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  • The LUNA aneurysm embolization system for intracranial aneurysm treatment: short-term, mid-term and long-term clinical and angiographic results

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Original research
The LUNA aneurysm embolization system for intracranial aneurysm treatment: short-term, mid-term and long-term clinical and angiographic results
  1. Michel Piotin1,
  2. Alessandra Biondi2,
  3. Nader Sourour3,
  4. Charbel Mounayer4,
  5. Maciej Jaworski5,
  6. Salvatore Mangiafico6,
  7. Tommy Andersson7,
  8. Michael Söderman7,
  9. Pierre Goffette8,
  10. René Anxionnat9,
  11. Raphaël Blanc1
  1. 1 Department of Interventional Neuroradiology, Foundation Rothschild Hospital, Paris, France
  2. 2 Department of Neuroradiology and Endovascular Therapy, CHU Besançon, Besançon, France
  3. 3 Department of Interventional Neuroradiology, CHU Pitié Salpêtrière, Paris, France
  4. 4 Department of Interventional Neuroradiology, CHU Limoges, Limoges, France
  5. 5 Second Department of Radiology, Medical University of Warsaw, Warsaw, Poland
  6. 6 Department of Interventional Neuroradiology, Careggi University Hospital, Florence, Italy
  7. 7 Department of Neuroradiology, The Karolinska University Hospital in Solna, Stockholm, Sweden
  8. 8 Department of Neuroradiology, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium
  9. 9 Department of Neuroradiology, CHU Nancy, Nancy, France
  1. Correspondence to Dr Michel Piotin, Department of Interventional Neuroradiology, Hôpital de la Fondation Ophtalmologique Adolphe de Rothschild, Paris 75019, France; mpiotin{at}free.fr

Abstract

Background and purpose Intrasaccular aneurysm flow disruption represents an emerging endovascular approach to treat intracranial aneurysms. The purpose of this study was to determine the clinical and angiographic outcomes of using the LUNA aneurysm embolization system (AES) for treatment of intracranial aneurysms.

Materials and methods The LUNA AES Post-Market Clinical Follow-Up study is a prospective, multicenter, single-arm study that was designed to evaluate device safety and efficacy. Bifurcation and sidewall aneurysms were included. Aneurysm occlusion was assessed using the Raymond-Roy classification scale. Disability was assessed using the Modified Rankin Scale (mRS). Morbidity was defined as mRS >2 if baseline mRS ≤2, increase in mRS of 1 or more if baseline mRS >2, or mRS >2 if aneurysm was ruptured at baseline. Clinical and angiographic follow-up was conducted at 6, 12 and 36 months.

Results Sixty-three subjects with 64 aneurysms were enrolled. Most aneurysms were unruptured (60/63 (95.2%)); 49 were bifurcation or terminal (49/64 (76.6%)). Mean aneurysm size was 5.6±1.8 mm (range, 3.6–14.9 mm), and mean neck size was 3.8±1.0 mm (range, 1.9–8.7 mm). Though immediate postoperative adequate occlusion was low (11/63, 18%), adequate occlusion was achieved in 78.0% (46/59) and 79.2% (42/53) of the aneurysms at 12 months and 36 months, respectively. Four patients were retreated by the 12-month follow-up (4/63 (6.3%)) and three patients were retreated by the 36-month follow-up (3/63 (4.8%)). There were two major strokes (2/63 (3.2%)), one minor stroke (1/63 (1.6%)) and three incidents of intracranial hemorrhage in two subjects (2/63 (3.2%)) prior to the 12-month follow-up. There was one instance of mortality (1/63, 1.6%). Morbidity was 0% (0/63) and 1.8% (1/63) at the 12-month and 36-month follow-ups, respectively.

Conclusions LUNA AES is safe and effective for the treatment of bifurcation and sidewall aneurysms.

Clinical trial registration ISRCTN72343080; Results.

  • aneurysm
  • endovascular procedures
  • flow disruption
  • LUNA device

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/neurintsurg-2018-013767

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    Footnotes

    • Contributors MP, AB, NS, CM, MJ, SM, TA, MSö, PG, RéA, RëB: made substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; drafted the work or revised it critically for important intellectual content; and gave final approval of the version to be published; and agreed to be accountable for all aspects of the work, ensuring that questions related to the accuracy or integrity of any part of the work were appropriately investigated and resolved.

    • Funding This research received funding from Medtronic.

    • Competing interests MP, consultancy agreement with Medtronic, Stryker, MicroVention, Penumbra, Balt; AB, none; NS, none; CM, consultancy agreement with Medtronic and MicroVention; MJ, none; SM, consultancy agreement with Codman; TA, none; MS, none; PG, none; RA, none; RB, consultancy agreement with Medtronic, Stryker, MicroVention, Penumbra, Balt.

    • Patient consent Obtained.

    • Ethics approval Comité de Protection des Personnes Ile de France XI.

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

    • Data sharing statement The authors are making available any additional unpublished data, such as unprocessed data, protocols, or images. The data are available upon request from the corresponding author.