Intracranial aneurysm treatment with intrasaccular flow disruption: comparison of WEB-21 and WEB-17 systems

BackgroundNew generations of Woven EndoBridge (WEB) devices (WEB-21 and WEB-17) are available to treat aneurysms with a width <6.5 mm. Limited comparisons between both systems exist in the literature, but mid-term efficacy has not been compared. Our study aimed to compare the indications, feasibility, and safety of both systems and to evaluate their efficacy at mid-term follow-up (12 months).MethodsAneurysms treated with WEB-21 and WEB-17 were extracted from a prospective database. Patient and aneurysm characteristics, complications, and anatomical results were analyzed by an interventional neuroradiologist, independent of the procedures.ResultsFrom June 2015 to November 2019, 87 patients with 92 aneurysms were treated with WEB-21 (38/92, 41.3%) and WEB-17 (54/92, 58.7%). WEB-21 and WEB-17 had high treatment feasibility (97.4% and 94.4%, respectively). A higher percentage of ruptured aneurysms were treated with WEB-17 (9.3%) than with WEB-21 (2.6%; p=0.03). Morbidity and mortality at 1 month were similar in both groups (no morbidity in either group, and mortality 2.7% in the WEB-21 group and 2.0% in the WEB-17 group). The rate of complete and adequate aneurysm occlusion was not significantly higher with the WEB-17 system (59.2% and 95.9%, respectively) compared with the WEB-21 (52.9% and 85.3%, respectively).ConclusionsThis study showed the high feasibility of aneurysm treatment with both the WEB-21 and WEB-17 systems. Indications were relatively similar with both devices except for ruptured aneurysms, which were more frequently treated with the WEB-17 device. Efficacy at 12 months (complete and adequate occlusions) was slightly, but not significantly, better with the WEB-17 device.

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Experimental testing of the dual-layer Woven EndoBridge device using an elastase-induced aneurysm model in rabbits

Interventional Neuroradiology ◽

10.1177/1591019916628202 ◽

2016 ◽

Vol 22 (3) ◽

pp. 299-303 ◽

Cited By ~ 4

Author(s):

Yong-Hong Ding ◽

Daying Dai ◽

Dana Schroeder ◽

Ramanathan Kadirvel ◽

David F Kallmes

Keyword(s):

First Generation ◽

Experimental Testing ◽

Histologic Evaluation ◽

Aneurysm Occlusion ◽

Woven Endobridge ◽

Web Device ◽

Aneurysm Model ◽

The Web ◽

Time Point

The dual-layer Woven EndoBridge (WEB) device (WEB II) is designed to improve the performance of the first-generation WEB device. This study was performed to evaluate the acute and chronic performance of WEB II for aneurysm occlusion in an elastase-induced aneurysm model in rabbits. We implanted WEB II devices in 36 elastase-induced aneurysms and followed up for one, three, six, and 12 months. Degree of aneurysm occlusion at follow-up was graded on the Web Occlusion Scale (WOS): Grade A, complete aneurysm occlusion; Grade B, complete occlusion with recess filling; Grade C, residual neck filling; and Grade D, residual aneurysm filling. Hematoxylin and eosin staining was performed for histological assessment of aneurysm healing. Grades A, B, C, and D aneurysm occlusion at one-month follow-up were noted in three (17%), three (17%), eight (44%), and four (22%) of 18 cases, respectively. At the three-month time point Grades A, B, C, and D were shown in two (33%), two (33%), one (17%), and one (17%) aneurysms. Six months after treatment, one (17%), two (33%), two (33%), and one (17%) cases demonstrated Grades A, B, C, and D occlusion. At the 12-month time point, Grades B, C, and D were shown in three (50%), two (33%), and one (17%) aneurysms. Histologic evaluation showed progressive thrombus organization within aneurysm lumen from one to 12 months. These results indicated that the WEB II device can achieve high rates of aneurysm occlusion over time in experimental aneurysms.

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Woven EndoBridge (WEB) device in the treatment of ruptured aneurysms

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2020-016405 ◽

2020 ◽

pp. neurintsurg-2020-016405 ◽

Cited By ~ 2

Author(s):

Patrick P Youssef ◽

David Dornbos III ◽

Jeremy Peterson ◽

Ahmad Sweid ◽

Amanda Zakeri ◽

...

