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Novel, braided, self-expandable stent designed for the treatment of pulsatile tinnitus caused by intracranial venous stenosis: first-in-human experience and long-term outcomes
  1. Arturo Consoli1,2,
  2. Nicole M Cancelliere2,
  3. Guillaume Charbonnier2,3,
  4. Hidehisa Nishi2,
  5. Irene Vanek4,
  6. Thomas R Marotta5,
  7. Julian Spears2,4,
  8. Vitor M Pereira2,4
    1. 1Diagnostic and Interventional Neuroradiology, Hospital Foch Department of Therapeutic and Interventional Neuroradiology, Suresnes, France
    2. 2RADIS Lab, St Michael's Hospital Li Ka Shing Knowledge Institute, Toronto, Ontario, Canada
    3. 3Neurology, Hôpital Jean Minjoz, Besancon, France
    4. 4Division of Neurosurgery, St Michael's Hospital Li Ka Shing Knowledge Institute, Toronto, Ontario, Canada
    5. 5Interventional Neuroradiology, St Michael's Hospital, Toronto, Ontario, Canada
    1. Correspondence to Dr Arturo Consoli, Diagnostic and Interventional Neuroradiology, Hospital Foch Department of Therapeutic and Interventional Neuroradiology, Suresnes, France; onemed21{at}gmail.com

    Abstract

    Background Pulsatile tinnitus (PT) can be a disabling clinical condition, which may be caused by a sigmoid/transverse sinus stenosis (STSS). Intracranial venous stenting with off-label carotid or peripheral venous stents has been used successfully to treat this condition. We present the results of a cohort of patients presenting with PT treated with a novel, dedicated, braided stent for the endovascular treatment of STSS.

    Methods Twelve patients presenting with PT and associated STSS were treated at our institution (December 2022–June 2023). All clinical and procedural variables were prospectively collected. We used the Tinnitus Function Index (TFI) and the Tinnitus Handicap Inventory (THI) scores to assess the impact of PT on quality of life before and after the treatment (mean follow-up: 10.3 months).

    Results Twelve women (mean age: 44±16.5 years) presenting with PT and STSS were treated. Mean pretreatment TFI/THI scores were 78.8/77. The BosStent was successfully deployed in all patients. We experienced no intraprocedural/postoperative complications. Intra-stent angioplasty was performed in three cases. All patients reported a complete resolution of PT symptoms within 1 month and remained stable and PT-free at the last follow-up (mean posttreatment TFI/THI score: 7.1/5, p<0001).

    Conclusions The BosStent was successfully used in a cohort of patients with PT without any intraprocedural complications. All the patients experienced a complete resolution of PT symptoms after 1 month, which was stable during the follow-up period. Further studies with larger populations will be necessary to investigate the safety and effectiveness of this novel stent for the treatment of PT with STSS.

    • Stent
    • Stenosis
    • Vein

    Data availability statement

    All data relevant to the study are included in the article or uploaded as supplementary information.

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    Data availability statement

    All data relevant to the study are included in the article or uploaded as supplementary information.

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    Footnotes

    • X @NMCancelliere, @gcharbonnier, @VitorMendesPer1

    • Contributors All authors met all the criteria for authorship. In particular, VMP and NMC made substantial contributions to the conception and design of the study. VMP, NMC and AC were the guarantors for the study. AC was responsible for drafting the work, data acquisition, and analysis and interpretation of the data. HN and GC helped with data acquisition, and analysis and interpretation of the data. TRM, IV, and JS revised the work critically for important intellectual content. All authors participated in the critical revision of the drafts, and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All authors gave final approval of the version to be published.

    • 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 Professor Vitor Mendes Pereira is a consultant for Sonorous.

    • 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.