Intracranial aneurysm treatment with WEB and adjunctive stent: preliminary evaluation in a single-center series

BackgroundIntrasaccular flow disruption with WEB is a safe and efficacious technique that has significantly changed endovascular management of wide-neck bifurcation aneurysms (WNBAs). Use of stent in combination with WEB is occasionally required. We analyzed the frequency of use, indications, safety, and efficacy of the WEB–stent combination.MethodsAll aneurysms treated with WEB and stent were extracted from a prospectively maintained database. Patient and aneurysm characteristics, complications, and anatomical results were independently analyzed by a physician independent of the procedures.ResultsFrom June 2011 to January 2020, 152 patients with 157 aneurysms were treated with WEB. Of these, 17/152 patients (11.2%) with 19/157 aneurysms (12.1%) were treated with WEB device and stent. Indications were very wide neck with a branch emerging from the neck in 1/19 (5.2%) aneurysms and WEB protrusion in 18/19 (94.7%). At 1 month, no morbimortality was reported. At 6 months, anatomical results were complete aneurysm occlusion in 15/17 aneurysms (88.2%), neck remnant in 1/17 (5.9%), and aneurysm remnant in 1/17 (5.9%). At 12 months, there was complete aneurysm occlusion in 13/14 aneurysms (92.9%) and neck remnant in 1/14 (7.1%).ConclusionsCombining WEB and stent is a therapeutic strategy to manage WNBA. In our series, this combination was used in 11.2% of patients treated with WEB, resulting in no morbidity or mortality with a high efficacy at 6 and 12 months (complete aneurysm occlusion in 88.2% and 92.9%, respectively).

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Ten Years of Clinical Evaluation of the Woven EndoBridge: A Safe and Effective Treatment for Wide-Neck Bifurcation Aneurysms

Neurointervention ◽

10.5469/neuroint.2021.00395 ◽

2021 ◽

Author(s):

Laurent Pierot

Keyword(s):

Clinical Evaluation ◽

Intracranial Aneurysms ◽

Current Knowledge ◽

Endovascular Technique ◽

Multicenter Studies ◽

Flow Disruption ◽

Woven Endobridge ◽

Web Device ◽

Wide Neck ◽

The Web

Intrasaccular flow disruption is an innovative approach for the endovascular treatment of intracranial aneurysms. As of now, only one device is currently available worldwide: the Woven EndoBridge (WEB) device (MicroVention, Aliso Viejo, CA, USA). After 10 years of clinical use and careful clinical evaluation of the WEB device by multiple prospective, multicenter studies, this article is summarizing the current knowledge regarding this endovascular technique; indications, modalities, safety and efficacy of the WEB procedure are described.

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Abstract 203: Safety And Efficacy Of WEB ® Aneurysm Treatment: Combined Analysis 0f WEBCAST, French Observatory, And WEBCAST2 Studies - Final Results.

Stroke ◽

10.1161/str.48.suppl_1.203 ◽

2017 ◽

Vol 48 (suppl_1) ◽

Author(s):

Laurent Pierot ◽

James Byrne ◽

Andrew Molyneux

Keyword(s):

