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  • Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification

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Hemorrhagic stroke
Original research
Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification
  1. Ricardo A Hanel1,
  2. Gustavo M Cortez1,
  3. Demetrius Klee Lopes2,
  4. Peter Kim Nelson3,
  5. Adnan H Siddiqui4,
  6. Pascal Jabbour5,
  7. Vitor Mendes Pereira6,
  8. Istvan Szikora István7,
  9. Osama O Zaidat8,
  10. Chetan Bettegowda9,
  11. Geoffrey P Colby10,
  12. Maxim Mokin11,
  13. Clemens M Schirmer12,
  14. Frank R Hellinger13,
  15. Curtis Given14,
  16. Timo Krings15,
  17. Philipp Taussky16,
  18. Gabor Toth17,
  19. Justin F Fraser18,
  20. Michael Chen19,
  21. Ryan Priest20,
  22. Peter Kan21,
  23. David Fiorella22,
  24. Donald Frei23,
  25. Beverly Aagaard-Kienitz24,
  26. Orlando Diaz25,
  27. Adel M Malek26,
  28. C Michael Cawley27,
  29. Ajit S Puri28,
  30. David F Kallmes29
  1. 1 Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA
  2. 2 Brain and Spine Institute, Advocate Aurora Health, Park Ridge, Illinois, USA
  3. 3 Interventional Radiology, NYU Langone Medical Center, New York, New York, USA
  4. 4 Department of Neurosurgery, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA
  5. 5 Department of Neurosurgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA
  6. 6 Division of Neuroradiology, Department of Medical Imaging and Division of Neurosurgery, Department of Surgery, Toronto Western Hospital, Toronto, Ontario, Canada
  7. 7 Department of Neuroradiology, National Institute of Neurosciences, Budapest, Hungary
  8. 8 Neuroscience Institute, Mercy Health Saint Vincent Medical Center, Toledo, Ohio, USA
  9. 9 Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
  10. 10 Department Neurosurgery, University of California Los Angeles, Los Angeles, California, USA
  11. 11 Department of Neurosurgery, University of South Florida College of Medicine, Tampa, Florida, USA
  12. 12 Department of Neurosurgery, Geisinger Health System, Danville, Pennsylvania, USA
  13. 13 Department of Radiology, Florida Hospital Neuroscience Institute, Winter Park, Florida, USA
  14. 14 Department of Radiology, Baptist Health Lexington, Lexington, Kentucky, USA
  15. 15 Department of Medical Imaging, Toronto Western Hospital, Toronto, Ontario, Canada
  16. 16 Department of Neurosurgery, University of Utah Health, Salt Lake City, Utah, USA
  17. 17 Cerebrovascular Center, Cleveland Clinic, Cleveland, Ohio, USA
  18. 18 Department of Neurological Surgery, University of Kentucky, Lexington, Kentucky, USA
  19. 19 Department of Neurological Surgery, Rush University Medical Center, Chicago, Illinois, USA
  20. 20 Charles T Dotter Department of Interventional Radiology, Dotter Interventional Institute, Oregon Health and Science University, Portland, Oregon, USA
  21. 21 Department of Neurosurgery, Baylor College of Medicine, Houston, Texas, USA
  22. 22 Department of Neurosurgery, Cerebrovascular Center, Stony Brook University, Stony Brook, New York, USA
  23. 23 Department of Neuroradiology, Swedish Medical Center, Englewood, Colorado, USA
  24. 24 Department of Neurological Surgery, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA
  25. 25 Cerebrovascular Center, Houston Methodist Research Institute, Houston, Texas, USA
  26. 26 Department of Neurosurgery, Tufts Medical Center, Boston, Massachusetts, USA
  27. 27 Department of Neurointerventional Radiology and Neurosurgery, Emory University School of Medicine, Atlanta, Georgia, USA
  28. 28 Department of Radiology, University of Massachusetts Medical School, Worcester, Massachusetts, USA
  29. 29 Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA
  1. Correspondence to Dr Ricardo A Hanel, Baptist Neurological Institute, Lyerly Neurosurgery 800 Prudential Drive, Weaver Tower B, 11th Floor, Jacksonville, Florida 32207, USA; rhanel{at}lyerlyneuro.com

Abstract

Background The pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale.

Methods PREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) is a prospective, single-arm trial. Inclusion criteria were patients with unruptured wide-necked intracranial aneurysms ≤12 mm. Primary effectiveness (complete aneurysm occlusion) and safety (major neurologic event) endpoints were independently monitored and adjudicated.

Results As per the protocol, of 141 patients treated with a PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. According to the Core Radiology Laboratory review, three (12%) of these patients progressed to complete occlusion, with an overall rate of complete aneurysm occlusion at 3 years of 83.3% (115/138). Further angiographic evaluation using the modified Cekirge–Saatci classification demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in 97.1%. The overall combined safety endpoint at 3 years was 2.8% (4/141), with only one non-debilitating major event occurring after the first year. There was one case of aneurysm recurrence but no cases of delayed rupture in this series.

Conclusions The PED device presents as a safe and effective modality in treating small- and medium-sized intracranial aneurysms. The application of a flow diverter specific occlusion classification attested the long-term durability with higher rate of successful aneurysm occlusion and no documented aneurysm rupture.

Trial registration NCT02186561.

  • aneurysm
  • flow diverter
  • intervention

Data availability statement

Data are available upon reasonable request.

http://creativecommons.org/licenses/by-nc/4.0/

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, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/neurintsurg-2021-018501

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • RAH and GMC are joint first authors.

