scholarly journals Demographic, procedural and 30-day safety results from the WEB Intra-saccular Therapy Study (WEB-IT)

2017 ◽  
Vol 9 (12) ◽  
pp. 1191-1196 ◽  
Author(s):  
David Fiorella ◽  
Andrew Molyneux ◽  
Alexander Coon ◽  
Istvan Szikora ◽  
Isil Saatci ◽  
...  
Keyword(s):  
Therapeutic Option ◽  
Anterior Communicating Artery ◽  
Clinical Practices ◽  
Neck Size ◽  
Safety Event ◽  
Registration Number ◽  
High Level ◽  
Woven Endobridge ◽  
Web Device ◽  
The Web

IntroductionThe Woven EndoBridge (WEB) represents a novel intrasaccular therapeutic option for the treatment of intracranial wide-necked bifurcation aneurysms (WNBAs). The WEB-IT Study is a pivotal Investigational Device Exemption (IDE) study to determine the safety and effectiveness of the WEB device for the treatment of WNBAs located in the anterior and posterior intracranial circulations. We present the patient demographics, procedural characteristics, and 30-day adverse event data for the US WEB-IT study.MethodsWEB-IT is a prospective multicenter single-arm interventional study conducted at 25 US and 6 international centers. The study enrolled 150 adults with WNBAs of the anterior and posterior intracranial circulations. All patients were intended to receive a WEB device delivered via standard endovascular neurosurgical embolization techniques. The study was conducted under Good Clinical Practices and included independent adjudication effectiveness outcomes and all adverse events.ResultsOne hundred and fifty patients enrolled at 27 investigational sites underwent attempted treatment with the WEB. Mean age was 59 years (range 29–79) and 110 (73.3%) of the patients were female. Treated aneurysms were located at the basilar apex (n=59, 39.3%), middle cerebral artery bifurcation (n=45, 30%), anterior communicating artery (n=40, 26.7%), and internal carotid artery terminus (n=6, 4%). Average aneurysm size was 6.4 mm (range 3.6–11.4) with a mean neck size of 4.8 mm (range 2.0–8.2, mean dome to neck ratio 1.34). Nine patients presented with ruptured aneurysms. Of the enrolled patients, 98.7% were treated successfully with WEB devices. Mean±SD fluoroscopy time was 30.2±15.7 min. One primary safety event (PSE) (0.7%)—a delayed parenchymal hemorrhage 22 days after treatment—occurred between the index procedure and 30-day follow-up. In addition to the single PSE, there were seven (4.7%) minor ischemic strokes (5 resolved without sequelae and 2 had a modified Rankin Scale score of 1 at 30 days), five (2.7%) transient ischemic attacks, and two (1.3%) minor subarachnoid hemorrhages, which did not meet the prospectively established criteria for PSEs.ConclusionsThe WEB device can be used to treat WNBAs with a high level of procedural safety and a high degree of technical success.Trial registration numberNCT02191618; Pre-results.

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 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.

Balloon remodeling-assisted Woven EndoBridge technique: description and feasibility for complex bifurcation aneurysms

2018 ◽  
Vol 11 (4) ◽  
pp. 386-389 ◽  
Author(s):  
Cristian Mihalea ◽  
Simon Escalard ◽  
Jildaz Caroff ◽  
Léon Ikka ◽  
Aymeric Rouchaud ◽  
...  
Keyword(s):  
Artery Aneurysm ◽  
Anterior Communicating Artery ◽  
Neck Size ◽  
Complex Anatomy ◽  
Woven Endobridge ◽  
Web Device ◽  
Middle Cerebral Artery Aneurysms ◽  
Wide Neck

BackgroundWoven EndoBridge (WEB) deployment remains challenging in aneurysms with a complex shape or orientation.ObjectiveTo show that embolization of wide-neck bifurcation aneurysms using the WEB device balloon remodeling-assisted technique is a feasible and elegant endovascular solution compared with other techniques, such as balloon remodeling or stent-assisted coiling.Materials and methods10 cases (10 aneurysms in 9 patients) of balloon remodeling-assisted WEB treatment of unruptured complex bifurcation aneurysms were treated in our institution and retrospectively analyzed. Details of clinical presentations, technical details, perioperative and postoperative complications, and outcomes were collected. Immediate and long-term angiographic results were also evaluated.ResultsAneurysms included six middle cerebral artery aneurysms, one anterior communicating artery aneurysm, one posterior communicating artery aneurysm, one basilar artery aneurysm, and one T-shaped carotid aneurysm. Mean dome width was 6.55 mm, mean neck size 4.5 mm, mean height 4.79 mm, and mean dome-to-neck ratio was 1:1.46. Treatment was performed exclusively with the balloon remodeling-assisted WEB technique in all cases. The device was successfully deployed in every case. Periprocedural thromboembolic or hemorrhagic events did not occur. The modified Rankin Scale score at discharge was 0 for all patients. At mid-term or long-term angiographic follow-up, adequate occlusion was observed in 7 aneurysms from 8 controlled cases (87.5%), and one patient (2 aneurysms) did not have angiographic follow-up.ConclusionThe balloon remodeling-assisted WEB technique seems to be a safe and effective solution for endovascular treatment of unruptured wide-neck bifurcation aneurysms with specific complex anatomy. However, further studies are needed to evaluate the rate of complications and long-term efficacy.

