scholarly journals CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): results of 1-month and 1-year assessment of rebleeding protection and clinical safety in a multicenter study

2021 ◽  
pp. neurintsurg-2021-017416
Author(s):  
Laurent Spelle ◽  
Denis Herbreteau ◽  
Jildaz Caroff ◽  
Xavier Barreau ◽  
Jean-Christophe Ferré ◽  
...  
Keyword(s):  
Multicenter Study ◽  
Clinical Safety ◽  
Intraoperative Complication ◽  
Rebleeding Rate ◽  
Secondary Endpoints ◽  
The Mean ◽  
Woven Endobridge ◽  
Web Device ◽  
Total Procedure ◽  
The Web

BackgroundThe primary goal of the CLARYS study is to assess the protection against rebleeding when treating ruptured bifurcation aneurysms with the Woven EndoBridge (WEB) device.MethodsThe CLARYS study is a prospective, multicenter study conducted in 13 European centers. Patients with ruptured bifurcation aneurysms were consecutively included between February 2016 and September 2017. The primary endpoint was defined as the rebleeding rate of the target aneurysm treated with the WEB within 30 days postprocedure. Secondary endpoints included periprocedural and postprocedural adverse events, total procedure and fluoroscopy times, and modified Rankin Scale score at 1 month and 1 year.ResultsSixty patients with 60 ruptured bifurcation aneurysms to be treated with the WEB were included. A WEB device was successfully implanted in 93.3%. The rebleeding rate at 1 month and 1 year was 0%. The mean fluoroscopy time was 27.0 min. Twenty-three periprocedural complications were observed in 18 patients and resolved without sequelae in 16 patients. Two of these complications were attributed to the procedure and/or the use of the WEB, leading to a procedure/device-related intraoperative complication rate of 3.3%. Overall mortality at 1 month and 1 year was 1.7% and 3.8%, respectively and overall morbidity at 1 month and 1 year was 15% and 9.6%, respectively. WEB-related 1-month and 1-year morbidity and mortality was 0%.ConclusionsThe interim results of CLARYS show that the endovascular treatment of ruptured bifurcation aneurysms with the WEB is safe and effective and, in particular, provides effective protection against rebleeding. It may induce profound change in the endovascular management of ruptured bifurcation aneurysms.

Woven EndoBridge device shape modification can be mitigated with an appropriate oversizing strategy: a VasoCT based study

2021 ◽  
pp. neurintsurg-2020-017232
Author(s):  
Jildaz Caroff ◽  
Jonathan Cortese ◽  
Jean-Baptiste Girot ◽  
Cristian Mihalea ◽  
Guilherme Aguiar ◽  
...  
Keyword(s):  
Cone Beam ◽  
Shape Modification ◽  
Complete Occlusion ◽  
The Mean ◽  
Woven Endobridge ◽  
Web Device ◽  
Recurrence Group ◽  
Over Time ◽  
The Web

BackgroundThe Woven EndoBridge (WEB) shape modification (WShM) during follow-up may be a potential cause of poor angiographic outcomes. WShM predisposing factors have not yet been determined. Our systematic use of rotational cone beam computed tomography (VasoCT) imaging during follow-up allowed us to perform the first quantitative analysis of the shape of WEBs over time. Our goal was to identify possible strategies to reduce the occurrence of this phenomenon.MethodsAll patients treated in our hospital with a WEB device between October 2015 and January 2019 were included. Using VasoCT acquisitions, systematically performed after implantation and during follow-up, we analyzed WEB morphology. WShM was defined as the percentage reduction in the distance between the two WEB markers.ResultsSixty-three aneurysms treated with a WEB device were finally included in this analysis. At the last follow-up (mean 15.5 months), mean WShM was 48%±24. The mean WShM was significantly higher in the aneurysm recurrence group than in the adequate occlusion group (51±6.5% vs 36±3.4%, difference 15% points (95% CI 0.7 to 30); p<0.05). Conversely, the extent of WShM did not directly correlate with occlusion rates. Indeed, 32% of completely occluded aneurysms presented severe WShM (≥50%). Importantly, the absence of WShM guaranteed complete occlusion in our study (n=12). We demonstrated that oversizing the width of the WEB significantly correlated with WShM reduction during follow-up (r=−0.38, p=0.002).ConclusionWShM can be partly overcome by use of an appropriate width oversizing strategy that could lead to improved angiographic results.

Woven EndoBridge Embolized Aneurysm Clippings: 2-Dimensional Operative Video

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.