Keyword(s):

Adverse Events ◽

Intracranial Aneurysms ◽

Anterior Communicating Artery ◽

Safety And Efficacy ◽

Ruptured Aneurysms ◽

Primary Treatment Modality ◽

Woven Endobridge ◽

Web Device ◽

The Web

BackgroundWide-necked bifurcation aneurysms (WNBAs) present unique challenges for endovascular treatment. The Woven EndoBridge (WEB) device is an intrasaccular braided device, recently approved by the FDA for treatment of WNBAs. While treatment of intracranial aneurysms with the WEB device has been shown to yield an adequate occlusion rate of 85% at 1 year, few data have been published for patients with ruptured aneurysms.ObjectiveTo present a multi-institutional series depicting the safety and efficacy of using the WEB device as the primary treatment modality in ruptured intracranial aneurysms.MethodsA multi-institutional retrospective analysis was conducted, assessing patients presenting with aneurysmal subarachnoid hemorrhage treated with the WEB between January 2014 and April 2020. Baseline demographics, aneurysm characteristics, adverse events, and long-term outcomes (occlusion, re-treatment, functional status) were collected. A descriptive analysis was performed, and variables potentially associated with aneurysm recurrence or re-treatment were assessed.ResultsForty-eight patients were included. Anterior communicating artery aneurysms were the most common (35.4%) location for treatment, followed by middle cerebral artery (20.8%) and basilar apex (16.7%). Procedural success was noted in 95.8% of patients, and clinically significant periprocedural adverse events occurred in 12.5%. After a median follow-up of 5.5 months, 54.2% of patients had follow-up angiographic imaging. Complete occlusion was seen in 61.5% of cases with adequate occlusion in 92.3%. Re-treatment was required in only 4.2% of patients during the study period. Tobacco use was significantly higher in patients with aneurysm recurrence (88.9% vs 35.7%; p=0.012). No other characteristics were associated with recurrence/re-treatment. At 30 days, 81.1% were functionally independent (modified Rankin Scale score ≤2).ConclusionTreatment of acutely ruptured aneurysms with the WEB device demonstrates both safety and efficacy on par with rates of conventional treatment strategies.

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The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2019-014815 ◽

2019 ◽

Vol 11 (9) ◽

pp. 924-930 ◽

Cited By ~ 44

Author(s):

Adam S Arthur ◽

Andy Molyneux ◽

Alexander L Coon ◽

Isil Saatci ◽

Istvan Szikora ◽

...

Keyword(s):

Data Monitoring Committee ◽

Clinical Events ◽

Safety Event ◽

Registration Number ◽

Aneurysm Occlusion ◽

Woven Endobridge ◽

Web Device ◽

Wide Neck ◽

The Web

IntroductionThe Woven EndoBridge Intrasaccular Therapy (WEB-IT) Study is a pivotal, prospective, single-arm, investigational device exemption study designed to evaluate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms.MethodsOne-hundred and fifty patients with wide-neck bifurcation aneurysms were enrolled at 21 US and six international centers. Angiograms from the index procedure, and 6-month and 1-year follow-up visits were all reviewed by a core laboratory. All adverse events were reviewed and adjudicated by a clinical events adjudicator. A data monitoring committee provided oversight during the trial to ensure subject safety.ResultsOne-hundred and forty-eight patients received the WEB implant. One (0.7%) primary safety event occurred during the study—a delayed ipsilateral parenchymal hemorrhage—on postoperative day 22. No primary safety events occurred after 30 days through 1 year. At the 12-month angiographic follow-up, 77/143 patients (53.8%) had complete aneurysm occlusion. Adequate occlusion was achieved in 121/143 (84.6%) subjects.ConclusionsThe prespecified safety and effectiveness endpoints for the aneurysms studied in the WEB-IT trial were met. The results of this trial suggest that the WEB device provides an option for patients with wide-neck bifurcation aneurysms that is as effective as currently available therapies and markedly safer.Trial registration numberNCT02191618

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Endovascular treatment of cerebral aneurysms using the Woven EndoBridge technique in a single center: preliminary results

Journal of Neurosurgery ◽

10.3171/2015.4.jns142456 ◽

2017 ◽

Vol 126 (1) ◽

pp. 17-28 ◽

Cited By ~ 13

Author(s):

Aimee Lawson ◽

Tony Goddard ◽

Stuart Ross ◽

Atul Tyagi ◽

Kenan Deniz ◽

...

