The safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide-necked bifurcation aneurysms: final 12-month results of the pivotal WEB Intrasaccular Therapy (WEB-IT) Study

The WEB-IT trial, is a prospective, single-arm study of 150 patients conducted at 21 U.S. and 6 international centers that led to the Premarket Approval by the FDA for wide neck intracranial aneurysms.

Study points

• 150 patients were enrolled, and 148 devices were successfully implanted
• At 1-year follow-up the rate of complete occlusion was 54%
• Primary Safety event occurred in 0.7%
• At the time of the procedure 77% of patients were given antiplatelet therapy and 50% at 1-year follow-up

Some discussion points

• The device safety has proven to be excellent and this point should be highlighted because it should remain our main concern in our patients’ care
• The rate of complete occlusion can appear low but compares with most endovascular published series
• The trial cases represented the first experience of the US physician and this might have had an impact on the occlusion rates as there is a trend to undersize the WEB in early experience

Perspectives

• Last WEB generation was not used here, the 0.017 generation, a major evolution, opens the way to smaller, narrow-neck and sidewall aneurysms where occlusion rates might be higher
• Research focusing on WEB shape modification during follow-up and strategies to prevent it (oversizing?) are required