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New devices and techniques
Original research
Intrasaccular flow disruption for ruptured aneurysms: an international multicenter study
  1. Jose Danilo Bengzon Diestro1,
  2. Mahmoud Dibas2,
  3. Nimer Adeeb3,
  4. Robert W Regenhardt4,
  5. Justin E Vranic4,
  6. Adrien Guenego5,
  7. Sovann V Lay6,
  8. Leonardo Renieri7,
  9. Ali Al Balushi8,
  10. Eimad Shotar9,
  11. Kevin Premat9,
  12. Kareem El Naamani10,
  13. Guillaume Saliou11,
  14. Markus A. Möhlenbruch12,
  15. Ivan Lylyk13,
  16. Paul M Foreman14,
  17. Jay A Vachhani14,
  18. Vedran Župančić15,
  19. Muhammad U Hafeez16,
  20. Caleb Rutledge17,
  21. Hamid Rai18,
  22. Vincent M Tutino18,
  23. Shervin Mirshani2,
  24. Sherief Ghozy19,
  25. Pablo Harker4,
  26. Naif M Alotaibi4,
  27. James D Rabinov4,
  28. Yifan Ren20,
  29. Clemens M Schirmer21,
  30. Oded Goren22,
  31. Mariangela Piano23,
  32. Anna Luisa Kuhn24,
  33. Caterina Michelozzi25,
  34. Stephanie Elens5,
  35. Robert M Starke26,
  36. Ameer Hassan27,
  37. Arsalaan Salehani28,
  38. Anh Nguyen29,
  39. Jesse Jones28,
  40. Marios Psychogios29,
  41. Julian Spears1,30,
  42. Carmen Parra-Fariñas1,
  43. Maria Bres Bullrich31,
  44. Michael Mayich32,
  45. Mohamed M Salem33,
  46. Jan-Karl Burkhardt33,
  47. Brian T Jankowitz33,
  48. Ricardo A Domingo34,
  49. Thien Huynh35,
  50. Rabih Tawk34,
  51. Christian Ulfert36,
  52. Boris Lubicz5,
  53. Pietro Panni25,
  54. Ajit S Puri24,
  55. Guglielmo Pero37,
  56. Christoph J Griessenauer38,39,
  57. Hamed Asadi20,
  58. Adnan Siddiqui18,
  59. Andrew F Ducruet17,
  60. Felipe C Albuquerque17,
  61. Rose Du40,
  62. Peter Kan16,
  63. Vladimir Kalousek15,
  64. Pedro Lylyk13,
  65. Srikanth Reddy Boddu8,
  66. Christopher J Stapleton4,
  67. Jared Knopman8,
  68. Pascal Jabbour10,
  69. Stavropoula Tjoumakaris10,
  70. Frédéric Clarençon41,
  71. Nicola Limbucci7,
  72. Mohammad A Aziz-Sultan2,
  73. Hugo H Cuellar-Saenz3,
  74. Christophe Cognard6,
  75. Aman B Patel4,
  76. Adam A Dmytriw2,4
  1. 1 Department of Medical Imaging, Division of Diagnostic and Therapeutic Neuroradiology, St Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada
  2. 2 Neuroradiology & Neurointervention Service, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA
  3. 3 Department of Neurosurgery and Neurointerventional Surgery, Louisiana State University, Shreveport, Louisiana, USA
  4. 4 Neuroendovascular Program, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA
  5. 5 Service de Neuroradiologie Interventionnelle, Hôpital Universitaire Erasme, Bruxelles, Belgique
  6. 6 Service de Neuroradiologie Diagnostique et Thérapeutique, Centre Hospitalier de Toulouse, Hôpital Purpan, Toulouse, France
  7. 7 Interventistica Neurovascolare, Ospedale Careggi di Firenze, Florence, Italy
  8. 8 Neurosurgery & Interventional Neuroradiology, New York Presbyterian Hospital, Weill Cornell School of Medicine, New York, New York, USA
  9. 9 Department of Interventional Neuroradiology, Sorbonne University, AP-HP, Pitié Salpêtrière - Charles Foix Hospital, Paris, France
  10. 10 Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
  11. 11 Service de radiodiagnostic et radiologie interventionnelle, Centre Hospitalier Vaudois de Lausanne, Lausanne, Switzerland
