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Original research
Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series
  1. Laurent Pierot1,
  2. Jacques Moret2,
  3. Xavier Barreau3,
  4. Istvan Szikora4,
  5. Denis Herbreteau5,
  6. Francis Turjman6,
  7. Markus Holtmannspötter7,
  8. Anne-Christine Januel8,
  9. Vincent Costalat9,
  10. Jens Fiehler10,
  11. Joachim Klisch11,
  12. Jean-Yves Gauvrit12,
  13. Werner Weber13,
  14. Hubert Desal14,
  15. Stéphane Velasco15,
  16. Thomas Liebig16,
  17. Luc Stockx17,
  18. Joachim Berkefeld18,
  19. Andrew Molyneux19,
  20. James Byrne19,
  21. Laurent Spelle2
  1. 1Hôpital Maison-Blanche, Université Reims-Champagne-Ardenne, Reims, France
  2. 2Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, Kremlin-Bicêtre, France
  3. 3CHU Bordeaux, Bordeaux, BORDEAUX, France
  4. 4National Institute of Clinical Neurosciences, Budapest, Hungary
  5. 5CHU Tours, Tours, France
  6. 6CHU Lyon, Lyon, France
  7. 7Rigshospitalet, Copenhagen, Denmark
  8. 8CHU Toulouse, Toulouse, France
  9. 9CHU Montpellier, Montpellier, France
  10. 10Departrment of Neuroradiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  11. 11Helios General Hospital, Erfurt, Germany
  12. 12CHU Rennes, Rennes, France
  13. 13Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH, Bochum, Germany
  14. 14CHU Nantes, Nantes, France
  15. 15CHU Poitiers, Poitiers, France
  16. 16Universitätsklinikum Köln, Cologne, Germany
  17. 17ZOL(Ziekenhuis Oost-Limburg) Genk, Genk, Belgium
  18. 18Institutfür Neuroradiologie, Klinikum der Johann Wolfgang Goethe-Universitaet, Frankfurt, Germany
  19. 19Nuffield Department of Surgical Sciences, Oxford University, Oxford, UK
  1. Correspondence to Professor Laurent Pierot, Department of Neuroradiology, Hôpital Maison-Blanche45rue Cognacq-Jay, 51092 Reims cedex, France; lpierot{at}gmail.com

Abstract

Background Flow disruption with the WEB is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown a low complication rate with good efficacy.

Purpose To report clinical and anatomical results of the WEB treatment in the cumulative population of three Good Clinical Practice (GCP) studies: WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm), French Observatory, and WEBCAST-2.

Methods WEBCAST, French Observatory, and WEBCAST-2 are single-arm, prospective, multicenter, GCP studies dedicated to the evaluation of WEB treatment. Clinical data were independently evaluated. Postoperative and 1-year aneurysm occlusion was independently evaluated using the 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant.

Results The cumulative population comprised 168 patients with 169 aneurysms, including 112 female subjects (66.7%). The patients' ages ranged between 27 and 77 years (mean 55.5±10.2 years). Aneurysm locations were middle cerebral artery in 86/169 aneurysms (50.9%), anterior communicating artery in 36/169 (21.3%), basilar artery in 30/169 (17.8%), and internal carotid artery terminus in 17/169 (10.1%). The aneurysm was ruptured in 14/169 (8.3%). There was no mortality at 1 month and procedure/device-related morbidity was 1.2% (2/168). At 1 year, complete aneurysm occlusion was observed in 81/153 aneurysms (52.9%), neck remnant in 40/153 aneurysms (26.1%), and aneurysm remnant in 32/153 aneurysms (20.9%). Re-treatment was carried out in 6.9%.

Conclusions This series is at the moment the largest prospective, multicenter, GCP series of patients with aneurysms treated with WEB. It shows the high safety and good mid-term efficacy of this treatment.

Clinical trial registration French Observatory: Unique identifier (NCT18069); WEBCAST and WEBCAST-2: Unique identifier (NCT01778322).

  • aneurysm

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Footnotes

  • Contributors All authors have provided a substantial contribution to the conception and design of the studies and/or the acquisition and/or the analysis of the data and/or the interpretation of the data; drafted the work or revised it for significant intellectual content; approved the final version of the manuscript; agree to be accountable for all aspects of the work, including its accuracy and integrity.

  • Funding WEBCAST, WEBCAST-2, and French Observatory have been funded by Sequent.

  • Competing interests LP: consultant for Balt, Microvention, Neuravi, and Penumbra. JM: consultant for Medtronic, Microvention, Stryker, and Balt. XB: consultant for Microvention and Stryker. ISI: consultant for Codman, Medtronic, Sequent, and Stryker. VC: consultant for Microvention and Balt and receives educational grants from Medtronic and Stryker. JF: has received fees as consultant or lecturer from Acandis, Bayer, Boehringer-Ingelheim, Codman, Covidien, MicroVention, Penumbra, Philips, Sequent, Siemens, and Stryker; his institution received funding from MicroVention, Medtronic, BMBF, BMWi, DFG, EU. JK: consultant for Microvention/Sequent. WW: consultant for Microvention, Phenox, and Medtronic. TL: consultant for Medtronic, Mentice, Microvention, and Route92. AM: consultant for Microvention/Sequent and Cerus Endovascular. JB: consultant and shareholder for Oxford Endovascular Ltd; his institution received funding from MicroVention. LS: consultant for Stryker, MicroVention, Medtronic, Balt. J-YG, HD, and SV have no disclosures.

  • Patient consent Obtained.

  • Ethics approval Reims institutional review board.

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

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