CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): results of 1-month and 1-year assessment of rebleeding protection and clinical safety in a multicenter study

Spelle, Laurent; Herbreteau, Denis; Caroff, Jildaz; Barreau, Xavier; Ferré, Jean-Christophe; Fiehler, Jens; Januel, Anne-Christine; Costalat, Vincent; Liebig, Thomas; Bourcier, Romain; Möhlenbruch, Markus; Berkefeld, Joachim; Weber, W.; Mihalea, Cristian; Ikka, Léon; Ozanne, Augustin; Cognard, Christophe; Narata, Ana Paula; Bibi, Richard; Gauvrit, Jean‐Yves; Raoult, Hélène; Velasco, Stéphane; Buhk, Jan‐Hendrik; Chalumeau, Vanessa; Bester, Maxim; Desal, Hubert; Rochemont, Richard du Mesnil de; Böhner, Georg; Fischer, Sebastian; Biondi, Alessandra; Grimaldi, Lamiae; Moret, Jacques; Byrne, James; Piérot, Laurent

doi:10.1136/neurintsurg-2021-017416

Cited by 39 publications

(40 citation statements)

References 28 publications

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“…In accordance with recent publications,2 25 the use of the WEB in a ruptured aneurysm or in association with a stent was feasible and effective, without significantly influencing the rate of angiographic occlusion. Also, we noted that the use of antiplatelet therapy after embolization did not significantly influence the outcome.…”

Section: Discussionsupporting

confidence: 79%

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Determinants of cerebral aneurysm occlusion after embolization with the WEB device: a single-institution series of 215 cases with angiographic follow-up

Cortese

Caroff

Chalumeau

et al. 2022

J NeuroIntervent Surg

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BackgroundWoven EndoBridge (WEB) devices are becoming a reliable option for the treatment of wide-neck bifurcation aneurysms, but clear predictive factors are still missing to understand the one in five aneurysm remnant rate.ObjectiveTo evaluate occlusion outcomes after WEB treatment to identify potential determinants of aneurysm occlusion.MethodsA single-center database with consecutive aneurysms treated with WEB between July 2012 and October 2021 was reviewed for potential determinants of aneurysm adequate occlusion (defined as a Bicêtre Occlusion Scale Score (BOSS) of 0, 0’, 1 or 2), through univariate and multivariable analysis. Patients without angiographic follow-up were excluded.Results215 of 247 individual aneurysms were included in the final analysis, of which 59 (27%) were ruptured. Mean age of patients was 56 years (range 23–90 years) and 65% were female. Mean angiographic follow-up was at 18 months (range 3–97 months). Adequate and complete occlusion were achieved in 171/215 (79.5%) and 135/215 (62.8%) of cases, respectively. Aneurysm irregular shape (aOR=0.42, 95% CI 0.20 to 0.88; p=0.02), aneurysm height (aOR=0.79, 95% CI 0.66 to 0.94; p<0.01), and WEB shape modification (aOR=0.98, 95% CI 0.97 to 1.00; p=0.02) were all independent predictors of aneurysm recurrence, whereas the WEB oversizing ratio (WEB width/aneurysm mean width) (aOR=16.4, 95% CI 1.4 to 266.7; p=0.04) was an independent predictor of adequate occlusion.ConclusionIn this study we demonstrated that a width oversizing strategy of the WEB device was an independent predictor of aneurysm angiographic occlusion. Conversely, aneurysm height, irregular aneurysm, and WEB shape modification were all independent determinants of angiographic aneurysm remnant. These results may help to select aneurysms suitable for the WEB device and WEB sizing.

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Section: Discussionsupporting

confidence: 79%

“…Since then indications for WEB have been widened—for example, to ruptured aneurysms, side-wall aneurysms. or in association with other devices 2–4…”

Section: Introductionmentioning

confidence: 99%

Determinants of cerebral aneurysm occlusion after embolization with the WEB device: a single-institution series of 215 cases with angiographic follow-up

Cortese

Caroff

Chalumeau

et al. 2022

J NeuroIntervent Surg

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“…In addition, we show overall mortality to be higher than that reported by others (range between 1% and 10%) [ 7 , 20 ]. Particularly, Pierot et al in 2021 reported a 6.3% of global mortality at 3 years, with 1 death related to the procedure and 4 deaths unrelated to the procedure.…”

