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.

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 Treatment of Acutely Ruptured Cerebral Aneurysms With the Woven EndoBridge (WEB) Flow Disruptor: A Multicenter Experience

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Fadi Al Saiegh ◽  
David M Hasan ◽  
Nikolaos Mouchtouris ◽  
Mario Zanaty ◽  
Nohra Chalouhi ◽  
...  
Keyword(s):  
Cerebral Aneurysms ◽  
University Hospitals ◽  
Unruptured Aneurysms ◽  
Ruptured Aneurysms ◽  
Anti Platelet Therapy ◽  
Acute Subarachnoid Hemorrhage ◽  
Woven Endobridge ◽  
Web Device ◽  
Intraoperative Rupture ◽  
The Web

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.

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.

Clipping of recanalized intracerebral aneurysms initially treated by the Woven EndoBridge device

2019 ◽  
Vol 11 (8) ◽  
pp. 807-811 ◽  
Author(s):  
Laurent Pierot ◽  
Christophe Bannery ◽  
Valery Batchinsky-Parrou ◽  
Jean-Charles Kleiber ◽  
Sebastien Soize ◽  
...  
Keyword(s):  
Initial Treatment ◽  
Present Series ◽  
Anterior Communicating Artery ◽  
Flow Disruption ◽  
Long Term Follow Up ◽  
Feasible Option ◽  
Woven Endobridge ◽  
Web Device ◽  
Incomplete Occlusion ◽  
The Web

Background and purposeIntrasaccular flow disruption using the Woven EndoBridge (WEB) is a safe and effective method to treat intracranial aneurysms, particularly wide neck bifurcation aneurysms. However mid term and long term follow-up imaging can show aneurysm remnant or recanalization, and retreatment is therefore sometimes necessary. In most cases, retreatment is performed using an endovascular approach. The present series reports and analyzes aneurysm clipping of recanalized or incompletely occluded aneurysms following WEB treatment.MethodsAll patients treated with the WEB device since the beginning of our experience in June 2011 were prospectively collected in a local database. Among them, patients who were retreated by clipping for aneurysm remnants were included in the present series.ResultsIn the cumulative population of 130 patients with aneurysms treated by the WEB device from June 2011 to February 2019, 4 patients (3.1%) were retreated with surgical clipping due to incomplete occlusion (2 patients) and aneurysm recanalization (2 patients). Three of the four aneurysms retreated (75%) were located in the middle cerebral artery and one in the anterior communicating artery (25.0%). The aneurysm was ruptured in 1 of 4 patients (25%). Clipping was performed 10–54 months after initial treatment with the WEB. Surgical exposure showed that the WEB device was inside the aneurysm sac in all cases. Clipping was easily performed in all but 1 case. Control DSA showed complete occlusion in two aneurysms and a neck remnant in two.ConclusionClipping is a feasible option for treating aneurysm remnants following initial treatment with intrasaccular flow disruption using the WEB.

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.

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 for unruptured intracranial aneurysms: Results in 95 aneurysms from a single center

2021 ◽  
pp. 159101992110034
Author(s):  
Tom De Beule ◽  
Thierry Boulanger ◽  
Sam Heye ◽  
Williem J van Rooij ◽  
Wim van Zwam ◽  
...  
Keyword(s):  
Posterior Inferior Cerebellar Artery ◽  
Superior Cerebellar Artery ◽  
Morbidity Rate ◽  
Anterior Communicating Artery ◽  
Unruptured Aneurysms ◽  
Unruptured Intracranial Aneurysms ◽  
Cerebellar Artery ◽  
Woven Endobridge ◽  
The Web

Background and purpose The Woven EndoBridge (WEB) is an intrasaccular flowdisruptor that is increasingly used for the treatment of (wide-necked) aneurysms. We present our experience with the WEB for unruptured aneurysms. Materials and methods Between April 2014 and August 2019, 93 patients with 95 unruptured aneurysms were primarily treated with the WEB. There were 69 women and 24 men, mean age 61 years (median 58, range 37–80). Results Of 95 aneurysms, 86 had been discovered incidentally, 3 were symptomatic and 6 were additional to another ruptured aneurysm. Location was anterior communicating artery 33, middle cerebral artery 29, basilar tip 19, carotid tip 8, posterior communicating artery 4, posterior inferior cerebellar artery 1, superior cerebellar artery 1. Mean aneurysm size was 6 mm (median 6, range 3–13 mm). In one aneurysm additional coils were used and in another, a stent was placed. There was one procedural rupture without clinical sequelae. There were two thrombo-embolic complications leading to permanent deficit in one patient (mRS 2). Morbidity rate was 1.0% (1 of 93, 95%CI 0.01–6.5%) and mortality was 0% (0 of 93, 95%CI 0.0–4.8%). Angiographic follow-up at six months was available in 85 patients with 87 aneurysms (91%). Of 87 aneurysms, 68 (78%) were completely occluded, 14 (16%) had a neck remnant and 5 were incompletely occluded. Four aneurysms were retreated. Retreatment rate was 4.5% (4 of 87, 95%CI 1.7–13.6%). Conclusion WEB treatment of unruptured aneurysms is safe and effective. Additional devices are needed only rarely and retreatment at follow-up is infrequent.

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.

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