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

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.

scholarly journals Technical aspects of web device in aneurysm treatment

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).

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

2020 ◽  
pp. neurintsurg-2020-016405 ◽  
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.

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

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.

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

2018 ◽  
Vol 11 (5) ◽  
pp. 503-510 ◽  
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.

Woven EndoBridge device for ruptured aneurysms: perioperative results of a US multicenter experience

2021 ◽  
pp. neurintsurg-2020-017105
Author(s):  
Gustavo M Cortez ◽  
Erinc Akture ◽  
Andre Monteiro ◽  
Adam S Arthur ◽  
Jeremy Peterson ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Intraoperative Complications ◽  
Anterior Communicating Artery ◽  
The Usa ◽  
Perioperative Safety ◽  
Woven Endobridge ◽  
Web Device ◽  
Ruptured Intracranial Aneurysms ◽  
The Web

BackgroundThe Woven EndoBridge (WEB) device is approved in the USA for treatment of unruptured wide-neck bifurcation aneurysms. However, the safety and effectiveness of the WEB device in the treatment of ruptured intracranial aneurysms is not clear. We aim to evaluate the perioperative safety and effectiveness of the WEB device in patients with ruptured intracranial aneurysms.MethodsThis retrospective study, conducted at eight centers in the USA, included patients with ruptured intracranial aneurysms treated with the WEB device in the setting of subarachnoid hemorrhage (SAH). Safety outcomes included intraoperative complications such as vessel perforation, thromboembolic events, and postoperative hemorrhagic or thromboembolic complications based on radiologic imaging. The primary effectiveness outcome was adequate (complete and neck remnant) aneurysm occlusion, according to the Raymond–Roy classification.ResultsA total of 91 patients with 94 ruptured intracranial aneurysms were included (mean age 57.7±15.2 years; 68.1% women; 82.9% wide-necked). Aneurysms were located in the anterior communicating artery (42/94, 44.6%), middle cerebral artery (16/94, 17%), and basilar artery (15/94, 16%). Adequate occlusion was achieved in 48.8% (41/84) and 80.0% (40/50) at discharge and last follow-up (mean of 3.4 months), respectively. At discharge, procedural-related morbidity was 3.3% (3/91) and there was no procedure-related mortality. No re-rupture or delayed aneurysm rupture was observed.ConclusionsThis study demonstrates the perioperative safety and effectiveness of the WEB device for the treatment of patients with ruptured intracranial aneurysms in the setting of SAH, with low periprocedural morbidity and mortality. Long-term follow-up is warranted.

scholarly journals 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

2019 ◽  
Vol 11 (9) ◽  
pp. 924-930 ◽  
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

Woven EndoBridge device for the treatment of ruptured intracranial aneurysms: A systematic review of clinical and angiographic results

2021 ◽  
pp. 159101992110267
Author(s):  
Yong Xie ◽  
Huan Tian ◽  
Bin Xiang ◽  
Jian Liu ◽  
Hua Xiang
Keyword(s):  
Success Rate ◽  
Intracranial Aneurysms ◽  
Perioperative Mortality ◽  
Occlusion Rate ◽  
Woven Endobridge ◽  
Web Device ◽  
Intraoperative Rupture ◽  
Ruptured Intracranial Aneurysms ◽  
The Web

Background and objective The clinical outcome and angiographic outcome data of Woven EndoBridge (WEB) device for the treatment of ruptured intracranial aneurysms (IAs) are limited. We conducted a meta-analysis of the latest literature on the WEB device in the treatment of ruptured IAs. Methods A comprehensive literature search of 4 databases (PubMed, Web of Science, Cochrane library, and Embase) was conducted for studies published from January 1, 2010 to December 31, 2020. Two reviewers independently extracted variables (aneurysm and patient characteristics) using a prespecified data-collection sheet. Outcomes studied included initial and latest follow-up angiographic outcomes, technical success rate, perioperative mortality, retreated rate, perioperative re-bleeding, complication, intraoperative rupture, favorable neurologic outcome at discharge. We used random-effects model to pool the data. Results We finally presented the results of 7 articles including 276 patients with 283 aneurysms. Initial complete and adequate occlusion rate were 38% (95% CI, 25%–50%) and 98% (95% CI, 95%–100%), respectively. Latest follow-up complete and adequate occlusion rate were 61% (95% CI, 46%–75%) and 91% (95% CI, 84%–98%), respectively.Technical success rate was 99% (95% CI, 98%–100%). Perioperative mortality rates and perioperative re-bleeding rate were 9% (95% CI, 3%–15%) and 1% (95% CI, 0%–2%), respectively. Retreated rate was 6% (95% CI, 3%–10%). Overall and WEB treatment-related thromboembolic complication was 10% (95% CI, 6%–13%) and 7% (95% CI, 2%–12%), respectively. Intraoperative rupture rate was 3% (95% CI, 0%–6%). Conclusion Endovascular treatment of ruptured IAs with the WEB device has a good safety profile and an acceptable aneurysm occlusion rate.

