OBJECT WEB is an innovative intrasaccular treatment for intracranial aneurysms. Preliminary series have shown good safety and efficacy. The WEB Clinical Assessment of Intrasaccular Aneurysm Therapy ...(WEBCAST) trial is a prospective European trial evaluating the safety and efficacy of WEB in wide-neck bifurcation aneurysms. METHODS Patients with wide-neck bifurcation aneurysms for which WEB treatment was indicated were included in this multicentergood clinical practices study. Clinical data including adverse events and clinical status at 1 and 6 months were collected and independently analyzed by a medical monitor. Six-month follow-up digital subtraction angiography was also performed and independently analyzed by a core laboratory. Success was defined at 6 months as complete occlusion or stable neck remnant, no worsening in angiographic appearance from postprocedure, and no retreatment performed or planned. RESULTS Ten European neurointerventional centers enrolled 51 patients with 51 aneurysms. Treatment with WEB was achieved in 48 of 51 aneurysms (94.1%). Adjunctive implants (coils/stents) were used in 4 of 48 aneurysms (8.3%). Thromboembolic events were observed in 9 of 51 patients (17.6%), resulting in a permanent deficit (modified Rankin Scale mRS Score 1) in 1 patient (2.0%). Intraoperative rupture was not observed. Morbidity (mRS score > 2) and mortality were 2.0% (1 of 51 patients, related to rupture status on entry to study) and 0.0% at 1 month, respectively. Success was achieved at 6 months in 85.4% of patients treated with WEB: 23 of 41 patients (56.1%) had complete occlusion, 12 of 41 (29.3%) had a neck remnant, and 6 of 41 (14.6%) had an aneurysm remnant. CONCLUSIONS The WEBCAST study showed good procedural and short-term safety of aneurysm treatment with WEB and good 6-month anatomical results.
Purpose
Of patients presenting with subarachnoid haemorrhage, most are due to rupture of a small aneurysm. It has been postulated that in most cases, these aneurysms form and rupture rapidly over a ...short period of time of days to weeks. We evaluated the hypothesis that such aneurysms therefore should never be discoverable as a pre-existing condition on medical imaging studies.
Methods
All patients presenting with subarachnoid haemorrhage due to a small cerebral aneurysm over an 11-year period were reviewed for prior imaging studies capable of detecting small aneurysms. In the subgroup that had such imaging studies, these were reviewed for the presence or absence of the index aneurysm.
Results
Of 851 patients presenting with subarachnoid haemorrhage over an 11-year period, 35 had prior imaging studies capable of detecting small aneurysms. In 18 out of these 35 (51%) patients, the index aneurysm was identified as a small unruptured aneurysm on these prior studies. The median time between prior imaging and aneurysm rupture was 31 months.
Conclusion
The theory that nearly all cases of subarachnoid haemorrhage due to small aneurysms occur as a result of aneurysm formation, and rupture over a short time period is incorrect. Our findings indicate that at least half of all subarachnoid haemorrhage cases arise from the population harbouring small aneurysms as a pre-existing condition.
Abstract only Introduction: Flow Disruption with WEB is an innovative endovascular approach for wide-neck bifurcation aneurysms. Initial series have shown a low complication rate with good efficacy. ...Hypothesis: To confirm the safety and efficacy of the WEB aneurysm treatment in the cumulated population of WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm), French Observatory, and WEBCAST 2 series. Methods: WEBCAST, WEBCAST 2, and French Observatory are single-arm, prospective, multicenter, GCP (Good Clinical Practice) studies dedicated to the evaluation of WEB treatment, conducted in Europe and France. Inclusion criteria were ruptured and unruptured aneurysms in both studies, located in basilar artery, middle cerebral artery, anterior communicating artery, and internal carotid artery terminus. Clinical data were independently evaluated. Post-operative, 6-months (in WEBCAST and WEBCAST 2), and 1-year aneurysm occlusion was independently evaluated using the 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant. Evolution of aneurysm occlusion was evaluated using a simple 3-grade scale: stable, improved, worsened. Results: The cumulated population was 168 patients (112 females, 66.7%) with 169 aneurysms. WEB implant success was 96.4%. Mortality at discharge was 0.6% and morbidity 1.8%. At one-year (mean 12.6 months), complete aneurysm occlusion was observed in 56.0%, neck remnant in 26.0%, and aneurysm remnant in 18.0% (WEBCAST and French Observatory). Conclusions: The analysis in this large cumulated population of studies (WEBCAST, French Observatory, WEBCAST 2) confirms great safety and efficacy of WEB treatment.
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
AbstractObjectiveTo develop and validate a set of practical prediction tools that reliably estimate the outcome of subarachnoid haemorrhage from ruptured intracranial aneurysms (SAH).DesignCohort ...study with logistic regression analysis to combine predictors and treatment modality.SettingSubarachnoid Haemorrhage International Trialists’ (SAHIT) data repository, including randomised clinical trials, prospective observational studies, and hospital registries.ParticipantsResearchers collaborated to pool datasets of prospective observational studies, hospital registries, and randomised clinical trials of SAH from multiple geographical regions to develop and validate clinical prediction models.Main outcome measurePredicted risk of mortality or functional outcome at three months according to score on the Glasgow outcome scale.ResultsClinical prediction models were developed with individual patient data from 10 936 patients and validated with data from 3355 patients after development of the model. In the validation cohort, a core model including patient age, premorbid hypertension, and neurological grade on admission to predict risk of functional outcome had good discrimination, with an area under the receiver operator characteristics curve (AUC) of 0.80 (95% confidence interval 0.78 to 0.82). When the core model was extended to a “neuroimaging model,” with inclusion of clot volume, aneurysm size, and location, the AUC improved to 0.81 (0.79 to 0.84). A full model that extended the neuroimaging model by including treatment modality had AUC of 0.81 (0.79 to 0.83). Discrimination was lower for a similar set of models to predict risk of mortality (AUC for full model 0.76, 0.69 to 0.82). All models showed satisfactory calibration in the validation cohort.ConclusionThe prediction models reliably estimate the outcome of patients who were managed in various settings for ruptured intracranial aneurysms that caused subarachnoid haemorrhage. The predictor items are readily derived at hospital admission. The web based SAHIT prognostic calculator (http://sahitscore.com) and the related app could be adjunctive tools to support management of patients.
BackgroundFlow 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.PurposeTo 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.MethodsWEBCAST, 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.ResultsThe 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%.ConclusionsThis 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.Clinical trial registrationFrench Observatory: Unique identifier (NCT18069); WEBCAST and WEBCAST-2: Unique identifier (NCT01778322).
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