Keyword(s):

Thromboembolic Event ◽

Cerebral Aneurysms ◽

Single Layer ◽

New Device ◽

Radiological Evidence ◽

Aneurysm Occlusion ◽

Woven Endobridge ◽

Web Device ◽

The Web

OBJECTIVE The Woven EndoBridge (WEB) is an innovative new technique for securing cerebral aneurysms. It is designed particularly for wide-necked bifurcation aneurysms that otherwise would be difficult to treat. There is a paucity of follow-up data in the literature due to the novelty of this technique. The authors reviewed their data from cases involving patients treated at Leeds General Infirmary with the WEB device. They assessed the safety and complication risk associated with the device and clinical and radiological follow-up outcomes in their patients. This is, to their knowledge, the first publication to include the new single-layer sphere device (WEB SLS) in addition to the original dual-layer (WEB DL) and the (nonsphere) single-layer (WEB SL) devices. METHODS Data from 22 patients who underwent 25 WEB treatments were analyzed. Of the 25 WEB procedures, 3 were performed on an acute basis, 1 was performed on a semiacute basis, and the remaining 21 were elective. A novel 6-point scoring system called the Leeds WEB aneurysm occlusion scale was created to ensure accurate assessment based on the morphology of the WEB device. Outcome was assessed at follow-up by MR angiography with or without digital subtraction angiography and the modified Rankin Scale (mRS). RESULTS Deployment of the WEB device was successful in 22 (88%) of 25 procedures; 3 (12%) of the attempts at WEB treatment were abandoned. One of the patients in whom treatment was abandoned underwent a successful second attempt. Immediately after the 22 procedures with successful deployment, 4 (18%) of the patients had a complete occlusion of the aneurysm and WEB device; 10 (45%) had varying degrees of occlusion within the WEB device but no aneurysm neck or remnant; 3 (14%) had a neck remnant; and 5 (23%) had an aneurysm remnant. Of the patients with an aneurysm remnant, 1 had a complete aneurysm occlusion at ≥ 3-months follow-up. In total, 6 (27%) patients had a residual aneurysm at ≥ 3-months radiological follow-up. One of these patients was admitted with hydrocephalus secondary to a recurrent aneurysm and later received a second WEB treatment with additional coiling. Only 1 patient developed new neurological symptoms. This patient went from an mRS score of 0 to a score of 1 and had radiological evidence of a thromboembolic event. Two patients showed radiological evidence of a new thromboembolic event on follow-up MRI but were clinically asymptomatic. CONCLUSIONS The WEB has shown itself to be a promising new device with the potential to increase the scope of treatment for difficult wide-necked bifurcation aneurysms. The technique is safe, and short-term results show effective occlusion of complex aneurysms with minimal complications associated with the procedure. Long-term efficacy, however, still needs to be assessed.

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Woven EndoBridge (WEB) Width at the Aneurysm Neck Level Affects Early Angiographic Aneurysm Occlusion

Clinical Neuroradiology ◽

10.1007/s00062-021-01034-0 ◽

2021 ◽

Author(s):

Marie Teresa Nawka ◽

Gabriel Broocks ◽

Rosalie McDonough ◽

Jens Fiehler ◽

Maxim Bester

Keyword(s):

External Validation ◽

Short Term ◽

Aneurysm Neck ◽

Aneurysm Occlusion ◽

Woven Endobridge ◽

Web Device ◽

Aneurysm Diameter ◽

The Web ◽

Web Size

Abstract Purpose Endovascular therapy with the Woven EndoBridge (WEB) device is a safe treatment approach, whereby neoendothelialization at the neck area is a crucial element for aneurysm occlusion. We hypothesized that WEB sizing at the aneurysmal neck level has an impact on early aneurysm occlusion. Methods Patients with short-term follow-up digital subtraction angiography following WEB treatment of unruptured aneurysms were included. Aneurysms were categorized according to the Bicêtre Occlusion Scale Score (BOSS) as adequately (BOSS 0, 0′, 1) or partially occluded (BOSS 2, 3, 1 + 3). The WEB device dimensions, including the average aneurysm diameter (AADi) and the average neck diameter (ANDi) as well as baseline patient characteristics were documented. Results In this study 75 patients with 76 aneurysms were included and 65 aneurysms showed adequate occlusion at short-term follow-up (86%). In univariable logistic regression analysis, smaller differences in WEB size to ANDi (D-ANDi) were significantly associated with adequate aneurysm occlusion (odds ratio, OR = 0.41, 95% confidence interval, CI 0.23–0.71, p = 0.002). Receiver operating characteristic (ROC) curve analyses displayed higher discriminative power for the D‑ANDi (AUC = 0.77, 95% CI 0.66–0.86, cut-off ≤2.9 mm) compared to the difference in WEB size to the average aneurysm diameter (D-AADi, AUC = 0.65, 95% CI 0.53–0.75, cut-off ≤1.0 mm). Conclusion Smaller differences between the WEB width and ANDi were associated with adequate early aneurysm occlusion and might thus have a higher impact on the results than the traditional device sizing considering the mean aneurysm diameter. D‑ANDi ≤2.9 mm served as an optimal cut-off to classify occlusion after WEB treatment at the short-term follow-up. Further external validation is warranted.

