Background The Woven EndoBridge (WEB) device is designed to treat wide-necked bifurcation aneurysms. The WEB 17 is the latest iteration and can be delivered through a 0.017″ microcatheter. The CLEVER study demonstrated that WEB 17 is safe and effective for providing protection against bleeding or rebleeding at 1 month and 1 year. Objective To evaluate angiographic stability at 1 year. Methods The CLEVER study was a prospective multicenter study conducted in 17 European centers, involved 163 subjects, comprising 60 ruptured and 103 unruptured aneurysms. Independent assessment of 1-year follow-up imaging was incorporated into the study design. Results Aneurysm diameters ranged from 2.0 to 9.2 mm, with 95.7% being broad-based (dome-to-neck ratio <2). Follow-up imaging at 1 year was completed for 146 out of 163 subjects (89.6%) and evaluated by an independent core laboratory. The primary efficacy endpoint of adequate occlusion without re-treatment at 1 year was achieved for 120 (82.2%) of all subjects. At 1 year, the adequate occlusion rate was 86.5% for ruptured aneurysms (73.1% complete occlusion) and 82.4% for unruptured aneurysms (57.1% complete occlusion). The overall re-treatment rate at 1 year was 2.6% (4/152), with 3.1% (3/97) for unruptured aneurysms and 1.8% (1/55) for ruptured aneurysms Conclusion Delivery of the WEB 17 via 0.017 inch catheters represents a significant evolution of the WEB design. The results of CLEVER presented here demonstrate that it maintains the same efficacy as previous generations of WEB.
Preoperative endovascular embolisation is a widely used adjunct for the surgical treatment of brain arteriovenous malformations (AVMs). However, whether this improves completeness of AVM resection is unknown, as previous analyses have not adjusted for potential confounding factors. We aimed to determine if preoperative endovascular embolisation was associated with increased rate of complete AVM resection at first surgery, following adjustment for Spetzler-Martin grade items. We identified a cohort of all patients undergoing first ever AVM resection in a specialist neurosciences unit in the NHS Lothian Health Board region of Scotland between June 2004 and June 2022. Data was prospectively extracted from medical records. Our primary outcome was completeness of AVM resection. We determined the odds of complete AVM resection using binomial logistic regression with adjustment for Spetzler-Martin grading system items: maximum nidus diameter, eloquence of adjacent brain and the presence of deep venous drainage. 88 patients (median age 40y [IQR 19–53], 55
BACKGROUND:Intrasaccular flow disruption is an endovascular approach for the treatment of wide-neck aneurysms and, more specifically, wide-neck bifurcation aneurysms, which are challenging to treat with previously developed technologies. The Woven EndoBridge (WEB) device has demonstrated its efficacy and safety, for both unruptured and ruptured aneurysms. METHODS:The CLEVER study was an observational, multicenter, prospective study conducted in 17 European investigational sites using the WEB 17 device, for the treatment of ruptured and unruptured aneurysms. The study objective was to provide safety and efficacy data on the WEB 17 device in the treatment of wide-neck bifurcation aneurysms. Imaging results were assessed independently by a Corelab and adverse events adjudicated by a Clinical Event Adjudicator. This analysis reports procedural results and safety at 30 days and 12 months. RESULTS:A total of 163 patients (mean age 58.1 years; 68.1% women) with 103 unruptured aneurysms and 60 ruptured aneurysms were enrolled. Most aneurysms were located on the anterior communicating artery (ACom) (37.4%) or the middle cerebral artery (MCA) bifurcation (30.1%). Aneurysm widths ranged from 2.0-9.2 mm, and the mean sac width was 5.0 mm. The WEB procedure was successfully completed in 163 patients (100%). At the 12-month follow-up, major stroke events occurred in 3 of 163 patients (1.8%), and no device-related mortality was observed. CONCLUSION:Endovascular treatment of ruptured and unruptured wide-neck bifurcation aneurysms using WEB 17 is safe, with a low complication rate and no device-related mortality. In particular, none of the ruptured aneurysms bled again up to 1 year of follow-up. TRIAL REGISTRATION NUMBER:NCT03844334.
