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LB-010 Safety and effectiveness assessment of the surpass evolve (SEASE): a real-world international multicenter study
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  1. J Vivanco-Suarez1,
  2. J Fifi2,
  3. D Lopes3,
  4. A Rodriguez-Calienes1,
  5. A Devarajan2,
  6. G Toth4,
  7. T Patterson4,
  8. D Altschul5,
  9. G Cortez6,
  10. R Hanel6,
  11. E Liu7,
  12. V Pereira7,
  13. A Kühn8,
  14. A Puri8,
  15. W Guerrero9,
  16. I Bach10,
  17. P Khandelwal10,
  18. S Satti11,
  19. G Edhayan12,
  20. P Kan12,
  21. M Martinez-Galdamez13,
  22. C Given14,
  23. B Gross15,
  24. Y Lu1,
  25. M Galecio-Castillo1,
  26. C Alva1,
  27. M Farooqui1,
  28. S Drakhshani16,
  29. S Ortega-Gutierrez1
  1. 1Neurology, Neurosurgery and Radiology, The University of Iowa Hospitals and Clinics, Iowa City, IA
  2. 2Neurosurgery, The Mount Sinai Hospital, New York, NY
  3. 3Neurosurgery, Advocate Aurora Health, Park Ridge, IL
  4. 4Cerebrovascular Center, Cleveland Clinic, Cleveland, OH
  5. 5Neurosurgery, Montefiore Medical Center, Bronx, NY
  6. 6Lyerly Neurosurgery, Baptist Neurological Institute, Jacksonville, FL
  7. 7Neurosurgery, St Michael’s Hospital, Toronto, ON, CANADA
  8. 8Radiology, University of Massachusetts Chan Medical School, Worcester, MA
  9. 9Neurology and Brain Repair, University of South Florida, Tampa, FL
  10. 10Neurological Surgery, New Jersey Medical School, Rutgers, Newark, NJ
  11. 11Neurointerventional Surgery, Christiana Care Medical Center, Newark, DE
  12. 12Neurosurgery, The University of Texas Medical Branch, Galveston, TX
  13. 13Neuroradiology/Endovascular Neurosurgery, Hospital Clínico Universitario de Valladolid, Valladolid, SPAIN
  14. 14Radiology, Baptist Health Lexington, Lexington, KY
  15. 15Neurosurgery, University of Pittsburgh Medical Center, Pittsburgh, PA
  16. 16Diagnostic and Therapeutic Neuroradiology, Queen’s University Hospital, Romford, UK

Abstract

Introduction/Purpose Flow diverters (FDs) are a well-established first-line treatment for specific intracranial aneurysms. The Surpass Evolve (SE) was introduced in 2019, and it is constructed with 48-64 wires (depending on the diameter) which enables navigation through an 0.027’ microcatheter. It has a high braid angle (rhomboid cell shape) that can be deployed through a significantly lower-profile delivery system. It maintains a high mesh density and uniform rhomboid cell shape regardless of its post-deployment state. Previously published studies on the SE are limited (case reports and series). Here we report the first international multi-center study evaluating the safety and effectiveness of the SE.

Materials and Methods We performed an international, multicenter, cross-sectional, single-arm cohort study at 16 large-volume centers. All patients treated with the SE for intracranial aneurysms between 2020-2021 were included. Demographic, clinical, angiographic, and follow-up data were collected. Primary effectiveness outcome was complete occlusion (Raymond-Roy Class 1) at 1-year follow-up. Safety outcomes included the incidence of ischemic/hemorrhagic at 30 days and mortality. All radiographical outcomes were evaluated by independent core lab adjudication.

Results 299 patients with 333 aneurysms underwent treatment with SE. Median age was 59 [50-67] years, and 252 (84%) were female. Most patients were white (187, 62%). Hypertension was the most common comorbidity in 150 (50%), and 115 (39%) patients were smokers. The baseline modified Rankin scale (mRS) was 0-2 in 290 (93%) of the cases, and the majority were unruptured (279, 93%) and saccular (269, 90%). Previous treatment was present in 76 (25%) patients, primarily with coils (54, 18%). Median aneurysm size was 5.5 [3.5-9] mm, and median neck width was 3.4 [2.6-4.8] mm. Most aneurysms were located in the paraophthalmic segment of the internal carotid artery (127, 43%), followed by the supraclinoid (93; 31%), and petrocavernous segments (39, 13%). Mean number of SEs implanted per patient was 1.00 (range 1-3). Radial access was used in 59 (20%) cases. Adjunctive coils in 29 (10%) and balloon-assisted angioplasty in 118 (40%) cases. At 10.8 [6.5-14.1] months median follow-up, 183/259 (71%) cases achieved complete aneurysm occlusion. Ischemic events were reported in 7 (3%) cases, hemorrhagic events in 1 (0.4%), and 4 (1%) deaths.

Conclusion SEASE is the largest international multicenter study reporting outcomes after the implantation of the SE. Our results demonstrate that a 64-wire FD such as the SE has reliable effectiveness and carries a low rate of safety events in the treatment of mainly medium-sized aneurysms.

Disclosures J. Vivanco-Suarez: None. J. Fifi: None. D. Lopes: None. A. Rodriguez-Calienes: None. A. Devarajan: None. G. Toth: None. T. Patterson: None. D. Altschul: None. G. Cortez: None. R. Hanel: None. E. Liu: None. V. Pereira: None. A. Kühn: None. A. Puri: None. W. Guerrero: None. I. Bach: None. P. Khandelwal: None. S. Satti: None. G. Edhayan: None. P. Kan: None. M. Martinez-Galdamez: None. C. Given: None. B. Gross: None. Y. Lu: None. M. Galecio-Castillo: None. C. Alva: None. M. Farooqui: None. S. Drakhshani: None. S. Ortega-Gutierrez: None.

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