International Study of Intracranial Aneurysm Treatment Using Woven EndoBridge: Results of the WorldWideWEB Consortium.
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SUBMITTER: Dmytriw AA
PROVIDER: S-EPMC8792251 | biostudies-literature | 2022 Feb
REPOSITORIES: biostudies-literature
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International Study of Intracranial Aneurysm Treatment Using Woven EndoBridge: Results of the WorldWideWEB Consortium.
Dmytriw Adam A AA Diestro Jose Danilo Bengzon JDB Dibas Mahmoud M Phan Kevin K Sweid Ahmad A Cuellar-Saenz Hugo H HH Lay Sovann V SV Guenego Adrien A Renieri Leonardo L Al Balushi Ali A Sundararajan Sri Hari SH Carnevale Joseph J Saliou Guillaume G Möhlenbruch Markus M Vranic Justin E JE Harker Pablo P Rabinov James D JD Lylyk Ivan I Foreman Paul M PM Vachhani Jay A JA Župančić Vedran V Hafeez Muhammad U MU Rutledge Caleb C Waqas Muhammad M Tutino Vincent M VM Abbas Rawad R Inoue Yasuaki Y Capirossi Carolina C Ren Yifan Y Schirmer Clemens M CM Piano Mariangela M Kühn Anna Luisa AL Michelozzi Caterina C Elens Stéphanie S Regenhardt Robert W RW Ghozy Sherief S Alotaibi Naif M NM Tjoumakaris Stavropoula S Starke Robert M RM Lubicz Boris B Panni Pietro P Puri Ajit S AS Pero Guglielmo G Griessenauer Christoph J CJ Ulfert Christian C Asadi Hamed H Brooks Mark M Maingard Julian J Jhamb Ashu A Siddiqui Adnan A Ducruet Andrew F AF Albuquerque Felipe C FC Kan Peter P Kalousek Vladimir V Lylyk Pedro P Savardekar Amey A Boddu Srikanth S Knopman Jared J Limbucci Nicola N Chen Karen S KS Aziz-Sultan Mohammad A MA Stapleton Christopher J CJ Jabbour Pascal P Cognard Christophe C Patel Aman B AB Adeeb Nimer N
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Project description: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.
| S-EPMC6116134 | biostudies-literature
Project description:Background and objectiveThe clinical outcome and angiographic outcome data of Woven EndoBridge (WEB) device for the treatment of ruptured intracranial aneurysms (IAs) are limited. We conducted a meta-analysis of the latest literature on the WEB device in the treatment of ruptured IAs.MethodsA comprehensive literature search of 4 databases (PubMed, Web of Science, Cochrane library, and Embase) was conducted for studies published from January 1, 2010 to December 31, 2020. Two reviewers independently extracted variables (aneurysm and patient characteristics) using a prespecified data-collection sheet. Outcomes studied included initial and latest follow-up angiographic outcomes, technical success rate, perioperative mortality, retreated rate, perioperative re-bleeding, complication, intraoperative rupture, favorable neurologic outcome at discharge. We used random-effects model to pool the data.ResultsWe finally presented the results of 7 articles including 276 patients with 283 aneurysms. Initial complete and adequate occlusion rate were 38% (95% CI, 25%-50%) and 98% (95% CI, 95%-100%), respectively. Latest follow-up complete and adequate occlusion rate were 61% (95% CI, 46%-75%) and 91% (95% CI, 84%-98%), respectively.Technical success rate was 99% (95% CI, 98%-100%). Perioperative mortality rates and perioperative re-bleeding rate were 9% (95% CI, 3%-15%) and 1% (95% CI, 0%-2%), respectively. Retreated rate was 6% (95% CI, 3%-10%). Overall and WEB treatment-related thromboembolic complication was 10% (95% CI, 6%-13%) and 7% (95% CI, 2%-12%), respectively. Intraoperative rupture rate was 3% (95% CI, 0%-6%).ConclusionEndovascular treatment of ruptured IAs with the WEB device has a good safety profile and an acceptable aneurysm occlusion rate.
| S-EPMC9131500 | biostudies-literature
Project description:Background and purposeThe Woven EndoBridge has proved to be a safe and effective treatment, especially for wide-neck intracranial aneurysms. The recent fifth-generation Woven EndoBridge came with smaller devices. The purpose of this study was to assess the safety and efficiency of Woven EndoBridge treatment of small and very small aneurysms.Materials and methodsBetween September 2017 and March 2020, all consecutive patients treated with a 3- or 3.5 mm-width Woven EndoBridge device were included in this retrospective intention-to-treat study. Clinical and radiologic findings were evaluated at immediate and last-available follow-up. Angiographic outcome was assessed by an external expert reader.ResultsOne hundred twenty-eight aneurysms were treated with a fifth-generation Woven EndoBridge device including 29 with a width of ≤3.5 mm. Ten aneurysms were ruptured (34%). In 3 cases (10%), Woven EndoBridge treatment could not be performed because the aneurysm was still too small for the smallest available Woven EndoBridge device and another endovascular strategy was chosen. The median follow-up time was 11.2 months. Complete and adequate occlusion was obtained in 71% and 90% of the treated aneurysms, respectively. Retreatment was needed in 2 cases (10%). Symptomatic ischemic complications leading to transient neurologic deficits occurred in 2 cases (7%) (1 procedure-related and 1 device-related) but with full spontaneous recovery at discharge.ConclusionsThe fifth-generation Woven EndoBridge device seems to be a safe and technically feasible treatment for both ruptured and unruptured small and very small intracranial aneurysms, with satisfactory occlusion rates on midterm follow-up. However, further study is needed to evaluate longer-term efficiency.
