1. Validity of Woven EndoBridge sizing based on the device-to-aneurysm volume ratio.
- Author
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Pressman E, Weinberg JH, Baig AA, Rainone GJ, Schimmel S, Vignolles-Jeong J, Smith T, Youssef P, Davies JM, Siddiqui AH, Levy EI, Guerrero WR, Mokin M, and Vakharia K
- Abstract
Background: The Woven EndoBridge (WEB) is a treatment modality available for the treatment of intracranial aneurysms, specifically beneficial in wide-necked bifurcation aneurysms. Conventional sizing methods rely on the manipulation of aneurysm width and height measurements. This results in frequent need for re-sizing after initial WEB insertion attempts. Previous studies have suggested that volume-based sizing may decrease this rate., Methods: We conducted a multicenter retrospective cohort study in three complex vascular centers in the United States from 1 January 2020 to 30 June 2023. All patients who underwent attempted aneurysmal WEB embolization were included. Using three-dimensional angiogram reconstructions, we measured the aneurysm volume. We calculated the WEB volume and measured the WEB-aneurysm volume (WAVe) ratio. The primary outcome was whether a WEB required re-sizing., Results: A total of 133 cases were identified, 114 correctly sized and 19 incorrectly sized. Twelve patients (9.0%) required additional stent placement during WEB insertion. One patient (0.8%) had WEB abandonment. There were no differences in demographic or baseline characteristics between the size/re-sizing cohorts aside from aneurysm location ("other" and basilar locations increased the rate of re-sizing). The median WAVe ratio in our appropriately sized cohort was 0.997 (interquartile range (IQR) 0.826, 1.30) versus 1.14 in our re-sizing cohort (IQR 0.734, 1.51; p = 0.728). Using logistic regression, we identified a WAVe ratio ranging from 0.76 to 1.24 yielding > 80% probability of a successful sizing with 95% confidence., Conclusions: Incorporating volume-based measurements in aneurysm embolization with WEBs may improve rates of re-sizing but has an unclear effect on aneurysm occlusion. A WAVe ratio of 0.76-1.24 provides the greatest probability of appropriate initial WEB sizing., Competing Interests: Declaration of conflicting interestsCompeting interests: EP: None. JHW: None. AAB: None. GJR: None. SS: None. JVJ: None. TS: None. PY: None. JMD: Stock options: Synchron, Cerebrotech, QAS.AI; Payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events: Medtronic, Rapid Medical; Support for attending meetings and/or travel: Medtronic, Rapid Medical; Patents planned, issued or pending: QAS.AI; Participation on a Data Safety Monitoring Board or Advisory Board: NIH NIHDS Strokenet. AHS: Financial Interest/Investor/Stock Options/Ownership: Adona Medical, Bend IT Technologies, BlinkTBI, Borvo Medical, Cerebrotech Medical Systems, Code Zero Medical, Cognition Medical, Collavidence, CVAID, E8, Endostream Medical, Galaxy Therapeutics, Hyperion Surgical, Imperative Care, InspireMD, Instylla, Launch NY, Neurolutions, NeuroRadial Technologies (sold to Medtronic in 2021), Neurovascular Diagnostics, Peijia Medical, PerFlow Medical, Piraeus Medical, Q’Apel Medical, QAS.ai, Radical Catheter Technologies, Rebound Therapeutics Corp (purchased 2019 by Integra Lifesciences Corp), Rist Neurovascular (purchased 2020 by Medtronic), Sense Diagnostics, Serenity Medical, Silk Road Medical, Sim & Cure, Spinnaker Medical, StimMed, Synchron, Tulavi Therapeutics, Vastrax, Viseon, Whisper Medical, Willow Medtech, Consultant/Advisory Board: Amnis Therapeutics, Apellis Pharmaceuticals, Boston Scientific, Canon Medical Systems USA, Cardinal Health 200, Cerebrotech Medical Systems, Cerenovus, Cordis, Corindus, Endostream Medical, Hyperfine Operations, Imperative Care, InspireMD, Integra, IRRAS AB, Medtronic, MicroVention, Minnetronix Neuro, Peijia Medical, Penumbra, Piraeus Medical, Q’Apel Medical, Rapid Medical, Serenity Medical, Silk Road Medical, StimMed, Stryker Neurovascular, VasSol, Viz.ai; 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; Patent: Patent No. US 11,464,528 B2, Date: October 11, 2022, Clot Retrieval System for Removing Occlusive Clot from a Blood Vessel, Applicant and Assignee: Neuravi Limited (Galway), Role: Co-Inventor. EIL: Consulting fees: Clarion, GLG Consulting, Guidepoint Global, Imperative Care, Medtronic, StimMed, Misionix, Mosiac; Payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events: Medtronic, Penumbra, MicroVention, Integra; Patents planned, issued or pending: Ultrasonic Surgical Blade; Participation on a Data Safety Monitoring Board or Advisory Board: Stryker (AIS Clinical Advisory Board), NeXtGen Biologics, MEDX, Cognition Medical; Endostream Medical, IRRAS AB; Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: CNS, ABNS, UBNS: Stock or stock options (shareholder or ownership interest): NeXtGen Biologics, RAPID Medical, Claret Medical, Cognition Medical, Imperative Care, Rebound Therapeutics, StimMed, Three Rivers Medical; Other financial or non-financial interests: Haniva Medical Technology (Chief Medical Officer); Medtronic (National PI: Steering Committee for SWIFT Prime and SWIFT Direct trials; Site PI: STRATIS Study Sub 1), MicroVention (Site PI: CONFIDENCE Study). WRG: None. MM: Grants: NIH; Consultant: Balt, Cerenovus, Medtronic, Rapid Pulse; Stock options: Bendit Technologies, Borvo Medical, BrainQ, Endostream, Radical Catheter Technologies, Serenity Medical, Synchron, Sim&Cure, QAS.AI, Quantanosis.AI; Payment for expert testimony: Foley Mansfield, Huff Powell Bailey. KV: Consultant: Imperative Care, MicroVention.
- Published
- 2024
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