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New devices and techniques
Original research
Braids and beyond: a comprehensive study on pipeline device braid stability from PREMIER data
  1. Fernanda Rodriguez-Erazú1,2,
  2. Gustavo M Cortez1,3,
  3. Demetrius K Lopes4,
  4. Salvador F Gutierrez-Aguirre1,2,
  5. Otavio Frederico De Toledo1,2,
  6. Amin Aghaebrahim1,
  7. Eric Sauvageau1,
  8. David F Kallmes5,
  9. Jens Fiehler6,
  10. Ricardo A Hanel1
    1. 1Lyerly Neurosurgery, Baptist Medical Center Downtown, Jacksonville, Florida, USA
    2. 2Research Department, Jacksonville University, Jacksonville, Florida, USA
    3. 3Department of Neurological Surgery, Mount Sinai Health System, New York, New York, USA
    4. 4Department of Neurosurgery, Rush University Medical Center, Chicago, Illinois, USA
    5. 5Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA
    6. 6Department of Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany
    1. Correspondence to Dr Ricardo A Hanel; Ricardo.Hanel{at}bmcjax.com

    Abstract

    Background The pipeline embolization device (PED) has been increasingly used to treat brain aneurysms; however, concerns have been raised about braid stability with newer drawn filled tubing technology devices.

    Objective To evaluate braid stability of PED early generations using data from the PREMIER trial.

    Methods All consecutive intracranial aneurysms treated with PED (Classic and Flex) within the PREMIER trial were reviewed for braid stability (fish mouthing, foreshortening, braid bump, braid collapsing). Immediate postprocedure cone-beam CT and angiography were compared with 1- and 2- years' follow-up. Analyses included safety, measured with the modified Rankin Scale (mRS) score, including +1 mRS point and a good clinical outcome (mRS score 0–2), vessel stenosis ≥50%, effectiveness measured with Raymond-Roy Scale, and re-treatment rates.

    Results 133/141 aneurysms had a complete dataset. 8/133 (6%) aneurysms showed braid deformations. Inter-reader agreement was excellent (κ=0.83). Braid deformations were statistically significantly associated with in-stent vessel stenosis >50% (P=0.029), without impact on effectiveness or safety. Fish mouthing was found in 1/133 (0.75%) at 1 year, causing >50% vessel stenosis. Foreshortening occurred in 6/133 (4.5%), and braid bump in 1/133 (0.75%) associated with severe in-stent stenosis. Four other cases (3.0%) of asymptomatic in-stent stenosis due to neointimal hyperplasia were seen without braid changes. No new braid stability deformations were found at the 2-year follow-up.

    Conclusion Our study demonstrates excellent braid stability among patients treated with the PED Classic and Flex in the PREMIER trial. Within the uncommon braid changes observed, none affected the PED safety or efficacy.

    Trial registration number NCT02186561.

    • Flow Diverter
    • Aneurysm
    • Stenosis
    • Angiography

    Data availability statement

    Data are available upon reasonable request.

    https://doi.org/10.1136/jnis-2024-022350

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      Data availability statement

      Data are available upon reasonable request.

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      Footnotes

      • X @drnimajax, @Fie0815

      • Contributors RAH and FR-E were responsible for conception and design of the manuscript and interpretation of the data. All authors drafted the work or revised it for significant intellectual content; All authors approved the final version of the manuscript. RAH is responsible for the overall content as the guarantor.

      • Funding The PREMIER study was supported by Medtronic.

      • Competing interests DKL is a consultant for Asahi, Medtronic, and Stryker; has received honoraria from Siemens, Medtronic, Stryker, and Phenox. DFK received research support from Cerenovus, Sensome, Neurogami Medical, Insera Therapeutics, Medtronic, Microvention, Balt, Monarch Biosciences, Brainomix, MiVi, Stryker, and NIH; royalties from Medtronic; is on the DSMB of NoNO Inc and Vesalio; is a stockholder Nested Knowledge, Superior Medical Experts, Marblehead Medical, and Conway Medical. JF: research support: German Ministry of Science & Education (BMBF) and of Economy and Innovation (BMWi), German Research Foundation (DFG), European Union (EU), Hamburgische Investitions, and Förderbank (IFB), Medtronic, Microvention, Route92, Stryker; consultant for: Acandis, Cerenovus, Medtronic, Microvention, Penumbra, Phenox, Roche, Stryker, TG Med, Tonbridge. Stockholder: Tegus Medical, Vastrax, Eppdata. RAH is a consultant for Medtronic, Stryker, Cerenovus, Microvention, Balt, Phenox, Rapid Medical, and Q’Apel; he is on the advisory board for MiVI, eLum, Three Rivers, Shape Medical, and Corindus; he has received unrestricted research grants from NIH, Interline Endowment, Microvention, Stryker, CNX; he is an investor/stockholder for InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical Inc, Scientia, RisT, BlinkTBI, and Corindus.

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.