  12. 12 Department of Neuroradiology, Heidelberg University, Heidelberg, Germany
  13. 13 Equipo de Neurocirugía Endovascular y Radiología Intervencionista, Clínica La Sagrada Familia, Buenos Aires, Argentina
  14. 14 Neurosurgery Department, Orlando Health Neuroscience and Rehabilitation Institute, Orlando, Florida, USA
  15. 15 Subdivision of Interventional Neuroradiology, Department of Radiology, Clinical Hospital Center 'Sisters of Mercy', Zagreb, Croatia
  16. 16 Department of Neurosurgery, UTMB and Baylor School of Medicine, Houston, Texas, USA
  17. 17 Department of Neurosurgery, Barrow Neurological Institute, Phoenix, Arizona, USA
  18. 18 Department of Neurosurgery, State University of New York at Buffalo, Buffalo, New York, USA
  19. 19 Department of Neuroradiology, Mayo Clinic, Rochester, Minnesota, USA
  20. 20 Interventional Radiology and Neurointerventional Services, Department of Radiology, Austin Health, Melbourne, Melbourne, Victoria, Australia
  21. 21 Department of Neurosurgery, Geisinger, Wilkes-Barre, Pennsylvania, USA
  22. 22 Department of Neurosurgery, Geisinger, Danville, Pennsylvania, USA
  23. 23 Neuroradiology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy
  24. 24 Department of Neurointerventional Radiology, UMass Memorial Hospital, Worcester, Massachusetts, USA
  25. 25 Interventistica Neurovascolare, Ospedale San Raffaele, Milano, Italy
  26. 26 Deparment of Neurosurgery, University of Miami, Miami, Florida, USA
  27. 27 Deparment of Neuroscience, Valley Baptist Neuroscience Institute, Harlingen, Texas, USA
  28. 28 Deparments of Neurosurgery and Radiology, University of Alabama at Birmingham, Birmingham, Alabama, USA
  29. 29 Department of Diagnostic and Interventional Neuroradiology, University Hospital Basel, Basel, Switzerland
  30. 30 Department of Surgery, Division of Neurosurgery, University of Toronto, University of Toronto, Toronto, Ontario, Canada
  31. 31 Department of Clinical Neurological Sciences, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
  32. 32 Departments of Medical Imaging, and Clinical Neurological Sciences, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
  33. 33 Department of Neurosurgery, University of Pennsylvania, Penn Medicine, Philadelphia, Pennsylvania, USA
  34. 34 Department of Neurologic Surgery, Mayo Clinic, Jacksonville, Florida, USA
  35. 35 Department of Radiology, Mayo Clinic, Jacksonville, Florida
  36. 36 Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany
  37. 37 Interventistica Neurovascolare, Ospedale Niguarda Cà Granda, Milano, Italy
  38. 38 Department of Neurosurgery, Christian Doppler University Hospital, Paracelsus Medical University, Salzburg, Austria, Salzburg, Austria
  39. 39 Institute of Neurointervention, Paracelsus Medical University, Salzburg, Austria
  40. 40 Neuroradiology & Neurointervention Service, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, Canada
  41. 41 Department of Interventional Neuroradiology, Hopitaux Universitaires Pitie Salpetriere-Charles Foix, Paris, France
  1. Correspondence to Dr Jose Danilo Bengzon Diestro, Medical Imaging, University ot Toronto (St. Michael's Hospital), Toronto, Canada; danni.diestro{at}gmail.com

