Comparison of PED and FRED flow diverters for posterior circulation aneurysms: a propensity score matched cohort study.

BACKGROUND: Flow diversion is a common endovascular treatment for cerebral aneurysms, but studies comparing different types of flow diverters are scarce. OBJECTIVE: To perform a propensity score matched cohort study comparing the Pipeline Embolization Device (PED) and Flow Redirection Intraluminal Device (FRED) for posterior circulation aneurysms. METHODS: Consecutive aneurysms of the posterior circulation treated at 25 neurovascular centers with either PED or FRED were collected. Propensity score matching was used to control for age, duration of follow-up imaging, adjunctive coiling, and aneurysm location, size, and morphology; previously ruptured aneurysms were excluded. The two devices were compared for the following outcomes: procedural complications, aneurysm occlusion, and functional outcome. RESULTS: A total of 375 aneurysms of the posterior circulation were treated in 369 patients. The PED was used in 285 (77.2%) and FRED in 84 (22.8%) procedures. Aneurysms treated with the PED were more commonly fusiform and larger than those treated with FRED. To account for these important differences, propensity score matching was performed resulting in 33 PED and FRED unruptured aneurysm pairs. No differences were found in occlusion status and neurologic thromboembolic or hemorrhagic complications between the two devices. The proportion of patients with favorable functional outcome was higher with FRED (100% vs 87.9%, p=0.04). CONCLUSION: Comparative analysis of PED and FRED for the treatment of unruptured posterior circulation aneurysms did not identify significant differences in aneurysm occlusion or neurologic complications. Variations in functional outcomes warrant additional investigations.

Biomodex patient-specific brain aneurysm models: the value of simulation for first in-human experiences using new devices and robotics.

BACKGROUND: With the recent advent of advanced technologies in the field, treatment of neurovascular diseases using endovascular techniques is rapidly evolving. Here we describe our experience with pre-surgical simulation using the Biomodex EVIAS patient-specific 3D-printed models to plan aneurysm treatment using endovascular robotics and novel flow diverter devices. METHODS: Pre-procedural rehearsals with 3D-printed patient-specific models of eight cases harboring brain aneurysms were performed before the first in-human experiences. To assess the reliability of the experimental model, the characteristics of the aneurysms were compared between the patient and 3D models. The rehearsals were used to define the patient treatment plan, including technique, device sizing, and operative working projections. RESULTS: The study included eight patients with their respective EVIAS 3D aneurysm models. Pre-operative simulation was performed for the first in-human robotic-assisted neurovascular interventions (n=2) and new generation flow-diverter stents (n=6). Aneurysms were located in both the anterior (n=5) and posterior (n=3) circulation and were on average 11.0±6.5 mm in size. We found reliable reproduction of the aneurysm features and similar dimensions of the parent vessel anatomy between the 3D models and patient anatomy. Information learned from pre-surgical in vitro simulation are described in detail, including an improved patient treatment plan, which contributed to successful first in-world procedures with no intraprocedural complications. CONCLUSIONS: Pre-procedural rehearsal using patient-specific 3D models provides precise procedure planning, which can potentially lead to greater operator confidence, decreased radiation dose and improvements in patient safety, particularly in first in-human experiences.

Clinical outcomes and survival following placement of self-expandable metallic stents for central airway stenosis and fistula.

