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Case series
Multicenter early United States feasibility study and periprocedural safety of LVIS EVO for the treatment of unruptured intracranial aneurysms
  1. Yasha Kayan1,
  2. Josser E Delgado Almandoz1,
  3. Alexander Copelan1,
  4. Charles Matouk2,
  5. M Imran Chaudry3,
  6. David Altschul4,
  7. Muhammed Amir Essibayi4,
  8. Oded Goren5,
  9. Benjamin Yim6,
  10. Sam Tsappidi7,
  11. Yi Jonathan Zhang7,
  12. Ferdinand K Hui7,
  13. Edgar A Samaniego8,
  14. Andres Gudino8,
  15. Adnan Siddiqui9,
  16. Vinay Jaikumar9,
  17. Ajit S Puri10,
  18. Anna Luisa Kühn10,
  19. Jasmeet Singh10,
  20. Andrew Ringer11,
  21. Ricardo A Hanel12,
  22. Otavio Frederico De Toledo12,
  23. Guilherme Dabus13,
  24. M Reid Gooch14,
  25. Saman Sizdahkhani14,
  26. Nicholas C Field15,
  27. Alexandra R Paul15
    1. 1Neurointerventional Radiology, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA
    2. 2Neurosurgery, Yale University, New Haven, Connecticut, USA
    3. 3Neuroradiology, Prisma Health, Greenville, South Carolina, USA
    4. 4Neurosurgery, Montefiore Medical Center, Bronx, New York, USA
    5. 5Neurosurgery, Geisinger, Danville, Pennsylvania, USA
    6. 6Neurosurgery, John Muir Health, Walnut Creek, California, USA
    7. 7Department of Neurosurgery, Queen's Medical Center, Honolulu, Hawaii, USA
    8. 8Neurology, University of Iowa, Iowa City, Iowa, USA
    9. 9Neurosurgery, University at Buffalo School of Medicine and Biomedical Sciences, Buffalo, New York, USA
    10. 10Neurointerventional Radiology, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA
    11. 11Neurosurgery, Mayfield Brain and Spine, Cincinnati, Ohio, USA
    12. 12Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA
    13. 13Neurosurgery, Baptist Health Miami Neuroscience Institute, Miami, Florida, USA
    14. 14Neurological Surgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA
    15. 15Neurosurgery, Albany Medical Center, Albany, New York, USA
    1. Correspondence to Dr Alexandra R Paul, Department of Neurosurgery, Albany Medical Center, Albany, New York, USA; PaulA1{at}amc.edu

    Abstract

    Background Stent development has focused recently on low-profile, self-expandable stents compatible with 0.0165 inch microcatheters. The LVIS EVO is the second-generation version of the Low-Profile Visualized Intraluminal Support (LVIS) with improved visibility and resheathability. The LVIS EVO underwent a limited premarket release (PMR) in December 2023. This study aims to report the early safety and feasibility experience with the LVIS EVO stent for the treatment of intracranial aneurysms in the United States (US).

    Methods This was a multicenter, retrospective, observational study evaluating patients who underwent treatment of an intracranial aneurysm with an LVIS EVO stent after the limited PMR. All physicians who had placed an LVIS EVO stent were asked to input their cases after institutional review board approval was obtained. The data were then sent to a single center for analysis. Any patient aged 18 years or older who underwent treatment of an intracranial aneurysm with a LVIS EVO stent in the US was included from the initial PMR in December 2023 until April 2024. Patient age (or ≤90 years old), sex, preoperative modified Rankin Scale (mRS), aneurysm location, aneurysm measurements, and information about preoperative antiplatelet management were all collected. Data on periprocedural complications, 30-day mortality, discharge mRS, and length of stay were also collected.

    Results Some 53 patients with 55 aneurysms underwent treatment with the LVIS EVO stent at 15 institutions. All aneurysms were unruptured. The most common location was the anterior communicating artery (35%) followed by the middle cerebral artery bifurcation (31%). All patients were on dual antiplatelet therapy. The average aneurysm size was 5.2 mm with a neck size of 3.7 mm. The smallest distal parent vessel size was 1.2 mm and 36% of stents were deployed in distal parent vessels <2 mm. All (100%) cases had successful deployment and the stent was repositioned in 10% of cases. A single stent was utilized in 91% of cases. Coils were placed in 48 cases (87.2%) and a microcatheter was jailed in 98% of those cases. Immediate Raymond Roy (RR) Class I occlusion was obtained in 33%, Class II in 22%, Class IIIa in 37%, and Class IIIb in 8% of cases. There were no delayed thromboembolic or hemorrhagic complications.