Abstract

Background The Woven EndoBridge (WEB) device is a novel intrasaccular flow disruptor tailored for bifurcation aneurysms. We aim to describe the degree of aneurysm occlusion at the latest follow-up, and the rate of complications of aneurysms treated with the WEB device stratified according to rupture status.

Methods Our data were taken from the WorldWideWeb Consortium, an international multicenter cohort including patients treated with the WEB device. Aneurysms were classified into two groups: ruptured and unruptured. We compared clinical and radiologic outcomes of both groups. Propensity score matching (PSM) was done to match according to age, gender, bifurcation, location, prior treatment, neck, height, dome width, daughter sac, incorporated branch, pretreatment antiplatelets, and last imaging follow-up.

Results The study included 676 patients with 691 intracranial aneurysms (529 unruptured and 162 ruptured) treated with the WEB device. The PSM analysis had 55 pairs. In both the unmatched (85.8% vs 84.3%, p=0.692) and matched (94.4% vs 83.3%, p=0.066) cohorts there was no significant difference in the adequate occlusion rate at the last follow-up. Likewise, there were no significant differences in both ischemic and hemorrhagic complications between the two groups. There was no documented aneurysm rebleeding after WEB device implantation.

Conclusion There was no significant difference in both the radiologic outcomes and complications between unruptured and ruptured aneurysms. Our findings support the feasibility of treatment of ruptured aneurysms with the WEB device.

  • Aneurysm

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/jnis-2022-019153

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • Twitter @danni.diestro, @GuenegoAdrien, @eneri_neuro, @Starke_neurosurgery, @MMSalemMD, @thienhuynh15, @AjitSPuri1, @cgriessenauer, @PeterKa80460001, @VladoKZg, @PascalJabbourMD

    • Contributors JBD, MD, NA and AAD were the lead investigators. AAD is the main guarantor of the study. They were involved in the design of the study, acquisition and analysis of data, drafting and revising the manuscript for intellectual content and final approval of the version to be published. RWR, JEV, AG, SVL, LR, AAB, ES, KP, KEN, GS, MAM, IL, PMF, JAV, VŽ, MUH, CR, HR, VMT, SM, SG, PH, NMA, JDR, YR, CMS, OG, MP, ALK, CM, SE, RMS, AH, AS, AN, JJ, MP, JS, CPF, MBB, MM, MMS, JKB, BTJ, RAD, TH, RT, CU, BL, PP, ASP, GP, CJG, HA, AS, AFD, FCA, RD, PK, VK, PL, SB, CJS, JK, PJ, ST, FC, ML, MAA, HHC, CC, ABP were coinvestigators. There were involved in the acquisition and analysis of data, drafting and revising the manuscript for intellectual content and final approval of the version to be published. All authors have agreed 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.