    • Twitter @cure4stroke, @PascalJabbourMD, @VitorMendesPer1, @GaborTothMD, @dr_mchen, @PeterKa80460001, @donfreimd, @AjitSPuri1

    • Contributors RAH and GMC were responsible for the initial draft of the manuscript. All authors were involved and made substantial contributions to the conception or design of the work, or the acquisition, analysis, or interpretation of the data; drafting the work or revising it critically for important intellectual content; final approval of the version published; and agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. RAH is responsible for the overall content as the guarantor.

    • Funding The PREMIER study was supported by by Medtronic, Inc.

    • Competing interests RAH is a consultant for Medtronic, Stryker, Cerenovous, Microvention, Balt, Phenox, Rapid Medical, and Q’Apel; he is on advisory board for MiVI, eLum, Three Rivers, Shape Medical and Corindus; he has received unrestricted research grants from NIH, Interline Endowment, Microvention, Stryker, CNX; he is an investor/stockholder for InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical Inc, Scientia, RisT, BlinkTBI, and Corindus. DKL is a consultant for Asahi, Medtronic, and Stryker; has received honoraria from Siemens, Medtronic, Stryker, and Phenox. PKN is a consultant for Medtronic, Phenox, and GmbH. AHS is a modest consultant for Amnis Therapeutics, Boston Scientific, Canon Medical Systems USA, Cerebrotech Medical Systems, Claret Medical, Corindus, Endostream Medical, Guidepoint Global Consulting, Imperative Care, Integra, Rapid Medical, Rebound Therapeutics Corp, Silk Road Medical, StimMed, Stryker, Three Rivers Medical, VasSol, and WL Gore and Associates; he is a consultant and serves on the national PI/steering committee for Cerenovus, Medtronic, MicroVention, and Penumbra; he serves on the National PI/steering committee for the POSITIVE Trial for the Medical University of South Carolina and as DSMB Chair for the HEAT Trial for Northwest University and has ownership interest in Amnis Therapeutics, Apama Medical, BlinkTBI, Buffalo Technology Partners, Cardinal Health, Cerebrotech Medical Systems, Claret Medical, Cognition Medical, Endostream Medical Ltd, Imperative Care, International Medical Distribution Partners, Rebound Therapeutics Corp, Silk Road Medical, StimMed, Synchron, Three Rivers Medical, and Viseon. PJ serves as a consultant for Medtronic, Cerenovus, and Microvention. VMP serves as a consultant/steering committee member for Stryker, Penumbra, and Balt, and as a consultant for Medtronic and Neurovasc, and receives a research grant from Philips. ISI serves as a scientific consultant regarding trial design and conduct to Medtronic. OOZ is a consultant for Medtronic, Stryker, Penumbra, and Cerenovus. CB is a consultant for Depuy-Synthes, Bionaut labs, and Galectin Therapeutics. GPC serves as a consultant for Medtronic, Microvention-Terumo, and Stryker. MM serves as a consultant for Cerebrotech, Imperative Care, and Penumbra; receives consulting fees from Medtronic, Cerenovus, and Canon Medical; and is a member of the Journal of NeuroInterventional Surgery editorial board. CMS has received honoraria from the American Association of Neurological Surgeons and Toshiba, and has ownership interest in NTI. CG serves as a consultant, proctor, and on the Speakers’ Bureau for Medtronic and Stryker. TK is a consultant for Stryker, Cerenovus, Penumbra, and Medtronic. PT serves as a consultant for Stryker Neurovascular, Cerenovus, and Medtronic. GT serves as a consultant for Dynamed EBSCO and Microvention; and is a member of the Journal of NeuroInterventional Surgery editorial board. JFF is an equity interest holder for Fawkes Biotechnology, LLC, and Cerelux; is a consultant for Stream Biomedical, Penumbra, and Medtronic; and is a member of the Journal of NeuroInterventional Surgery editorial board. MC is a consultant for Medtronic, Stryker, Penumbra, Genentech, and GE; and a member of the Journal of NeuroInterventional Surgery editorial board. RP is a consultant for Medtronic, Stryker, and Cerenovus. PK is a consultant for Stryker Neurovascular, Medtronic, and Cerenovus; and a member of the Journal of NeuroInterventional Surgery editorial board. DFi is a consultant for Arsenal Medical, Balt USA, Cerenovous, Marblehead, Medtronic, MENTICE-Vascular Simulations, Microvention, Neurogami, Qapel Medical, RAPID Medical, RAPID.AI, Stryker, and Siemens; received research support from Balt USA, Microvention, Penumbra, Siemens, and Stryker; has received honorarium from Qapel Medicine; is a stockholder in Marblehead, MENTICE-Vascular Simulations, and Neurogami; and a member of the Journal of NeuroInterventional Surgery editorial board. DFr is a consultant and on the Speakers’ Bureau for Penumbra, Stryker Neurovascular, Genentech, MicroVention, and Codman. OD serves as a proctor for Microvention/Terumo. AMM is a cofounder, investor, and shareholder of CereVasc. ASP consults for and has received research grants from Medtronic Neurovascular, Stryker Neurovascular, and Cerenovus; serves as a consultant for Microvention, Agile, Merit, Corindus, QApel, Arsenal, and Imperative Care. DFK is president of Marblehead Medical and has patent pending in balloon catheter technologies; he has received research support from Medtronic, MicroVention, NeuroSave, Neurogami, Sequent Medical, NeuroSigma, and Insera; and serves on the Scientific Advisory Board for Triticum and Boston Scientific.

    • 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.