Safety results from the treatment of 109 cerebral aneurysms using the Woven EndoBridge technique: preliminary results in the United Kingdom

2018 ◽  
Vol 128 (1) ◽  
pp. 144-153 ◽  
Author(s):  
Aimee Lawson ◽  
Andy Molyneux ◽  
Robin Sellar ◽  
Saleh Lamin ◽  
Allan Thomas ◽  
...  
Keyword(s):  
United Kingdom ◽  
Clinical Outcome ◽  
Cerebral Aneurysms ◽  
Clinical Use ◽  
The United Kingdom ◽  
The Uk ◽  
Woven Endobridge ◽  
Web Device ◽  
The Web

OBJECTIVEThe Woven Endobridge (WEB) device has been in clinical use for the treatment of brain aneurysms for the past 4 years. Observational studies to assess clinical outcome and related complications have been published. Clear evidence is required to better understand the safety profile of the WEB device. The authors here present a multicenter series that provides a detailed safety analysis focused on patient selection, procedural events, and technical issues of treated patients throughout the United Kingdom (UK).METHODSA nationwide password-protected database was set up to collect anonymous information across the UK (14 centers). Complications and clinical outcome were analyzed for the initial 109 patients (112 procedures). An independent root cause analysis classified the complications into groups (procedural, disease, device, ancillary device, and other). The modified Rankin Scale (mRS) was used as a marker of clinical outcome.RESULTSEach of the 109 patients had 1 aneurysm suitable for WEB treatment (109 aneurysms). Three patients had 2 procedures, making a total of 112 procedures performed. Eight procedures were abandoned because of access issues; 2 patients went on to have a successful procedure. All 109 patients had a preprocedure and discharge mRS scores recorded. One hundred patients had a recorded mRS score from a > 3-month follow-up.Deployment of the WEB device was successful in 103 (94.5%) of 109 patients and 104 (92.9%) of 112 procedures. One patient had 2 successful WEB procedures on separate occasions. Patients without a successfully implanted WEB device were included in the analysis. Selection analysis showed that the average patient age was 56.5 years among 34 men and 75 women. The percentage of incidental aneurysms was 58.7%, acute 16.5%, symptomatic 18.3%, and recurrent 6.4%. Further results analysis showed that 40 (36.7%) of 109 patients had recorded adverse events, including those unrelated to the WEB device. Events that could be related to the WEB device numbered 17 (15.6%) among the 109 patients. Two patients with device-related complications were symptomatic. Overall, 11 patients (10.1%) had persistent clinical sequelae. Thromboembolism was the most prevalent event, affecting 15.6% of the patients (17 of 109), and 6.4% of the patients (7 of 109) with a thromboembolism were symptomatic.Overall mortality before discharge was 0% and at the > 3-month follow-up was 5% (5 of 100 patients). Morbidity was defined as an mRS score increase to > 2. Overall morbidity at discharge was 1.8% (2 of 109) and at the > 3-month follow-up was 6% (6 of 100). No device-related morbidity or mortality was associated with this group.CONCLUSIONSThe UK data show that the WEB device is safe for clinical use. Thromboembolic complication adds a risk that should be minimized with appropriate anticoagulation and correct sizing of the device. There is scope for further evaluation and standardization of an anticoagulation regimen for the WEB device.

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.

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 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.

Survey of the Use of Diffusion-Weighted Imaging for Cholesteatoma in the United Kingdom

ORL ◽  
2021 ◽  
pp. 1-7
Author(s):  
Sunil Dutt Sharma ◽  
Ahmad Hariri ◽  
Ravi Kumar Lingam ◽  
Arvind Singh
Keyword(s):  
United Kingdom ◽  
British Society ◽  
Petrous Apex ◽  
The United Kingdom ◽  
Diffusion Weighted ◽  
Clinical Scenarios ◽  
Head And Neck Imaging ◽  
The Mean ◽  
The Uk

<b><i>Background:</i></b> Non-echoplanar diffusion-weighted MRI (DWMRI) has a role in the surgical planning for cholesteatoma. <b><i>Aims/Objectives:</i></b> The aim of the study was to assess the use of DWMRI in the management of cholesteatoma across the UK, and measure clinicians’ confidence in the use of DWMRI. <b><i>Materials and Methods:</i></b> Telephone survey in 139 Otolaryngology Departments in the United Kingdom between March 2017 and July 2017, and asking radiology delegates at the British Society of Head and Neck Imaging 2017 meeting. <b><i>Results:</i></b> The response rate was 101 out of 139 Trusts (73%). Of those respondents who did have DWMRI available, 68/88 respondents (77%) use it for cholesteatoma. The mean confidence (±standard deviation) of the respondents with DWMRI in identifying cholesteatoma presence was 7.3 ± 2.1, in identifying volume of cholesteatoma was 6.8 ± 1.8, and in identifying subsites of cholesteatoma was 4.6 ± 2.1. <b><i>Conclusions and Significance:</i></b> DWMRI has a well-defined role in the follow-up of patients after cholesteatoma surgery, and those primary cases of cholesteatoma where the diagnosis is in question. The use of DWMRI for cholesteatoma is variable across the UK, but there are certain clinical scenarios where there is not enough awareness regarding the benefits of imaging (such as petrous apex cases of cholesteatoma).

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 Further Aspects of the UK Engine Technology Demonstrator Programme

1988 ◽  
Author(s):  
D. W. Hughes ◽  
W. J. Chrispin
Keyword(s):  
United Kingdom ◽  
Scale Development ◽  
Gas Turbine ◽  
Full Scale ◽  
Cost Overrun ◽  
The United Kingdom ◽  
Technology Demonstration ◽  
The Uk ◽  
Technology Demonstrator

In 1987, a paper entitled ‘The United Kingdom Engine Technology Demonstrator Programme’ (ASME 87-GT-203) was presented at the Gas Turbine Conference in Anaheim. That paper postulated that a programme of engine technology demonstration ahead of commitment to full-scale development was essential if past problems of cost overrun and inadequate performance at service entry were to be avoided. The paper concluded that the UK had established a balanced programme of technology demonstration, emphasising that Industry and Government must invest this activity with the same commitment traditionally given to projects if the full benefits were to be realised. This follow-up paper presents an expanded view of future programme objectives and how the programme elements formulated for their achievement are to be managed.

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.

Sign in / Sign up

Export Citation Format

Share Document