Postmarket American Experience With Woven EndoBridge Device: Adjudicated Multicenter Case Series

Abstract

BACKGROUND The Woven EndoBridge (WEB) device was granted premarket approval in the United States following results of the Woven EndoBridge Intrasaccular Therapy (WEB-IT) study. WEB-IT reported excellent adequate angiographic occlusion of treated aneurysms with a high safety profile. These results were achieved, however, in the context of a prospective study with strict inclusion criteria and rigorous training support. OBJECTIVE To review early as-practiced clinical experience with the WEB device in the United States. METHODS Retrospective review across 6 institutions identified 91 patients undergoing 92 treatment sessions for WEB device placement in treatment of 91 intracranial aneurysms. Details regarding demographics, aneurysm characteristics, treatment considerations, clinical outcomes, and aneurysm occlusion were obtained and analyzed in a multicenter database. Angiograms from the index procedure and follow-up studies were reviewed by a blinded and independent adjudicator. RESULTS The middle cerebral, anterior communicating, and basilar artery complexes were the commonly treated locations. Eight patients presented with ruptured aneurysms. A mean of 1.2 devices were introduced per case. Technical failure without deployment of a WEB device occurred in 2% (2/92) of sessions. Adequate aneurysm occlusion for patients with imaging follow-up was 49% (mean follow-up of 8 mo). Four aneurysms were retreated. 90% of patients had modified Rankin Scale ≤ 2 at last clinical follow-up with no mortalities. CONCLUSION Immediate postmarket experience with the WEB device, newly introduced at American centers, confirms safe procedural use, but long-term efficacy remains unclear. Early challenges include accurate sizing and device selection.

Retreatment of Residual and Recurrent Aneurysms After Embolization With the Woven EndoBridge Device: Multicenter Case Series

“…Among the challenges noted has been optimal sizing of the device. Multiple devices have been trialed within a single session in 20% of cases 2 ; even experienced centers have struggled with this. 14 Thus, failure of WEB has partially been categorized as either device migration or device compression, both of which can occur as a result of poor sizing match during initial treatment.…”

“…The initial description for standard deployment of WEB devices was previously described. 2 For subsequent endovascular treatments, patients were prescribed aspirin and clopidogrel before retreatment with intraluminal devices. Patients were maintained on combined antiplatelet therapy for at least 3 months after treatment and longer if flow diversion was used as the retreatment strategy.…”

“…Using a published data set, 2 we selected for aneurysms with independently adjudicated WOS A or B outcome (complete occlusion). These were compared with the 30 aneurysms in this cohort, assessing for potential predictors of failure.…”

“…1 This study concluded that aneurysm obliteration with WEB was favorable, with 85% adequate occlusion at 12 months and a good safety profile. However, a recent postmarket series by Cherian et al, 2 found an adequate occlusion rate of 79% but 49% complete occlusion. In their series, 4% of aneurysms were retreated; however, based on the occlusion rate and independent adjudication, 14% more were recommended to be retreated.…”

Woven EndoBridge embolization in the retreatment of basilar apex aneurysm

“…The patient was a 60-yearold man who underwent treatment of his unruptured basilar apex aneurysm with the WEB SL device, sized 7 × 5 mm. [1][2][3] Note the oversizing of the device relative to the aneurysm dimensions. At the 12-month follow-up, he was noted to have significant recurrence of aneurysm with growth around the base of the aneurysm, with compaction of the device.…”