WEB Treatment of Intracranial Aneurysms: Feasibility,Complications, and 1-Month Safety Results with the WEB DL and WEB SL/SLS in the French Observatory

BACKGROUND AND PURPOSE:Safety analyses in the French Observatory have shown that treatment of intracranial aneurysms by using flow disruption with the Woven EndoBridge Device (WEB) is safe, with low morbidity and no mortality. The objective of this study was to analyze treatment feasibility, complications, and safety results in patients treated with the Woven EndoBridge Device Dual-Layer (WEB DL) and Woven EndoBridge Device Single-Layer/Single-Layer Sphere (WEB SL/SLS) in the French Observatory.MATERIALS AND METHODS:Patients with bifurcation aneurysms were included in this prospective, multicenter good clinical practices study. A medical monitor independently analyzed procedural and clinical data. The study started with the WEB DL, and secondarily, the WEB SL/SLS was authorized in the study.RESULTS:Between November 2012 and January 2014, 10 French centers included 62 patients with 63 aneurysms. Thirty patients with 31 aneurysms were treated with the WEB DL, and 32 patients with 32 aneurysms, with the WEB SL/SLS. The percentage of anterior communicating artery aneurysms treated with WEB SL/SLS was significantly higher (37.5%) compared with WEB DL (12.9%) (P = .04). The WEB SL/SLS was more frequently used in aneurysms of <10 mm than the WEB DL (respectively, 96.9% and 67.7%; P = .002). Morbidity was similar in both groups (WEB DL, 3.3%; WEB SL/SLS, 3.1%), and mortality was 0.0% in both groups.CONCLUSIONS:This comparative study shows increased use of WEB treatment in ruptured, small, and anterior communicating artery aneurysms when using WEB SL/SLS. There was a trend toward fewer thromboembolic complications with the WEB SL/SLS. With both the WEB DL and WEB SL/SLS, the treatment was safe, with low morbidity and no mortality.

Endovascular treatment is the preferred therapeutic option for ruptured aneurysms that are anatomically suitable for endovascular coil treatment, supported by randomized studies, especially in locations less suitable for surgery.^1,2 It also has an important place in the management of unruptured aneurysms that are judged appropriate for treatment.³ Complex aneurysms (fusiform, wide-neck, large, or giant) are often untreatable or difficult to treat with standard coiling. For these complex cases, endovascular techniques such as balloon-assisted coiling, stent-assisted coiling, or flow diversion have been used with good results.^4–9Flow disruption is a new endovascular approach, which involves placement of a Woven EndoBridge Device (WEB; Sequent Medical, Aliso Viejo, California), which modifies the blood flow at the level of the neck and induces intra-aneurysmal thrombosis. The WEB was designed initially to treat wide-neck and bifurcation aneurysms. The initial clinical results have shown that treatment is feasible with a low level of complications, low morbidity, and no mortality.^10–14 The device has been progressively developed from a dual-layer version (WEB Dual-Layer DL] aneurysm embolization system; Sequent Medical) to single-layer versions (WEB Single-Layer SL] and WEB Single-Layer Sphere SLS]).The French Observatory is a prospective, multicenter observational study of consecutive cases, with independent monitoring, across 10 French centers.It has 2 major objectives:

1. To carefully evaluate the safety of this treatment with an independent assessment of all adverse events and morbidity/mortality.
2. To evaluate the efficacy of this treatment at 12 and 24 months with independent core lab adjudication.

Patients treated with both WEB DL and WEB SL/SLS were included in the French Observatory. The present analysis reports the feasibility of treatment, adverse events, and morbidity/mortality at 1 month in patients treated with WEB DL and WEB SL/SLS.