OBJECTIVE:The aim of our multi-center study is to examine 5-year radiological outcomes of intracranial aneurysms (IAs) treated with the Woven EndoBridge (WEB). METHODS:All patients treated with WEB between January 2013 and December 2016 were included. Patient and aneurysm characteristic data was collected from the electronic patient record. Aneurysm occlusion was assessed using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant. Complete occlusion and neck remnant were considered as adequate occlusion, whereas aneurysm remnant was assessed as an inadequate occlusion. RESULTS:A total of 66 patients (72.7% female) with 66 IAs (n = 25 acutely ruptured) were treated with WEB. The mean age of patients was 55.6 years (range: 36-71 years). The mean width of the aneurysm neck was 4.5 mm (range: 2-9 mm). 5-year imaging follow-up data was not available for 16.6% patients (n = 11). During the follow up period, 14.5% of IAs (n = 8/55) required retreatment within 24 months of initial treatment with the WEB. A total of 55 IAs were analyzed for 5-year radiological outcome. Of these, including IAs required retreatment, 47.3% of IAs (n = 26/55) were occluded completely, 36.4% (n = 20/55) had neck remnant and 16.3% (n = 9/55) had recanalized. 83.7% of IAs were occluded adequately. None of the IAs rebled after initial treatment with WEB. CONCLUSION:WEB can provide acceptable adequate occlusion rates at 5 years. Furthermore, recanalization appears to be unlikely after the first two years post-treatment. The results of large studies are needed to confirm these promising long term radiological outcomes.
Background: Flow diverting stents (FDS) are an established endovascular treatment for intracranial aneurysms but are reported to have varying rates of adequate occlusion and thromboembolic complications. This study reports clinical safety and efficacy results of the FRED and FRED Jr FDS in clinical practice in the UK at 6 months and 1 year. Methods: The FRED-UK study is a single arm, multicentre, prospective, observational study conducted in the UK. Safety was reviewed by evaluating morbidity (modified Rankin Score <= 2) and mortality. Efficacy was assessed as adequate occlusion of the treated aneurysm. A clinical event committee and core laboratory independently assessed clinical and anatomical results. Results: Seven neurointerventional centers treated 61 patients, 57 of which met the full inclusion and exclusion criteria. Of these, 75.4% were treated with FRED and 24.6% with FRED Jr. The aneurysms were located on the cavernous or supraclinoid internal carotid artery (ICA) in 75.4%, on the anterior cerebral artery (ACA) or anterior communicating artery (Acom) in 21.1%, and on the middle cerebral artery (MCA) in 3.5%. 57.9% of aneurysms were small (<10 mm), 40.4% were large (10-24 mm) and 1.8% were giant (>= 25 mm). All-cause morbidity and mortality were 0% at 6 and 12 months, and adequate occlusion was 86.7% at 12 months in the per protocol population. Conclusions: The FRED and FRED Jr devices are safe and efficacious in the treatment of intracranial aneurysms
BackgroundPhysician variablity in preoperative planning of endovascular implant deployment and associated inaccuracies have not been documented. This study aimed to quantify the variability in accuracy of physician flow diverter (FD) planning and directly compares it with PreSize Neurovascular (Oxford Heartbeat Ltd) software simulations.MethodsEight experienced neurointerventionalists (NIs), blinded to procedural details, were provided with preoperative 3D rotational angiography (3D-RA) volumetric data along with images annotated with the distal landing location of a deployed Surpass Evolve (Stryker Neurovascular) FD from 51 patient cases. NIs were asked to perform a planning routine reflecting their normal practice and estimate the stent’s proximal landing using volumetric data and the labeled dimensions of the FD used. Equivalent deployed length estimation was performed using PreSize software. NI- and software-estimated lengths were compared with postprocedural observed deployed stent length (control) using Bland–Altman plots. NI assessment agreement was assessed with the intraclass correlation coefficient (ICC).ResultsThe mean accuracy of NI-estimated deployed FD length was 81% (±15%) versus PreSize’s accuracy of 95% (±4%), demonstrating significantly higher accuracy for the software (p<0.001). The mean absolute error between estimated and control lengths was 4 mm (±3.5 mm, range 0.03–30.2 mm) for NIs and 1 mm (±0.9 mm, range 0.01–3.9 mm) for PreSize. No discernable trends in accuracy among NIs or across vasculature and aneurysm morphology (size, vessel diameter, tortuousity) were found.ConclusionsThe study quantified experienced physicians’ significant variablity in predicting an FD deployment with current planning approaches. In comparison, PreSize-simulated FD deployment was consistently more accurate and reliable, demonstrating its potential to improve standard of practice.
