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 ◽  
...  

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.

Neurosurgery ◽  
2020 ◽  
Vol 87 (1) ◽  
pp. E16-E22 ◽  
Author(s):  
Fadi Al Saiegh ◽  
David Hasan ◽  
Nikolaos Mouchtouris ◽  
Mario Zanaty ◽  
Ahmad Sweid ◽  
...  

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.


2016 ◽  
Vol 9 (4) ◽  
pp. 411-417 ◽  
Author(s):  
Christin Clajus ◽  
Christoph Strasilla ◽  
Tom Fiebig ◽  
Vojtech Sychra ◽  
David Fiorella ◽  
...  

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.


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Nikolaos Mouchtouris ◽  
David Hasan ◽  
Fadi Al Saiegh ◽  
Ahmad Sweid ◽  
Mario Zanaty ◽  
...  

Introduction: Wide-neck bifurcation cerebral aneurysms have always posed a treatment challenge and have historically required either clip ligation, or stent vs. balloon-assisted coil embolization. This predicament led to the development of the newly FDA-approved Woven EndoBridge (WEB) aneurysm embolization system (Sequent Medical Inc, Aliso Viejo, CA) Which is a self-expanding mesh that achieves intrasaccular flow disruption and does not require antithrombotic medications. In this study, we report our experience with the first 64 consecutive aneurysms treated via WEB embolization at two high-volume institutions. Methods: We reviewed our first 61 consecutive patients with 64 cerebral aneurysms who underwent WEB embolization from February-August 2019. We collected data on patient demographics and clinical presentation, aneurysm characteristics, device and procedural details, and functional outcomes. Results: A total of 64 aneurysms were included in our study. Fifteen patients (24.1%) presented with acutely ruptured aneurysm while the rest were unruptured. The majority of patients (82.8%) required only one attempt for successful device deployment, while a stent was necessary as an adjunct treatment in 4 patients (6.3%) due to WEB herniation. Two patients had residual aneurysm that had to undergo additional treatment; one of them underwent second WEB embolization and one underwent clip ligation. One patient with a PICA aneurysm had device dislodgment with injury to the parent vessel—Onyx and coils were used to deconstruct the vertebral artery. Conclusions: The advent of the WEB device has significantly impacted the surgical decision-making for the treatment of bifurcation, wide-neck aneurysms. We discuss in detail the lessons learned from patient selection, device size selection, technique, and complications from two institutions with high-volume endovascular and microsurgical aneurysm treatment experience.


2018 ◽  
Vol 128 (1) ◽  
pp. 144-153 ◽  
Author(s):  
Aimee Lawson ◽  
Andy Molyneux ◽  
Robin Sellar ◽  
Saleh Lamin ◽  
Allan Thomas ◽  
...  

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.


2019 ◽  
Vol 11 (9) ◽  
pp. 924-930 ◽  
Author(s):  
Adam S Arthur ◽  
Andy Molyneux ◽  
Alexander L Coon ◽  
Isil Saatci ◽  
Istvan Szikora ◽  
...  

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


Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Fadi Al Saiegh ◽  
David M Hasan ◽  
Nikolaos Mouchtouris ◽  
Mario Zanaty ◽  
Nohra Chalouhi ◽  
...  

Abstract INTRODUCTION Coiling has become the first-line treatment option for acutely ruptured aneurysms 1 to 3. However, coiling of wide-necked bifurcation aneurysms is challenging and stent-assisted coiling requires dual anti-platelet therapy. The Woven EndoBridge (WEB) flow disruptor has been recently Food and Drug Administration (FDA)-approved for bifurcation aneurysms and is designed to achieve intrasaccular flow diversion without the need for antiplatelet therapy. However, its use has been mostly reserved for unruptured aneurysms. Here, we present our series of ruptured aneurysms that were treated with the WEB-device post FDA approval. METHODS We performed a review of the first cohort of patients with acute subarachnoid hemorrhage (SAH) from ruptured aneurysms who underwent endovascular treatment with the WEB-device at Thomas Jefferson and Iowa University Hospitals and identified 7 patients. RESULTS All 7 patients were female and the mean age was 71 yr (range 57-81). Hunt and Hess grades ranged from 2 to 5. The aneurysms treated included anterior communicating, posterior communicating, posterior-inferior cerebellar (PICA), basilar apex, and vertebrobasilar junction (VBJ). In 6 of the 7 aneurysms, 1 WEB device was sufficient to achieve adequate obliteration; the VBJ aneurysm was 14 mm in size and required 2. The majority of patients underwent treatment via transfemoral access followed by transradial. One patient underwent direct carotid puncture due to vessel tortuosity. Aneurysm rebleeding was not encountered in any of the WEB-treated aneurysms. One patient had an intraoperative rupture of their PICA aneurysm after dislodgment of the WEB device. There were no treatment-related deaths, but one patient died of cardiopulmonary failure. CONCLUSION Our series shows that the WEB device can be safely used in ruptured bifurcation aneurysms of various sizes in the anterior and posterior circulation. It does not require adjunctive stent use and is a valuable alternative to stent-assisted coiling as it obviates the need for anti-platelet therapy.