BACKGROUND: Self-expandable metallic stent (SEMS) placement is an urgent procedure for patients with malignant central airway stenoses (CASs) and central airway fistulas (CAFs). The aim of this study was to determine the outcome and survival after SEMS placement in patients with malignant CASs and CAFs. METHODS: SEMSs were inserted into 20 patients with malignant CASs and four with malignant CAFs. Hospital records, the modified Medical Research Council dyspnea scale (mMRC) grade, performance status (PS), symptoms, procedure-related complications and survival after placement were retrospectively reviewed. RESULTS: Spiral Z stents were inserted in nine patients, covered Ultraflex stents in 14, and a bare Ultraflex in one patient. After SEMS placement, 20 patients (83.3%) showed improvement in mMRC grade, 19 (79.2%) showed improvement in PS, and 21 (87.5%) showed improvement in symptoms. There were three patients whose stents migrated out of place, but there were no patients with obstructive granulation, infection, or mucous plugs. Median survival days after stent insertion was 98 days for CAS and 103 days for CAF, and mean survival days was 383 ± 707 days for CAS and 93 ± 33 days for CAF. Two patients with CAS by malignant lymphoma and thymic cancer survived more than six years because they were also treated with efficient therapies. The five-year survival rate after stent insertion was 7.7%. CONCLUSIONS: SEMS placement for CAS and CAF is associated with improvement in mMRC grade, PS and symptoms in 87.5% of patients. Patients with a malignant CAS are usually terminal, but the possibility of increasing survival rate will become a reality with new efficient therapies. KEY POINTS: SIGNIFICANT FINDINGS OF THE STUDY: Reasonable clinical outcomes and improved survival of patients following SEMS placement for thoracic malignancy with central airway stenosis and fistula. WHAT THIS STUDY ADDS: The possibility of increasing survival rate will become a reality with new efficient therapies.

Predictors for Treatment Failure of Self-Expandable Metal Stents for Anastomotic Leak after Gastro-Esophageal Resection.

BACKGROUND AND AIMS: Self-expandable metal stents are used for the treatment of anastomotic leaks after gastro- esophageal surgery. Predictors for treatment failure and complications are unknown. In this observational retrospective study, we summarize our experience with self-expandable metal stents for the treatment of anastomotic leaks, in order to determine the predictors of treatment failure. METHODS: Between 2009 and 2015, 34 patients with anastomotic leak after curative resection of gastro- esophageal cancer were treated with self-expandable metal stents. Gender, histology, comorbidity, body mass index, neoadjuvant therapy, previous surgery, leak size, and stent diameter were analyzed for their predictive value according to treatment success and complication rate. RESULTS: Leak closure rate was 76%. Risk factors for treatment failure were neoadjuvant chemo-radiotherapy, squamous cell histology, and esophageal tumor location. Gender, comorbidity, body mass index, neoadjuvant chemotherapy, and previous surgery were not correlated with outcome. Mortality rate was 20%, most often due to uncontrolled leak. Severe stent-related complications occurred in 15% of patients, most of them following insertion of a large-sized stent. CONCLUSION: Squamous cell histology, neoadjuvant chemo-radiotherapy, and esophageal tumor location are predictors for treatment failure. Severe stent-related complications seem to be preferentially associated with the use of large-sized stents.

Accuracy of optical coherence tomography imaging in assessing aneurysmal remnants after flow diversion.

BACKGROUND: Optical coherence tomography (OCT) is an ultra-high resolution real-time intravascular imaging method that is gaining interest in cerebrovascular applications. OBJECTIVE: To compare, in a rabbit elastase aneurysm model, digital subtraction angiography (DSA) and OCT as diagnostic tools for the assessment of aneurysmal remnants and baseline characteristics of aneurysms after flow diverter (FD) implantation. METHODS: With Institutional Animal Care and Use Committee approval, saccular aneurysms were created in 28 rabbits and treated with Derivo FDs. DSA was performed before, and immediately after, stent implantation. As a follow-up, DSA and OCT were performed 28 days after device implantation. RESULTS: DSA and OCT were successfully performed in 23 cases. OCT could not be achieved in 5 cases owing to navigational difficulties in the stent lumen with the OCT catheter. Residual aneurysms were significantly more often visible with OCT (18/23 (78%) than with DSA 12/23 (52%), p = 0.031). CONCLUSION: OCT was more sensitive than conventional angiography for the assessment of residual aneurysms at 28 days after FD implantation in an animal model.

Colorectal stenting in England: a cross-sectional study of practice.

