Abstract
BACKGROUND:
Flow disruption with the WEB technique has been developed to treat large-neck bifurcation aneurysms.
OBJECTIVE:
To report our anatomic angiographic results at first (3-6 months) ...and second (18 ± 3 months) angiographic follow-up in a series of 15 patients.
METHODS:
Fifteen patients (15 aneurysms) were consecutively treated in our center by 2 operators for a large-neck bifurcation aneurysm between March 2012 and February 2014. Results were evaluated by assessing WEB cage position at the aneurysm neck on angiography and high-resolution contrast-enhanced flat-panel detector computed tomography, contrast medium stagnation within the WEB and aneurysm on intraprocedural angiography, and 1-day time-of-flight magnetic resonance angiography. All aneurysms were followed up by angiography. Results at follow-up were graded as complete occlusion, neck remnant, or residual aneurysm. The 2 operators compared postprocedural and follow-up images and classified them as better, same, or worse. Subtracted images were compared in different projections to assess any WEB device compression or shape changes.
RESULTS:
A worsening was observed between the postprocedural and first follow-up angiography in 10 of 14 (71.5%) and in 4 of 7 (57.2%) between the first and second control angiography. Compression of the WEB cage was observed at first follow-up in 8 of 14 (57.2%) and in an additional 3 of 7 cases (42.8%) at second control. Last angiography showed complete occlusion in 1 of 14 (7.2%), neck remnant in 8 of 14 (57.2%), and residual aneurysm in 5 of 14 (35.7%) cases.
CONCLUSION:
This article draws attention to the risk of WEB compression and aneurysm recanalization. Future prospective studies should evaluate delayed WEB shape changes with different types of WEB devices (dual layer, single layer, single layer spherical).
The purpose of this study is to present the authors' medium-term results, with special emphasis on complications, occlusion rate of the aneurysm sac (digital subtraction angiography DSA and MRI), and ...the fate of cortical branches and perforating arteries covered ("jailed") by the flow diverter (FD) stent.
Between January 2010 and September 2017, 29 patients (14 female) with 30 aneurysms were treated with an FD stent. Twenty-one aneurysms were at the middle cerebral artery bifurcation, 8 were in the anterior communicating artery region, and 1 was a pericallosal artery bifurcation. Thirty-five cortical branches were covered. A single FD stent was used in all patients. Symptomatic and asymptomatic periprocedural and delayed complications were reported. DSA and MRI controls were analyzed to evaluate modification of the aneurysm sac and jailed branches.
Permanent morbidity was 3.4% (1/29), due to a jailed branch occlusion, with a modified Rankin Scale (mRS) score of 2 at the last follow-up. Mortality and permanent complication with poor prognosis (mRS score > 2) rates were 0%. The mean follow-up time for DSA and MRI (mean ± SD) was 21 ± 14.5 months (range 3-66 months) and 19 ± 16 months (range 3-41 months), respectively. The mean time to aneurysm sac occlusion (available for 24 patients), including stable remodeling, was 11.8 ± 6 months (median 13, range 3-27 months). The overall occlusion rate was 82.1% (23/28), and it was 91.7% (22/24) in the group of patients with at least 2 DSA control sequences. One recanalization occurred at 41 months posttreatment. At the time of publication, at the latest follow-up, 7 (20%) of 35 covered branches were occluded, 18 (51.4%) showed a decreased caliber, and the remaining 10 (28.5%) were unchanged. MRI T2-weighted sequences showed complete sac reabsorption in 7/29 aneurysms (24.1%), and the remaining lesions were either smaller (55.2%) or unchanged (17.2%). MRI revealed asymptomatic and symptomatic ischemic events in perforator territories in 7/28 (25%) and 4/28 (14.3%) patients, respectively, which were reversible within 24 hours.
Flow diversion of bifurcation aneurysms is feasible, with low rates of permanent morbidity and mortality and high occlusion rates; however, recurrence may occur. Caliber reduction and asymptomatic occlusion of covered cortical branches as well as silent perforator stroke are common. Ischemic complications may occur with no identified predictable factors. MRI controls should be required in all patients to evaluate silent ischemic lesions and aneurysm sac reabsorption over time.
