The Source for Neurovascular News and Education

June 06, 2020

 

An analysis of findings from three studies has confirmed the high safety of this treatment, with no mortality and low morbidity at 1 month,” researchers say.

 

Flow diversion using the WEB device for the treatment of wide neck bifurcation aneurysms is feasible, safe, and results in good midterm outcomes, according to an analysis of three clinical studies published online recently ahead of print in the Journal of NeuroInterventional Surgery.

 

 “Flow disruption involves the placement of an intrasaccular cage that will disrupt the blood flow at the level of the neck and induce aneurysmal thrombosis,” explain investigators led by Laurent Pierot, MD (Hôpital Maison-Blanche, Reims, France). They note that WEB is one of two currently available devices in this category.

 

For their new analysis, Pierot and colleagues reported on the clinical and anatomical results of use of the WEB device (Sequent Medical, Aliso Viejo, CA) for the treatment of wide neck bifurcation aneurysms in three Good Clinical Practice (GCP) studies: WEBCAST, French Observatory, and WEBCAST-2.

 

Each study was a single-arm, prospective, multicenter, trial. Postoperative and 1-year aneurysm occlusion were independently evaluated using the 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant.

 

Together, the three trials comprised 168 patients with 169 aneurysms. Most (66.7%) of the patients were female, and their ages ranged from 27 to 77 years (mean 55.5 ± 10.2 years). Aneurysms occurred in the middle cerebral artery in 50.9%, anterior communicating artery in 21.3%, basilar artery in 17.8%, and internal carotid artery terminus in 10.1%. Overall, 8.3% of the aneurysms were ruptured.

 

Rates of early mortality and procedure/device-related morbidity were low. One-year outcome data were available for 153 cases. Among these patients, complete occlusion was seen in about half, with neck remnants occurring slightly more frequently than aneurysm remnants. Less than 10% of patients required retreatment.

 

Outcomes of WEB Repair

1-Month Mortality

0

Procedure/Device-Related Morbidity

1.2%

1-Year Complete Occlusion

52.9%

Neck Remnant

26.1%

Aneurysm Remnant

20.9%

Retreatment

6.9%

 

The authors conclude that treatment of wide neck bifurcation aneurysms is “highly feasible (96.4%) knowing that three of six failures were related to the lack of appropriate size availability. Adjunctive devices were used in a relatively limited percentage of cases (7.4%).”

 

Compares Favorably to Other Treatments

 

Pierot et al note that while the rate of thromboembolic events seen in this analysis (14.4%) is higher than those seen in the ATENA with unruptured aneurysms (7.1%) and CLARTY with ruptured aneurysms (13.3%), the other trials included several different types of aneurysms; the current paper focused on wide neck bifurcation aneurysms alone. In addition, the rate of intraoperative rupture was lower in this analysis (1.2%) than in ATENA (2.0%) or CALRITY (3.7%). Similarly, global morbidity and mortality in this analysis (1.2% and 0, respectively), compared favorably with ATENA (1.7% and 1.4%, respectively) and CLARITY (3.7% and1.5%, respectively).

 

The complete (52.9%) and adequate (79.1%) 1-year occlusion rates seen in this analysis are similar to those in other studies that investigated use of the WEB device, and they compare favorably with treatments of wide neck aneurysms using other methods, the authors point out.

 

This series comprising three GCP studies exploring use of the WEB device for the treatment of wide neck bifurcation aneurysms “confirmed the high safety of this treatment with no mortality and low morbidity at 1 month,” write the authors, adding, “It shows the high safety and good midterm efficacy of this treatment.”

 

 


Source:

Pierot L, Moret J, Barreau X, et al. Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series. J NeuroInterv Surg. 2017;Epub ahead of print.

 

Disclosures:

Pierot reports being a consultant for Balt, Microvention, Neuravi, and Penumbra.