| S-EPMC8324278 | biostudies-literature
Project description:PurposeEndovascular 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.MethodsPatients 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.ResultsIn 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).ConclusionSmaller 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.
| S-EPMC8894173 | biostudies-literature
Project description:The Woven EndoBridge (WEB) device is FDA-approved for the treatment of bifurcation aneurysms. Despite its wide popularity, it has been under scrutiny for its association with potential aneurysm recanalization and retreatment due to device shape modification. This study aims to analyze the shape modification rate of WEB devices and identify factors associated with this phenomenon, as well as its correlation with aneurysm retreatment. We conducted a retrospective review of the WorldWide WEB Consortium database, including adult patients treated for intracranial aneurysms with the WEB device. We assessed aneurysm occlusion using the WEB Occlusion Scale and defined WEB shape modification as a percentage reduction in the distance between two WEB markers. Logistic regression and Cox proportional hazards models were utilized to evaluate predictors of shape modification and retreatment. Kaplan-Meier curves were used to estimate the time-dependent probability of no or minor shape modification. A total of 405 patients were analyzed, with minor and major shape modification occurring in 31.4% and 10.1% of cases, respectively. Major shape modification was associated with lower rates of adequate occlusion (70.7%) compared to no or minor shape modification (86.6%) and a higher rate of retreatment (26.8% vs. 8.1%). Predictors of major shape modification included the presence of daughter sac, bifurcation aneurysms, absence of immediate flow stagnation, and a WEB width minus aneurysm width ratio ≤ 0.5. The probability of no or minor shape modification declined within the first 25 months and stabilized thereafter. WEB device shape modification is a significant predictor of aneurysm occlusion efficacy and retreatment. Recognizing the factors influencing shape modification can guide treatment decisions and follow-up protocols to improve patient outcomes.
| S-EPMC11850463 | biostudies-literature
Project description:Background and purposeThe Woven EndoBridge is an intrasaccular device for the treatment of intracranial aneurysms. The first generation consisted of a high-profile double-layer braid. This review aims to evaluate the outcomes of the new generation low-profile Woven EndoBridge single layer device for intracranial aneurysm treatment.MethodsA systematic review was conducted with Medline, Embase, and Web of Science Conference Proceedings databases. The search strategy provided 589 articles, 15 articles were included.ResultsFifteen articles were identified reporting the use of Woven EndoBridge single-layer devices in 963 aneurysms, mostly wide-necked bifurcation aneurysms. Procedural aneurysm rupture was reported in 8 of 963 patients (0.83%; 95%CI 0.39-1.66%) and thromboembolic events in 54 of 963 patients (5.61%, 95CI 4.31-7.26%). Cumulative morbidity was 2.85% (27/949, 95%CI 1.95-4.12%) and mortality 0.93% (9/963, 95%CI 0.46-1.80%). The overall rate of adequate aneurysm occlusion at last follow-up was 83.3% (613/736; 95%CI 80.4-85.8%). Retreatment was reported in 38 aneurysms in eight studies with 450 aneurysms with follow-up (38/450; 8.4%, 95CI 6.2-11.4%). In 12 studies comprising 644 aneurysms with follow-up, rebleeds occurred in three patients in three studies with mean follow-up between 3.3 and 14.4 months (0.47%, 95%CI 0.09-1.43%).ConclusionWoven EndoBridge single-layer is a promising new low-profile device especially for wide-neck bifurcation aneurysms, both ruptured and unruptured. No antiplatelet medication is needed which is a great advantage, especially in ruptured aneurysms. Efficacy and safety compare favorably with (stent-assisted) coiling. However, no direct comparison with other treatments is available as yet.