Objective
Mechanical thrombectomy (MT) is not recommended for acute stroke with large vessel occlusion (LVO) and a large volume of irreversibly injured tissue (“core”). Perfusion imaging may identify ...a subset of patients with large core who benefit from MT.
Methods
We compared two cohorts of LVO‐related patients with large core (>50 ml on diffusion‐weighted‐imaging or CT‐perfusion using RAPID), available perfusion imaging, and treated within 6 hours from onset by either MT + Best Medical Management (BMM) in one prospective study, or BMM alone in the pre‐MT era from a prospective registry. Primary outcome was 90‐day modified Rankin Scale ≤2. We searched for an interaction between treatment group and amount of penumbra as estimated by the mismatch ratio (MMRatio = critical hypoperfusion/core volume).
Results
Overall, 107 patients were included (56 MT + BMM and 51 BMM): Mean age was 68 ± 15 years, median core volume 99 ml (IQR: 72–131) and MMRatio 1.4 (IQR: 1.0–1.9). Baseline clinical and radiological variables were similar between the two groups, except for a higher intravenous thrombolysis rate in the BMM group. The MMRatio strongly modified the clinical outcome following MT (
p
interaction
< 0.001 for continuous MMRatio); MT was associated with a higher rate of good outcome in patients with, but not in those without, MMRatio>1.2 (adjusted OR 95% CI = 6.8 1.7–27.0 vs 0.7 0.1–6.2, respectively). Similar findings were present for MMRatio ≥1.8 in the subgroup with core ≥70 ml. Parenchymal hemorrhage on follow‐up imaging was more frequent in the MT + BMM group regardless of the MMRatio.
Interpretation
Perfusion imaging may help select which patients with large core should be considered for MT. Randomized studies are warranted. ANN NEUROL 2021;90:417–427
Abstract
BACKGROUND
Woven EndoBridge (WEB; Sequent Medical) treatment is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown high safety ...with good efficacy at short term confirmed by trials conducted in United States (WEB-Intrasaccular Therapy) and in Europe (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy WEBCAST, French Observatory, and WEBCAST-2).
OBJECTIVE
To report the 2-yr clinical and anatomical results of WEB treatment in the combined population of 3 European trials.
METHODS
In a French Observatory, 2-yr clinical and anatomical data were collected. In WEBCAST and WEBCAST-2, 2-yr follow-up was optional, and data were collected when follow-up was performed. Aneurysm occlusion was evaluated using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant.
RESULTS
The population for safety was 138/168 patients (82.1%), including 89 females (64.5%), with mean age of 55.5 ± 10.2 yr. The population for efficacy was 121/169 aneurysms (71.6%). Aneurysm locations were middle cerebral artery in 65/121 aneurysms (53.7%), anterior-communicating artery in 25/121 (20.7%), basilar artery in 17/121 (14.0%), and internal carotid artery terminus in 14/121 (11.6%). No clinically relevant adverse events occurred between years 1 and 2. At 2 yr, complete occlusion was observed in 62/121 (51.2%) aneurysms, neck remnant in 36/121 (29.8%) aneurysms, and aneurysm remnant in 23/121 (19.0%) aneurysms. The global retreatment rate at 2 yr was 9.3%.
CONCLUSION
This analysis confirms the high safety profile of WEB treatment at 2 yr. Aneurysm occlusion is generally stable at 2 yr, and the retreatment rate between 1 yr and 2 yr is low (2.0%).
Graphical Abstract
Graphical Abstract
SummaryThe Contour is a promising new device designed to treat large-neck intra-cranial aneurysms. We describe a first case of Contour device displacement 18 months after initial treatment.A patient ...with a 10 mm unruptured right middle cerebral artery bifurcation aneurysm was treated with a 9 mm Contour. The device was correctly positioned at the neck during treatment and at the 6 month angiography follow-up. At 18 months follow-up we noticed a full displacement of the device into the aneurysm dome. The Contour had a reversed shape and the aneurysm was still fully opacified. No neurological event occurred during the whole follow-up. Contour may be a promising tool but needs to be assessed over a long-term period.
