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New devices and techniques
Original research
Safety of the APOLLO Onyx delivery microcatheter for embolization of brain arteriovenous malformations: results from a prospective post-market study
  1. Philip M Meyers1,
  2. Johanna T. Fifi2,
  3. Kevin M. Cockroft3,
  4. Timothy R. Miller4,
  5. Curtis A. Given5,
  6. Ali R. Zomorodi6,
  7. Bharathi D. Jagadeesan7,
  8. Maxim Mokin8,
  9. Peter Kan9,
  10. Tom L. Yao10,
  11. Orlando Diaz11,
  12. Daniel Huddle12,
  13. Richard J. Bellon13,
  14. Joshua Seinfeld14,
  15. Adam J Polifka15,
  16. David Fiorella16,
  17. Rohan V. Chitale17,
  18. Peter Kvamme18,
  19. Jay T. Morrow19,
  20. Justin Singer19,
  21. Ajay K. Wakhloo20,
  22. Ajit S. Puri21,
  23. Vivek R. Deshmukh22,
  24. Ricardo A. Hanel23,
  25. L. Fernando Gonzalez24,
  26. Henry H. Woo25,
  27. Mohammad Ali Aziz-Sultan26
  1. 1Departments of Radiology and Neurological Surgery, Columbia University, New York, New York, USA
  2. 2Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA
  3. 3Department of Neurosurgery, Pennsylvania State University College of Medicine, Hershey, Pennsylvania, USA
  4. 4Division of Interventional Neuroradiology, University of Maryland Medical Center, Baltimore, Maryland, USA
  5. 5Department of Radiology, Baptist Health Lexington, Lexington, Kentucky, USA
  6. 6Division of Neurosurgery, Duke University Medical Center, Durham, North Carolina, USA
  7. 7Department of Radiology, Neurosurgery and Neurology, University of Minnesota, Minneapolis, Minnesota, USA
  8. 8Department of Neurosurgery, University of South Florida, Tampa, Florida, USA
  9. 9Department of Neurosurgery, Baylor College of Medicine, Houston, Texas, USA
  10. 10Department of Neurosurgery, Norton Neuroscience Institute, Norton Healthcare, Louisville, Kentucky, USA
  11. 11Division of Interventional Neuroradiology, Houston Methodist Hospital, Houston, Texas, USA
  12. 12Department of Brain, Spine, Physical Medicine and Rehabilitation, UC Health Medical Group (UCHMG), Colorado Springs, Colorado, USA
  13. 13Department of Neurology, Swedish Medical Center, Englewood, Colorado, USA
  14. 14Department of Neurosurgery and Radiology, University of Colorado Medical Center, Aurora, Colorado, USA
  15. 15Department of Neurological Surgery, University of Florida, Gainesville, Florida, USA
  16. 16Department of Neurosurgery, Cerebrovascular Center, Stony Brook University Hospital, Stony Brook, New York, USA
  17. 17Department of Neurosurgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA
  18. 18Department of Radiology, The University of Tennessee Medical Center, Knoxville, Tennessee, USA
  19. 19Neuroscience Institute, Division of Neurosurgery, Michigan State University, Spectrum Health, Grand Rapids, Michigan, USA
  20. 20Department of Neurointerventional Radiology, Beth Israel Lahey Health, Tufts School of Medicine, Burlington, Massachusetts, USA
  21. 21Department of Radiology, University of Massachusetts Medical Center, Worcester, Massachusetts, USA
  22. 22Providence Brain and Spine Institute, Portland, Oregon, USA
  23. 23Baptist Health Research Institute, Lyerly Neurosurgery, Jacksonville, Florida, USA
  24. 24Department of Neurosurgery, Duke University, Durham, North Carolina, USA
  25. 25Department of Neurosurgery and Radiology, Zucker School of Medicine at Hofstra/Northwell Health, Manhasset, New York, USA
  26. 26Department of Neurosurgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA
  1. Correspondence to Dr Philip M Meyers, Departments of Radiology and Neurological Surgery, Columbia University, New York, New York, USA; pmm2002{at}columbia.edu

Abstract

Background Catheter retention and difficulty in retrieval have been observed during embolization of brain arteriovenous malformations (bAVMs) with the Onyx liquid embolic system (Onyx). The Apollo Onyx delivery microcatheter (Apollo) is a single lumen catheter designed for controlled delivery of Onyx into the neurovasculature, with a detachable distal tip to aid catheter retrieval. This study evaluates the safety of the Apollo for delivery of Onyx during embolization of bAVMs.