INTRODUCTION: UK and European guidelines recommend consideration of a self-expandable metallic stent (SEMS) as an alternative to emergency surgery in left-sided colonic obstruction. However, there is no clear consensus on stenting owing to concern for complications and long-term outcomes. Our study is the first to explore SEMS provision across England. METHODS: All colorectal surgery department leads in England were contacted in 2018 and invited to complete an objective multiple choice questionnaire pertaining to service provision of colorectal stenting (including referrals, time, location and specialty). RESULTS: Of 182 hospitals contacted, 79 responded (24 teaching hospitals, 55 district general hospitals). All hospitals considered stenting, with 92% performing stenting and the remainder referring. The majority (93%) performed fewer than four stenting procedures per month. Most (96%) stented during normal weekday hours, with only 25% stenting out of hours and 23% at weekends. Compared with district general hospitals, a higher proportion of teaching hospitals stented out of hours and at weekends. Stenting was performed in the radiology department (64%), the endoscopy department (44%) and operating theatres (15%), by surgeons (63%), radiologists (60%) and gastroenterologists (48%). A radiologist was present in 66% of cases. Of 14 hospitals that received referrals, 3 had a protocol, 3 returned patients the same day and 4 returned patients for management in the event of failure. CONCLUSIONS: All responding hospitals in England consider the use of SEMS in colonic obstruction. Nevertheless, there is great variation in stenting practices, and challenges in terms of access and expertise. Centralisation and regional referral networks may help maximise availability and expertise but more work is needed to support this.

Virtual simulation with Sim&Size software for Pipeline Flex Embolization: evaluation of the technical and clinical impact.

INTRODUCTION: During flow diversion, the choice of the length, diameter, and location of the deployed stent are critical for the success of the procedure. Sim&Size software, based on the three-dimensional rotational angiography (3D-RA) acquisition, simulates the release of the stent, suggesting optimal sizing, and displaying the degree of the wall apposition. OBJECTIVE: To demonstrate technical and clinical impacts of the Sim&Size simulation during treatment with the Pipeline Flex Embolization Device. METHODS: Consecutive patients who underwent aneurysm embolization with Pipeline at our department were retrospectively enrolled (January 2015-December 2017) and divided into two groups: treated with and without simulation. Through univariate and multivariate models, we evaluated: (1) rate of corrective intervention for non-optimal stent placement, (2) duration of intervention, (3) radiation dose, and (4) stent length. RESULTS: 189 patients, 95 (50.2%) without and 94 (49.7%) with software assistance were analyzed. Age, sex, comorbidities, aneurysm characteristics, and operator's experience were comparable among the two groups. Procedures performed with the software had a lower rate of corrective intervention (9% vs 20%, p=0.036), a shorter intervention duration (46 min vs 52 min, p=0.002), a lower median radiation dose (1150 mGy vs 1558 mGy, p<0.001), and a shorter stent length (14 mm vs 16 mm, p<0.001). CONCLUSIONS: In our experience, the use of the virtual simulation during Pipeline treatment significantly reduced the need for corrective intervention, the procedural time, the radiation dose, and the length of the stent.

Versatile use of catheter systems for deployment of the Pipeline embolization device: a comparison of biaxial and triaxial catheter systems.

BACKGROUND: A Pipeline embolization device (PED; Medtronic, Dublin, Ireland) can be deployed using either a biaxial or a triaxial catheter delivery system. OBJECTIVE: To compare the use of these two catheter delivery systems for intracranial aneurysm treatment with the PED. METHODS: A retrospective study of patients undergoing PED deployment with biaxial or triaxial catheter systems between 2014 and 2016 was conducted. Experienced neurointerventionalists performed the procedures. Patients who received multiple PEDs or adjunctive coils were excluded. The two groups were compared for PED deployment time, total fluoroscopy time, patient radiation exposure, complications, and cost. RESULTS: Eighty-two patients with 89 intracranial aneurysms were treated with one PED each. In 49 cases, PEDs were deployed using biaxial access; triaxial access was used in 33 cases. Time (min) from guide catheter run to PED deployment was significantly shorter in the biaxial group (24.0±18.7 vs 38.4±31.1, P=0.006) as was fluoroscopy time (28.8±23.0 vs 50.3±27.1, P=0.001). Peak radiation skin exposure (mGy) in the biaxial group was less than in the triaxial group (1243.7±808.2 vs 2074.6±1505.6, P=0.003). No statistically significant differences were observed in transient and permanent complication rates or modified Rankin Scale scores at 30 days. The triaxial access system cost more than the biaxial access system (average $3285 vs $1790, respectively). Occlusion rates at last follow-up (mean 6 months) were similar between the two systems (average 88.1%: biaxial, 89.2%: triaxial). CONCLUSION: Our results indicate near-equivalent safety and effectiveness between biaxial and triaxial approaches. Some reductions in cost and procedure time were noted with the biaxial system.