Interventional Neuroradiology ◽

Good Clinical Practice ◽

Morbidity And Mortality ◽

Anterior Communicating Artery ◽

Safety And Efficacy ◽

Complete Occlusion ◽

Independent Expert ◽

Aneurysm Occlusion ◽

Web Device ◽

Wide Neck

Purpose: WEB Flow disruption is an innovative endovascular treatment for wide-neck bifurcation aneurysms. Safety and efficacy are analyzed in the cumulated population of 3 prospective multicenter GCP (Good Clinical Practice) studies conducted in Europe (WEBCAST, French Observatory, WEBCAST2). Methods: Patients with wide neck bifurcation aneurysms were included in these 3 studies. An independent medical monitor independently analyzed adverse events. An independent expert in Interventional Neuroradiology evaluated anatomical results at 12 months using the 3 grades scale: complete occlusion, neck remnant, and aneurysm remnant. Results: A total of 168 patients with 169 aneurysms including 14 ruptured (8.3%) were included in the 3 studies. Eighty-six out 169 aneurysms were located at middle cerebral artery (50.9%), 36/169 at anterior communicating artery (21.3%), 30/169 at basilar artery (17.8%), and 17/169 at internal carotid artery terminus (10.1%). Placement of the WEB device was feasible in 163/169 aneurysms (96.4%). Morbidity and mortality at one month were reported in 4/168 patients (2.4%) and 0/168 patients (0.0%), respectively. Anatomical results at 12 months were complete aneurysm occlusion in 82/149 aneurysms (55.0%), neck remnant in 38/149 aneurysms (25.5%), and aneurysm remnant in 29/149 aneurysms (19.5%). Conclusion: This analysis in the large cumulated population of 3 GCP studies confirms the high safety of WEB treatment with low morbidity and mortality. At 12 months, adequate occlusion (complete occlusion and neck remnant) was obtained in a high percentage of aneurysms (80.5%).

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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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Technical aspects of web device in aneurysm treatment

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2019-015748 ◽

2020 ◽

Vol 12 (9) ◽

pp. 924-924

Author(s):

Jeremy Peterson ◽

Nitin Goyal ◽

Adam S Arthur ◽

David Fiorella

Keyword(s):

Intracranial Aneurysms ◽

Flow Disruption ◽

Selection Strategies ◽

United States Food ◽

States Food ◽

Brain Aneurysms ◽

Woven Endobridge ◽

Web Device ◽

Wide Neck ◽

The Web

Wide-neck bifurcation aneurysms (WNBAs) make up 26–36% of all brain aneurysms. Intrasaccular flow disruption is an innovative technique for the treatment of WNBAs. The Woven EndoBridge (WEB) device (Sequent Medical, Aliso Viejo, California USA) is the only United States Food and Drug Administration approved intrasaccular flow disruption device. In this video article, a few cases of intracranial aneurysms treated with the WEB device are presented and various aspects of treating WNBAs with the WEB device, including aneurysm/device selection strategies, and procedural technique, are discussed (video 1).

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Abstract WP33: Early Lessons Learned From the WEB Device: Feasibility, Technique and Complications—A Real Life Experience

Stroke ◽

10.1161/str.51.suppl_1.wp33 ◽

2020 ◽

Vol 51 (Suppl_1) ◽

Author(s):

Nikolaos Mouchtouris ◽

David Hasan ◽

Fadi Al Saiegh ◽

Ahmad Sweid ◽

Mario Zanaty ◽

...

Keyword(s):

Real Life ◽

Cerebral Aneurysms ◽

High Volume ◽

Additional Treatment ◽

Lessons Learned ◽

Parent Vessel ◽

Aneurysm Embolization ◽

Web Device ◽

Wide Neck ◽

The Web

Introduction: Wide-neck bifurcation cerebral aneurysms have always posed a treatment challenge and have historically required either clip ligation, or stent vs. balloon-assisted coil embolization. This predicament led to the development of the newly FDA-approved Woven EndoBridge (WEB) aneurysm embolization system (Sequent Medical Inc, Aliso Viejo, CA) Which is a self-expanding mesh that achieves intrasaccular flow disruption and does not require antithrombotic medications. In this study, we report our experience with the first 64 consecutive aneurysms treated via WEB embolization at two high-volume institutions. Methods: We reviewed our first 61 consecutive patients with 64 cerebral aneurysms who underwent WEB embolization from February-August 2019. We collected data on patient demographics and clinical presentation, aneurysm characteristics, device and procedural details, and functional outcomes. Results: A total of 64 aneurysms were included in our study. Fifteen patients (24.1%) presented with acutely ruptured aneurysm while the rest were unruptured. The majority of patients (82.8%) required only one attempt for successful device deployment, while a stent was necessary as an adjunct treatment in 4 patients (6.3%) due to WEB herniation. Two patients had residual aneurysm that had to undergo additional treatment; one of them underwent second WEB embolization and one underwent clip ligation. One patient with a PICA aneurysm had device dislodgment with injury to the parent vessel—Onyx and coils were used to deconstruct the vertebral artery. Conclusions: The advent of the WEB device has significantly impacted the surgical decision-making for the treatment of bifurcation, wide-neck aneurysms. We discuss in detail the lessons learned from patient selection, device size selection, technique, and complications from two institutions with high-volume endovascular and microsurgical aneurysm treatment experience.

