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Hemorrhagic stroke
Original research
Safety and effectiveness assessment of the surpass evolve (SEASE): a post-market international multicenter study
  1. Juan Vivanco-Suarez1,
  2. Mahmoud Dibas1,
  3. Demetrius Klee Lopes2,
  4. Ricardo A Hanel3,
  5. Mario Martínez-Galdámez4,
  6. Aaron Rodriguez-Calienes1,
  7. Gustavo M Cortez3,
  8. Johanna T Fifi5,
  9. Alex Devarajan5,
  10. Gabor Toth6,
  11. Thomas Patterson6,
  12. David Altschul7,
  13. Vitor M Pereira8,
  14. Eileen Liu8,
  15. Ajit S Puri9,
  16. Anna Luisa Kuhn9,
  17. Waldo R Guerrero10,
  18. Priyank Khandelwal11,
  19. Ivo Bach11,
  20. Peter Kan12,
  21. Gautam Edhayan12,
  22. Curtis Given13,
  23. Sandra Narayanan14,
  24. Bradley A Gross15,
  25. Mudassir Farooqui1,
  26. Milagros Galecio-Castillo1,
  27. Shahram Derakhshani16,
  28. Santiago Ortega-Gutierrez1
  1. 1Department of Neurology, Neurosurgery & Radiology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA
  2. 2Department of Neurosurgery, Advocate Aurora Health Inc, Park Ridge, Illinois, USA
  3. 3Department of Neurosurgery, Lyerly Neurosurgery, Jacksonville, Florida, USA
  4. 4Department of Interventional Neuroradiology, Hospital Clínico Universitario de Valladolid, Valladolid, Spain
  5. 5Department of Neurosurgery, Mount Sinai Health System, New York, New York, USA
  6. 6Cerebrovascular Center, Cleveland Clinic, Cleveland, Ohio, USA
  7. 7Department of Neurosurgery, Montefiore Medical Center, New York, New York, USA
  8. 8Department of Neurosurgery, St Michael's Hospital, Toronto, Ontario, Canada
  9. 9Department of Radiology, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA
  10. 10Department of Neurology and Brain Repair, University of South Florida, Tampa, Florida, USA
  11. 11Department of Neurosurgery, Robert Wood Johnson University Hospital, New Brunswick, New Jersey, USA
  12. 12Department of Neurosurgery, The University of Texas Medical Branch at Galveston, Galveston, Texas, USA
  13. 13Department of Radiology, Baptist Health Lexington, Lexington, Kentucky, USA
  14. 14Neurointerventional Program and Comprehensive Stroke Program, Pacific Neuroscience Institute, Santa Monica, California, USA
  15. 15Department of Neurosurgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
  16. 16Department of Diagnostic and Therapeutic Neuroradiology, Queen's University Hospital, Romford, UK
  1. Correspondence to Dr Santiago Ortega-Gutierrez, Department of Neurology, Neurosurgery, and Radiology, University of Iowa Hospitals and Clinics, Iowa City, USA; santy-ortega{at}uiowa.edu

Abstract

Background Flow diverters are the first-line treatment for specific intracranial aneurysms (iA). Surpass Evolve (SE) is a new-generation 64-wire flow diverter with a high braid angle. Current literature on the SE is limited. We aimed to report the first international real-world experience evaluating the safety and effectiveness of the SE.

Methods The Safety and Effectiveness Assessment of the Surpass Evolve (SEASE) was a multicenter retrospective international post-marketing cohort study including consecutive patients treated with SE for iAs between 2020 and 2022. Demographic, clinical, and angiographic data were collected. Primary effectiveness was independent core lab adjudicated complete occlusion rates (Raymond-Roy Class 1) at last follow-up. Primary safety were major ischemic/hemorrhagic events and mortality.

Results In total, 305 patients with 332 aneurysms underwent SE implantation. The patients had a median age of 59 [50-67] years, and 256 (83.9%) were female. The baseline modified Rankin scale score was 0–2 in 291 patients (96.7%). Most aneurysms were unruptured (285, 93.4%) and saccular (309, 93.1%). Previous treatment was present in 76 (22.9%) patients. The median aneurysm size was 5.1 [3.4–9.0] mm, and the median neck width was 3.6 [2.7–5.1] mm. Most aneurysms were in the internal carotid artery C6 ophthalmic segment (126, 38.0%), followed by the communicating segment (58, 17.5%). At median 10.2 [6.4–12.9] months follow-up, 233 (73.0%) aneurysms achieved complete occlusion. After adjusting for confounders, complete occlusion remained consistent. Major stroke and procedure-related mortality were reported in 6 (2%) and 2 (0.7%) cases, respectively.

Conclusion These results demonstrate that SE has a consistently high effectiveness and favorable safety for the treatment of iAs.

  • Aneurysm
  • Flow Diverter
  • Hemorrhage
  • Subarachnoid

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/jnis-2024-021503

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • X @jsvivanco1, @Doctorgaldamez, @AaronCalienes, @AlexDevarajan, @GaborTothMD, @DavidAltschulMD, @VitorMendesPer1, @AjitSPuri1, @WaldoGuerrero82, @PeterKa80460001, @SandraNarayanan, @mili_galecio, @CerebrovascLab

    • Contributors Study conception and design: SOG, JVS, MF; data collection: JVS, MD, DKL, RAH, MMG, ARC, GMC, JTF, AD, GT, TP, DA, VMP, EL, ASP, ALK, WRG, PK, IB, PK, GE, CG, SN, BAG, MF, MGC, SD, SOG; analysis and interpretation of results: JVS, MD, ARC, MF, MGC, SOG; draft manuscript preparation: JVS, MD, ARC, MF, MGC, SOG. All authors reviewed the results and approved the final version of the manuscript. SOG is responsible for the overall content and is the guarantor of this study.

    • Funding Stryker funded this study through an investigator-initiated grant (Grant/Award Number: 2021-HEM-034).

    • Competing interests Vivanco-Suarez – None; Dibas – None; Klee Lopes – Consultant: Asahi, Stryker, Corindus, Siemens, and Medtronic. Honoraria: Cerenovus, Medtronic, and Stryker. Advisory Board: INFINITY [trial]. Grants: Mentice. Leadership role: WLNC and Advocate Health. Stock: Syncron, Three Rivers Inc., Q’apel, VIZ.AI, Methinks, Vastrax, Borvo, BendIT, Collavidence, NDI, Prometheus, NextGen, Galaxy, Global Intervention, and Sim&Cure. Hanel – Consultant: Medtronic, Stryker, Cerenovous, Microvention, Balt, Phenox, Rapid Medical, and Q’Apel. Advisory board: MiVI, eLum, Three Rivers Medical Inc., Shape Medical, and Corindus. Grants: from NIH, Interline Endowment, Microvention, Stryker, and CNX. Investor/Stoker: InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical Inc., Scientia, RisT, BlinkTBI, and Corindus. Martinez-Galdamez – Consultant: Medtronic. Rodriguez-Calienes – None; Cortez – None; Fifi – Consultant: Penumbra, Stryker, Microvention, and Cerenovus. Grants: Viz. Investor/Stoker: Imperative care and Cerebrotech. Devarajan – None; Toth – Consultant: Medtronic and Dynamed. Patterson – None; Altschul – