CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): procedural, 30-day and 1-year safety results for ruptured and unruptured aneurysms.

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.

High variability in physician estimations of flow-diverting stent deployment versus PreSize Neurovascular software simulation: a comparison study.

BACKGROUND: Physician 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. METHODS: Eight 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). RESULTS: The 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. CONCLUSIONS: The 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.

Risk of Aneurysm Rupture (ROAR) study: protocol for a long-term, longitudinal, UK multicentre study of unruptured intracranial aneurysms.

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.

pCONUS 2 and pCONUS 2-HPC in the treatment of wide-necked intracranial aneurysms: Multicentre UK experience.

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%).

Long term WEB results - still going strong at 5 years?

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.

How precise is PreSize Neurovascular? Accuracy evaluation of flow diverter deployed-length prediction.

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.

The outcomes of recurrent wide-necked intracranial aneurysms treated with the Woven EndoBridge (WEB): A retrospective bicenter study.

BACKGROUND: The Woven EndoBridge (WEB) is a device for the treatment of intracranial wide-necked bifurcation aneurysms. The safety and effectiveness of WEB for intracranial aneurysms have both been evaluated in previous trials. Our aim was to study the outcomes of recurrent intracranial aneurysms (IAs) treated with WEB. METHODS: Clinical and radiological outcomes of patients with a wide-necked aneurysm recurrence, which was treated with WEB device, were assessed. 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 radiological outcome. RESULTS: Twenty-two patients with 23 recurrent IAs were treated with WEB. Of which, 17 of recurrent IAs (74%) previously treated by coiling, three (13%) by clipping and three (13%) by WEB. The most common location of the recurrent IA was the middle cerebral artery (n = 10, 43%). Endovascular treatment with WEB alone was suitable for 20 recurrent IAs (87%). Ancillary devices were also used: coils in two (9%), and a stent in one (4%). Radiological follow-up results available for all patients (range: 3-60 months; median 24 months). Adequate occlusion (RROC I and II) was achieved in 20 recurrent IAs (87%). A hemorrhagic complication occurred 2 weeks post treatment in one patient (5%). CONCLUSIONS: WEB could be an effective treatment with low rates of complications for challenging cases of recurrent wide-necked IAs.

Early experience treating intracranial aneurysms using Accero: a novel, fully visible, low profile braided stent with platinum-nitinol composite wire technology.

BACKGROUND: Accero is an innovative, fully visible, self-expanding braided stent with platinum-nitinol composite wire technology, produced by Acandis. OBJECTIVE: To 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. METHODS: Forty-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. RESULTS: Forty-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. CONCLUSION: Stent-assisted coiling with the Accero braided stent proved safe and effective.

Woven Endobridge (WEB) Device as a Retreatment Strategy After Unsuccessful Surgical Clipping.

BACKGROUND: Surgical clipping of intracranial aneurysms is typically robust and durable. However, residual aneurysmal components may be seen after clipping. Furthermore, there may be occasional aneurysmal recurrence. These factors are both clinically relevant because subarachnoid hemorrhage after clipping is a rare but important event. The rationale for any treatment is to substantially decrease the future risk of hemorrhage. Small series have shown coiling as a retreatment strategy after unsuccessful clipping, but none has explored the feasibility of Woven Endobridge (WEB) implantation. CASE DESCRIPTION: We examined the feasibility of WEB implantation as second-line treatment for wide-necked residual aneurysms after unsuccessful clipping. We also recorded the safety and efficacy in this small series of 6 patients. To determine safety, we measured the modified Rankin Scale score before and after the procedure, and at 2 later time points (mean follow-up, 5 months and 15 months). To determine efficacy, we obtained radiographic aneurysm occlusion outcomes (including WEB Occlusion Scale) at these 2 time points. Four middle cerebral artery and 2 anterior communicating artery complex aneurysms were treated with WEB implantation, showing feasibility in 6/6 cases (100%). Follow-up at 15 months showed no change from preprocedural modified Rankin Scale score and there were no other complications. There was adequate occlusion in 5/6 cases (83%). CONCLUSIONS: WEB implantation provided a feasible option in this challenging retreatment scenario. This is a small series and prospective data are required to make outcome inferences for this population. Nonetheless, we observed no complications and high adequate occlusion rates.

