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  • The ARTISSE intrasaccular device for intracranial aneurysm treatment: short-term, mid-term and long-term clinical and angiographic results

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New devices and techniques
Case series
The ARTISSE intrasaccular device for intracranial aneurysm treatment: short-term, mid-term and long-term clinical and angiographic results
  1. Michel Piotin1,2,
  2. Robert Fahed1,3,
  3. Hocine Redjem1,
  4. Stanislas Smajda1,
  5. Jean Philippe Desilles1,2,
  6. Simon Escalard1,
  7. Benjamin Maïer1,
  8. Solène Hebert1,
  9. François Delvoye1,
  10. Mikael Mazighi1,2,
  11. Raphaël Blanc1,2
  1. 1 Department of Interventional Neuroradiology, FHU NeuroVasc, Adolphe de Rothschild Foundation Hospital, Paris, France
  2. 2 Laboratory for Vascular Translational Science UMRS 1148, INSERM, Paris, France
  3. 3 Department of Medicine / Division of Neurology and Department of Medical Imaging / Division of Radiology, The Ottawa Hospital, Ottawa, Ontario, Canada
  1. Correspondence to Dr Michel Piotin, Department of Interventional Neuroradiology, FHU NeuroVasc, Adolphe de Rothschild Foundation Hospital, Paris, Île-de-France, France; mpiotin{at}for.paris

Abstract

Background The concept of intra-aneurysmal flow disruption has emerged as a new paradigm for the treatment of primarily bifurcation aneurysms. The purpose of this study was to determine the clinical and angiographic outcomes of patients treated with the new ARTISSE intrasaccular device (ISD).

Methods Selected patients with bifurcation aneurysms that matched the indications of the ARTISSE ISD defined by the manufacturer were treated in a single center. Clinical and angiographic follow-up was conducted at 6 and 36 months. Aneurysm occlusion was assessed using the Raymond–Roy classification scale.

Results Nine subjects with nine unruptured bifurcation aneurysms were enrolled. Mean aneurysm size was 7.2±1.2 mm (range 5.5–9.7 mm). An adequate aneurysm occlusion (defined as a complete occlusion or a neck remnant) was achieved in 6/9 patients (66.7%) at 6 months and 4/7 patients (57.1%) at 36 months follow-up. Two of the nine subjects experienced a major stroke (22.2%), including one on postoperative day 1 due to a procedure-related parent vessel occlusion and subsequent ischemic stroke. The other major stroke occurred within the 36-month follow-up period during treatment of a separate aneurysm with coils, leading to perforation with hemorrhagic stroke causing a permanent neurological deficit.

Conclusion The ARTISSE ISD was successfully deployed in all nine cases. There were, however, several procedure-related complications and results in terms of angiographic aneurysm occlusion were modest.

  • aneurysm
  • device

Data availability statement

Access to the data that support the findings of this study are available from the corresponding author upon reasonable request.

https://doi.org/10.1136/neurintsurg-2021-017806

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    Data availability statement

    Access to the data that support the findings of this study are available from the corresponding author upon reasonable request.

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    Footnotes

    • Contributors Study design: MP, RF, RB. Acquisition, analysis, or interpretation of data: All authors. Drafting of the manuscript: MP, RF, RB. Statistical analysis: NA. Supervision: MP and RB.

    • 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 None declared.

    • 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.