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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 Woven EndoBridge (WEB) device: feasibility, techniques, and outcomes after FDA approval

Journal of Neurosurgery ◽

10.3171/2021.5.jns21889 ◽

2021 ◽

pp. 1-7

Author(s):

Nikolaos Mouchtouris ◽

David Hasan ◽

Edgar A. Samaniego ◽

Fadi Al Saiegh ◽

Ahmad Sweid ◽

...

Keyword(s):

Cerebral Aneurysms ◽

Arterial Phase ◽

Unruptured Aneurysms ◽

Fda Approval ◽

Aneurysm Embolization ◽

Woven Endobridge ◽

Web Device ◽

Wide Neck ◽

The Web

OBJECTIVE Wide-neck bifurcation cerebral aneurysms have historically required either clip ligation or stent- or balloon-assisted coil embolization. This predicament led to the development of the Woven EndoBridge (WEB) aneurysm embolization system, a self-expanding mesh device that achieves intrasaccular flow disruption and does not require antithrombotic medications. The authors report their operative experience and 6-month follow-up occlusion outcomes with the first 115 aneurysms they treated via WEB embolization. METHODS The authors reviewed the first 115 cerebral aneurysms they treated by WEB embolization after FDA approval of the WEB embolization device (from February 2019 to January 2021). Data were collected on patient demographics and clinical presentation, aneurysm characteristics, procedural details, postembolization angiographic contrast stasis, and functional outcomes. RESULTS A total of 110 patients and 115 aneurysms were included in our study (34 ruptured and 81 unruptured aneurysms). WEB embolization was successful in 106 (92.2%) aneurysms, with a complication occurring in 6 (5.5%) patients. Contrast clearance was seen in the arterial phase in 14 (12.2%) aneurysms, in the capillary phase in 16 (13.9%), in the venous phase in 63 (54.8%), and no contrast was seen in 13 (11.3%) of the aneurysms studied. Follow-up angiography was performed on 60 (52.6%) of the aneurysms, with complete occlusion in 38 (63.3%), neck remnant in 14 (23.3%), and aneurysmal remnant in 8 (13.3%). Six (5.5%) patients required re-treatment for persistent aneurysmal residual on follow-up angiography. CONCLUSIONS The WEB device has been successfully used for the treatment of both unruptured and ruptured wide-neck bifurcation aneurysms by achieving intrasaccular flow diversion. Here, the authors have shared their experience with its unique technical considerations and device size selection, as well as critically reviewed complications and aneurysm occlusion rates.

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Endovascular treatment of bifurcation intracranial aneurysms with the WEB SL/SLS: 6-month clinical and angiographic results

Interventional Neuroradiology ◽

10.1177/1591019915590083 ◽

2015 ◽

Vol 21 (4) ◽

pp. 462-469 ◽

Cited By ~ 20

Author(s):

Patricia Bozzetto Ambrosi ◽

Benjamin Gory ◽

Rotem Sivan-Hoffmann ◽

Roberto Riva ◽

Francesco Signorelli ◽

...