Management of extracranial arteriovenous malformations of the head and neck.

The purpose of this study was to review the outcomes of the different therapies for extracranial head and neck arteriovenous malformations (AVMs). AVMs are high-flow congenital vascular anomalies. They are composed of a complex system of vessels directly connecting feeding arteries to draining veins forming a nidus. They may be potentially life-threatening due to progressive symptoms and infiltrative disease. Extracranial AVMs most commonly affect the head and neck area (47.4%) followed by the extremities (28.5%). AVMs are best characterized as being either focal or diffuse. Focal AVMs have good outcomes following adequate treatment. Diffuse lesions have multiple feeding vessel, which results in high rates of recurrence despite treatment. The management of AVMs includes conventional surgery and endovascular techniques. A combination of embolization and surgical resection has become the treatment of choice over the last years. The main goal of both forms of treatment being the complete blockage or resection of the nidus. Transcatheter embolization of vessels has evolved over the years and new embolic agents have emerged. The types of materials available for embolization are classified into mechanical devices, liquid agents and particulates. Efficacy, rate of recurrence and most common complications were evaluated. AVMs recurrence after embolization or resection is reported in up to 80% of cases. Incomplete resection and embolization can induce aggressive growth of the remaining nidus and the risk of progression is up to 50% within the first 5 years and recurrences can occur up to 10 years later. Although ethanol seems to be associated with the highest degree of cure and permanent occlusion, the overall complication rate reported was 48%. Other materials, such as cyanoacrylate, have obtained modest rates of complete remission, while the reported rates of complete regression of AVMs with Fibrin glue and Polyvinyl alcohol are above 50%. At present, there are no unified agreement on the ideal embolic agent. Therefore, a multidisciplinary approach is recommended to support decision making about the best therapeutic approach and to achieve optimal outcome. A long-term post-treatment follow-up is recommended to recognize early recurrence.

Functional outcomes and recanalization rates of stent retrievers in acute ischaemic stroke: A systematic review and meta-analysis.

BACKGROUND AND PURPOSE: Intra-arterial therapy for acute ischaemic stroke has evolved rapidly in the last few years. Stent retrievers have now replaced 'first-generation' devices, which have been the principle devices tested in stroke trials.Our aims were to determine the rates of successful recanalization and functional independence in acute stroke patients treated with stent retrievers. We also sought to assess the safety outcomes of stent retrievers by assessing the rates of mortality and intra-cranial haemorrhage. MATERIALS AND METHODS: We conducted a systematic review and meta-analysis of studies which utilized stent retrievers as sole treatment or as part of a multi-modal approach in acute ischaemic stroke. RESULTS: We identified 20 eligible studies: 17 on Solitaire (ev3/Covidien, Irvine, California, USA) (n = 762) and three on Trevo (Stryker, Kalamazoo, Michigan, USA) (n = 210). The mean age of participants was 66.8 (range 62.1-73.0) years and the M:F ratio was 1.1:1. The average stroke severity score (National Institutes of Health Stroke Scale (NIHSS)) at presentation was 17.2. The weighted mean symptom onset to arterial puncture and procedural duration were 265.4 minutes and 54.8 minutes, respectively.Successful recanalization was achieved in 84.5% of patients with a weighted mean of 2.0 stent retriever passes. Independent functional outcome was achieved in 51.2% and the mortality rate was 16.8%. CONCLUSION: Stent retrievers have the potential to achieve a high rate of recanalization and functional independence whilst being relatively safe. They should be assessed in well-designed randomized controlled trials to determine their efficacy and assess whether they compare favourably with 'standard treatment' in stroke.

Non-invasive assessment of vasospasm following aneurysmal SAH using C-arm FDCT parenchymal blood volume measurement in the neuro-interventional suite: Technical feasibility.

