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

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.

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 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

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

2017 ◽  
Vol 126 (1) ◽  
pp. 17-28 ◽  
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.

Volume-based sizing of the Woven EndoBridge (WEB) device: A preliminary assessment of a novel method for device size selection

2021 ◽  
pp. 159101992098768
Author(s):  
Kevin A Shah ◽  
Timothy G White ◽  
Ina Teron ◽  
Thomas Link ◽  
Amir R Dehdashti ◽  
...  
Keyword(s):  
Pearson Correlation ◽  
Three Dimensional ◽  
Size Selection ◽  
Significant Difference ◽  
Width Measurements ◽  
Woven Endobridge ◽  
Web Device ◽  
The Web ◽  
Web Size

Introduction Accurate sizing of the Woven EndoBridge (WEB) device is of critical importance as it determines procedural safety and successful occlusion of wide neck bifurcation aneurysms. The aim of this study was to assess the ability of aneurysm volume to assist in accurate WEB size selection. Methods All patients with an intracranial aneurysm treated with the WEB SL or WEB SLS device between March 2019 and October 2019 were identified for this retrospective study. Aneurysm volumes were calculated with auto-segmentation using a three-dimensional volume rendering program on an independent Syngo workstation (Siemens Healthineers AG). Pearson correlation coefficients were calculated for aneurysm auto-segmented volumes and WEB volumes, as well as for aneurysm height × width and WEB height × width. Follow-up angiographic outcomes were collected at 6–9 months post-procedure. Results Twenty-nine aneurysms were evaluated by 3D rotational angiography. The correlation coefficient with WEB size was larger for auto-segmented aneurysm volumes (r = 0.979) compared to height × width measurements (r = 0.867). Using Fisher r-to-z transformations, we found the difference between the two correlations to be statistically significant (p = 0.0007). Follow-up angiography available in 13 subjects demonstrated an 85% complete aneurysm occlusion rate. Conclusion Aneurysm volumes are highly correlated with WEB volumes, with auto-segmentation volumes displaying statistically significant difference against conventional height by width measurements. These results suggest that volumetric measurements of aneurysm size provide a useful adjuvant measure to assist in appropriate size selection of the WEB device.

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.

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.

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.

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.

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.

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