Preliminary in vitro angiographic comparison of the flow diversion behavior of Evolve and Pipeline devices.

BACKGROUND AND PURPOSE: Flow diverters are increasingly used to treat a broad category of cerebral aneurysms. We conducted an in vitro study to angiographically compare the flow diversion effect of Surpass Evolve from Stryker Neurovascular with the Pipeline Shield Embolization Device from Medtronic Neurovascular. METHODS: Three copies each of three carotid aneurysm geometries were manufactured from silicone. Evolve and Pipeline flow diverters were deployed in one copy of each geometry; the third copy was used as Control. High-speed angiography was acquired under pulsatile flow in each replica, contrast concentration-time curves within the aneurysms were recorded, and the curves were quantified with six parameters. The parameters were statistically evaluated to compare the flow diversion effect of both devices. RESULTS: The Evolve showed greater flow diversion trends in almost all intra-geometry comparisons than the Pipeline. When aggregated over the three geometries, the Evolve was statistically significantly better than the Pipeline in four of the six parameters, and about the same or better (not statistically significant) than the Pipeline in the other two parameters. CONCLUSIONS: The Evolve device demonstrated greater in vitro flow diversion effects than Pipeline. Comparative efficacy of the devices will need to be adjudicated based on clinical outcomes.

Partially Covered Versus Uncovered Self-Expandable Metal Stents: Coating Nor Diameter Affect Clinical Outcomes.

INTRODUCTION: Jaundice is a common initial presentation of malignant biliary stricture. In patients with life expectancies that are greater than 3 months, self-expanding metal stents (SEMS) offer a larger diameter stent with longer patency and fewer complications compared to plastic stents. There have been conflicting results in the published literature as to efficacy and safety between the various SEMS types and diameters. We compared stent coating (PCSEMS vs USEMS) and diameter on clinical outcomes regarding management of malignant biliary obstruction. METHODS: A retrospective cohort study was conducted using a database of consecutive patients who underwent an ERCP with biliary SEMS placement (only 8 and 10 mm) between 2009 and 2017. RESULTS: In total, 278 patients who had SEMS at ERCP for malignant biliary obstruction were included (213 PCSEMS vs 65 USEMS). The groups were demographically evenly matched. Clinical success rates and patency duration were not statistically significant between PCSEMS and USEMS (98.1% vs 95.5%, P = 0.36, and 302.5 vs 225.5 days, P = 0.72, respectively). Adverse event rates were similar between both PCSEMS and USEMS with regard to overall adverse events. Stent diameter did not have an impact on overall clinical success (98.9% vs 95.3%, P = 0.11) or patency duration (239 days vs 336 days, P = 0.51). CONCLUSIONS: Our comparison of PCSEMS versus USEMS and 8 mm versus 10 mm showed no difference in clinical efficacy or adverse events between the two SEMS coatings and diameter, illustrating that coating and size do not matter in regard to stent choice, despite prior suggestive data.

A curious case of forceps delivery in IR.

Self-expanding nitinol stents are routinely used to treat left common iliac vein compression in patients with May-Thurner syndrome. On occasion these stents do not provide adequate radial force to achieve a sufficient iliac lumen. If symptoms persist and persistent iliac vein compression is noted then balloon-expandable stents may be used to provide buttressing support at the compression site. We present a case where the buttressing balloon-expandable stent is crushed and subsequently removed percutaneously prior to placement of a high radial force self-expanding stent at the compressive site.