INTRODUCTION: Cerebral vasospasm is the leading cause of morbidity and mortality in patients with aneurysmal subarachnoid haemorrhage (SAH) surviving the initial ictus. Commonly used techniques for vasospasm assessment are digital subtraction angiography and transcranial Doppler sonography. These techniques can reliably identify only the major vessel spasm and fail to estimate its haemodynamic significance. To overcome these issues and to enable comprehensive non-invasive assessment of vasospasm inside the interventional suite, a novel protocol involving measurement of parenchymal blood volume (PBV) using C-arm flat detector computed tomography (FDCT) was implemented. MATERIALS AND METHODS: Patients from the neuro-intensive treatment unit (ITU) with suspected vasospasm following aneurysmal SAH were scanned with a biplane C-arm angiography system using an intravenous contrast injection protocol. The PBV maps were generated using prototype software. Contemporaneous clinically indicated MR scan including the diffusion- and perfusion-weighted sequences was performed. C-arm PBV maps were compared against the MR perfusion maps. RESULTS: Distribution of haemodynamic impairment on C-arm PBV maps closely matched the pattern of abnormality on MR perfusion maps. On visual comparison between the two techniques, the extent of abnormality indicated PBV to be both cerebral blood flow and cerebral blood volume weighted. CONCLUSION: C-arm FDCT PBV measurements allow an objective assessment of the severity and localisation of cerebral hypoperfusion resulting from vasospasm. The technique has proved feasible and useful in very sick patients after aneurysmal SAH. The promise shown in this early study indicates that it deserves further evaluation both for post-SAH vasospasm and in other relevant clinical settings.

Diagnosis of neuromyelitis optica (NMO) spectrum disorders: is MRI obsolete?

INTRODUCTION: Neuromyelitis optica (NMO) is a severe demyelinating disease that preferentially involves spinal cord and optic nerve. It is part of a spectrum of neurological conditions associated with antibodies to aquaporin-4 (AQP4). This study investigates the role of MRI where novel, more sensitive AQP4 antibody immunoassay techniques are being used. METHODS: Retrospective review of neuroimaging in 69 patients (25 antibody positive, 44 antibody negative), investigated in the context of suspected NMO or NMO spectrum disorder, was performed independently by two consultant neuroradiologists. RESULTS: Longitudinally extensive, central spinal cord lesions were more frequent in AQP4 positive patients (95.2% vs 35.5%, p < 0.0001; 85.7% vs 45.2%, p = 0.015). Multiple sclerosis diagnostic criteria were less frequently fulfilled on brain MRI in antibody positive patients (5.6% vs 33.3%, p = 0.035). Juxtacortical and corpus callosal lesions were also less common in this group (16.7% vs 46.7%, p = 0.063; 5.6% vs 46.7%, p = 0.0034). Hypothalamic and periependymal disease related to the aqueduct was not seen in antibody negative patients. T1 hypointensity was more common in cord lesions of antibody positive patients (75.0% vs 35.3%, p = 0.037). However, this characteristic did not discriminate antibody positive and negative longitudinally extensive cord lesions (73.3% vs 62.5%, p = 0.66). CONCLUSION: The NMO spectrum of diseases are among an increasing number of neurological conditions defined by serological tests. However, despite improved immunoassay techniques, MRI of the brain and spinal cord continues to be among the first-line investigations in these patients, providing valuable diagnostic information that will help guide patient management.

Pleomorphic adenoma of the nasopharyngeal mucosal space with locally aggressive appearance (2010: 11b).

Pleomorphic adenoma arising from submucosal minor salivary gland tissue in the head and neck is well described in the published literature. Where associated bone changes are present, benign-appearing bone remodelling is the rule, reflecting the slow growth of this benign tumour. Aggressive-appearing bone destruction was observed in this case. This atypical appearance has not been widely described.

Late recurrence of a hepatic artery aneurysm after treatment using an endovascular stent.

Endovascular stent placement and coil embolization have become established options in the treatment of visceral arterial aneurysms. In this article we report the case of an 83-year-old presenting with gastrointestinal hemorrhage due to a recurrent hepatic arterial aneurysm occurring 12 years after treatment with an endovascular stent. The recurrent aneurysm had resulted from stent fracture and was successfully treated by coil embolization. To our knowledge, stent fracture complicating the endovascular treatment of a visceral artery aneurysm has not been described in the published literature. With the increasing use of metallic endoprostheses in interventional radiology, recognizing and reporting device failure are of critical importance.