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On Flow Diversion: The Changing Landscape of Intracerebral Aneurysm Management.

ABSTRACT: Uptake of flow-diverting technology is rapidly outpacing the availability of clinical evidence. Most current usage is off-label, and the endovascular community is nearer the beginning than the end of the learning curve, given the number of devices in development. A comprehensive overview of technical specifications alongside key outcome data is essential both for clinical decision-making and to direct further investigations. Most-studied has been the Pipeline Embolization Device, which has undergone a transition to the Pipeline Flex for which outcome data are sparse or heterogeneous. Alternative endoluminal devices do not appear to be outperforming the Pipeline Embolization Device to date, though prospective studies and long-term data mostly are lacking, and between-study comparisons must be treated with caution. Nominal technical specifications may be unrelated to in situ performance, emphasizing the importance of correct radiologic sizing and device placement. Devices designed specifically for bifurcation aneurysms also lack long-term outcome data or have only recently become available for clinical use. There are no major studies directly comparing a flow-diverting device with standard coiling or microsurgical clipping. Data on flow-diverting stents are too limited in terms of long-term outcomes to reliably inform clinical decision-making. The best available evidence supports using a single endoluminal device for most indications. Recommendations on the suitability and choice of a device for bifurcation or ruptured aneurysms or for anatomically complex lesions cannot be made on the basis of current evidence. The appropriateness of flow-diverting treatment must be decided on a case-by-case basis, considering experience and the relative risks against standard approaches or observation.

SUBMITTER: Dmytriw AA

PROVIDER: S-EPMC7048527 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background and purposeThe goal of aneurysm treatment is occlusion of an aneurysm without morbidity or mortality. Using well-established, traditional endovascular techniques, this is generally achievable with a high level of safety and efficacy. These techniques involve either constructive treatment of the aneurysm (coils with or without an intravascular stent) or deconstruction (coil occlusion) of the aneurysm and the parent artery. While established as safe and efficacious, the constructive treatment of large and giant aneurysms with coils has typically been associated with relatively lower rates of complete occlusion and higher rates of recurrence. Parent artery deconstruction, though immediately efficacious in achieving complete and durable occlusion, does require occlusion of a major intracranial blood vessel and is associated with risk of stroke.Materials and methodsFlow diversion represents a new technology that can be used to constructively treat large and giant aneurysms. Once excluded successfully, the vessel reconstruction and aneurysm occlusion appears durable. The ability to definitively reconstruct cerebral blood vessels is an attractive approach to these large and giant complex aneurysms and allows the treatment of some aneurysms which were previously not amenable to other therapies. By comparison, conventional coiling techniques have traditionally been used for endovascular treatment of large aneurysms. Large and giant aneurysms that are amenable to either flow diversion or traditional endovascular treatment will be randomized to either therapy with FDA (or appropriate regulatory body) approved devices.ResultsThe trial is currently enrolling and results of the data are pending the completion of enrollment and follow-up.ConclusionsThis paper details the trial design of the LARGE trial, a blinded, prospective randomized trial of large anterior circulation aneurysms amenable to either traditional endovascular treatments using coils or reconstruction with flow diverters.

Project description:Background and purposeAlthough grading scales for angiography outcomes following cerebral aneurysm treatment with flow diversion have been published, physicians have not widely adopted these scales in practice. The aim of this study is to propose and validate a novel Flow diversion Predictive Score (4F-FPS) grading scale based on previously established scales that is simple and reliable.MethodsWe retrospectively analyzed consecutive patients who underwent endovascular treatment for cerebral aneurysms with flow diversion between January 2014 and September 2019. The included patients were randomly divided into the derivation and validation group in a 70/30 ratio, respectively. Aneurysms were classified as incomplete or complete occlusion based on final angiography outcomes. 4F-FPS was derived to predict aneurysm occlusion from multivariate logistic regression analyses in the derivation group and validated with previously published grading scales in the validation group.ResultsOverall, 662 patients [mean age, 53.8 years; 72.5% (480/662) female] with 662 aneurysms treated with the PipelineTM flow diverter were included [69.9% (463/662) derivation group, 30.1% (199/662) validation group]. The incidence of aneurysm occlusion was 82.7%. 4F-FPS demonstrated significant discrimination in 10-fold cross validation [mean receiver operating characteristic (ROC) area, 0.862 ± 0.055] and calibration (Cox & Snell R 2, 0.251; Nagelkerke R 2, 0.413) in the derivation group. The ROC area of 4F-FPS score in both the derivation and validation groups is the largest compared with previously published grading scales/scores (p < 0.05), which shows better sensitivity and specificity. The 4F-FPS score showed excellent prediction, discrimination, and calibration properties.ConclusionThe 4F-FPS score is a simple and reliable tool to predict angiography outcome after flow diversion treatment. If widely adopted, it may provide a common language to be used in future reporting of flow diversion results for clinical trials and daily practice.Clinical trial registrationhttp://www.clinicaltrials.gov. Unique identifier: NCT03831672.

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On Flow Diversion: The Changing Landscape of Intracerebral Aneurysm Management.

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