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O14/141  FIRST, International Prospective Multicenter Study of Endovascular Treatment of Intracranial Aneurysms with SILK VISTA and SILK VISTA BABY: 1-year study results
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  1. Mario Martinez-Galdamez1,
  2. Omer Eker2,
  3. Charbel Mounayer3,
  4. Jose Cohen4,
  5. Michel Piotin5,
  6. Gaultier Marna6,
  7. Florian Gariel6,
  8. Pedro Vega Valdes7,
  9. Jean-Christophe Gentric8,
  10. Francesco DI Paola9,
  11. Chrysanthi Papagiannaki10,
  12. Charlotte Barbier11,
  13. Massimo Sponza12,
  14. Laurent Spelle13,
  15. Nader Sourour14,
  16. Joost DE Vries15,
  17. Aurelio Vega Astudillo16,
  18. Richard Bibi17,
  19. Eva Maria Gonzalez Diaz18,
  20. Edoardo Boccardi19,
  21. Denis Brisbois20,
  22. Jose Carlos Mendez21,
  23. David Ozretic22,
  24. Thomas Liebig23,
  25. Paolo Remida24,
  26. Emmanuel Chabert25,
  27. Shady Jahshan26,
  28. Olivier Levrier27,
  29. Kamel Boubagra28,
  30. Monika Killer Oberpfalzer29,
  31. Alain Bonafe30,
  32. Alessandra Biondi31,
  33. Michael Froehler32,
  34. Elisa Ciceri33,
  35. Romain Bourcier34
  1. 1Hospital Clínico Universitario de Valladolid, Valladolid, Spain
  2. 2Hospices Civils de Lyon, Hôpital Neurologique Pierre-Wertheimer, LYON, France
  3. 3Dupuytren Hospital, Limoges University, Limoges, France
  4. 4Hadassah-Hebrew University Medical Center, Jerusalem, Israel
  5. 5Rothschild Foundation Hospital, Paris, France
  6. 6CHU Pellegrin, Bordeaux, France
  7. 7Hospital Central de Asturias, Oviedo, France
  8. 8Brest University Hospital, Brest, France
  9. 9Azienda ULSS, Treviso, Italy
  10. 10CHU Rouen, Rouen, France
  11. 11CHU de Caen, Caen, France
  12. 12Santa Maria della Misericordia Hospital, Udine, Italy
  13. 13Bicêtre Hospital, Paris, France
  14. 14Pitié-Salpêtrière Hospital, Paris, France
  15. 15Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands
  16. 16Puerta de Hierro Majadahonda University Hospital, Madrid, Spain
  17. 17Bretonneau Hospital, Tours, France
  18. 18Cruces University Hospital, Bilbao, Spain
  19. 19ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy
  20. 20CHC Clinique MontLégia, Liège, Belgium
  21. 21Hospital Ramón y Cajal, Madrid, Spain
  22. 22University Hospital Centre Zagreb, Zagreb, Croatia
  23. 23University Hospital, LMU Munich, Munich, Germany
  24. 24San Gerardo Hospital, Monza, Italy
  25. 25Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France
  26. 26Galilee Medical Center, Nahariya, Israel
  27. 27Polyclinique Clairval, Marseille, France
  28. 28Grenoble University Hospital, Grenoble, France
  29. 29Paracelsus Medical University, Salzburg, Austria
  30. 30Hôpital Gui-de-Chauliac, Montpellier, France
  31. 31Besançon University Hospital, Besancon, France
  32. 32Vanderbilt University Medical Center, Nashville, USA
  33. 33AOUI Borgo Trento Hospital, Verona, Italy
  34. 34CHU de Nantes, Nantes, France

Abstract

Introduction Flow diverters (FD) are increasingly used, becoming an established treatment option for complex intracranial aneurysms. Delivered through a 0.017’ microcatheter, the low-profile Silk Vista Baby FD (Balt Extrusion SAS, France) has widened treatment opportunities in distal vasculature.

Aim of Study The purpose of this study is to assess the Silk Vista and the Silk Vista Baby FD in the treatment of intracranial aneurysm.

Methods An international, prospective, observational, multicenter study including 29 centers was performed on patients with ruptured or unruptured, untreated or recanalized (previously treated with coils exclusively) aneurysms and followed for 5 years. The primary safety endpoint was the morbi-mortality at 12 months post-procedure. Efficacy was assessed by the rate of aneurysm occlusion rate immediately after the procedure, at 30 days, 6 months and 12 months post-procedure. Long-term safety and efficacy will be assessed at 3- and 5-years post-procedure.

Results Between November 2019 and June 2021, 232 patients were enrolled and completed follow-up at 1-year. Statistical analyses are underway and presentation of the study results will be made at the congress.

Conclusion This is the largest prospective cohort study of patients with aneurysms treated with Silk Vista and Silk Vista Baby to date. Our result will reflect the use of Silk Vista and Silk Vista Baby in real-world conditions.

Disclosure of Interest Study sponsored by BALT.

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