WEB treatment is an endovascular approach for wide-neck bifurcation aneurysms that has demonstrated high safety and good efficacy in mid-term follow-up. While evaluating safety in the long term is ...important to determine if delayed adverse events occur affecting late morbidity and mortality, the most important point to evaluate is the long-term stability of aneurysm occlusion. The current analysis reports the 3-year clinical and anatomical results of WEB treatment in the combined population of two European trials (WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy) and WEBCAST-2).
Aneurysm occlusion was evaluated using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant.
The safety population comprised 79 patients. The efficacy population comprised 61 aneurysms. Aneurysm locations were middle cerebral artery in 32/61 aneurysms (52.5%), anterior communicating artery in 13/61 (21.3%), basilar artery in 9/61 (14.8%), and internal carotid artery terminus in 7/61 (11.5%). No adverse events related to the device or procedure occurred between 2 and 3 years. At 3 years, complete occlusion was observed in 31/61 (50.8%) aneurysms, neck remnant in 20/61 (32.8%), and aneurysm remnant in 10/61 (16.4%). Between 1 year and 3 years, aneurysm occlusion was improved or stable in 53/61 (86.9%) aneurysms and worsened in 8/61 (13.1%). Worsening was mostly from complete occlusion to neck remnant in 6/61 (9.8%) aneurysms. The retreatment rate at 3 years was 11.4%.
This analysis confirms the high safety profile of WEB. Moreover, evidence demonstrates the great stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) in 83.6% of aneurysms.
URL: http://www.clinicaltrials.gov. WEBCAST and WEBCAST-2: Unique identifier: NCT01778322.
BACKGROUND:The endovascular treatment of middle cerebral artery (MCA) aneurysms with unfavorable anatomy (wide neck, unfavorable morphology) is frequently challenging. Flow disruption with the WEB is ...a potentially interesting endovascular treatment for this type of aneurysm.
OBJECTIVE:To report in a multicenter series the preliminary treatment experience of MCA aneurysms with flow disruption by the WEB.
METHODS:Thirty-three patients with 34 MCA aneurysms were treated with the WEB in 5 European centers. The ability to successfully deploy the WEB, procedure- and device-related adverse events, morbidity and mortality of the treatment, and short-term angiographic follow-up results were analyzed.
RESULTS:Most treated aneurysms were unruptured (85.3%) and were between 5 and 10 mm (85.3%) with a neck size ≥ 4 mm (88.2%). The treatment failed in 1 of the 34 aneurysms (2.9%) owing to a lack of appropriate device size. Treatment was performed exclusively with the WEB in 29 of 33 aneurysms (87.9%). Additional treatment (coiling and/or stenting) was used in 4 of 33 aneurysms (12.1%). Mortality of the treatment was 0.0% and morbidity was 3.1% (intraoperative rupture with modified Rankin Scale score of 3 at the 1-month follow-up). In short-term follow-up (range, 2-12 months), adequate occlusion (total occlusion or neck remnant) was observed in 83.3% of aneurysms.
CONCLUSION:WEB flow disruption seems to be a promising technique for the treatment of complex MCA aneurysms, particularly those with a wide neck or unfavorable dome-to-neck ratio.
ABBREVIATIONS:ATENA, Analysis of Treatment by Endovascular Approach of Nonruptured AneurysmsBRAT, Barrow Ruptured Aneurysm TrialCLARITY, Clinical and Anatomical Results in the Treatment of Ruptured Intracranial AneurysmsDSA, digital subtraction angiographyISAT, International Subarachnoid TrialMCA, middle cerebral arterymRS, modified Rankin Scale
Evaluating a new endovascular treatment for intracranial aneurysms must not only demonstrate short-term safety and efficacy, but also evaluate longer-term outcomes (eg, delayed complications, ...anatomical results, retreatment). The current analysis reports the 5-year clinical and anatomical results of Woven EndoBridge (WEB) treatment in two European combined trial populations (WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy) and WEBCAST-2).
All adverse events occurring between the procedure and 5-year follow-up were independently evaluated by an expert. Aneurysm occlusion was evaluated by an independent core laboratory using a three-grade scale: complete occlusion, neck remnant, and aneurysm remnant. In cases where data were not available at 5-year follow-up, the last observation carry forward (LOCF) method was used.
