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Original research
Safety and efficacy of balloon-mounted stent in the treatment of symptomatic intracranial atherosclerotic disease: a multicenter experience
  1. Mahmoud H Mohammaden1,2,3,
  2. Raul G Nogueira1,2,
  3. Wondwossen Tekle4,5,
  4. Santiago Ortega-Gutierrez6,
  5. Mudassir Farooqui7,
  6. Cynthia B. Zevallos7,
  7. Ricardo A Hanel8,
  8. Gustavo M Cortez8,
  9. Amin Aghaebrahim8,
  10. Robert M Starke9,
  11. Hany Aref10,
  12. Ahmed Elbassiouny10,
  13. Ayman Gamea3,
  14. Ali Alaraj11,
  15. Morteza Sadeh11,
  16. Mikayel Grigoryan12,
  17. Okkes Kuybu1,2,
  18. Diogo C Haussen1,2,
  19. Sunil A Sheth13,
  20. Alberto Maud14,
  21. Steve M Cordina15,
  22. Omar Tanweer16,
  23. Peter Kan17,
  24. Jan-Karl Burkhardt18,
  25. Ramesh Grandhi19,
  26. Farhan Siddiq20,
  27. Ameer E Hassan4,5
  1. 1Department of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA
  2. 2Marcus Stroke & Neuroscience Center, Grady Memorial Hospital, Atlanta, Georgia, USA
  3. 3Department of Neurology, South Valley University Faculty of Medicine, Qena, Egypt
  4. 4Department of Neurology, UTRGV School of Medicine, Harlingen, Texas, USA
  5. 5Department of Neurology, Valley Baptist Medical Center, Harlingen, Texas, USA
  6. 6Department of Neuroloy, Neurosurgery and Radiology, The University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA
  7. 7Department of Neurology, The University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA
  8. 8Lyerly Neurosurgery, Baptist Medical Center Downtown, Jacksonville, Florida, USA
  9. 9Department of Neurosurgery and Radiology, University of Miami Miller School of Medicine, Miami, Florida, USA
  10. 10Department of Neurology, Ain Shams University Faculty of Medicine, Cairo, Egypt
  11. 11Department of Neurosurgery, University of Illinois at Chicago, Chicago, Illinois, USA
  12. 12Adventist Health Glendale, Glendale, California, USA
  13. 13Department of Neurology, University of Texas Health Science Center at Houston, Houston, Texas, USA
  14. 14Department of Neurology, Texas Tech University Health Sciences Center El Paso, El Paso, Texas, USA
  15. 15Department of Neurology, University of South Alabama Health System, Mobile, Alabama, USA
  16. 16Department of Neurosurgery, NYU Langone Health, New York, New York, USA
  17. 17Department of Neurosurgery, Baylor Health Care System, Dallas, Texas, USA
  18. 18Department of Neurosurgery, University of Pennsylvania Health System, Philadelphia, Pennsylvania, USA
  19. 19Department of Neurosurgery, University of Utah Health, Salt Lake City, Utah, USA
  20. 20Department of Neurosurgery, University of Missouri System, Columbia, Missouri, USA
  1. Correspondence to Dr Ameer E Hassan, UTRGV School of Medicine, Harlingen, TX 78541, USA; ameerehassan{at}gmail.com

Abstract

Background Randomized clinical trials have failed to prove that the safety and efficacy of endovascular treatment for symptomatic intracranial atherosclerotic disease (ICAD) is better than that of medical management. A recent study using a self-expandable stent showed acceptable lower rates of periprocedural complications.

Objective To study the safety and efficacy of a balloon-mounted stent (BMS) in the treatment of symptomatic ICAD.

Methods Prospectively maintained databases from 15 neuroendovascular centers between 2010 and 2020 were reviewed. Patients were included if they had severe symptomatic intracranial stenosis in the target artery, medical management had failed, and they underwent intracranial stenting with BMS after 24 hours of the qualifying event. The primary outcome was the occurrence of stroke and mortality within 72 hours after the procedure. Secondary outcomes were the occurrence of stroke, transient ischemic attacks (TIAs), and mortality on long-term follow-up.

Results A total of 232 patients were eligible for the analysis (mean age 62.8 years, 34.1% female). The intracranial stenotic lesions were located in the anterior circulation in 135 (58.2%) cases. Recurrent stroke was the qualifying event in 165 (71.1%) while recurrent TIA was identified in 67 (28.9%) cases. The median (IQR) time from the qualifying event to stenting was 5 (2–20.75) days. Strokes were reported in 13 (5.6%) patients within 72 hours of the procedure; 9 (3.9%) ischemic and 4 (1.7%) hemorrhagic, and mortality in 2 (0.9%) cases. Among 189 patients with median follow-up time 6 (3–14.5) months, 12 (6.3%) had TIA and 7 (3.7%) had strokes. Three patients (1.6%) died from causes not related to stroke.

Conclusion Our study has shown that BMS may be a safe and effective treatment for medically refractory symptomatic ICAD. Additional prospective randomized clinical trials are warranted.

  • stroke
  • stent
  • stenosis
  • atherosclerosis
  • balloon

Data availability statement

Anonymized data from the study are available upon reasonable request to the corresponding author.

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Data availability statement

Anonymized data from the study are available upon reasonable request to the corresponding author.

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Footnotes

  • Twitter @wondeasa, @diogohaussen

  • Collaborators NA.

  • Contributors MHM: Study conception, design of the work, statistical analysis, interpretation of data, drafting of the manuscript. RGN: Study conception, interpretation of data, critical revision of manuscript. AEH: Study conception, design of the work, critical revision of the manuscript. Other co-authors: interpretation of data, critical revision of 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 RGN reports consulting fees for advisory roles with Stryker Neurovascular, Cerenovus, Medtronic, Phenox, Anaconda, Genentech, Biogen, Prolong Pharmaceuticals, Imperative Care and stock options for advisory roles with Brainomix, Viz-AI, Corindus Vascular Robotics, Vesalio, Ceretrieve, Astrocyte and Cerebrotech. DCH is a consultant for Stryker and Vesalio and holds stock options at Viz.AI. AEH - 1.Consultant/speaker: Medtronic, Microvention, Stryker, Penumbra, Cerenovus, Genentech, GE Healthcare, Scientia, Balt, Viz.ai, Insera therapeutics, Proximie, NovaSignal and Vesalio. 2.Principal investigator: COMPLETE study- Penumbra, LVO SYNCHRONISE-Viz.ai. 3.Steering committee/publication committee member: SELECT, DAWN, SELECT 2, EXPEDITE II, EMBOLISE, CLEAR. 4.Proctor: Pipeline, FRED, Wingspan, and Onyx. 5.Supported by grants from: GE Healthcare. PK is on the editorial board of JNIS. The other authors report no conflicts.

  • 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.

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