Introduction Clinician variability in preoperative planning of endovascular implant deployment and associated inaccuracies have not been yet documented. Aim of Study This study aims to quantify the accuracy of clinician flow diverter (FD) planning and directly compares it with PreSize® Neurovascular (Oxford Heartbeat Ltd.) software simulations. Methods Eight experienced neurointerventionalists (NIs), blinded to procedural details, were provided preoperative 3D-RA volumetric data along with images annotated with the distal landing location of a deployed Surpass Evolve (Stryker Neurovascular) FD from 51 retrospective patient cases. NIs were asked to perform a planning routine reflecting their normal practice and estimate the stent's proximal landing using volumetric data and the labelled dimensions of the FD used. Deployed length estimation was also performed using PreSize software for the same cases. NI and software estimated lengths were compared to post-procedural observed deployed stent length (control) with Bland-Altman plots. Intraclass correlation coefficient (ICC) was used for NI agreement assessment. Results Mean NI accuracy of estimated deployed FD length was 81%(±15) versus PreSize's accuracy of 95%(±4). Software demonstrated significantly higher accuracy (p<.001). The mean absolute error between estimated and control lengths was 4 mm(±3.5 mm, range 0.03–30.2 mm) for NIs and 1 mm(±0.9 mm, range 0.01–3.9 mm) for PreSize. No discernable accuracy trends among NIs or across vasculature and aneurysm morphology (size, vessel diameter, tortuosity) were found. Conclusion The study quantified experienced clinicians' significant variability in predicting an FD deployment with current planning approaches. Comparatively, PreSize simulated FD deployment was consistently more accurate and reliable, demonstrating its potential to improve standard-of-practice. Disclosure of Interest AR, SB: Consulting agreement Stryker, Cerenovus, Microvention J Dower: PI for Oxford Heartbeat Multicentre Prospective Oxford Heartbeat PreSize study. Consulting agreement Stryker, Phenox, Microvention, Oxford Endovascular VN, CG: Consulting agreement Stryker and Medtronic RR: Consulting agreement Stryker, Balt, Medtronic, Microvention, Acandis JP, TP, MS, J DuPlessis: No disclosures
INTRODUCTION:Unruptured intracranial aneurysms (UIA) are common in the adult population, but only a relatively small proportion will rupture. It is therefore essential to have accurate estimates of rupture risk to target treatment towards those who stand to benefit and avoid exposing patients to the risks of unnecessary treatment. The best available UIA natural history data are the PHASES study. However, this has never been validated and given the known heterogeneity in the populations, methods and biases of the constituent studies, there is a need to do so. There are also many potential predictors not considered in PHASES that require evaluation, and the estimated rupture risk is largely based on short-term follow-up (mostly 1 year). The aims of this study are to: (1) test the accuracy of PHASES in a UK population, (2) evaluate additional predictors of rupture and (3) assess long-term UIA rupture rates. METHODS AND ANALYSIS:The Risk of Aneurysm Rupture study is a longitudinal multicentre study that will identify patients with known UIA seen in neurosurgery units. Patients will have baseline demographics and aneurysm characteristics collected by their neurosurgery unit and then a single aggregated national cohort will be linked to databases of hospital admissions and deaths to identify all patients who may have subsequently suffered a subarachnoid haemorrhage. All matched admissions and deaths will be checked against medical records to confirm the diagnosis of aneurysmal subarachnoid haemorrhage. The target sample size is 20 000 patients. The primary outcome will be aneurysm rupture resulting in hospital admission or death. Cox regression models will be built to test each of the study's aims. ETHICS AND DISSEMINATION:Ethical approval has been given by South Central Hampshire A Research Ethics Committee (21SC0064) and Confidentiality Advisory Group support (21CAG0033) provided under Section 251 of the NHS Act 2006. The results will be disseminated in peer-reviewed journals. TRIAL REGISTRATION NUMBER:ISRCTN17658526.