The safety and efficacy populations comprised 100 patients and 95 aneurysms, respectively. No adverse event related to the device occurred after the procedure during the 5-year follow-up period. Mortality at 5 years was 7.0% (7/100 patients) including mortality related to the WEB (0/100, 0.0%), the procedure (1/100, 1.0%), and another condition (6/100, 6.0%). At 5 years, complete aneurysm occlusion was observed in 49/95 (51.6%) aneurysms, neck remnant in 25/95 (26.3%), and aneurysm remnant in 21/95 (22.1%). Retreatment rate at 5 years was 11.6% (11/95 aneurysms).
This analysis conducted in a population of patients with wide-neck bifurcation aneurysms confirms WEB's safety profile. Additional evidence demonstrates good stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) at 5 years in 77.9% of aneurysms with a low retreatment rate (11.6%).
WEBCAST and WEBCAST-2: Unique identifier: NCT01778322.
Flow disruption with the WEB is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown a low complication rate with good efficacy.
To report ...clinical and anatomical results of the WEB treatment in the cumulative population of three Good Clinical Practice (GCP) studies: WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm), French Observatory, and WEBCAST-2.
WEBCAST, French Observatory, and WEBCAST-2 are single-arm, prospective, multicenter, GCP studies dedicated to the evaluation of WEB treatment. Clinical data were independently evaluated. Postoperative and 1-year aneurysm occlusion was independently evaluated using the 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant.
The cumulative population comprised 168 patients with 169 aneurysms, including 112 female subjects (66.7%). The patients' ages ranged between 27 and 77 years (mean 55.5±10.2 years). Aneurysm locations were middle cerebral artery in 86/169 aneurysms (50.9%), anterior communicating artery in 36/169 (21.3%), basilar artery in 30/169 (17.8%), and internal carotid artery terminus in 17/169 (10.1%). The aneurysm was ruptured in 14/169 (8.3%). There was no mortality at 1 month and procedure/device-related morbidity was 1.2% (2/168). At 1 year, complete aneurysm occlusion was observed in 81/153 aneurysms (52.9%), neck remnant in 40/153 aneurysms (26.1%), and aneurysm remnant in 32/153 aneurysms (20.9%). Re-treatment was carried out in 6.9%.
This series is at the moment the largest prospective, multicenter, GCP series of patients with aneurysms treated with WEB. It shows the high safety and good mid-term efficacy of this treatment.
French Observatory: Unique identifier (NCT18069); WEBCAST and WEBCAST-2: Unique identifier (NCT01778322).
Flow diversion is an innovative and increasingly used endovascular treatment for intracranial aneurysms. Its initial evaluation with the first devices available showed good efficacy of this treatment ...with variable safety results. The Flow Direction Endoluminal Device (FRED) has a specific design and was evaluated in a single-arm, multicenter, prospective, Good Clinical Practice study: SAFE (Safety and efficacy Analysis of FRED Embolic device in aneurysm treatment). This analysis reports clinical results at 1 year and anatomical results at 6 months and 1 year.
Patients with unruptured and recanalized aneurysms located in the anterior circulation treated with FRED and FRED Jr were prospectively included. A Clinical Event Committee and a Core Laboratory independently evaluated clinical outcome and anatomical results.
Thirteen interventional neuroradiology centers included 103 patients/aneurysms. Aneurysm locations were supraclinoid internal carotid artery (ICA) in 71 (68.9%), cavernous ICA in 15 (14.6%), anterior cerebral or anterior communicating artery in 9 (8.7%), and middle cerebral artery in 8 (7.8%). Most aneurysms were small (<10 mm) in 71 patients (68.9%). Cumulative 1-year mortality and morbidity rates were 2/103 (1.9%) and 3/103 (2.9%), respectively, one death being related to cancer. At 1 year, anatomical results were: complete occlusion in 66/90 patients (73.3%), neck remnant in 7/90 patients (7.8%), and aneurysm remnant in 17/90 patients (18.9%).
SAFE study analysis at 1 year confirms the excellent safety profile of the FRED device for aneurysm treatment, with low morbidity and mortality rates (2.9% and 1.9%, respectively) and demonstrates its efficacy (adequate occlusion in 73/90 (81.1%)).
Unique identifier: NCT02921698; Results.
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