| S-EPMC7446584 | biostudies-literature
Project description:BackgroundThe Woven EndoBridge 17 (WEB-17) is the latest advancement in the WEB device family. Comprehensive data on its occlusion rates, procedural complications, and mortality is lacking. This meta-analysis aimed to evaluate the efficacy and safety of the WEB-17 device in intracranial aneurysms (IAs).MethodsA systematic literature search was conducted from inception to October 2023 across four databases for studies on IAs treated with WEB 17. Primary outcomes included adequate angiographic occlusion at last follow-up and a composite of intraprocedural and postprocedural complications. Comparative meta-analysis between WEB-17 and its predecessor versions (pvWEB) was performed. Subgroup analyses by IA rupture status were also conducted for the primary outcomes.ResultsEleven studies with 880 patients and 933 IAs were included. Regarding efficacy, the rate of adequate occlusion at last follow-up was 91% (95% CI 86%-94%) and the complete occlusion rate was 69% (95% CI 65%-73%). Safety outcomes demonstrated a composite complication rate of 7% (95% CI 4%-11%), an intraprocedural complication rate of 7% (95% CI 5%-9%; I2 = 0%), and a postprocedural complication rate of 2% (95% CI 1%-5%; I2 = 0%). No differences were found between WEB-17 and pvWEB in terms of adequate occlusion (WEB-17: 87.7% vs pvWEB: 80.4%; OR = 1.35, 95% CI 0.71-2.55) and safety composite outcome (WEB-17: 8.7% vs pvWEB: 10%; OR = 1.05, 95% CI 0.51-2.16). Subgroup analysis did not evidence heterogeneity between subgroups.ConclusionsThe WEB-17 device demonstrates promising efficacy and safety profiles for the treatment of IAs. However, these results should be interpreted with caution due to the limited quality of evidence in the included studies. Further prospective, randomized studies are needed to validate these findings.
| S-EPMC11775924 | biostudies-literature
Project description:BackgroundWoven EndoBridge (WEB; Sequent Medical) treatment is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown high safety with good efficacy at short term confirmed by trials conducted in United States (WEB-Intrasaccular Therapy) and in Europe (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy [WEBCAST], French Observatory, and WEBCAST-2).ObjectiveTo report the 2-yr clinical and anatomical results of WEB treatment in the combined population of 3 European trials.MethodsIn a French Observatory, 2-yr clinical and anatomical data were collected. In WEBCAST and WEBCAST-2, 2-yr follow-up was optional, and data were collected when follow-up was performed. Aneurysm occlusion was evaluated using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant.ResultsThe population for safety was 138/168 patients (82.1%), including 89 females (64.5%), with mean age of 55.5 ± 10.2 yr. The population for efficacy was 121/169 aneurysms (71.6%). Aneurysm locations were middle cerebral artery in 65/121 aneurysms (53.7%), anterior-communicating artery in 25/121 (20.7%), basilar artery in 17/121 (14.0%), and internal carotid artery terminus in 14/121 (11.6%). No clinically relevant adverse events occurred between years 1 and 2. At 2 yr, complete occlusion was observed in 62/121 (51.2%) aneurysms, neck remnant in 36/121 (29.8%) aneurysms, and aneurysm remnant in 23/121 (19.0%) aneurysms. The global retreatment rate at 2 yr was 9.3%.ConclusionThis analysis confirms the high safety profile of WEB treatment at 2 yr. Aneurysm occlusion is generally stable at 2 yr, and the retreatment rate between 1 yr and 2 yr is low (2.0%).
| S-EPMC7534535 | biostudies-literature
Project description:IntroductionAngiography is the standard follow-up modality for treated aneurysms with the Woven EndoBridge (WEB), and magnetic resonance angiography (MRA) is useful for extended follow-up. We present the results of WEB-treated aneurysms with angiographic follow-up at three months and at least 18 months' 3T MRA follow-up.Materials and methodsIncluded were 52 patients with 53 aneurysms treated with the WEB between February 2015 and July 2016. There were 29 women and 23 men with a mean age of 60 years (median 62, range 23-76). Mean aneurysm size was 6.2 mm (median 6, range 3-16 mm).Results3T MRA follow-up was mean 19.6 months (median 18, range 18-36 months). One patient had an aneurysm remnant at three-month angiography that was additionally coiled and with stable complete occlusion at 18 months' 3T MRA follow-up. At three-month follow-up angiography, 44 aneurysms were completely occluded and eight had a neck remnant. At latest 3T MRA, stable complete occlusion was present in 43 aneurysms and stable neck remnant in eight. One posterior cerebral artery (PCA) dissection aneurysm was stable at three and six months but was enlarged and reopened at 18 months, confirmed with angiography. Focal signal loss by the proximal marker of the WEB was apparent in four patients without compromising diagnostic evaluation.ConclusionWEB-treated aneurysms with adequate occlusion at three-month angiography remained stable during serial 3T MRA follow-up of 18-36 months. One PCA aneurysm reopened during the 6- to 18-month interval. Once the WEB-treated aneurysm is adequately occluded in the short term, later reopening is uncommon.
| S-EPMC6259330 | biostudies-literature
Project description:The treatment of intracranial aneurysms has seen incredible advancements over the last few decades. Long-term occlusion of wide-neck bifurcation aneurysms remains technically challenging. The Woven Endobridge (WEB) embolization device is innovative in its construction and uses. The design of the device has evolved over the last decade. Pre-clinical and clinical trials are ongoing and continue to inform the development of intrasaccular flow-diverting devices. The WEB device is currently approved by the U.S. Food and Drug Administration (FDA) for treating wide-neck aneurysms. The safety and efficacy of the WEB device have yielded promising clinical results that may have additional indications. This review aims to discuss the development of the WEB device and the current state of the WEB device in the treatment of wide-neck aneurysms. We also summarize ongoing clinical studies and potential innovative uses.
| S-EPMC10310294 | biostudies-literature