Intrasaccular flow disruption is an innovative approach for the endovascular treatment of intracranial aneurysms. As of now, only one device is currently available worldwide: the Woven EndoBridge ...(WEB) device (MicroVention, Aliso Viejo, CA, USA). After 10 years of clinical use and careful clinical evaluation of the WEB device by multiple prospective, multicenter studies, this article is summarizing the current knowledge regarding this endovascular technique; indications, modalities, safety and efficacy of the WEB procedure are described.
To analyze the clinical and anatomic factors that affect the occurrence and outcome of complications (thromboembolic events and intraoperative rupture) in the endovascular treatment of ruptured ...intracranial aneurysms in a large multicenter series, the CLARITY study (Clinical and Anatomic Results in the Treatment of Ruptured Intracranial Aneurysms).
This study was approved by the institutional review boards of the participating centers, and written informed consent was obtained from all patients. In the CLARITY series, 782 patients (314 men, 468 women; age range, 19-80 years, mean age, 51.3 years +/- 13.2 standard deviation) with 782 ruptured aneurysms underwent endovascular treatment for ruptured intracranial aneurysms at 20 institutions. Uni- and multivariate analyses were performed to determine factors (demographic characteristics, risk factors, anatomic factors, and therapeutic factors) that affect the occurrence of treatment-related complications.
A higher rate of thromboembolic events was observed in patients with aneurysms larger than 10 mm (28.0% vs 10.7% in patients with aneurysms < or =10 mm, P < .001), in smokers (16.1% vs 10.1% in nonsmokers, P = .015), and in patients with aneurysms with a neck larger than 4 mm (20.8% vs 11.0% in aneurysms with a neck < or =4 mm, P = .004).The frequency of intraoperative rupture was higher in patients with middle cerebral artery (MCA) aneurysms (8.5% vs 3.7% in patients without MCA aneurysms, P = .029), in patients younger than 65 years (5.0% vs 0.8% in patients older than 65 years, P = .032), and in patients without hypertension (5.4% vs 1.5% in patients with hypertension, P = .017).
The rate of thromboembolic events in the endovascular treatment of ruptured aneurysms is significantly affected by aneurysm size and neck size but not by aneurysm location. Conversely, the rate of intraoperative rupture is significantly affected by aneurysm location but not aneurysm size.
The original version of this consensus statement on mechanical thrombectomy was approved at the European Stroke Organisation (ESO)-Karolinska Stroke Update conference in Stockholm, 16–18 November ...2014. The statement has later, during 2015, been updated with new clinical trials data in accordance with a decision made at the conference. Revisions have been made at a face-to-face meeting during the ESO Winter School in Berne in February, through email exchanges and the final version has then been approved by each society. The recommendations are identical to the original version with evidence level upgraded by 20 February 2015 and confirmed by 15 May 2015. The purpose of the ESO-Karolinska Stroke Update meetings is to provide updates on recent stroke therapy research and to discuss how the results may be implemented into clinical routine. Selected topics are discussed at consensus sessions, for which a consensus statement is prepared and discussed by the participants at the meeting. The statements are advisory to the ESO guidelines committee. This consensus statement includes recommendations on mechanical thrombectomy after acute stroke. The statement is supported by ESO, European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), and European Academy of Neurology (EAN).
Wide-necked bifurcation aneurysms (WNBAs) make up 26–36% of all brain aneurysms. Treatments for WNBAs pose unique challenges due to the need to preserve major bifurcation vessels while achieving a ...durable occlusion of the aneurysm. Intrasaccular flow disruption is an innovative technique for the treatment of WNBAs. The Woven EndoBridge (WEB) device is the only United States Food and Drug Administration approved intrasaccular flow disruption device. In this review article we discuss various aspects of treating WNBAs with the WEB device, including indications for use, aneurysm/device selection strategies, antiplatelet therapy requirement, procedural technique, potential complications and bailouts, and management strategies for residual/recurrent aneurysms after initial WEB treatment.
OBJECTIVETo test the hypothesis that selection by initial imaging modality (MRI vs CT) is associated with rate of futile recanalizations (FRs) after mechanical thrombectomy (MT), we assessed this ...association in a multicenter, retrospective observational registry (BEYOND-SWIFT Registry for Evaluating Outcome of Acute Ischemic Stroke Patients Treated With Mechanical Thrombectomy, NCT03496064).
METHODSIn 2,011 patients (49.7% female, median age 73 years 61–81) included between 2009 and 2017, we performed univariate and multivariate analyses regarding the occurrence of FR. FRs were defined as 90-day modified Rankin Scale (mRS) score 4–6 despite successful recanalization in patients selected by MRI (n = 690) and CT (n = 1,321) with a sensitivity analysis considering only patients with mRS 5–6 as futile.
