Safety and efficacy of aneurysm treatment with WEB: results of the WEBCAST study

Abstract

E ndovascular treatment is now the first-line treatment for both ruptured and unruptured aneurysms. 1,7,17 However, aneurysms with a complex anatomy (singularly wide-neck aneurysms) are in some cases untreatable or difficult to treat with standard coiling. For this reason, more complex endovascular techniques have been developed, such as balloon-assisted coiling, stent-assisted coiling, and flow diversion. 18Flow disruption is a new endovascular approach, which involves placement of an endosaccular device (WEB), abbreviatioNs ACoA = anterior communicating artery; BA = basilar artery; CCT = Cerecyte Coil Trial; DSA = digital subtraction angiography; ICA = internal carotid artery; ITT = intention to treat; MCA = middle cerebral artery; mRS = modified Rankin Scale; WEBCAST = WEB Clinical Assessment of Intrasaccular Aneurysm Therapy. obJective WEB is an innovative intrasaccular treatment for intracranial aneurysms. Preliminary series have shown good safety and efficacy. The WEB Clinical Assessment of Intrasaccular Aneurysm Therapy (WEBCAST) trial is a prospective European trial evaluating the safety and efficacy of WEB in wide-neck bifurcation aneurysms. methods Patients with wide-neck bifurcation aneurysms for which WEB treatment was indicated were included in this multicenter good clinical practices study. Clinical data including adverse events and clinical status at 1 and 6 months were collected and independently analyzed by a medical monitor. Six-month follow-up digital subtraction angiography was also performed and independently analyzed by a core laboratory. Success was defined at 6 months as complete occlusion or stable neck remnant, no worsening in angiographic appearance from postprocedure, and no retreatment performed or planned. results Ten European neurointerventional centers enrolled 51 patients with 51 aneurysms. Treatment with WEB was achieved in 48 of 51 aneurysms (94.1%). Adjunctive implants (coils/stents) were used in 4 of 48 aneurysms (8.3%). Thromboembolic events were observed in 9 of 51 patients (17.6%), resulting in a permanent deficit (modified Rankin Scale [mRS] Score 1) in 1 patient (2.0%). Intraoperative rupture was not observed. Morbidity (mRS score > 2) and mortality were 2.0% (1 of 51 patients, related to rupture status on entry to study) and 0.0% at 1 month, respectively. Success was achieved at 6 months in 85.4% of patients treated with WEB: 23 of 41 patients (56.1%) had complete occlusion, 12 of 41 (29.3%) had a neck remnant, and 6 of 41 (14.6%) had an aneurysm remnant. coNclusioNs The WEBCAST study showed good procedural and short-term safety of aneurysm treatment with WEB and good 6-month anatomical results.Clinical trial registration no.: NCT01778322 (clinicaltrials.gov) http://thejns.org/doi/abs/10.3171/2015.2.JNS142634

WEB Treatment of Intracranial Aneurysms: Clinical and Anatomic Results in the French Observatory

“…[10][11][12][13][14][15][16][17] The rate of thromboembolic events with the WEB (14.5%) was quite similar to that reported in the Analysis of Treatment by Endovascular Approach of Nonruptured Aneurysms (ATENA) and Clinical and Anatomical Results In the Treatment of Ruptured Intracranial Aneurysms (CLARITY) series (respectively, 7.3% and 13.3%).…”

“…The short-term (6-month) results of the WEBCAST trial and a comparison of safety between the WEB DL and WEB SL/SLS in the French Observatory were published previously. 16,17 These initial analyses confirmed the good safety and efficacy of the device in the short-term. This article reports the clinical and anatomic results of the French Observatory study with midterm (1-year) follow-up.…”

“…20,21 The present results also highlight the high quality of aneurysm occlusion obtained with this technique, confirming the data from 6-month follow-up in the WEBCAST and from an already published retrospective European series. 14,15,17 initial experience with WEB aneurysm treatment. At short-term follow-up, among 14 aneurysms, 1 was completely occluded (7.2%) and neck and aneurysm remnants were observed in, respectively, 9 (64.3%) and 4 (28.6%) aneurysms.…”

Endovascular Treatment of Intracranial Aneurysms with the WEB Device: A Systematic Review of Clinical Outcomes

“…In our opinion, the results of angiographic outcomes reported with the WEB device should be analyzed with caution. Among the European studies, only 2 were conducted according to good clinical practices (the French Observatory 19 and the WEB Clinical Assessment of Intrasaccular Aneurysm Therapy [WEBCAST] study 26 ). No comparative data (either historical or prospective) are available to accurately determine the clinical and anatomic benefit of the WEB device in comparison with existing strategies.…”

WEB Treatment of Ruptured Intracranial Aneurysms

“…Most of the published series comprised wide-necked, unruptured aneurysms. [4][5][6][7][8][9][10][11][12][13][14][15][16] When the WEB became available in our hospital, our initial results in unruptured aneurysms were encouraging, and we decided to expand the indications to both ruptured and unruptured aneurysms suitable for accommodating a WEB device, regardless of neck size. Our intention was to avoid using stents or balloons in ruptured aneurysms.…”