twin of coronary stenting that can reliably mimic the patient-specific clinical reality could lead to improvements in individual treatments. A starting step to pursue this goal is the development of simple, but at the same time, robust and effective computational methods to obtain a good compromise between the accuracy of the description of physical phenomena and computational costs. Specifically, this work proposes an approach for the development of a patient-specific artery model to be used in stenting simulations. The finite element model was generated through a 3D reconstruction based on the clinical imaging (coronary Optical Coherence Tomography (OCT) and angiography) acquired on the pre-treatment patient. From a mechanical point of view, the coronary wall was described with a suitable phenomenological model, which is consistent with more complex constitutive approaches and accounts for the in vivo pressurization and axial pre-stretch. The effectiveness of this artery modeling method was tested by reproducing in silico the stenting procedures of two clinical cases and comparing the computational results with the in vivo lumen area of the stented vessel.

The optimal treatment of intracranial aneurysms using flow diverting devices is a fundamental issue for neuroradiologists as well as neurosurgeons. Due to highly irregular manifold aneurysm shapes and locations, the choice of the stent and the patient-specific deployment strategy can be a very difficult decision. To support the therapy planning, a new method is introduced that combines a three-dimensional CFD-based optimization with a realistic deployment of a virtual flow diverting stent for a given aneurysm. To demonstrate the feasibility of this method, it was applied to a patient-specific intracranial giant aneurysm that was successfully treated using a commercial flow diverter. Eight treatment scenarios with different local compressions were considered in a fully automated simulation loop. The impact on the corresponding blood flow behavior was evaluated qualitatively as well as quantitatively, and the optimal configuration for this specific case was identified. The virtual deployment of an uncompressed flow diverter reduced the inflow into the aneurysm by 24.4% compared to the untreated case. Depending on the positioning of the local stent compression below the ostium, blood flow reduction could vary between 27.3% and 33.4%. Therefore, a broad range of potential treatment outcomes was identified, illustrating the variability of a given flow diverter deployment in general. This method represents a proof of concept to automatically identify the optimal treatment for a patient in a virtual study under certain assumptions. Hence, it contributes to the improvement of virtual stenting for intracranial aneurysms and can support physicians during therapy planning in the future.

Nitinol stent oversizing is frequently performed in peripheral arteries to ensure a desirable lumen gain. However, the clinical effect of mis-sizing remains controversial. The goal of this study was to provide a better understanding of the structural and hemodynamic effects of Nitinol stent oversizing. Five patient-specific numerical models of non-calcified popliteal arteries were developed to simulate the deployment of Nitinol stents with oversizing ratios ranging from 1.1 to 1.8. In addition to arterial biomechanics, computational fluid dynamics methods were adopted to simulate the physiological blood flow inside the stented arteries. Results showed that stent oversizing led to a limited increase in the acute lumen gain, albeit at the cost of a significant increase in arterial wall stresses. Furthermore, localized areas affected by low Wall Shear Stress increased with higher oversizing ratios. Stents were also negatively impacted by the procedure as their fatigue safety factors gradually decreased with oversizing. These adverse effects to both the artery walls and stents may create circumstances for restenosis. Although the ideal oversizing ratio is stent-specific, this study showed that Nitinol stent oversizing has a very small impact on the immediate lumen gain, which contradicts the clinical motivations of the procedure.

Oversizing of the Nitinol stents in the femoro-popliteal arterial tract is commonly performed by clinicians and further encouraged by stent manufacturers. However, in spite of the procedure’s supposed benefits of strong wall apposition and increased luminal gain, its effects on the mechanical behavior of arteries with peripheral arterial disease are not fully clear. In this study, finite element (FE) analyses of endovascular revascularization of an idealized artery with 70% stenosis and three different plaque types have been performed to examine the influence of Nitinol stent oversizing on the arterial stresses and acute lumen gain. The analyses included the simulation of balloon angioplasty to model plaque failure, followed by stent implantation, in which four different oversizing ratios were investigated. Results showed that balloon angioplasty was crucial in determining the stress levels of the artery prior to stent implantation and heavily affected the outcome of endovascular therapy. For all plaque types, Nitinol stent oversizing was found to produce a marginal lumen gain in contrast to a significant increase in arterial stresses. For the arteries with lightly and moderately calcified plaques, oversizing was found to be non-critical; whereas for the arteries with heavily calcified plaques, the procedure should be avoided due to a risk of tissue failure.