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      Effect and safety of Tubridge flow diverter in the treatment of unruptured intracranial aneurysms

      research-article
      , MD a , , MD a , , MD, PhD a , * , , , MD a , , MD a , , MD, PhD a
      Medicine
      Lippincott Williams & Wilkins
      flow diverter, Tubridge, intracranial aneurysms, unruptured, complications

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          Abstract

          The effect and safety of the Tubridge flow diverting device are unknown in the treatment of intracranial aneurysms after optimization of the device, improvement in the deployment of the device, and accumulation of experience of using the device. This retrospective one-center study was performed to investigate the clinical effect and safety of the Tubridge flow diverting device in the treatment of unruptured intracranial aneurysms. Twenty-three patients with 33 unruptured intracranial aneurysms which were treated with the Tubridge device were retrospectively enrolled. The clinical data, endovascular procedure, complications, and follow-up were analyzed. Twenty-seven Tubridge devices were deployed to treat the 33 aneurysms, and the deployment was failed in 1 case, resulting in the success stenting rate of 96.3%. In 5 (15.2%) aneurysms, coils were loosely packed. Peri-procedural complications occurred in 2 patients (8.7%), including 1 procedure-related complication in which the distal end of a Tubridge device herniated into the aneurysm cavity. In another case, weakness of left upper limb occurred on the second day post procedure, with instent thrombosis being suspected, which was recovered after medication. No other complications occurred. Twenty-three (100%) patients had clinical follow-up 6 months later, with the mRS of 0 in 21 patients, 1 in 1, and 2 in 1. Five (21.7%) patients with 11 aneurysms underwent digital subtraction angiography at 6-month follow-up, with 8 aneurysms being completely occluded (Raymond grade I) and 3 aneurysms still visible (Raymond grade III). The Tubridge flow diverter may be safe and effective in the treatment of unruptured intracranial aneurysms with low perioperative complications and good follow-up outcomes even though multi-center and prospective clinical studies with a large size sample are still needed to validate these results.

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          Most cited references21

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          Long-Term Clinical and Angiographic Outcomes Following Pipeline Embolization Device Treatment of Complex Internal Carotid Artery Aneurysms: Five-Year Results of the Pipeline for Uncoilable or Failed Aneurysms Trial.

          Early and mid-term safety and efficacy of aneurysm treatment with the Pipeline Embolization Device (PED) has been well demonstrated in prior studies.
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            Variable porosity of the pipeline embolization device in straight and curved vessels: a guide for optimal deployment strategy.

            Low-porosity endoluminal devices for the treatment of intracranial aneurysms, also known as flow diverters, have been in experimental and clinical use for close to 10 years. Despite rigorous evidence of their safety and efficacy in well-controlled trials, a number of key factors concerning their use remain poorly defined. Among these, none has received more attention to date than the debate on how many devices are optimally required to achieve a safe, effective, and economical outcome. Additional, related questions concern device sizing relative to the parent artery and optimal method of deployment of the devices. While some or all of these issues may be ultimately answered on an empiric basis via subgroup analysis of growing treatment cohorts, we believe that careful in vitro examination of relevant device properties can also help guide its in vivo use. We conducted a number of benchtop experiments to investigate the varied porosity of Pipeline Embolization Devices deployed in a simulated range of parent vessel diameters and applied these results toward conceptualizing optimal treatment strategies of fusiform and wide-neck aneurysms. The results of our studies confirm a predictable parabolic variability in device porosity based on the respective comparative sizes of the device and recipient artery, as well as device curvature. Even modest oversizing leads to a significant increase in porosity. The experiments demonstrate various deleterious effects of device oversizing relative to the parent artery and provide strategies for addressing size mismatches when they are unavoidable.
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              • Record: found
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              • Article: not found

              The Pipeline Embolization Device: learning curve and predictors of complications and aneurysm obliteration.

              The Pipeline Embolization Device (PED) has emerged as a promising treatment for intracranial aneurysms.
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                Author and article information

                Contributors
                Journal
                Medicine (Baltimore)
                Medicine (Baltimore)
                MD
                Medicine
                Lippincott Williams & Wilkins (Hagerstown, MD )
                0025-7974
                1536-5964
                16 December 2022
                16 December 2022
                : 101
                : 50
                : e31672
                Affiliations
                [a ] Henan Provincial People’s Hospital, Zhengzhou University, Zhengzhou, China.
                Author notes
                * Correspondence: Tian-Xiao Li, Henan Provincial People’s Hospital, Zhengzhou University, 7 Weiwu Road, Zhengzhou, Henan Province 450000, China (e-mail: litianxiaod@ 123456163.com ).
                Article
                00039
                10.1097/MD.0000000000031672
                9771248
                36550831
                208f237a-f82c-44bc-b0c5-1e7be1ac2a91
                Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial License 4.0 (CCBY-NC), where it is permissible to download, share, remix, transform, and buildup the work provided it is properly cited. The work cannot be used commercially without permission from the journal.

                History
                : 9 August 2022
                : 13 October 2022
                : 13 October 2022
                Categories
                7100
                Research Article
                Observational Study
                Custom metadata
                TRUE

                flow diverter,tubridge,intracranial aneurysms,unruptured,complications

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