BACKGROUND/PURPOSE:pCONUS 2 and pCONUS 2-HPC are neck-bridging devices that provide coiling support in the endovascular treatment of wide-necked intracranial aneurysms. To date, limited multicentre data has been published. This study provides the first pooled data from multiple UK centres regarding outcomes for these devices covering the periprocedural period to 6-month follow-up. MATERIALS/METHODS:This retrospective, single-arm study assessed 65 patients treated over 3 years from the time of procedure to 6 months post-procedure across four UK centres. Data collected included patient demographics, aneurysm characteristics and antiplatelet regimens. Outcome measures were angiographic results and procedure-related complications from the immediate periprocedural period to 6-month follow-up. RESULTS:Fifty-four unruptured (83.1%) and 11 ruptured (16.9%) aneurysms were treated. Fifty-five aneurysms were located in the anterior circulation (87.7%). There were four device-related intraprocedural complications: three cases of asymptomatic, temporary thrombus formation and one mortality associated with branch vessel occlusion and aneurysm re-bleeding in a ruptured case. There were no post-procedural device-related complications. Satisfactory occlusion was achieved in 58/65 procedures (89.2%) at time of treatment and in 44/60 (73.3%) at 6 months. Satisfactory occlusion correlated with aneurysm size and coiling packing density. Retreatment was required for five unruptured cases (7.7%) and was straightforward with the device in situ. CONCLUSION:pCONUS 2 and pCONUS 2-HPC have good short-term safety profiles. The use of pCONUS 2-HPC in the acute treatment of ruptured aneurysms with postprocedural SAPT is feasible. The devices have an intraprocedural complication rate of 4/65 (6.2%) across multiple UK centres, including a single death (1.5%).
Introduction/Purpose WEB allows treatment of wide-neck bifurcation aneurysms. WEB 17 has been developed to be delivered through low profile 17-microcatheter, allowing to make easier the treatment and to manage smaller aneurysms. The WEB device has demonstrated its efficacy and safety, for both unruptured and ruptured aneurysms. The CLEVER objective has been set up to provide safety and efficacy data on the WEB 0.017 device in treatment of bifurcation aneurysms. These results report description of the efficacy and safety results at 12 months. Material/Methods CLEVER study is an observational, prospective and multicenter study conducted in 17 European sites (France, Germany, Hungary, Finland, United Kingdom) using the WEB 0.017 device, the last developed model of WEB product family with a lower profile. The data collected are 100% monitored and the primary endpoints independently evaluated. Patients'data are collected from baseline to 12-month post-treatment with evaluation visits at discharge, 1, 6 and 12-months post-treatment. Occlusion results are assessed independently by a Corelab and adverse events are adjudicated by a Clinical Events Committee. Study design allows to analyze the study results for the full population as well as separately for ruptured and unruptured aneurysm. An intention treat analysis is performed for the safety population, and sample size calculation is based on objective performance approach for safety and efficacy rates. Results From March 2019 to February 2021, 163 patients (mean age, 58.1 years; 68.1% of women) with 103 unruptured aneurysms and 60 ruptured aneurysms were enrolled. The aneurysms treated were ranging from 2 to 9.2mm (mean maximum sac width = 5.0mm) and dome-to-neck ratio was < 2 in 95.7% of cases. The WEB procedure was completed with success in 163 patients (100%). 147/163 (90.2%) of aneurysm were treated only with WEB implant and adjunctive implanted devices were used in 6/163 (3.7%) of cases. The primary safety endpoint was the proportion of patients with death of any nonaccidental cause or any major stroke (defined as ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the NIHSS) within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment. Four major strokes on 3/163 patients (1.8%) met the primary safety endpoint. The WEB related mortality rate at 12 months was 0%. The primary efficacy endpoint, defined as the 12-month rate of adequate occlusion without retreatment, was 82.2% (120/146 patients). A detailed description of events reported from per procedure up to 30 days will be provided with a specific attention to the aneurysm initial presentation (ruptured vs unruptured). Conclusion These results show good efficacy and safety results at 12 months month, and no WEB related mortality at 12 months. These data confirm the safety and efficacy of WEB 0.017 use in intracranial aneurysm treatment, unruptured as well as ruptured, and are consistent with the results published up to date. Disclosures L. Spelle: 1; C; Philips. 