Article Text
Abstract
Background Surface-modified flow diverters (FDs) designed to reduce thrombogenicity represent the next frontier for intracranial aneurysm treatment. The Derivo Embolization Device (DED) is a novel FD with titanium oxide and titanium oxynitride finishing of the struts. We performed a systematic review of pertinent literature, aiming to evaluate the device’s effectiveness and safety.
Methods A literature search of PubMed, Embase, and MEDLINE was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
Results Five studies comprising 481 aneurysms were included. These studies were conducted in Turkey, Brazil, Germany, Poland, and Italy; two were prospective and three were retrospective. Twenty-six aneurysms (5.4%) were ruptured. The antiplatelet regimens were heterogeneous, but dual antiplatelet therapy was administered preprocedurally in all studies and maintained for 3–12 months before a switch to single antiplatelet therapy. The rate of periprocedural ischemic and hemorrhagic complications was 4.9% (95% CI 2.9% to 7%). Adjunctive coiling was used in 25.6% (95% CI 11.4% to 39.8%) of aneurysms. The complete angiographic occlusion rate was 81.4% (95% CI 71.3% to 91.5%), mortality rate was 2.1% (95% CI 0.4% to 3.9%), with follow-up ranging from 9 to 18 months. Delayed aneurysm rupture was reported in one patient.
Conclusions The DED has been increasingly used in other countries. We identified low rates of periprocedural complications and mortality and a high rate of complete occlusion.
- aneurysm
- device
- flow diverter
- technology
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Footnotes
Twitter @amdbaig
Contributors Conception and design: AM; Data acquisition: SMB, SK; Data analysis and interpretation: All authors; Drafting the manuscript: AM, SMB; Critically revising the manuscript: All authors; Final approval of the manuscript: All authors.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests EIL--Consulting fees: Claret Medical, GLG Consulting, Guidepoint Global, Imperial Care, Medtronic, Rebound, StimMed, Misionix, Mosiac, Clarion, IRRAS. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Medtronic; Payment for testimony: for rendering medical/legal opinions as an expert. Support for attending meetings and/or travel: Reimbursement for travel and food for some meetings with the CNS and ABNS. Stock or stock options: NeXtGen Biologics, RAPID Medical, Claret Medical, Cognition Medical, Imperative Care, Rebound Therapeutics, StimMed, Three Rivers Medical. AHS—Consulting fees: Amnis Therapeutics, Apellis Pharmaceuticals, Inc, Boston Scientific, Canon Medical Systems USA, Inc, Cardinal Health 200, LLC, Cerebrotech Medical Systems, Inc, Cerenovus, Cerevatech Medical, Inc, Cordis, Corindus, Inc, Endostream Medical, Ltd, Imperative Care, Integra, IRRAS AB, Medtronic, MicroVention, Minnetronix Neuro, Inc, Penumbra, Q’Apel Medical, Inc, Rapid Medical, Serenity Medical, Inc, Silk Road Medical, StimMed, LLC, Stryker Neurovascular, Three Rivers Medical, Inc, VasSol, Viz.ai, Inc, W.L. Gore & Associates. Leadership or fiduciary role in other board, society, committee or advocacy group: Past Secretary of the Board of the Society of NeuroInterventional Surgery, Chair of the Cerebrovascular Section of the AANS/CNS. Stock or stock options: Adona Medical, Inc, Amnis Therapeutics, Bend IT Technologies, Ltd, BlinkTBI, Inc, Buffalo Technology Partners, Inc, Cardinal Consultants, LLC, Cerebrotech Medical Systems, Inc, Cerevatech Medical, Inc, Cognition Medical, CVAID Ltd, E8, Inc, Endostream Medical, Ltd, Imperative Care, Inc, Instylla, Inc, International Medical Distribution Partners, Launch NY, Inc, NeuroRadial Technologies, Inc, Neurotechnology Investors, Neurovascular Diagnostics, Inc, PerFlow Medical, Ltd, Q’Apel Medical, Inc, QAS.ai, Inc, Radical Catheter Technologies, Inc, Rebound Therapeutics Corp (purchased 2019 by Integra Lifesciences, Corp), Rist Neurovascular, Inc (purchased 2020 by Medtronic), Sense Diagnostics, Inc, Serenity Medical, Inc, Silk Road Medical, Adona Medical, Inc, Amnis Therapeutics, Bend IT Technologies, Ltd, BlinkTBI, Inc, Buffalo Technology Partners, Inc, Cardinal Consultants, LLC, Cerebrotech Medical Systems, Inc, Cerevatech Medical, Inc, Cognition Medical, CVAID Ltd, E8, Inc, Endostream Medical, Ltd, Imperative Care, Inc, Instylla, Inc, International Medical Distribution Partners, Launch NY, Inc, NeuroRadial Technologies, Inc, Neurotechnology Investors, Neurovascular Diagnostics, Inc, PerFlow Medical, Ltd, Q’Apel Medical, Inc, QAS.ai, Inc, Radical Catheter Technologies, Inc, Rebound Therapeutics Corp (purchased 2019 by Integra Lifesciences, Corp), Rist Neurovascular, Inc (purchased 2020 by Medtronic), Sense Diagnostics, Inc, Serenity Medical, Inc, Silk Road Medical, SongBird Therapy, Spinnaker Medical, Inc, StimMed, LLC, Synchron, Inc, Three Rivers Medical, Inc, Truvic Medical, Inc, Tulavi Therapeutics, Inc, Vastrax, LLC, VICIS, Inc, Viseon, Inc. Other financial or non-financial interests: National PI/Steering Committees: Cerenovus EXCELLENT and ARISE II Trial; Medtronic SWIFT PRIME, VANTAGE, EMBOLISE and SWIFT DIRECT Trials; MicroVention FRED Trial & CONFIDENCE Study; MUSC POSITIVE Trial; Penumbra 3D Separator Trial, COMPASS Trial, INVEST Trial, MIVI neuroscience EVAQ Trial; Rapid Medical SUCCESS Trial; InspireMD C-GUARDIANS IDE Pivotal Trial. The remaining authors disclose no relationships.
Provenance and peer review Not commissioned; externally peer reviewed.
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