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Hemorrhagic stroke
Original research
Woven EndoBridge device for ruptured aneurysms: perioperative results of a US multicenter experience
  1. Gustavo M Cortez1,2,
  2. Erinc Akture1,
  3. Andre Monteiro1,
  4. Adam S Arthur3,4,
  5. Jeremy Peterson3,4,
  6. David Dornbos3,4,
  7. Pascal Jabbour5,
  8. M Reid Gooch5,
  9. Ahmad Sweid5,
  10. Stavropoula I Tjoumakaris5,
  11. Josser E Delgado Almandoz6,
  12. Yasha Kayan6,
  13. Ansaar T Rai7,
  14. SoHyun Boo7,
  15. David Fiorella8,
  16. Jay Vachhani9,
  17. Paul Foreman9,
  18. Marshall Cress9,
  19. Adnan H Siddiqui10,
  20. Muhammad Waqas10,
  21. Amin Aghaebrahim1,
  22. Eric Sauvageau1,
  23. Ricardo A Hanel1
  1. 1 Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, Florida, USA
  2. 2 Research Department, Jacksonville University, Jacksonville, Florida, USA
  3. 3 Semmes-Murphey Neurologic and Spine Institute, Memphis, Tennessee, USA
  4. 4 Department of Neurosurgery, University of Tennessee Health Science Center, Memphis, Tennessee, USA
  5. 5 Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA
  6. 6 Interventional Neuroradiology, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA
  7. 7 Interventional Neuroradiology, West Virginia University Rockefeller Neuroscience Institute, Morgantown, West Virginia, USA
  8. 8 Department of Neurosurgery, State University of New York at Stony Brook, Stony Brook, New York, USA
  9. 9 Department of Neurosurgery, Orlando Health, Orlando, Florida, USA
  10. 10 Department Neurosurgery, University at Buffalo School of Medicine and Biomedical Sciences, Buffalo, New York, USA
  1. Correspondence to Dr Ricardo A Hanel, Neurosurgery, Baptist Medical Center Jacksonville, Jacksonville, FL 32207, USA; rhanel{at}lyerlyneuro.com

Abstract

Background The Woven EndoBridge (WEB) device is approved in the USA for treatment of unruptured wide-neck bifurcation aneurysms. However, the safety and effectiveness of the WEB device in the treatment of ruptured intracranial aneurysms is not clear. We aim to evaluate the perioperative safety and effectiveness of the WEB device in patients with ruptured intracranial aneurysms.

Methods This retrospective study, conducted at eight centers in the USA, included patients with ruptured intracranial aneurysms treated with the WEB device in the setting of subarachnoid hemorrhage (SAH). Safety outcomes included intraoperative complications such as vessel perforation, thromboembolic events, and postoperative hemorrhagic or thromboembolic complications based on radiologic imaging. The primary effectiveness outcome was adequate (complete and neck remnant) aneurysm occlusion, according to the Raymond–Roy classification.

Results A total of 91 patients with 94 ruptured intracranial aneurysms were included (mean age 57.7±15.2 years; 68.1% women; 82.9% wide-necked). Aneurysms were located in the anterior communicating artery (42/94, 44.6%), middle cerebral artery (16/94, 17%), and basilar artery (15/94, 16%). Adequate occlusion was achieved in 48.8% (41/84) and 80.0% (40/50) at discharge and last follow-up (mean of 3.4 months), respectively. At discharge, procedural-related morbidity was 3.3% (3/91) and there was no procedure-related mortality. No re-rupture or delayed aneurysm rupture was observed.

Conclusions This study demonstrates the perioperative safety and effectiveness of the WEB device for the treatment of patients with ruptured intracranial aneurysms in the setting of SAH, with low periprocedural morbidity and mortality. Long-term follow-up is warranted.

  • aneurysm
  • angiography
  • device
  • stroke
  • subarachnoid

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/neurintsurg-2020-017105

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • Twitter @AdamArthurMD, @PascalJabbourMD, @AhmadSweidMD, @Ansaar_Rai, @drnimajax

    • Correction notice This article has been corrected since it first published. The provenance and peer review statement has been included.

    • Contributors All authors have substantially contributed to the conception and design of the study and/or data acquisition. GMC was responsible for the initial draft, and RAH for its critical revision. All the authors revised the manuscript and approved the final version 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 ASA is a consultant for Balt, Johnson and Johnson, Leica, Medtronic, Microvention, Penumbra, Scientia, Siemens, and Stryker; receives research support from Microvention, Penumbra, and Siemens; and is a shareholder in Bendit, Cerebrotech, Endostream, Magneto, Marblehead, Neurogami, Serenity, Synchron, Triad Medical and Vascular Simulations outside the submitted work. PJ is a consultant for Medtronic, Microvention, Balt, and Cerus. MRG and SITs are consultants to Stryker. JEDA is a consultant to Medtronic, Penumbra, and Sequent. YK is a consultant for Penumbra and for Medtronic Neurovascular. ATR is a consultant to Stryker and Cerenovus. SB is a consultant to Stryker Neurovascular and MicroVention. DF is a consultant to Balt, Marblehead, Medtronic, Stryker, Microvention, Penumbra, and Cerenovus; receives research support from Cerenovus, Medtronic, Stryker, Siemens, Microvention, and Penumbra, and royalties from Codman; and is a stockholder for Marblehead, Neurogami, and Vascular Simulations outside of the submitted work. JV is a proctor for Microvention for the WEB device. MC is a consultant to Cerenovus. AHS reports grants from Coinvestigator: NIH/NINDS 1R01NS091075 Virtual Intervention of Intracranial Aneurysms; personal fees from Adona Medical, Amnis Therapeutics, BlinkTBI, Boston Scientific Corp (for purchase of Claret Medical), Buffalo Technology Partners, Cardinal Consultants, Cerebrotech Medical Systems, Cognition Medical, Endostream Medical, Imperative Care, International Medical Distribution Partners, Neurovascular Diagnostics, Q’Apel Medical, Rebound Therapeutics Corp (purchased 2019 by Integra Lifesciences), Rist Neurovascular, Sense Diagnostics, Serenity Medical, Silk Road Medical, Spinnaker Medical, StimMed, Synchron, Three Rivers Medical, Vastrax, VICIS, Viseon; additional personal fees from Amnis Therapeutics, Canon Medical Systems USA, Cerenovus, Corindus, Integra LifeSciences, Medtronic, MicroVention, Minnetronix Neuro, Northwest University, Penumbra, Rapid Medical, Stryker, VasSol, WL Gore & Associates; consultant fees for opinion on the design of clinical trials. RAH reports conflict of interest with Medtronic, Stryker, Cerenovous, Microvention, Balt, Phenox, MiVI, and Codman and is a stockholder for Neurvana, Elum, Endostream, Three Rivers Medical, Synchron, RisT, Cerebrotech, Deinde, BendIT, and InNeurCo. All the other authors have no competing interests to report.

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