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

2016 ◽  
Vol 22 (3) ◽  
pp. 299-303 ◽  
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.

scholarly journals Treatment of Acutely Ruptured Cerebral Aneurysms With the Woven EndoBridge Device: Experience Post-FDA Approval

Neurosurgery ◽  
2020 ◽  
Vol 87 (1) ◽  
pp. E16-E22 ◽  
Author(s):  
Fadi Al Saiegh ◽  
David Hasan ◽  
Nikolaos Mouchtouris ◽  
Mario Zanaty ◽  
Ahmad Sweid ◽  
...  
Keyword(s):  
Cerebral Aneurysms ◽  
Antiplatelet Agents ◽  
Anterior Communicating Artery ◽  
Unruptured Aneurysms ◽  
Fda Approval ◽  
Long Term Follow Up ◽  
Woven Endobridge ◽  
Web Device ◽  
Intraoperative Rupture ◽  
The Web

Abstract BACKGROUND Coil embolization of ruptured bifurcation aneurysms is challenging and often necessitates adjunctive stenting, which requires antiplatelet therapy in the setting of subarachnoid hemorrhage (SAH). The Woven EndoBridge (WEB; Terumo) device is an alternative self-expanding 3D mesh that does not require antiplatelet agents. However, its use has been mostly reserved for unruptured aneurysms. OBJECTIVE To assess the safety and feasibility of ruptured aneurysm treatment with the WEB. METHODS Retrospective analysis of 9 SAH patients with 11 aneurysms that were treated with the WEB device at 2 institutions after FDA approval. RESULTS Hunt and Hess grades were III and IV in 4 (44%) each and V in 1 (11%). All patients were treated within 24 h of hospitalization, and a single WEB was used in all but one aneurysm. Aneurysms treated were 3 basilar tip, 2 anterior communicating artery, 2 posterior inferior cerebellarartery, 1 middle cerebral artery, 1 carotid-ophthalmic artery, 1 posterior communicating artery, and 1 vertebrobasilar junction. Mean aneurysm height and width were 6.2 ± 2.2 mm (range: 3-10) and 5.6 ± 3.0 mm (range: 3.3-14), respectively. Mean dome-to-neck ratio was 1.7 ± 0.8 (range: 1.0-3.8). There was one intraoperative rupture that occurred because of device dislodgement and was managed with embolization. There were no treatment-related mortalities and no re-rupture after securement of the aneurysms with the WEB. CONCLUSION Our preliminary experience indicates that the WEB device can be used safely for ruptured aneurysms of various sizes in the anterior and posterior circulation. Larger series with long-term follow-up are necessary to confirm our findings.

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.

scholarly journals The Woven EndoBridge (WEB) for recurrent aneurysms: Clinical and imaging results

2018 ◽  
Vol 25 (1) ◽  
pp. 21-26 ◽  
Author(s):  
SBT van Rooij ◽  
WJ van Rooij ◽  
M Sluzewski ◽  
JP Peluso
Keyword(s):  
Additional Treatment ◽  
Thromboembolic Complications ◽  
Complete Occlusion ◽  
Imaging Result ◽  
Imaging Results ◽  
Previously Treated ◽  
Woven Endobridge ◽  
Web Device ◽  
The Web

Introduction The Woven EndoBridge (WEB) device is a novel intrasaccular flow disrupter designed for wide-necked aneurysms. We present our results of WEB treatment in previously treated and reopened aneurysms. Materials and methods Between February 2015 and December 2017, 17 patients with reopening of previously treated aneurysms were treated using the WEB device. Initial treatment was clipping in one, WEB in five and coiling in 11 aneurysms. Six aneurysms had two or three previous treatments. Mechanism of aneurysm reopening was clip remnant in one, compaction without regrowth in three, focal regrowth in five, reopening in partially thrombosed aneurysms in three and WEB compression in five aneurysms. Results Endovascular treatment of the recurrent aneurysm was possible in all 17 patients with good WEB position obtained. Additional devices were used in three of 17 patients (18%): coils in two and stent in one patient.  No technical, hemorrhagic or thromboembolic complications occurred (0%, 97.5% confidence interval 0–22%). Overall imaging result at latest follow-up was complete occlusion in five (29%), neck remnant in six (35%), aneurysm reopening in six (35%) and persistent WEB filling in one aneurysm (6%). After retreatment with the WEB, two aneurysms were again additionally treated and three aneurysms are scheduled for additional treatment. Worst results were in partially thrombosed aneurysms. Conclusion The WEB device for recurrent aneurysms may be a feasible and safe option, especially in wide-necked, shallow aneurysm recurrences. Results were poor in partially thrombosed recurrent aneurysms.