    • 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 JDBD: Honoraria from Medtronic. Travel grant from Microvention. MD: No relevant relationships NA: No relevant relationships RWR: Grants from National Institutes of Health, Heitman foundation, Society of vascular and interventional neurology; Advisory board participation for Rapid medical; Site PI for Microvention and Penumbra JEV: No relevant relationships AG : No relevant relationships SVL: No relevant relationships LR: No relevant relationships AAB: No relevant relationships ES: No relevant relationships KP: No relevant relationships KEL: No relevant relationships GS : No relevant relationships MAM: No relevant relationships IL: No relevant relationships PMR: No relevant relationships JAV: Fees from MicroVention for proctoring cases for new physician users of the Woven EndoBridge device; Medtronic travel expense VŽ: Participation on the data safety monitoring board or advisory board for KBC Sestre Milosrdnice, Zagreb / OB Nova Gradiška MUH: No relevant relationships CR: No relevant relationships HR: No relevant relationships VMT: No relevant relationships SM: No relevant relationships SG: No relevant relationships PH: No relevant relationships NA: No relevant relationships JDR: No relevant relationships YR: No relevant relationships CMS: No relevant relationships OG: No relevant relationships MP: No relevant relationships ALK: No relevant relationships CM: No relevant relationships SE: No relevant relationships RMS: Supported by the NREF, Joe Niekro Foundation, Brain Aneurysm Foundation, Bee Foundation, and the National Institutes of Health (R01NS111119-01A1, UL1TR002736, and KL2TR002737) through the Miami Clinical and Translational Science Institute, from the National Center for Advancing Translational Sciences and the National Institute on Minority Health and Health Disparities. AH: Consulting or speaker fees from Medtronic, MicroVention, Stryker, Penumbra, Cerenovus, Genentech, GE Healthcare, Scientia, Balt, Viz.ai, Insera Therapeutics, Proximie, NeuroVasc, NovaSignal, Vesalio, and Galaxy Therapeutics. AS: No relevant relationships AN: No relevant relationships JJ: Consulting and speaker fees from Cerenovus MP: No relevant relationships JS: No relevant relationships CPF: No relevant relationships MBB: No relevant relationships MM: Grants from Balt, Medtronic, MicroVention, and Stryker. MMS: No relevant relationships JB: No relevant relationships BTJ: No relevant relationships RAD: No relevant relationships TH: No relevant relationships RT: Medtronic Stocks CU: No relevant relationships BL : No relevant relationships PP: No relevant relationships ASP: Grants from NIH, Microvention, Cerenovus, Medtronic and Stryker; Consulting fees from Neurovascular, Stryker NeurovascularBalt, Q’Apel Medical, Cerenovus, Microvention, Imperative Care, Agile, Merit, CereVasc and Arsenal Medical; stock options from InNeuroCo, Agile, Perfuze, Galaxy and NTI GP: No relevant relationships CJG: Grants to institution from Medtronic and Penumbra; consulting fees from Stryker and MicroVention. HA: Proctoring fees from MicroVention. Grants to institution from the National Institutes of Health; consulting fees from Amnis Therapeutics, Apellis Pharmaceuticals, Boston Scientific, Canon Medical Systems, Cardinal Health 200, Cerebrotech Medical Systems, Cerenovus, Cerevatech Medical, Cordis, Corindus, EndoStream Medical, Imperative Care, Integra, IRRAS, Medtronic, MicroVention, Minnetronix Neuro, Penumbra, Q’Apel Medical, Rapid Medical, Serenity Medical, Silk Road Medical, StimMed, Stryker Neurovascular, Three Rivers Medical, VasSol, Viz.ai, and W.L. Gore & Associates; payment for participation on the steering committees for the Cerenovus EXCELLENT and ARISE II Trial; Medtronic SWIFT PRIME, VANTAGE, EMBOLISE, and SWIFT DIRECT Trials; MicroVention FRED Trial and CONFIDENCE Study; MUSC POSITIVE Trial; Penumbra 3D Separator Trial, COMPASS Trial, INVEST Trial, MIVI Neuroscience EVAQ Trial; Rapid Medical SUCCESS Trial; InspireMD C-GUARDIANS IDE Pivotal Trial; stock or stock options in Adona Medical, Amnis Therapeutics, Bend IT Technologies, BlinkTBI, Buffalo Technology Partners, Cardinal Consultants, Cerebrotech Medical Systems, Cerevatech Medical, Cognition Medical, CVAID, E8, EndoStream Medical, Imperative Care, Instylla, International Medical Distribution Partners, Launch NY, NeuroRadial Technologies, Neurotechnology Investors, Neurovascular Diagnostics, Perflow Medical, Q’Apel Medical, QAS.ai, Radical Catheter Technologies, Rebound Therapeutics (purchased in 2019 by Integra Lifesciences), Rist Neurovascular (purchased in 2020 by Medtronic), Sense Diagnostics, Serenity Medical, Silk Road Medical, Songbird Therapy, Spinnaker Medical, StimMed, Synchron, Three Rivers Medical, Truvic Medical, Tulavi Therapeutics, Vastrax, VICIS, and Viseon AFD: Consulting fees from Cerenovus, Penumbra, Medtronic, Stryker, Oculus, and Koswire. No relevant relationships RD: No relevant relationships PK: No relevant relationships. VK: No relevant relationships. PL: No relevant relationships SB: No relevant relationships CJS: Participation on the data safety monitoring board or advisory board for Zoll Circulation JK: No relevant relationships PJ: No relevant relationships ST: No relevant relationships FC: No relevant relationships NL: Honoraria for lectures from Cerenovus, Stryker, and CrossMed. MAA: Funding to institution from MicroVention for WEBIT trial; proctoring fees from MicroVention. HHC: No relevant relationships CC: Consulting fees from MicroVention, Stryker, Medtronic, MIVI, and Cerenovus. ABP: Grant to institution from Medtronic; consulting fees from MicroVention, Medtronic, and Q’Apel; workstation for research from Siemens AAD: No relevant relationships

    • 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.