Section: Discussioncontrasting

confidence: 56%

“…The ability of WEB to prevent rebleeding has been investigated by the CLARYS study [ 7 ]. Specifically, this trial included 56 ruptured WNBAs, showing a zero rate of rebleeding at 1 month and 1 year, indicating that an implanted WEB device is highly effective in preventing early and mid-late rebleeding.…”

Section: Introductionmentioning

confidence: 99%

Woven EndoBridge in Wide-Neck Bifurcation Aneurysms: Digital Subtraction Angiography at 3-Year Follow-Up

Stanca

Carriero

Negroni

et al. 2022

JCM

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Introduction: The Woven EndoBridge (WEB) device is a self-expanding intrasaccular braided-wire device for the treatment of wide-neck bifurcation aneurysms (WNBAs). Even though this device has an excellent safety profile and a low risk of rebleeding, little is known about its long-term effects. Material and Methods: All patients treated with WEB due to ruptured WNBAs were subjected to follow-up digital subtraction angiography (DSA) at 2 and 3 years after device deployment. The degree of residual neck was assessed through BOSS, Lubicz, and WEBCAST scales. Data on modified Rankin scale (mRS), bleeding events, and ischemic events occurring during this time period were collected as well. Lastly, overall and procedure-related mortality rates were calculated. Results: A total of 21 patients were treated between 1 January 2016, and 31 December 2018. DSA demonstrated a patency grade of 57.1% and 61.1% at 2 and 3 years, respectively. The overall 2-year mortality rate due to causes unrelated to the aneurysm was 14.3%. None of the patients were retreated between the 2- and the 3-year follow-up. No rebleeding or stroke events occurred during the follow-up. Conclusions: WEB-treated ruptured aneurysms showed an excellent degree of stability over time. The overall mortality rate—unrelated to the procedure–observed in our sample was higher than what reported in the literature, a possible bias associated with the COVID-19 pandemic.

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“…[13][14][15][16][17] The CLinical Assessment of WEB device in Ruptured aneu-rYSms (CLARYS) study is a post-market, open label, nonrandomized, prospective study in Europe. The interim results have already been analyzed and published, 18 showing that the endovascular treatment of ruptured bifurcation aneurysms with the WEB is safe and effective, as evidenced by a zero rebleeding rate and a low complication rate observed at 1-month follow-up. The present analyses focus on safety and anatomical results at 1 year.…”

Section: Hemorrhagic Strokementioning

confidence: 99%

CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): 12-month angiographic results of a multicenter study

Spelle

Herbreteau²,

Caroff

et al. 2022

J NeuroIntervent Surg

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BackgroundThe CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS) study has shown that the endovascular treatment of ruptured bifurcation aneurysms with the Woven EndoBridge (WEB) is safe and effective and provides protection against rebleeding at 1 month and 1 year. The 12-month angiographic follow-up is an important endpoint of the study.MethodsThe CLARYS study is a prospective multicenter study conducted in 13 European centers. The study enrolled 60 patients with 60 ruptured aneurysms of the anterior and posterior circulation. The study was conducted with an independent assessment of safety outcomes and imaging.ResultsSixty patients with 60 ruptured bifurcation aneurysms to be treated with the WEB were included. Fifty-three aneurysms (88.3%) had a broad base with a dome to neck ratio <2 (mean 1.6). Of these, 46 patients were evaluated by an independent core laboratory with follow-up imaging performed at 12 months or before eventual retreatment. At 1 year, 19/46 aneurysms (41.3%) were completely occluded (Raymond–Roy grade I), 21/46 (45.7%) had a residual neck and 6/46 (13.0%) had residual aneurysm filling. Adequate occlusion was reported in 40/46 (87%) aneurysms. Six patients underwent target aneurysm retreatment.ConclusionsThe CLARYS study has previously shown that the use of the WEB in the endovascular treatment of ruptured bifurcation aneurysms provides effective protection against rebleeding with a good safety profile. The angiographic occlusion rates at 1 year reported here are comparable to those already seen in previous multicenter studies which primarily included unruptured aneurysms.

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CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): results of 1-month and 1-year assessment of rebleeding protection and clinical safety in a multicenter study

Cited by 39 publications

References 28 publications

Determinants of cerebral aneurysm occlusion after embolization with the WEB device: a single-institution series of 215 cases with angiographic follow-up

Determinants of cerebral aneurysm occlusion after embolization with the WEB device: a single-institution series of 215 cases with angiographic follow-up

Woven EndoBridge in Wide-Neck Bifurcation Aneurysms: Digital Subtraction Angiography at 3-Year Follow-Up

CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): 12-month angiographic results of a multicenter study

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