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Meta-Analysis
. 2024 Jun;30(3):350-360.
doi: 10.1177/15910199221117921. Epub 2022 Aug 5.

Treatment of ruptured intracranial aneurysms using the novel generation of flow-diverters with surface modification: A systematic review and meta-analysis

Andre Monteiro  1   2 , Asham Khan  1   2 , Brianna M Donnelly  2 , Cathleen C Kuo  3 , Samantha M Burke  2 , Muhammad Waqas  1   2 , Steven B Housley  1   2 , Justin M Cappuzzo  1   2 , Jason M Davies  1   2   4   5   6 , Kenneth V Snyder  1   2   5   6 , Elad I Levy  1   2   5   6   7 , Adnan H Siddiqui  1   2   5   6   7
Affiliations
Meta-Analysis

Treatment of ruptured intracranial aneurysms using the novel generation of flow-diverters with surface modification: A systematic review and meta-analysis

Andre Monteiro et al. Interv Neuroradiol. 2024 Jun.

Abstract

Background: Surface modification of flow diverters (FDs) has been explored as a solution for reducing thrombotic risk of these devices, without necessarily using dual antiplatelet therapy (DAPT). If effective, this could pose a promising alternative for treatment of ruptured aneurysms not amenable to other modalities.

Methods: We performed a comprehensive search of PubMed, MEDLINE, and Embase databases following Preferred Reporting Items for Systematic reviews and Meta-analyzes guidelines. We included articles reporting use of surface-modified FDs for treatment of ruptured aneurysms. Demographics, subarachnoid hemorrhage (SAH) severity, aneurysm characteristics, devices used, periprocedural complications, angiographic outcomes, and mortality were extracted for sample size-based weighted analysis.

Results: Six studies comprising 59 patients with 64 aneurysms were included. Mean patient age was 56.6 ± 6.3 years and 60.6% (95% confidence interval [CI], 46.7-72.9%) were women. The anterior circulation was the location in 60.4% (95%CI, 45.5-73.5%) of aneurysms; 41.8% of the aneurysms were saccular (95%CI, 29.3-55.4%), 16.7% were fusiform (95%CI, 8.3-30.8%), 29.9% were dissecting (95%CI, 12.8-55.4%), 24.4% were blood-blister (95%CI, 15.2-36.7%), and 5.7% were mycotic (95%CI, 2-15.1%). Poor SAH grade was reported in 46.9% (95%CI, 33.3-60.9%). Adjunctive coiling was used in 33.2% (95%CI, 12.4-63.6%). Periprocedural thromboembolic and hemorrhagic complications occurred in 20% (95%CI, 7.1-45.1%) and 8.8% (95%CI, 3.7-19.5%), respectively. Complete occlusion was achieved in 76.4% (95%CI, 58.1-88.3%); no retreatments during follow-up were reported. Overall mortality was 15.1% (95%CI, 7.7-27.6%). There were no differences between single antiplatelet therapy (SAPT) and DAPT regimens with respect to periprocedural thromboembolic complications (P = 0.09), hemorrhagic (P = 0.834) complications, and mortality (P = 0.312).

Conclusion: Surface-modified FD treatment of ruptured aneurysms resulted in high rates of thromboembolic complications and acceptable rates of hemorrhagic complications. A considerable proportion of aneurysms were nonsaccular. Rates of complete occlusion were high and retreatment were low. Importantly, no statistically significant difference was found between SAPT and DAPT with respect to complications and mortality.

Keywords: Aneurysm; flow diverter; hemorrhagic stroke; subarachnoid hemorrhage; surface modification.

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Conflict of interest statement

Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: AM, AK, BD, CCK, SMB, MW, SBH—None. JMC—Consulting Fees: Cerenovus, J&J Medical Device Companies; Integra Lifesciences, Corp.; MIVI Neuroscience, Inc.; Penumbra, Inc.; Stryker, Corp. Support for attending meetings and/or travel: Stryker, Corp.; Penumbra, Inc. JMD—Consulting fees; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events; support for attending meetings and/or travel: Medtronic. Patents planned, issued, or pending: QAS.ai. Participation on a Data Safety Monitoring Board or Advisory Board: NIH NIHDS Strokenet. Stock or stock options: Synchron, Cerebrotech, QAS.ai. KVS—Consulting Fees: Boston Scientific, Canon Medical Systems USA, Inc., MicroVention, Medtronic, Stryker Neurovascular. Payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational event: Canon Medical Systems USA Inc. Stock or stock options: Boston Scientific, Access Closure Inc, Niagara Gorge Medical. EIL—Shareholder/Ownership Interest: NeXtGen Biologics, RAPID Medical, Claret Medical, Cognition Medical, Imperative Care, Rebound Therapeutics, StimMed, Three Rivers Medical; Patent: Bone Scalpel; Honorarium for Training & Lectures: Medtronic, Penumbra, Microvention, Integra, Consultant: Clarion, GLG Consulting, Guidepoint Global, Imperative Care, Medtronic, StimMed, Misionix, Mosiac; Chief Medical Officer: Haniva Technology; National PI: Medtronic- Steering Committees for SWIFT Prime and SWIFT Direct Trials; Site PI Study: Microvention (CONFIDENCE Study) Medtronic (STRATIS Study-Sub 1); Advisory Board: Stryker (AIS Clinical Advisory Board), NeXtGen Biologics, MEDX, Cognition Medical; Endostream Medical, IRRAS AB (Consultant/Advisory Board, Medical Legal Review: Dr Levy renders medical/legal opinions as an expert witness;); Leadership or fiduciary roles in other board society, committee, or advocacy group, paid and unpaid: CNS, ABNS, UBNS. 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, InspireMD, Ltd, Integra, IRRAS AB, Medtronic, MicroVention, Minnetronix Neuro, Inc., Peijia Medical, 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. Leadership or fiduciary role in other board, society, committee or advocacy group: Secretary—Board of the Society of NeuroInterventional Surgery 2020–2021, Chair—Cerebrovascular Section of the AANS/CNS 2020–2021. Stock or stock options: Adona Medical, Inc., Amnis Therapeutics, Bend, IT Technologies, Ltd, BlinkTBI, Inc, Cerebrotech Medical Systems, Inc., Cerevatech Medical, Inc., Cognition Medical, CVAID Ltd, E8, Inc., Endostream Medical, Ltd, Galaxy Therapeutics, Inc., Imperative; Care, Inc., InspireMD, Ltd, Instylla, Inc., International Medical Distribution Partners, Launch NY, Inc.; Neurolutions, Inc., NeuroRadial Technologies, Inc., NeuroTechnology Investors, Neurovascular Diagnostics, Inc., Peijia; Medical, 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, Sim & Cure, 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.

Figures

Figure 1.
Figure 1.
Estimated weighted rates of females (a) and anterior circulation located aneurysms (b).
Figure 2.
Figure 2.
Estimated weighted rates of adjunctive coiling (a), periprocedural thromboembolic complications (b), periprocedural hemorrhagic complications (c), complete occlusion (d), and mortality (e) in the studies.
See this image and copyright information in PMC

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