    Conclusions The LVIS EVO is a braided, self-expanding, retrievable stent with enhanced visibility and smaller cell size. The drawn filled tube (DFT) technology results in improved visibility of the stent, allowing for more controlled stent positioning and visualization of vessel wall apposition. All cases in our series had complete neck coverage and good wall apposition. There were no thromboembolic or hemorrhagic complications.

    • Aneurysm
    • Stent
    • Coil
    • Device

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    Footnotes

    • X @yashakayan, @DavidAltschulMD, @MAEssibayi, @esamaniego, @AjitSPuri1

    • Contributors The study was conceived and drafted by ARP. All authors are in agreement to be accountable for all aspects of the work and gave final approval of the version to be published. YK, JEDA, and AC provided multiple LVIS EVO cases as well as images and provided feedback on the manuscript. CM was instrumental in editing the manuscript and providing their own cases and images. MIC was an early collaborator and provided data from their institution. DA and MAE provided many cases to the series as well as edits to the final manuscript. OG provided their cases and feedback. BY provided cases from their institution as well as helped edit the final manuscript. ST, JYZ, and FKH provided cases from their series as well as angiographic images. EAS and AG provided their cases and contributions towards the editors’ comments. AS and VJ provided cases from their institution. ASP, ALK, and JS provided their cases as well as feedback. AR provided cases from their institution and guidance revising the manuscript. RH and OFdT provided their cases to the series. GD provided their cases as well as feedback. MRG and SS provided cases for the series as well as editing the final manuscript. NCF provided cases and editing of the manuscript.

    • 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 BY is a consultant for Imperative Care and Q’Apel Medical, Inc., and has received speaking honoria from Penumbra. EAS is a consultant for MicroVention, Medtronic, Rapid Medical, iSchemaview, and Cerenovus. AS is a consultant/advisory board member for Amnis Therapeutics, Apellis Pharmaceuticals, Inc., Asahi Intecc Co. Ltd., Boston Scientific, Canon Medical Systems USA, Inc., Cardinal Health 200, LLC, Cerebrotech Medical Systems, Inc., CerebrovaKP, Cerenovus, Contego Medical, Cordis, Corindus, Inc., Endostream Medical, Ltd, Hyperfine Operations, Inc., Imperative Care, InspireMD, Ltd., Integra, IRRAS AB, Medtronic, MicroVention, Minnetronix Neuro, Inc., Peijia Medical, Penumbra, Piraeus Medical, Inc., Q’Apel Medical, Inc., Rapid Medical, Serenity Medical, Inc., Shockwave Medical, Inc., Silk Road Medical, StimMed, LLC, Stryker Neurovascular., Synchron Australia Pty Ltd., VasSol, Vesalio, Viz.ai, Inc., WL Gore, and an investor in Adona Medical, Inc., Bend IT Technologies, Ltd., BlinkTBI, Inc., Borvo Medical, Inc., Cerebrotech Medical Systems, Inc., CerebrovaKP, Code Zero Medical, Inc., Cognition Medical, Collavidence, Inc., Contego Medical, CVAID Ltd., E8, Inc., Endostream Medical, Ltd., Galaxy Therapeutics, Inc., Hyperion Surgical, Inc., Imperative Care, Inc., InspireMD, Ltd., Instylla, Inc., Launch NY, Inc., Neurolutions, Inc., NeuroRadial Technologies, Inc. (sold to Medtronic in 2021), Neurovascular Diagnostics, Inc., Peijia Medical, PerFlow Medical, Ltd., Piraeus Medical, Inc., Q’Apel Medical, Inc., QAS.ai, Inc., Radical Catheter Technologies, Inc., Rebound Therapeutics Corp. (purchased 2019 by Integra Lifesciences, Corp.), Rist Neurovascular, Inc. (purchased 2020 by Medtronic), Sense Diagnostics, Inc., Serenity Medical, Inc., Silk Road Medical, Sim & Cure, Spinnaker Medical, Inc., StimMed, LLC, Synchron, Inc., Tulavi Therapeutics, Inc., Vastrax, LLC, Viseon, Inc., Whisper Medical, Inc., Willow Medtech, Inc. OG is a consultant for MicroVention, Stryker, and Route 92. CM is a consultant and proctor for Cerevasc and Silk Road Medical, and a consultant for MicroVention, Medtronic, Stryker, Navigantis, and Hyerbia. MRG is a consultant for Stryker and Rapid Medical. ARP is a consultant for Microvention, IRRAS, Penumbra, and NICO.

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