2; C; Microvention, Stryker, Medtronic, Balt, Phenox. C. Cognard: 2; C; Stryker, Medtronic, Mivi, Cerenovus, Microvention. I. Szikora: 2; C; Stryker, Cerenovus, Medtronic, Microvention, Brainomix. F. Wodarg: 2; C; Microvention, Stryker, Cerus Endovascular, Balt, Johnson & Johnson, Acandis. V. Costalat: 2; C; Stryker, Medtronic, Microvention. D. Herbreteau: 2; C; Microvention. S. Fischer: 2; C; Rapid Medical, Microvention, Phenox, Stryker, Kaneka. M. Möhlenbruch: 1; C; Balt, Medtronic, Microvention, Stryker. 2; C; Siemens. C. Papagiannaki: 2; C; Medtronic, Microvention, Stryker. J. Klisch: 2; C; Microvention, Phenox, Cerus. R. Rautio: 2; C; Medtronic, Stryker, Microvention. A. Berlis: None. J. Downer: 1; C; Stryker, Microvention, Oxford Heartbeat. 2; C; Microvention. 3; C; Microvention, Stryker, Medtronic. M. Bester: 2; C; Microvention, Acandis. S. Velasco: None. T. Liebig: 2; C; Cerus endovascular, Stryker, Medtronic, Phenox, Microvention. J. Byrne: 1; C; Microvention. 2; C; Microvention, Oxford Endovascular Ltd. 4; C; Oxford Endovascular Ltd. L. Pierot: 2; C; Balt, Microvention, Phenox, Perflow, Vesalio.
Introduction WEB is an endovascular device allowing treatment of wide-neck bifurcation aneurysms. WEB 17 has been developed to make easier the treatment and to manage smaller aneurysms. Aim of Study CLEVER objective is to provide safety and efficacy data on the WEB 0.017 in treatment of ruptured and unruptured bifurcation aneurysms at 12 months. Methods CLEVER is an observational, prospective multicenter study conducted in 17 European sites. Data collected are 100% monitored and primary endpoints independently evaluated (adverse events adjudicated by CEA, occlusion rates by Corelab). Data were analyzed on the full population as well as separately for ruptured and unruptured aneurysm. Sample size calculation is based on objective performance approach for safety and efficacy rates. Results 163 patients were enrolled with 103 unruptured aneurysms and 60 ruptured aneurysms. Aneurysms treated were ranging from 2 to 9.2 mm. The primary safety endpoint, defined as the proportion of patients with death of any nonaccidental cause or any major stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment, was 1.8%. The primary efficacy endpoint, defined as the 12-month rate of adequate occlusion without retreatment, was 82.2%. Detailed description of endpoints will be provided with a specific attention to the aneurysm initial presentation (ruptured vs unruptured). Conclusion These results show good efficacy and safety results at 12 months, and no WEB related mortality, confirming safety and efficacy of WEB 0.017 use in unruptured and ruptured aneurysms. Disclosure of Interest Istvan Szikora has a consulting agreement with Microvention. I Szikora, Chr Cognard and L Spelle served as research coordinators for the CLEVER study
A 62-year-old woman presented with 3 months of insidious-onset, persistent headache focused around the left temple. She had left-sided pulsatile tinnitus and the affected area was warm to touch. Neurologic examination, including hearing, was normal with no objective bruit. A minimally elevated alkaline phosphatase (282 U/L) was the only blood abnormality. Imaging (figure) revealed …
Background We aim to compare the safety and efficacy of WEB with coiling for acutely ruptured aneurysms. METHODS: All consecutive ruptured aneurysms with width suitable for WEB (2-10 mm) treated over 5 years (1/1/2015 to 31/12/2019) were included. We recorded WFNS, Fisher grade, patient demographics and aneurysm characteristics (size, location, D/W and aspect ratio, lobulation). Primary endpoints were mRS status at 3 months, aneurysm occlusion on latest available imaging follow-up, retreatment rate and procedural complications. We applied propensity score matching using aneurysm morphology (size, D/N ratio, ASPECT ratio and lobulation) to optimise matching for WEB versus coil comparison and minimise the effects of confounding. Result A total of 493 patients were identified, 97 treated with the WEB device. 1:1 propensity score matching was used to establish a matched group of 97 patients treated with coiling. The WEB arm showed 3% procedural complication rate, with no haemorrhagic complications and use of adjunctive device in 4%. Satisfactory occlusion on follow-up (mean 14 months) was 79%, with 19% retreatment rate. The coil arm had 8% complication rate, with use of an adjunctive device in 52% of cases (balloon 44%, stent 8%). Satisfactory occlusion on follow-up (mean 22 months) was 90%, with 8% retreatment rate. Conclusion Treatment of ruptured wide-necked bifurcation aneurysms with WEB has a lower complication rate than coiling with high rate of satisfactory occlusion. However, there was a higher retreatment rate when compared with patients treated with coiling. An adjunct device (balloon or stent), was used in over 50% of aneurysms in the coiling group.