Initial and mid-term results from 108 consecutive patients with cerebral aneurysms treated with the WEB device

2016 ◽  
Vol 9 (4) ◽  
pp. 411-417 ◽  
Author(s):  
Christin Clajus ◽  
Christoph Strasilla ◽  
Tom Fiebig ◽  
Vojtech Sychra ◽  
David Fiorella ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Cerebral Aneurysms ◽  
Clinical Results ◽  
Unruptured Aneurysms ◽  
Novel Device ◽  
High Level ◽  
Woven Endobridge ◽  
Web Device ◽  
The Web

IntroductionThe Woven EndoBridge (WEB) is a novel device for the treatment of wide-necked intracranial bifurcation aneurysms. The present series demonstrates our ‘real-world experience’ in the use of all iterations of WEB devices (available in Europe) in ruptured and unruptured aneurysms.MethodsWe analyzed our all-inclusive cerebrovascular database for patients treated with the WEB device between October 2010 and May 2015. Anatomic and clinical results are reported for all patients.ResultsOne hundred and eight patients with 114 intracranial aneurysms were included in the series. Forty-seven aneurysms (41.2%) were ruptured. Eighty-six patients received angiographic and clinical follow-up after a mean of 13.4 months. One hundred and ten of 114 WEB devices (96.5%) were deployed successfully. Thromboembolic complications occurred in 11 of 110 interventions (10.0%), with a new permanent deficit in one patient. Re-rupture after WEB treatment was detected in two aneurysms (4.3%), which had both initially presented with subarachnoid hemorrhage. Angiographic follow-up revealed adequate occlusion in 68 of 90 aneurysms (75.6%). Fifteen aneurysms required retreatment.ConclusionsThis series confirms a high level of safety and efficacy of the WEB device for the treatment of wide-necked intracranial aneurysms.

Clipping of recanalized intracerebral aneurysms initially treated by the Woven EndoBridge device

2019 ◽  
Vol 11 (8) ◽  
pp. 807-811 ◽  
Author(s):  
Laurent Pierot ◽  
Christophe Bannery ◽  
Valery Batchinsky-Parrou ◽  
Jean-Charles Kleiber ◽  
Sebastien Soize ◽  
...  
Keyword(s):  
Initial Treatment ◽  
Present Series ◽  
Anterior Communicating Artery ◽  
Flow Disruption ◽  
Long Term Follow Up ◽  
Feasible Option ◽  
Woven Endobridge ◽  
Web Device ◽  
Incomplete Occlusion ◽  
The Web

Background and purposeIntrasaccular flow disruption using the Woven EndoBridge (WEB) is a safe and effective method to treat intracranial aneurysms, particularly wide neck bifurcation aneurysms. However mid term and long term follow-up imaging can show aneurysm remnant or recanalization, and retreatment is therefore sometimes necessary. In most cases, retreatment is performed using an endovascular approach. The present series reports and analyzes aneurysm clipping of recanalized or incompletely occluded aneurysms following WEB treatment.MethodsAll patients treated with the WEB device since the beginning of our experience in June 2011 were prospectively collected in a local database. Among them, patients who were retreated by clipping for aneurysm remnants were included in the present series.ResultsIn the cumulative population of 130 patients with aneurysms treated by the WEB device from June 2011 to February 2019, 4 patients (3.1%) were retreated with surgical clipping due to incomplete occlusion (2 patients) and aneurysm recanalization (2 patients). Three of the four aneurysms retreated (75%) were located in the middle cerebral artery and one in the anterior communicating artery (25.0%). The aneurysm was ruptured in 1 of 4 patients (25%). Clipping was performed 10–54 months after initial treatment with the WEB. Surgical exposure showed that the WEB device was inside the aneurysm sac in all cases. Clipping was easily performed in all but 1 case. Control DSA showed complete occlusion in two aneurysms and a neck remnant in two.ConclusionClipping is a feasible option for treating aneurysm remnants following initial treatment with intrasaccular flow disruption using the WEB.

scholarly journals How to WEB: a practical review of methodology for the use of the Woven EndoBridge

2020 ◽  
Vol 12 (5) ◽  
pp. 512-520 ◽  
Author(s):  
Nitin Goyal ◽  
Daniel Hoit ◽  
Julie DiNitto ◽  
Lucas Elijovich ◽  
David Fiorella ◽  
...  
Keyword(s):  
Management Strategies ◽  
Review Article ◽  
Flow Disruption ◽  
Selection Strategies ◽  
United States Food ◽  
States Food ◽  
Woven Endobridge ◽  
Web Device ◽  
Indications For Use ◽  
The Web

Wide-necked bifurcation aneurysms (WNBAs) make up 26–36% of all brain aneurysms. Treatments for WNBAs pose unique challenges due to the need to preserve major bifurcation vessels while achieving a durable occlusion of the aneurysm. Intrasaccular flow disruption is an innovative technique for the treatment of WNBAs. The Woven EndoBridge (WEB) device is the only United States Food and Drug Administration approved intrasaccular flow disruption device. In this review article we discuss various aspects of treating WNBAs with the WEB device, including indications for use, aneurysm/device selection strategies, antiplatelet therapy requirement, procedural technique, potential complications and bailouts, and management strategies for residual/recurrent aneurysms after initial WEB treatment.

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