Hemodynamic differences between Pipeline and coil-adjunctive intracranial stents.

INTRODUCTION: Modern coil-adjunctive intracranial stent designs have increased metal surface coverage to construct putative 'flow diverter lights.' This is rooted in the assumption that flow diversion is linearly correlated with metal surface coverage rather than being a threshold to be reached by device porosity and design. OBJECTIVE: To evaluate this assumption, by performing computational flow analysis on three aneurysm models treated with low metal surface coverage stents (ATLAS and Enterprise), a Pipeline flow diverter, and the LVIS Blue stent. METHODS: Computational flow analysis was performed on virtual deployment models entailing deployment of an ATLAS, Enterprise, LVIS Blue, or Pipeline. The impact of device deployment on velocity vectors at the neck, maximum wall shear stress, inflow rate into the aneurysm, and turnover time was determined. RESULTS: Velocity vector plots demonstrated low magnitude, localized inflow jets for Pipeline only; asymmetric, selectively high inflow jets were seen for LVIS Blue, and broader velocity vector clusters were seen for Atlas and Enterprise. Reduction in wall shear stress as compared with baseline was significant for all devices and greatest for the Pipeline. Mean peak wall shear stress was significantly lower for LVIS Blue in comparison with ATLAS or Enterprise but significantly lower for Pipeline than for LVIS Blue. Reduction of inflow rate into the aneurysm was significant for LVIS Blue and Pipeline but significantly lower for Pipeline than for LVIS Blue. Turnover time was statistically similar for ATLAS, Enterprise, and LVIS Blue, but significantly increased for Pipeline. CONCLUSION: Considerable differences in peak wall shear stress, inflow rates, and turnover time between flow diverters, moderate- and low-porosity stents reinforce the assumption that effective flow diversion represents a threshold in device design, encompassing metal surface coverage only in part.

Evaluating the effectiveness and safety of the carotid Casper-RX stent for tandem lesions in acute ischemic stroke.

INTRODUCTION: A new generation of carotid artery stents that use a dual micromesh layer to reduce embolic events during carotid artery stenting has recently been introduced. We aimed to analyze the effectiveness and safety of the new Casper-RX stent in patients experiencing acute ischemic stroke with large vessel intracranial occlusion associated with a tandem lesion (another carotid occlusion or severe stenosis). METHODS: We retrospectively analyzed all consecutive patients treated with carotid Casper-RX stents from our stroke registry. We analyzed clinical, angiographic, and neuroimaging data. Endpoints included acute intra-stent thrombus formation, stent occlusion prior to hospital discharge, 3 month modified Rankin Scale score (mRS), and symptomatic intracranial hemorrhage. RESULTS: 21 patients were included: 10 patients had tandem carotid occlusions and 11 patients had severe carotid stenosis, 8 of whom had a hemodynamically significant stenosis. We observed acute in-stent thrombus formation in 11 patients. No stent occlusion occurred prior to hospital discharge. We report no stroke recurrence at 3 months but symptomatic intracranial hemorrhage in two patients. mRS score at 3 months was 0-2 (favorable) for 15 patients (71%), 3-5 for 3 patients, and 6 for 3 patients. CONCLUSIONS: In the present series, we frequently observed clot formation during the procedure with Casper-RX stents, which required periprocedural intravenous infusion of anticoagulant and antiplatelet treatment. This motivated us, in the absence of a prospective randomized controlled study demonstrating the non-inferiority of micromesh dual layer stents compared with the single layer design, to discontinue using this stent type in acute stroke requiring carotid angioplasty.

Self-expanding metal stent procedure for afferent loop syndrome with ascending cholangitis caused by remnant gastric cancer: A case report.