Introduction Intrasaccular flow disruption is an endovascular approach for treatment of wide-neck bifurcation aneurysms. Earlier models of The WEB device have demonstrated their efficacy and safety. Aim CLEVER objective is to provide safety and efficacy data on the WEB 0.017 model in treatment of ruptured and unruptured bifurcation aneurysms. We report description of the full population and safety results within 30 days post procedure. Methods CLEVER is a prospective, multicenter study conducted in 17 European sites. Data collected are 100% monitored and primary endpoints independently evaluated (occlusion rates assessed by a Corelab and adverse events adjudicated by CEC). Analysis was performed for the full population and separately for rutupred/unruptured aneurysm. ITT analysis is performed for safety population, and sample size calculation is based on OPC approach for safety and efficacy rates. Results 163 patients with 103 unruptured aneurysms and 60 ruptured aneurysms were enrolled. Aneurysms locations were mainlyACom (37.4%), and MCA bifurcation (30.1%) location. Aneurysms treated were ranging from 2 to 9.2mm (mean maximum sac width = 5.0mm). The WEB procedure was successfully completed in the 163 patients. For this report covering analysis of data up to 30 days post procedure: major strokes rate was 1.2% and mortality rate was 0%. A detailed description of events reported up to 30 days will be provided. Conclusion These results show good safety profile at 1 month, withlow rate of neurological/neurovascular event with permanent deficit and no mortality at 30 days,confirming the safety of WEB0.017use in intracranial aneurysm treatment, unruptured or ruptured. References Pierot et al. Aneurysm Treatment with Web in the Cumulative Population of Two Prospective, Multicenter Series: 3-year Follow-up. J Neurointerv Surg, 2020 Do you have any conflict of interest to declare?: Yes Conflict of Interest Statement Steering Committee member of the CLEVER study Consulting agreements with Microvention, Medtronic, Stryker, Cerenovus
OBJECTIVE:The use of flow-diverting stents has been increasingly important in intracranial aneurysm treatment. However, accurate sizing and landing zone prediction remain challenging. Inaccurate sizing can lead to suboptimal deployment, device waste, and complications. This study presents stent deployment length predictions offered in medical software (PreSize Neurovascular) that provides physicians with real-time planning support, allowing them to preoperatively "test" different devices in the patient's anatomy in a safe virtual environment. This study reports the software evaluation methodology and accuracy results when applied to real-world data from a wide range of cases and sources as a necessary step in demonstrating its reliability, prior to impact assessment in prospective clinical practice.METHODS:Imaging data from 138 consecutive stent cases using the Pipeline embolization device were collected from 5 interventional radiology centers in the United Kingdom and retrospectively analyzed. Prediction accuracy was calculated as the degree of agreement between stent deployed length measured intraoperatively and simulated in the software.RESULTS:The software predicted the deployed stent length with a mean accuracy of 95.61% (95% confidence interval [CI] 94.87%-96.35%), the highest reported accuracy in clinical stent simulations to date. By discounting 4 outlier cases, in which events such as interactions with coils and severe push/pull maneuvers impacted deployed length to an extent the software was not able to simulate or predict, the mean accuracy further increases to 96.13% (95% CI 95.58%-96.69%). A wide discrepancy was observed between labeled and measured deployed stent length, in some cases by more than double, with no demonstrable correlation between device dimensions and deployment elongation. These findings illustrate the complexity of stent behavior and need for simulation-assisted sizing for optimal surgical planning.CONCLUSIONS:The software predicts the deployed stent length with excellent accuracy and could provide physicians with real-time accurate device selection support.