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Aneurysm Treatment With Woven EndoBridge in the Cumulative Population of 3 Prospective, Multicenter Series: 2-Year Follow-Up

Neurosurgery ◽

10.1093/neuros/nyz557_s003 ◽

2021 ◽

Vol 89 (Supplement_2) ◽

pp. S3-S3

Author(s):

Laurent Pierot ◽

Jacques Moret ◽

Xavier Barreau ◽

Istvan Szikora ◽

Denis Herbreteau ◽

...

Keyword(s):

Aneurysm Treatment ◽

Woven Endobridge

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Woven EndoBridge Embolized Aneurysm Clippings: 2-Dimensional Operative Video

Operative Neurosurgery ◽

10.1093/ons/opab218 ◽

2021 ◽

Author(s):

Daniel M Heiferman ◽

Jeremy C Peterson ◽

Kendrick D Johnson ◽

Vincent N Nguyen ◽

David Dornbos ◽

...

Keyword(s):

Treatment Strategies ◽

The United States ◽

Lessons Learned ◽

Anterior Communicating Artery ◽

Surgical Clip ◽

Woven Endobridge ◽

Web Device ◽

Clip Occlusion ◽

The Web

Abstract The Woven EndoBridge (WEB) device (MicroVention, Aliso Viejo, California) is an intrasaccular flow disruptor used for the treatment of both unruptured and ruptured intracranial aneurysms. WEB has been shown to have 54% complete and 85% adequate aneurysm occlusion rates at 1-yr follow-up.1 Residual and recurrent ruptured aneurysms have been shown to have a higher risk of re-rupture than completely occluded aneurysms.2 With increased utilization of WEB in the United States, optimizing treatment strategies of residual aneurysms previously treated with the WEB device is essential, including surgical clipping.3,4 Here, we present an operative video demonstrating the surgical clip occlusion of previously ruptured middle cerebral artery and anterior communicating artery aneurysms that had been treated with the WEB device and had sizable recurrence on follow-up angiography. Informed consent was obtained from both patients. Lessons learned include the following: (1) the WEB device is highly compressible, unlike coils; (2) proximal WEB marker may interfere with clip closure; (3) no evidence of WEB extrusion into the subarachnoid space; (4) no more scarring than expected in ruptured cases; and (5) clipping is a feasible option for treating WEB recurrent or residual aneurysms.

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WEB device for treatment of posterior communicating artery aneurysms

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2021-017405 ◽

2021 ◽

pp. neurintsurg-2021-017405

Author(s):

Guilherme Aguiar ◽

Jildaz Caroff ◽

Cristian Mihalea ◽

Jonathan Cortese ◽

Jean-Baptiste Girot ◽

...

Keyword(s):

Case Series ◽

Posterior Communicating Artery ◽

Neck Size ◽

Ruptured Aneurysms ◽

Antiplatelet Medication ◽

Woven Endobridge ◽

Web Device ◽

Intraoperative Rupture ◽

Wide Neck

BackgroundWoven EndoBridge (WEB) device treatment of wide-neck bifurcation aneurysms has proved to be safe and effective, but the use of these devices in sidewall aneurysms has been reported only in a small number of case series.ObjectiveTo report our results in a cohort of consecutive patients in whom a WEB device was used as first-line treatment for posterior communicating artery (PComA) aneurysms.MethodsWe conducted a retrospective analysis of a prospectively maintained database of PComA aneurysms treated with a WEB device in our institution from June 1, 2012 to November 15, 2020. Clinical and radiological findings were evaluated at immediate and last follow-up.ResultsA total of 219 aneurysms were treated with a WEB device, including 15 PComA aneurysms in 15 patients, 10 of which were ruptured. Aneurysms were wide necked, with a mean aspect ratio of 1.6 (range 0.7–3.0) and a mean neck size of 4.2 mm (range 2.6–7.4 mm). No intraoperative rupture occurred and only one thromboembolic event was noted. Among the group with at least a 3-month digital subtraction angiography (DSA) follow-up, complete and adequate occlusion were obtained in 54% and 72%, respectively (average follow-up 13 months). Re-treatment was needed for two initially ruptured aneurysms. No procedure-related morbidity or mortality was reported.ConclusionThis series suggests the high safety profile of WEB devices even when used in off-label indications. Treatment with these devices seems to be a valuable strategy for ruptured wide-neck PComA aneurysms, avoiding the need for antiplatelet medication. However, occlusion rates should be investigated in further larger studies.

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