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

2015 ◽  
Vol 21 (4) ◽  
pp. 462-469 ◽  
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.

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 Woven EndoBridge (WEB) as primary treatment for unruptured intracranial aneurysms

2018 ◽  
Vol 24 (5) ◽  
pp. 475-481 ◽  
Author(s):  
Sanne BT van Rooij ◽  
Willem Jan van Rooij ◽  
Jo P Peluso ◽  
Menno Sluzewski
Keyword(s):  
Primary Treatment ◽  
Artery Occlusion ◽  
Unruptured Aneurysms ◽  
Neck Size ◽  
Unruptured Intracranial Aneurysms ◽  
Woven Endobridge ◽  
Web Device ◽  
Cerebral Artery Occlusion ◽  
The Web

Purpose The intrasaccular flow disruptor Woven EndoBridge (WEB) device is developed for the treatment of wide-necked aneurysms without supportive devices. We used the WEB as primary treatment for unruptured aneurysms suitable for the device, regardless of neck size. Methods Between February 2015 and June 2017, 59 aneurysms in 51 patients were selectively treated with the WEB. There were 15 men and 36 women with a mean age of 59 years. Mean aneurysm size was 7.0 mm (range 3–22 mm). Of 59 aneurysms, 45 (76%) had a wide neck defined as ≥4 mm or dome-neck ratio ≤1.5. No stents or supporting balloons were used. Results Initial WEB position was judged good in all 59 unruptured aneurysms. One patient with a basilar tip aneurysm had a late thrombotic posterior cerebral artery occlusion by protrusion of the WEB over the artery. There were no procedural ruptures. Overall complication rate was 2.0% (1 of 51, 95% CI 0.01–11.3%). Imaging follow-up was available in 55 of 59 aneurysms (93%). At 3 months, 41 of 57 aneurysms (72%) were completely occluded, 12 (21%) had a neck remnant and 4 (7%) were incompletely occluded. Conclusion WEB treatment is safe and effective in selected unruptured aneurysms suitable for the device, regardless of neck size or location. There was no need for supportive devices. Three-quarters of all unruptured small aneurysms could be treated with the WEB. In our opinion, the WEB is a valuable alternative to coils, especially in wide-necked aneurysms.

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.

scholarly journals Clipping as re-treatment strategy after treatment of a cerebral aneurysm with the Woven EndoBridge embolization device: case report

2019 ◽  
Vol 130 (3) ◽  
pp. 891-894 ◽  
Author(s):  
Gregor Durner ◽  
Yigit Özpeynirci ◽  
Bernd Schmitz ◽  
Christian Rainer Wirtz ◽  
Ralph König ◽  
...  
Keyword(s):  
Indocyanine Green Angiography ◽  
Cerebral Aneurysms ◽  
Artery Aneurysm ◽  
Flow Diverter ◽  
Anterior Communicating Artery ◽  
Woven Endobridge ◽  
Web Device ◽  
Prior Experiences ◽  
Over Time ◽  
The Web

Recently, treatment of cerebral aneurysms with the Woven EndoBridge (WEB) device has become an established endovascular strategy. However, over time, neurosurgeons and neuroradiologists will be confronted with the challenge of how to treat aneurysm recanalization. The authors report the case of a 49-year-old woman who underwent re-treatment with clipping after the recanalization of a 4 × 3–mm anterior communicating artery aneurysm that had previously been treated using a 4 × 3 WEB device. In contrast to the authors’ prior experiences with clipping of previously coiled aneurysms, the WEB device was found to have a responsive softness during clip placement, and the aneurysm was more maneuverable. Moreover, evaluation with indocyanine green angiography was easy to perform because of the transparent mesh of the WEB device. No profound scarring or WEB protrusion was noted during surgery, making the procedure easier and less dangerous with regard to additional complications. The authors suggest that re-treatment via clipping should be considered in select cases of aneurysm recurrence after treatment with an intraaneurysmal flow diverter.

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