Dataset Information

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.

SUBMITTER: Pierot L

PROVIDER: S-EPMC7965497 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background and purposeFlow diversion is a recent endovascular treatment for intracranial aneurysms. We compared the safety and efficacy of flow diversion with the alternative standard management options.Materials and methodsA parallel group, prerandomized, controlled, open-label pragmatic trial was conducted in 3 Canadian centers. The trial included all patients considered for flow diversion. A Web-based platform 1:1 randomly allocated patients to flow diversion or 1 of 4 alternative standard management options (coiling with/without stent placement, parent vessel occlusion, surgical clipping, or observation) as prespecified by clinical judgment. Patients ineligible for alternative standard management options were treated with flow diversion in a registry. The primary safety outcome was death or dependency (mRS > 2) at 3 months. The composite primary efficacy outcome included the core lab-determined angiographic presence of a residual aneurysm, aneurysm rupture, progressive mass effect during follow-up, or death or dependency (mRS > 2) at 3-12 months.ResultsBetween May 2011 and November 2020, three hundred twenty-three patients were recruited: Two hundred seventy-eight patients (86%) had treatment randomly allocated (139 to flow diversion and 139 to alternative standard management options), and 45 (14%) received flow diversion in the registry. Patients in the randomized trial frequently had unruptured (83%), large (52% ≥10 mm) carotid (64%) aneurysms. Death or dependency at 3 months occurred in 16/138 patients who underwent flow diversion and 12/137 patients receiving alternative standard management options (relative risk, 1.33; 95% CI, 0.65-2.69; P = .439). A poor primary efficacy outcome was found in 30.9% (43/139) with flow diversion and 45.6% (62/136) of patients receiving alternative standard management options, with an absolute risk difference of 14.7% (95% CI, 3.3%-26.0%; relative risk, 0.68; 95% CI, 0.50-0.92; P = .014).ConclusionsFor patients with mostly unruptured, large, anterior circulation (carotid) aneurysms, flow diversion was more effective than the alternative standard management option in terms of angiographic outcome.