RESULTSMRI as compared to CT resulted in similar rates of subsequent MT (adjusted odds ratio aOR 1.048, 95% confidence interval CI 0.677–1.624). Rates of FR were as follows571/1,489 (38%) FR mRS 4–6 including 393/1,489 (26%) FR mRS 5–6. CT-based selection was associated with increased rates of FRs compared to MRI (44% 41%–47% vs 29% 25%–32%, p < 0.001; aOR 1.77 95% CI 1.25–2.51). These findings were robust in sensitivity analysis. MRI-selected patients had a delay of approximately 30 minutes in workflow metrics in real-world university comprehensive stroke centers. However, functional outcome and mortality were more favorable in patients selected by MRI compared to patients selected with CT.
CONCLUSIONSCT selection for MT was associated with an increased risk of FRs as compared to MRI selection. Efforts are needed to shorten workflow delays in MRI patients. Further research is needed to clarify the role of the initial imaging modality on FR occurrence and to develop a reliable FR prediction algorithm.
IntroductionWide-necked bifurcation aneurysms (WNBAs) present unique technical challenges for both endovascular and surgical treatments which aim to achieve complete occlusion of the aneurysm without ...compromising the patency of the incorporated regional parent vessels. We present a meta-analysis of traditional therapies for WNBAs to provide critical benchmarks for safety and effectiveness.MethodsFollowing a systematic search of the literature and the application of pre-specified appropriateness criteria, 43 (including 2794 aneurysms treated) and 65 (including 5366 patients treated) references with sufficient detail were identified to include in a meta-analysis of efficacy and safety, respectively. Effectiveness endpoints of both complete and adequate occlusion were assessed. A composite safety endpoint was based upon commonly applied metrics for major adverse events. Fleiss analyses were performed for both effectiveness and safety endpoints for the entire group, and then parsed separately by treatment modality (surgical clipping (SC) or endovascular therapy (EVT)) and location (anterior or posterior circulation).ResultsUsing the above methods, the core laboratory adjusted rate of complete occlusion was 46.3% (standard error 3.6%), 39.8% (3.7%), and 52.5% (9.6%) for all therapies, EVT, and SC, respectively. The rate of adequate occlusion was 59.4% (12.2%), 43.8% (5.3%), and 69.7% (14.3%) for all therapies, EVT, and SC, respectively. The rates of occurrence for pre-specified safety endpoints were 18.7% (2.9%), 21.1% (2.8%), and 24.3% (4.9%) for all therapies, EVT, and SC, respectively.ConclusionsConventional therapies for WNBAs are associated with relatively low rates of complete occlusion and peri-procedural complications are not uncommon. As new treatment technologies are investigated, it is important that the available data regarding predicate treatments is understood.
Background and purposeFlow 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.MethodsPatients 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.ResultsThirteen 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%).ConclusionsSAFE 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%)).Clinical trial registrationUnique identifier: NCT02921698; Results.
BACKGROUND AND PURPOSE—We aimed to determine the safety and mortality after mechanical thrombectomy in patients taking vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs).
METHODS—In a ...multicenter observational cohort study, we used multiple logistic regression analysis to evaluate associations of symptomatic intracranial hemorrhage (sICH) with VKA or DOAC prescription before thrombectomy as compared with no anticoagulation. The primary outcomes were the rate of sICH and all-cause mortality at 90 days, incorporating sensitivity analysis regarding confirmed therapeutic anticoagulation. Additionally, we performed a systematic review and meta-analysis of literature on this topic.
RESULTS—Altogether, 1932 patients were included (VKA, n=222; DOAC, n=98; no anticoagulation, n=1612); median age, 74 years (interquartile range, 62–82); 49.6% women. VKA prescription was associated with increased odds for sICH and mortality (adjusted odds ratio aOR, 2.55 95% CI, 1.35–4.84 and 1.64 95% CI, 1.09–2.47) as compared with the control group, whereas no association with DOAC intake was observed (aOR, 0.98 95% CI, 0.29–3.35 and 1.35 95% CI, 0.72–2.53). Sensitivity analyses considering only patients within the confirmed therapeutic anticoagulation range did not alter the findings. A study-level meta-analysis incorporating data from 7462 patients (855 VKAs, 318 DOACs, and 6289 controls) from 15 observational cohorts corroborated these observations, yielding an increased rate of sICH in VKA patients (aOR, 1.62 95% CI, 1.22–2.17) but not in DOAC patients (aOR, 1.03 95% CI, 0.60–1.80).
CONCLUSIONS—Patients taking VKA have an increased risk of sICH and mortality after mechanical thrombectomy. The lower risk of sICH associated with DOAC may also be noticeable in the acute setting. Improved selection might be advisable in VKA-treated patients.
REGISTRATION—URLhttps://www.clinicaltrials.gov. Unique identifierNCT03496064. Systematic Review and Meta-AnalysisCRD42019127464.
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