2018 ◽  
Vol 24 (5) ◽  
pp. 475-481 ◽  
Author(s):  
Sanne BT van Rooij ◽  
Willem Jan van Rooij ◽  
Jo P Peluso ◽  
Menno Sluzewski

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.


2017 ◽  
Vol 126 (1) ◽  
pp. 17-28 ◽  
Author(s):  
Aimee Lawson ◽  
Tony Goddard ◽  
Stuart Ross ◽  
Atul Tyagi ◽  
Kenan Deniz ◽  
...  

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.


2020 ◽  
pp. 159101992097221
Author(s):  
Colin Son ◽  
Samon Tavakoli-Sabour

Background Transradial access is an increasingly utilized route for neurointerventions with benefits of lower rates of access site complications, earlier patient mobilization and increased patient satisfaction over transfemoral interventions. There is limited data on deployment of the Woven EndoBridge (WEB) via transradial access. We report a case series of consecutive patients undergoing cerebral aneurysm embolization with the WEB device via transradial biaxial access. Methods A database of neuroendovascular procedures was queried for consecutive aneurysm embolization procedures involving the WEB device and intended via the transradial approach between August 2019 and July 2020. Patient demographics, radiological aneurysm characteristics and procedure details were recorded and statistically evaluated. Google Scholar and Pubmed were searched for previous reports of transradial WEB embolization. Results Ten aneurysms were treated in ten patients. All aneurysms were treated with successful WEB deployment. Nine of the ten aneurysms were successfully treated via transradial biaxial access. One aneurysm required conversion to transfemoral access. There were no clinical complications and no morbidity or mortality. Conclusions Transradial embolization of cerebral aneurysms with the WEB device is safe and feasible with low rates of access failure or complications.


Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Nikolaos Mouchtouris ◽  
David M Hasan ◽  
Fadi Al Saiegh ◽  
Ahmad Sweid ◽  
Mario Zanaty ◽  
...  

Abstract INTRODUCTION Wide-neck bifurcation cerebral aneurysms have always posed a treatment challenge and have historically required either clip ligation, or stent vs balloon-assisted coil embolization. This predicament led to the development of the newly FDA-approved Woven EndoBridge (WEB) Aneurysm Embolization System (Sequent Medical Inc, Aliso Viejo, California), which is a self-expanding mesh that achieves intrasaccular flow disruption and does not require antithrombotic medications. In this study, we report our experience with the first 29 consecutive aneurysms treated via WEB embolization at 2 high-volume institutions. METHODS We reviewed our first 27 consecutive patients with 29 cerebral aneurysms who underwent WEB embolization from February to April 2019. We collected data on patient demographics and clinical presentation, aneurysm characteristics, device and procedural details, and functional outcomes. RESULTS A total of 29 aneurysms were included in our study. Seven patients (24.1%) presented with acutely ruptured aneurysm while the rest were unruptured. The majority of patients (82.8%) required only 1 attempt for successful device deployment, while a stent was necessary as an adjunct treatment in 4 patients (13.7%) due to WEB herniation. Two patients had residual aneurysm that had to undergo additional treatment; one of them underwent second WEB embolization and one underwent clip ligation. One patient with a PICA aneurysm had device dislodgment with injury to the parent vessel Onyx and coils were used to deconstruct the vertebral artery. CONCLUSION The advent of the WEB device has significantly impacted the surgical decision-making for the treatment of bifurcation, wide-neck aneurysms. We discuss in detail the lessons learned from patient selection, device size selection, technique, and complications from 2 institutions with a high-volume endovascular and microsurgical aneurysm treatment experience.


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