Ribosomal RNA transcription was one of the first model systems for molecular characterization of a transcription regulatory mechanism and certainly one of the best studied in the widest range of organisms. In multicellular organisms, however, the issue of cell-type-specific regulation of rRNA transcription has not been well addressed. Here I propose that a systematic study of cell-type-specific regulation of rRNA transcription may reveal new regulatory mechanisms that have not been previously realized. Specifically, issues concerning the cell-type-specific requirement for rRNA production, the universality of Pol I transcription complex and the division of rDNA into regulatory subdomains are discussed.
Introduction Intrasaccular flow disruption is an endovascular approach for treatment of wide-neck aneurysms and, more specifically, wide-neck bifurcation aneurysms (WNBA). The WEB device has demonstrated its efficacy and safety, for both unruptured and ruptured aneurysms. The CLEVER objective has been set up to provide safety and efficacy data on the WEB 0.017 device in treatment of bifurcation aneurysms.These results report description of the full population and safety results within 30 days post procedure. Material/Methods CLEVER study is an observational, prospective and multicenter study conducted in 17 European sites (France, Germany, Hungary, Finland, United Kingdom) using the WEB 0.017 device, the last developed model of WEB product family with a lower profile. The data collected are 100% monitored and the primary endpoints independently evaluated. Patients'data are collected from baseline to 12-month post-treatment with evaluation visits at discharge, 1, 6 and 12-months post-treatment. Occlusion results are assessed independently by a Corelab and adverse events are adjudicated by a Clinical Events Committee. Study design allows to analyze the study results for the full population as well as separately for ruptured and unruptured aneurysm. An intention treat analysis is performed for the safety population, and sample size calculation is based on objective performance approach for safety and efficacy rates. Results From March 2019 to February 2021, 163 patients (mean age, 58.1 years; 68.1% of women) with 103 unruptured aneurysms and 60 ruptured aneurysms were enrolled.The aneurysms locations were on the ACom (37.4%), the MCA bifurcation (30.1%), the PCom (10.4%), the BA (8.6%), the ICAt (3.7%), the pericallosal artery (3.7%), the ACA (0.6%) and other locations (5.5%). The aneurysms treated were ranging from 2 to 9.2 mm (mean maximum sac width = 5.0 mm). The WEB procedure was completed with success in 163 patients (100%). 147/163 (90.2%) of aneurysm were treated only with WEB implant and adjunctive implant devices were used in 16/163 (9.8%) of cases.For this report covering analysis of data up to 30 days, the primary safety endpoint was the proportion of patients with death of any nonaccidental cause or any major stroke (defined as ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the NIHSS) within the first 30 days after treatment. Two major strokes on 2/163 patients (1.2%) met the primary safety endpoint. The mortality rate at 30 days was 0%. A detailed description of events reported from per procedure up to 30 days will be provided with a specific attention to the aneurysm initial presentation (ruptured vs unruptured).The 12 months data are not yet available so will not be presented. Conclusion These results show good safety profile at 1 month, with low rate of neurological or neurovascular event with permanent deficit and no mortality at 30 days. These data confirm the safety of WEB use in intracranial aneurysm treatment, unruptured as well as ruptured, and are consistent with the results published up to date. Disclosures L. Spelle: 2; C; Microvention, Medtronic, Phenox, Stryker, Balt. C. Cognard: None. I. Szikora: None. V. Costalat: None. F. Wodarg: None. D. Herbreteau: None. S. Fischer: None. M. Möhlenbruch: None. C. Papagiannaki: None. J. Klisch: None. R. Rautio: None. J. Numminen: None. A. Berlis: None. J. Downer: None. M. Bester: None. S. Velasco: None. T. Liebig: None. J. Byrne: None. L. Pierot: None.