Keyword(s):

Endovascular Treatment ◽

Intracranial Aneurysms ◽

Single Layer ◽

Additional Treatment ◽

Anterior Communicating Artery ◽

Neck Size ◽

Aneurysm Occlusion ◽

Web Device ◽

The Web

Background The WEB device is a recent intrasaccular flow disruption technique developed for the treatment of wide-necked intracranial aneurysms. To date, a single report on the WEB Single-Layer (SL) treatment of intracranial aneurysms has been published with 1-months' safety results. The aim of this study is to report our experience and 6-month clinical and angiographic follow-up of endovascular treatment of wide-neck aneurysm with the WEB SL. Methods Ten patients with 10 unruptured wide-necked aneurysms were prospectively enrolled in this study. Feasibility, intraoperative and postoperative complications, and outcomes were recorded. Immediate and 6-month clinical and angiographic results were evaluated. Results Failure of WEB SL placement occurred in two cases. Eight aneurysms were successfully treated using one WEB SL without additional treatment. Three middle cerebral artery, four anterior communicating artery, and one basilar artery aneurysms were treated. Average dome width was 7.5 mm (range 5.4–10.7 mm), and average neck size was 4.9 mm (range 2.6–6.5 mm). No periprocedural complication was observed, and morbi-mortality at discharge and 6 months was 0.0%. Angiographic follow-up at 6 months demonstrated complete aneurysm occlusion in 2/8 aneurysms, neck remnant in 5/8 aneurysms, and aneurysm remnant in 1/8 aneurysm. Conclusions From this preliminary study, treatment of bifurcation intracranial aneurysms using WEB SL is feasible. WEB SL treatment seems safe at 6 months; however, the rate of neck remnants is not negligible due to compression of the WEB SL. Further technical improvements may be needed in order to ameliorate the occlusion in the WEB SL treatment.

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Factors that determine aneurysm occlusion after embolization with the Woven EndoBridge (WEB)

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2018-014361 ◽

2018 ◽

Vol 11 (5) ◽

pp. 503-510 ◽

Cited By ~ 9

Author(s):

Christoph Kabbasch ◽

Lukas Goertz ◽

Eberhard Siebert ◽

Moriz Herzberg ◽

Jan Borggrefe ◽

...

Keyword(s):

Intracranial Aneurysms ◽

Tertiary Care ◽

High Rate ◽

Simultaneous Treatment ◽

Aneurysm Size ◽

Aneurysm Occlusion ◽

Aneurysm Thrombosis ◽

Woven Endobridge ◽

Web Device ◽

The Web

BackgroundThe Woven EndoBridge (WEB) device is a novel endovascular tool for the treatment of wide-necked intracranial aneurysms.ObjectiveTo evaluate factors influencing aneurysm occlusion and aneurysm recurrence after WEB embolization.MethodsA total of 113 patients (mean age 58.9±11.9 years) with 114 aneurysms (mean size 8.6±4.6 mm) were successfully treated with the WEB device at three German tertiary care centers between May 2011 and February 2018. Aneurysm occlusion was evaluated using the Raymond-Roy occlusion classification. We retrospectively collected patient characteristics, anatomical details, and procedural aspects and evaluated their impact on aneurysm occlusion and recurrence.ResultsOf 98 patients available for a 6-month angiographic follow-up, complete occlusion was achieved in 62.2%, neck remnants in 21.4%, and aneurysm remnants in 16.3%. Aneurysm recurrence occurred in 15.3%. Initial partial aneurysm thrombosis, recurrent aneurysms, aneurysm size, and simultaneous treatment by WEB and coil were associated with aneurysm remnants (p<0.05). Initial partial aneurysm thrombosis, increasing aneurysm size, and treatment by WEB and coil also predicted aneurysm recurrence (p<0.05).In the subgroup analysis of 71 aneurysms treated with WEB only, initial incomplete occlusion and male sex were associated with aneurysm remnants (p<0.05), while aneurysm height correlated with aneurysm recurrence (p=0.008).ConclusionsThe WEB provides a high rate of adequate occlusion even in a subset of complex wide-necked intracranial aneurysms. Anatomic results tend to be less favourable in large and partially thrombosed aneurysms and after treatment with WEB and coil.

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