The balloon remodeling technique was initially designed for the endovascular treatment of anatomically complex aneurysms, specifically wide-neck aneurysms. A nondetachable balloon is inflated in ...front of the aneurysm neck during coil deposition and removed at the end of the procedure. Some controversies regarding the safety of the technique were introduced by the recent publication of a series showing a much higher rate of complications with the remodeling technique compared with the standard coiling technique. However, recent data from the literature review and from the large ATENA and CLARITY series show that the safety of standard coiling and remodeling is quite similar. Anatomic results are also probably better after remodeling. Finally, due to equivalent safety and better anatomic results, the remodeling technique can be widely used in the management of both ruptured and unruptured aneurysms.
Flow disruption with the WEB device is a new technique for the endovascular treatment of wide-neck bifurcation aneurysms. To obtain precise data regarding the safety and efficacy of this treatment ...with high-quality methodology, the prospective French Observatory study was conducted. Analysis of these data is presented, including 1-year follow-up.
Patients with bifurcation aneurysms for which WEB treatment was indicated were included in this prospective, multicenter Good Clinical Practice study. Clinical data, including adverse events and clinical status at 1 month and 1 year, were collected and independently analyzed by a medical monitor. An independent core laboratory evaluated the anatomic results at 1 year following the procedure.
Ten French neurointerventional centers included 62 patients (39 women), 33-74 years of age (mean, 56.6 ± 9.80 years) with 63 aneurysms. Aneurysm locations were the middle cerebral artery in 32 aneurysms (50.8%), anterior communicating artery in 16 (25.4%), basilar artery in 9 (14.3%), and internal carotid artery terminus in 6 (9.5%). Morbidity and mortality at 1 month were, respectively, 3.2% (2/62 patients) and 0.0% (0/62). Morbidity and mortality (unrelated to the treatment) at 1 year were, respectively, 0.0% (0/59) and 3.4% (2/59 patients). At 1 year, complete occlusion was observed in 30/58 aneurysms (51.7%); neck remnant, in 16/58 aneurysms (27.6%); and aneurysm remnant, in 12/58 aneurysms (20.7%).
This prospective French Observatory study showed very good safety of aneurysm treatment with the WEB, with a high rate of adequate aneurysm occlusion at 1 year (79.3%).
Flow disruption with the WEB-DL device has been used safely for the treatment of wide-neck bifurcation aneurysms, but the stability of aneurysm occlusion after this treatment is unknown. This ...retrospective multicenter European study analyzed short- and midterm data in patients treated with WEB-DL.
Twelve European neurointerventional centers participated in the study. Clinical data and pre- and postoperative short- and midterm images were collected. An experienced interventional neuroradiologist independently analyzed the images. Aneurysm occlusion was classified into 4 grades: complete occlusion, opacification of the proximal recess of the device, neck remnant, and aneurysm remnant.
Forty-five patients (34 women and 11 men) 35-74 years of age (mean, 56.3 ± 9.6 years) with 45 aneurysms treated with the WEB device were included. Aneurysm locations were the middle cerebral artery in 26 patients, the posterior circulation in 13 patients, the anterior communicating artery in 5 patients, and the internal carotid artery terminus in 1 patient. Forty-two aneurysms were unruptured. Good clinical outcome (mRS < 2) was observed in 93.3% of patients at the last follow-up. Adequate occlusion (complete occlusion, opacification of the proximal recess, or neck remnant) was observed in 30/37 patients (81.1%) in short-term follow-up (median, 6 months) and in 26/29 patients (89.7%) in midterm follow-up (median, 13 months). Worsening of the aneurysm occlusion was observed in 2/28 patients (7.1%) at midterm follow-up.
The results suggest that the WEB endovascular treatment of wide-neck bifurcation aneurysms offers stable occlusion in a class of aneurysms that are historically unstable. Additionally, our data show that opacification of the WEB recess can be delineated from true neck or aneurysm remnants.
Flow disruption with the Woven EndoBridge (WEB) device is an innovative technique for the endovascular treatment of wide-neck bifurcation aneurysms. The initial version of the device (WEB ...Double-Layer) was evaluated in the WEB Clinical Assessment of IntraSaccular Aneurysm Therapy (WEBCAST) study, whereas the French Observatory study evaluated both WEB Double-Layer and Single-Layer versions of the device. WEBCAST 2 was designed to evaluate the WEB Single-Layer with Enhanced Visualization.
Patients with wide-neck bifurcation aneurysms for which WEB treatment was possible were included. Clinical data including adverse events and clinical status at 1 month and 1 year were collected and analyzed. A core laboratory evaluated anatomic results at 1 year following the procedure.
Ten European neurointerventional centers included 55 patients (38 women; 27-77 years of age; mean, 54.4 ± 10.0 years) with 55 aneurysms. Aneurysm locations were the middle cerebral artery in 25 aneurysms (45.5%), the anterior communicating artery in 16 (29.1%), the basilar artery in 9 (16.4%), and the internal carotid artery terminus in 5 (9.1%). Procedural morbidity and mortality at 1 month were, respectively, 1.8% (1/55 patients) and 0.0% (0/55 patients). Morbidity and mortality at 1 year were, respectively, 3.9% (2/51 patients) and 2.0% (1/51 patients). At 1 year, complete occlusion was observed in 27/50 aneurysms (54.0%); neck remnant, in 13/50 (26.0%); and aneurysm remnant, in 10/50 (20.0%) (adequate occlusion in 40/50, 80.0%).
WEBCAST 2 confirms the high safety and efficacy of WEB aneurysm treatment demonstrated in the WEBCAST and French Observatory studies.
The endovascular treatment of intracranial aneurysms with unfavorable anatomy (large aneurysms, wide-neck) is frequently challenging and is also associated with a high incidence of significant ...recurrences. The WEB, an intrasaccular flow disrupter, was designed for use in this type of aneurysm. We report our early experience with this device in this multicenter study.
Twenty patients with 21 aneurysms were treated by using the WEB in 3 European centers. The ability to successfully deploy the WEB, immediate posttreatment angiographic results, adverse events, clinical outcome, and angiographic follow-up results were recorded.
Aneurysm location was the ICA (4/21, 19.1%), MCA (8/21, 38.1%), AcomA (5/21, 23.8%), and BA (4/21, 19.1%). No treatment failures were reported. Treatment was performed exclusively with the WEB in 16/21 (76.2%) patients. Additional treatment (coiling and/or stent placement) was used in 5/21 (23.8%) patients. One patient (4.8%) experienced transient clinical worsening (mRS 1 at 1 month, mRS 0 at 3 months) related to a thromboembolic event. Inadvertent detachment of the WEB was observed, and the WEB was retrieved in 1 patient, without adverse effects. In the short-term follow-up (2-8 months), adequate occlusion (total occlusion or neck remnant) was observed in 80.0% of aneurysms.
Intrasaccular flow disruption is a new endovascular approach for aneurysm treatment. In our preliminary experience, this treatment was feasible and mostly used in bifurcation aneurysms (MCA, BA, ICA) with unfavorable anatomy. Further studies are needed to precisely evaluate the indications, safety, and efficacy of this new technique.
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