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  • Safety and effectiveness of the Low Profile Visualized Intraluminal Support (LVIS and LVIS Jr) devices in the endovascular treatment of intracranial aneurysms: results of the TRAIL multicenter observational study

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New Devices
Original research
Safety and effectiveness of the Low Profile Visualized Intraluminal Support (LVIS and LVIS Jr) devices in the endovascular treatment of intracranial aneurysms: results of the TRAIL multicenter observational study
  1. Christina Iosif1,
  2. Michel Piotin2,
  3. Suzana Saleme1,
  4. Xavier Barreau3,
  5. Jacques Sedat4,
  6. Yves Chau4,
  7. Nader Sourour5,
  8. Mohamed Aggour6,
  9. Herve Brunel7,
  10. Alain Bonafe8,
  11. Paolo Machi8,
  12. Carlos Riquelme8,
  13. Vincent Costalat8,
  14. Laurent Pierot9,
  15. Raphael Blanc2,
  16. Charbel Mounayer1
  17. on behalf of the TRAIL Investigators
  1. 1 Department of Interventional Neuroradiology, CHU-Limoges Dupuytren University Hospital, Limoges, France
  2. 2 Department of Interventional Neuroradiology, Foundation Rothschild Hospital, Limoges, France
  3. 3 Department of Interventional Neuroradiology, CHU Pellegrin, Paris, France
  4. 4 Department of Interventional Neuroradiology, Hôpital Saint-Roch, Nice, France
  5. 5 Department of Interventional Neuroradiology, La Pitié-Salpétrière, Paris, France
  6. 6 Department of Interventional Neuroradiology, Hôpital Bellevue, Saint-Etienne, France
  7. 7 Department of Interventional Neuroradiology, Hôpital de la Timone, Marseille, France
  8. 8 Department of Interventional Neuroradiology, Hôpital Gui de Chauliac, Montpellier, France
  9. 9 Department of Interventional Neuroradiology, Hôpital Maison Blanche, Reims, France
  1. Correspondence to Dr Christina Iosif, Departments of Interventional Neuroradiology, CHU-Limoges Dupuytren University Hospital, Limoges 87042, France; christina.iosif{at}gmail.com

Abstract

Background and purpose To evaluate the safety and effectiveness of the low-profile braided intracranial stents called the Low Profile Visualized Intraluminal Support (LVIS) devices for stent-assisted coil embolization of wide-necked intracranial aneurysms.

Materials and methods This was a prospective, multicenter, observational study of unruptured and ruptured intracranial aneurysms treated with the LVIS devices. Imaging and clinical data were independently analyzed respectively by CoreLab and Clinical Event Committee. Primary endpoints were clinical safety, effectiveness, and angiographic stability of the results at 6 and 18 months.

Results Ten centers participated in the study; 102 patients were included and 90 patients (42.2% men, 57.8% women) were eventually analyzed, among which 27 (30.0%) had multiple aneurysms. Twenty-three (25.6%) were ruptured aneurysms, four of which (4.4%) were treated in the acute phase. One aneurysm was treated per patient; 92 LVIS and LVIS Jr devices were placed overall. The total aneurysm occlusion rate was 91.0% on immediate post-procedure angiograms, which remained unchanged at 6-month follow-up and was 92.4% at 18-month follow-up. One patient (1.1%) underwent retreatment between 6 and 18 months of follow-up. A modified Rankin score of 0 was documented for most cases immediately after the procedure (86.7%) and at 6-month (86.8%) and 18-month (83.3%) follow-up. The overall permanent morbidity rate at 18 months was 5.6% and the overall rate of events with sequelae related to the stent was 2.2%. The 18-month procedure-related mortality rate was 3.3%. No patient was deemed to require retreatment at 18-month follow-up.

Conclusion The LVIS/LVIS Jr endovascular devices are safe and effective in the treatment of ruptured and unruptured intracranial aneurysms, with acceptable complication rates, very high immediate total occlusion rates, and stable angiographic results.

  • aneurysm
  • stent

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-2017-013375

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    Footnotes

    • Contributors The investigators participated in the protocol by performing the cases, giving the necessary clinical and imaging feedback to the coreLab and complying with the study’s protocol. The investigators have read and approved the submitted manuscript.

    • Competing interests None declared.

    • Patient consent Obtained.

    • Ethics approval National Commission of Information Management and Liberties, France.

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