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 Diverse Use of the WEB Device: A Technical Note on WEB Stenting and WEB Coiling of Complex Aneurysms

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Jorge A Roa ◽  
Mario Zanaty ◽  
Sudeepta Dandapat ◽  
Edgar Samaniego ◽  
Pascal Jabbour ◽  
...  
Keyword(s):  
Artery Aneurysm ◽  
Acute Angle ◽  
Technical Note ◽  
Parent Vessel ◽  
Complex Aneurysms ◽  
Neurological Exam ◽  
Device Placement ◽  
Woven Endobridge ◽  
Web Device ◽  
The Web

Abstract INTRODUCTION The Woven EndoBridge (WEB) device has recently emerged as an alternative to embolize complex intracranial aneurysms (IAs). However, there are limitations to the WEB device such as inability to secure acutely ruptured and wide-neck IAs. METHODS We conducted a retrospective analysis of our prospectively collected database of patients with IAs who underwent treatment with WEB device in conjunction with stenting and/or coiling, or WEB device placement in challenging locations. RESULTS A total of 7 patients/IAs were included. Average age was 59.3 ± 7.8 yr. All patients were women, and 2 presented with SAH. Two patients were treated with simultaneous stenting and WEB placement. One patient had a previous stent through which the WEB was placed. One patient underwent coiling, WEB and stent placement simultaneously. Another patient had a post-coiling recurring aneurysm which was treated with WEB placement. One patient was treated with WEB and coiling. One patient had an ophthalmic artery aneurysm with an acute angle treated with WEB alone. Two patients developed an asymptomatic decrease in flow in the parent vessel, which was successfully restored with the initiation of Tirofiban. One patient developed a herniation of the WEB device through the stent, requiring salvage with an expandable balloon that crushed the WEB against the stent and pushed it back to the aneurysm. No permanent complications or clinical deficits were reported after the endovascular procedures. The occlusion score was as follows: 4/7 cases (57.1%) achieved 100% occlusion, 2/7 cases (28.6%) had neck remnants, and 1 case (14.3%) had an aneurysmal remnant. One patient with severe SAH (Hunt & Hess grade IV) died due to no improvement in neurological exam and withdrawal of care. CONCLUSION WEB can be safely used in adjunct to coiling and/or stenting, or as a wire-navigation tool. Accurate sizing before deployment is critical.

Treatment of ruptured intracranial aneurysms with the Woven EndoBridge device: a systematic review

2021 ◽  
pp. neurintsurg-2021-017613
Author(s):  
Andre Monteiro ◽  
Audrey L Lazar ◽  
Muhammad Waqas ◽  
Hamid H Rai ◽  
Ammad A Baig ◽  
...  
Keyword(s):  
Complication Rates ◽  
Parent Vessel ◽  
Anterior Circulation ◽  
Ruptured Aneurysms ◽  
Metallic Mesh ◽  
Rebleeding Rate ◽  
Meta Analyses ◽  
Woven Endobridge ◽  
Web Device

The Woven EndoBridge (WEB) device is a barrel-shaped nitinol mesh deployed within the aneurysmal sac. The absence of metallic mesh in the aneurysm’s parent vessel lumen obviates the need for potent antiplatelet therapy, making this device appealing for acutely ruptured aneurysms not amenable to clipping or coiling. To assess the literature regarding WEB treatment of these aneurysms, we performed a comprehensive systematic search of PubMed, MEDLINE, and EMBASE databases following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Keywords were combined with Boolean operators to increase search sensitivity and specificity (‘woven endobridge device’ AND ‘ruptured’). Nine studies comprising 377 acutely ruptured aneurysms were included. Overall, 82.7% were wide-necked, 85.9% were located in the anterior circulation, and 26.9% of patients presented with poor subarachnoid hemorrhage grade. Intraprocedure and postprocedure complications occurred in 8.4% (95% CI 3.6% to 13.3%) and 1% (95% CI 0% to 2%), respectively. The post-treatment rebleeding rate was 0%. Rates of adequate occlusion (complete occlusion to neck remnant) and retreatment at last follow-up were 84.8% (95% CI 73% to 96.6%) and 4.5% (95% CI 2.2% to 6.8%), respectively. The favorable outcome rate (modified Rankin Scale score 0–2) was 62.2% (95% CI 53% to 71.4%); mortality was 13.6% (95% CI 9.7% to 17.6%). WEB treatment of acutely ruptured aneurysms results in high adequate occlusion rates, low perioperative complication rates, no rebleeding, and low recurrence requiring retreatment. This device is promising for acutely ruptured aneurysms not amenable to clipping or coiling, considering the lower need for antiplatelet regimens during the procedure or follow-up.

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.

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