RATIONALE: Self-expanding metal stent placement is a useful procedure for intestinal obstruction. Afferent loop syndrome after gastrectomy is an uncommon complication of gastroenterostomy reconstruction. Ascending cholangitis caused by afferent loop syndrome is a potential, but rare, complication. PATIENT CONCERNS: A 73-year-old man with abdominal pain and vomiting was admitted to the emergency room. His medical history was significant for subtotal gastrectomy with Billroth II anastomosis for benign gastric ulcer perforation 40 years prior. He had notable tenderness to palpation, particularly on the epigastric area, and a temperature of 39.0°C. DIAGNOSIS: Abdominal computed tomography revealed afferent loop syndrome with ascending cholangitis caused by remnant gastric cancer. INTERVENTIONS: Percutaneous catheter drainage for management of ascending cholangitis was performed on the day of admission. He was subsequently treated with self-expandable metal stent insertion into the stenotic lesion. OUTCOMES: After treatment with percutaneous transhepatic insertion of a self-expanding stent, the patient achieved complete resolution of symptoms. The patient died of disease progression 2 months later, without further recurrence of afferent loop syndrome. LESSONS: Our case shows that insertion of a metal stent via percutaneous transhepatic biliary drainage (PTBD) can effectively treat ascending cholangitis and resolve afferent loop syndrome in inoperable patients.

No inferiority of Tonbridge thrombectomy device for acute thrombus retrial compared with Solitaire device: an experimental evaluation with a canine distal external carotid-maxillary artery occlusion model.

INTRODUCTION: Mechanical thrombectomy (MT) has been widely accepted as a safe and effective treatment for acute ischemic stroke (AIS). Development of stent retriever devices has been intensively developed over the past two decades. In this study, we compared the effectiveness and safety of a new thrombectomy device with Solitaire FR for the treatment of AIS models. METHODS: Mechanical performance of stent retrievers was tested in vitro. Thrombin-induced thrombus was pre-injected into the right distal external carotid-maxillary artery in 18 dogs to create an acute thrombus occlusion model, and these animals were divided into a Tonbridge group (n=9, with Tonbridge stent Tonbridge Medical Technology) and a Solitaire group as control (n=9, with Solitaire stent, ev3 Neurovascular). Final flow restoration, side branches, recanalization time, distal vessel embolism, and device-related complications were recorded and compared. A post-procedure angiogram was obtained at 30 and 90 days after thrombectomy. Device manipulation-related damage to the arterial walls was evaluated histologically. RESULTS: In vitro test showed that the maximum friction within the microcatheter was 0.763 for the Tonbridge device and 0.784 n for the Solitaire (P>0.05). Slight increase in radial force was noticed for the Tonbridge (0.035 N/mm vs 0.031 N/mm of Solitaire, P>0.05). Eighteen and 16 retriever attempts were done in the Tonbridge (mean 2.0 attempts) and the Solitaire (mean 1.8 attempts) groups (P=0.74). The Tonbridge device led to good flow restoration in all nine (100%) models compared with eight (88.9%) in the Solitaire group (P=0.30). Side branches' influence (P=0.39), distal thromboembolism (P=0.60), and device-related complications (P=1.00) found no difference between the two groups. The rates of disruption of the internal elastic lamina (IEL) were 8.3% (2/24) and 4.2% (1/24) of the specimens, respectively (P=0.683). TICI 2b/3 flow of the right CCA were similar between the two groups at 1 (6/6 vs 6/6) and 3 months (6/6 vs 6/6) follow-up (P>0.05). CONCLUSION: Our preliminary study indicated this new device was technically feasible and effective to be used in thrombectomy for the treatment of acute thrombus occlusion in canine models.

Direct comparison of coronary bare metal vs. drug-eluting stents: same platform, different mechanics?

