Intrasaccular flow-disruption treatment of intracranial aneurysms: preliminary results of a multicenter clinical study

Abstract

Background and purpose: 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.

Materials and methods: 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.

Results: 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.

Conclusions: 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.

Fig 1.

The WEB device. A, Proximal (arrow) and distal (arrowhead) compartments. B, Drawing shows the device in place in the aneurysm with a smooth coverage of the neck. (Figure provided with permission from Sequent Medical, Aliso Viejo, California.).

Fig 2.

Unruptured basilar artery aneurysm (patient 1). A, 3D angiography shows the aneurysm (arrow). B, Lateral view after the deployment of the device (arrow). C, Angiography performed 30 minutes after the deployment of the device shows that the proximal and distal compartments are still filled by the contrast media (arrow). D, Three-month follow-up 3D angiography shows that the aneurysm is occluded with a very small remnant at the neck (arrow).

Fig 3.

Unruptured middle cerebral artery aneurysm (patient 4). A, 3D angiography shows that the aneurysm (arrow) has a wide neck. B, Postoperative angiography, oblique unsubstracted view, shows that the WEB is deployed and the 3 markers are visible. C, Postoperative angiography, oblique view, shows that the proximal compartment is still filled by the contrast media. D, Three-month follow-up angiography shows total occlusion of the aneurysm.

Fig 4.

Unruptured anterior communicating artery aneurysm (patient 3). A, Preoperative angiography, oblique view, shows the aneurysm. B, After detachment of the WEB, a small residual opacification is visible. C, Unsubstracted oblique view shows the coils introduced after the WEB treatment. D, Final control angiogram shows a complete occlusion of the aneurysm.