BackgroundAccero is an innovative, fully visible, self-expanding braided stent with platinum–nitinol composite wire technology, produced by Acandis.ObjectiveTo assess the technical success and safety of this new stent by evaluating the intraprocedural behavior and complication rate, and the short-term follow-up results.MethodsForty-one consecutive patients suitable for stent-assisted coiling were selected for the use of Accero in an 11-month period. Clinical, procedural, and angiographic data, as well as 30-day morbidity, were recorded. The angiographic results, clinical follow-up at 30 days, and early imaging follow-up at 3 or 6 months were analyzed, when available.ResultsForty-one aneurysms were treated with stent-assisted coiling. All cases were elective, of which 19 were previously untreated aneurysms and 22 were recurrent aneurysms. Aneurysm location was anterior communicating artery complex (16), basilar (12 cases), middle cerebral artery bifurcation (9 cases), and internal cerebral artery (4 cases). The stent was successfully deployed and aneurysm occlusion with coils achieved in 100% of our patients. One case of on table in-stent thrombosis occurred, which resolved after administration of glycoprotein IIB/IIIA inhibitor, with no clinical consequence, and one case of postoperative hematoma at the arteriotomy site, which was managed conservatively. On early follow-up, available for 37 patients, the complete occlusion rate was 76%, with only two recurrences needing further treatment. Satisfactory aneurysm occlusion was therefore achieved in 95% of cases.ConclusionStent-assisted coiling with the Accero braided stent proved safe and effective.
Background and Aim To report the 5-year clinical and radiological outcomes of naïve intracranial aneurysms (IAs) treated with the Woven EndoBridge (WEB). Methods The data were collected retrospectively in three centers. The clinical and radiological outcomes of patients with 5-year radiological follow-up were included. Imaging follow-up was performed with digital subtraction angiography and/or magnetic resonance angiography. Aneurysm occlusion was determined using by the Raymond-Roy Occlusion Classification (RROC). RROC 1 and RROC 2 were considered as adequate outcome. Results The data were available for 22 patients (15 females; median age, 60.5 years, range; 39–69) with twenty-two IAs (16 unruptured IAs) treated with WEB. The median width and height of IAs were 5.5 mm (range; 3–9) and 7.5 mm (range; 4–19), respectively. The most common location of IAs treated with WEB was basilar tip (n=7, 23%). Endovascular treatment with WEB alone was suitable for 20 IAs (91%). The median follow-up time was 61 months (range: 56–63 months). The complete occlusion (RROC 1) was seen in thirteen IAs (59%) and neck remnant (RROC 2) were detected in nine IAs (41%) at 5-year follow-up. The radiological outcome of one IA (5%) worsened from RROC 1 to RROC 2 after 2-year follow-up. None of the IAs treated with WEB ruptured and/or re-ruptured. Conclusions This preliminary study shows the efficacy and safety of WEB treatment at 5-year. Aneurysm occlusion appears to be stable after 2 years. Disclosure KA has received personal research grants from Turku University Foundation and Maire Taponen Foundation. JD is proctor and consultant for Microvention, Stryker and Neurologic/Acandis. RR is consultant for Microvention, Stryker and Medtronic. Other authors reports nothing to disclose.