BACKGROUND: Drug-eluting stents (DES) compared to bare metal stents (BMS) have shown superior clinical performance, but are considered less suitable in complex cases. Most studies do not distinguish between DES and BMS with respect to their mechanical performance. The objective was to obtain mechanical parameters for direct comparison of BMS and DES. METHODS: In vitro bench tests evaluated crimped stent profiles, crossability in stenosis models, elastic recoil, bending stiffness (crimped and expanded), and scaffolding properties. The study included five pairs of BMS and DES each with the same stent platforms (all n = 5; PRO-Kinetic Energy, Orsiro: BIOTRONIK AG, Bülach, Switzerland; MULTI-LINK 8, XIENCE Xpedition: Abbott Vascular, Temecula, CA; REBEL Monorail, Promus PREMIER, Boston Scientific, Marlborough, MA; Integrity, Resolute Integrity, Medtronic, Minneapolis, MN; Kaname, Ultimaster: Terumo Corporation, Tokyo, Japan). Statistical analysis used pooled variance t tests for pairwise comparison of BMS with DES. RESULTS: Crimped profiles in BMS groups ranged from 0.97 ± 0.01 mm (PRO-Kinetic Energy) to 1.13 ± 0.01 mm (Kaname) and in DES groups from 1.02 ± 0.01 mm (Orsiro) to 1.13 ± 0.01 mm (Ultimaster). Crossability was best for low profile stent systems. Elastic recoil ranged from 4.07 ± 0.22% (Orsiro) to 5.87 ± 0.54% (REBEL Monorail) including both BMS and DES. The bending stiffness of crimped and expanded stents showed no systematic differences between BMS and DES neither did the scaffolding. CONCLUSIONS: Based on in vitro measurements BMS appear superior to DES in some aspects of mechanical performance, yet the differences are small and not class uniform. The data provide assistance in selecting the optimal system for treatment and assessment of new generations of bioresorbable scaffolds. TRIAL REGISTRATION: not applicable.

A comparison between the new Low-profile Visualized Intraluminal Support (LVIS Blue) stent and the Flow Redirection Endoluminal Device (FRED) in bench-top and cadaver studies.

OBJECT: The aim of this study is to demonstrate the differences between the new Low-profile Visualized Intraluminal Support (LVIS Blue) stenting device and the Flow Redirection Endoluminal Device (FRED) using a series of bench-top evaluations and optical coherence tomography (OCT) images in a cadaveric preparation of the basilar artery. METHODS: The first part of the evaluation was bench-top microscopic documentation of metal coverage for LVIS Blue and FRED stents. OCT images of the cerebral vessels and deployed stents were acquired using OCT intravascular imaging. The stents were deployed from the left posterior cerebral artery to the basilar artery in a fresh frozen cadaver. Wall apposition and the relationship to jailed perforators were evaluated. RESULTS: The metal coverage along the inner curves of the LVIS Blue stent was similar to that along the outer curves of the FRED stent. The LVIS Blue stent cell size was compatible for crossing with the tested microcatheters after deployment of the stent. The LVIS Blue stent showed better wall apposition and less coverage of the perforator than the FRED stent in the cadaver experiment. CONCLUSIONS: LVIS Blue has a good crossing profile for microcatheters, better wall apposition, and less perforator coverage than FRED. These are desirable features in territories with high densities of perforators such as the posterior circulation.

Novel characteristics of traction force in biliary self-expandable metallic stents.

BACKGROUND AND AIM: In recent years, knowledge concerning the mechanical properties of self-expandable metallic stents (SEMS) has increased. In a previous study, we defined traction force and traction momentum and reported that these characteristics are important for optimal stent deployment. However, traction force and traction momentum were represented as relative values and were not evaluated in various conditions. The purpose of the present study was to measure traction force in various situations assumed during SEMS placement. METHODS: Traction force and traction momentum were measured in non-stricture, stricture, and angled stricture models using in-house equipment. RESULTS: Stricture and angled stricture models had significantly higher traction force and traction momentum than those of the non-stricture model (stricture vs non-stricture: traction force, 7.2 N vs 1.4 N, P < 0.001; traction momentum, 237.8 Ns vs 62.3 Ns, P = 0.001; angled stricture vs non-stricture: traction force, 7.4 N vs 1.4 N, P < 0.001; traction momentum, 307.2 Ns vs 62.3 Ns, P < 0.001). Traction force was variable during SEMS placement and was categorized into five different stages, which were similar in both the stricture and angled stricture models. CONCLUSIONS: We measured traction force and traction momentum under simulated clinical conditions and demonstrated that strictures and the angular positioning of the stent influenced the traction force. Clinicians should be aware of the transition of the traction force and should schedule X-ray imaging during SEMS placement.