Methods This was a prospective, non-randomized, single-arm, multicenter, post-market study of patients with a bAVM who underwent Onyx embolization with the Apollo between May 2015 and February 2018. The primary endpoint was any catheter-related adverse event (AE) at 30 days, such as unintentional tip detachment or malfunction with clinical sequelae, or retained catheter. Procedure-related AEs (untoward medical occurrence, disease, injury, or clinical signs) and serious AEs (life threatening illness or injury, permanent physiological impairment, hospitalization, or requiring intervention) were also recorded.

Results A total of 112 patients were enrolled (mean age 44.1±17.6 years, 56.3% men), and 201 Apollo devices were used in 142 embolization procedures. The mean Spetzler–Martin grade was 2.38. The primary endpoint was not observed (0/112, 0%). The catheter tip detached during 83 (58.5%) procedures, of which 2 (2.4%) were unintentional and did not result in clinical sequelae. At 30 days, procedure related AEs occurred in 26 (23.2%) patients, and procedure-related serious AEs in 12 (10.7%). At 12 months, there were 3 (2.7%) mortalities, including 2 (1.8%) neurological deaths, none of which were device-related.

Conclusion This study demonstrates the safety of Apollo for Onyx embolization of bAVMs.

Clinical trial registration CNCT02378883.

  • vascular malformation
  • arteriovenous malformation
  • catheter
  • device
  • liquid embolic material

https://doi.org/10.1136/neurintsurg-2020-016830

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    Footnotes

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    • Contributors All authors made substantial contributions to the conception and design, analysis, and interpretation of data; drafted or critically revised the article; and gave final approval of the version to be published.

    • Funding This study was sponsored by Medtronic, Inc.

    • Competing interests JF reports grants and non-financial support from Stryker, grants and other funding from Penumbra, grants from Microvention, and equity in Cerebrotech and The Stroke Project. CAG serves on the speaker’s bureau and as a consultant and proctor for Medtronic and Stryker, and serves on the speaker’s bureau for Genentech. MM serves as a consultant for Toshiba/Canon Medical. PK serves as a consultant for Stryker Neurovascular, Medtronic, and Cerenovus. TY serves as a consultant and proctor for Medtronic. OD serves as a proctor for Microvention/Terumo. DF serves as a consultant for Balt, Marblehead Medical, Medtronic, Stryker, Microvention, Penumbra, and Cerenovus, receives research support from Cerenovus, Medtronic, Stryker, Siemens, Microvention, and Penumbra, receives royalties from Codman, and is a stockholder in Marblehead, Neurogami, and Vascular simulations outside the submitted work. RVC has received research funding from Microvention, Cerenovus, and Medtronic. AKW has received research grants from Philips Medical, serves as a consultant for Stryker and Phenox, is a stockholder in InNeuroCo, EpiEP, Neural Analytics, Rist, Analytics 4 Life, and ThrombX, and serves on the speaker’s bureau for SCENT trial presentations. ASP serves as a consultant for and has received research grants from Medtronic Neurovascular and Stryker Neurovascular. RAH serves as a consultant for Medtronic, Stryker, Codman, and Microvention, and is a stockholder in InNeuroCo. LFG holds stock in Culvert Therapeutics and NeuroCool, serves as a proctor for Medtronic Neurovascular, and participates in training other physicians in the use pipeline embolization device. MAA-S serves as a proctor for Medtronic Neurovascular, and participates in training other physicians in the use of the embolic agent Onyx and the pipeline embolization device.

    • Patient consent for publication Not required.

    • Ethics approval The institutional review board at each center approved the study.

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

    • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information. All data relevant to the study are included in the article or uploaded as supplementary information.

    • 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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