Evaluating a new endovascular treatment for intracranial aneurysms must not only demonstrate
short-term safety and efficacy, but also evaluate longer-term outcomes (eg, delayed
complications, anatomical results, retreatment). The current analysis reports the
5-year clinical and anatomical results of Woven EndoBridge (WEB) treatment in two
European combined trial populations (WEBCAST (WEB Clinical Assessment of Intrasaccular
Aneurysm Therapy) and WEBCAST-2).All adverse events occurring between the procedure
and 5-year follow-up were independently evaluated by an expert. Aneurysm occlusion
was evaluated by an independent core laboratory using a three-grade scale: complete
occlusion, neck remnant, and aneurysm remnant. In cases where data were not available
at 5-year follow-up, the last observation carry forward (LOCF) method was used.The
safety and efficacy populations comprised 100 patients and 95 aneurysms, respectively.
No adverse event related to the device occurred after the procedure during the 5-year
follow-up period. Mortality at 5 years was 7.0% (7/100 patients) including mortality
related to the WEB (0/100, 0.0%), the procedure (1/100, 1.0%), and another condition
(6/100, 6.0%). At 5 years, complete aneurysm occlusion was observed in 49/95 (51.6%)
aneurysms, neck remnant in 25/95 (26.3%), and aneurysm remnant in 21/95 (22.1%). Retreatment
rate at 5 years was 11.6% (11/95 aneurysms).This analysis conducted in a population
of patients with wide-neck bifurcation aneurysms confirms WEB's safety profile. Additional
evidence demonstrates good stability of aneurysm occlusion with adequate occlusion
(complete occlusion or neck remnant) at 5 years in 77.9% of aneurysms with a low retreatment
rate (11.6%).WEBCAST and WEBCAST-2: Unique identifier: NCT01778322.
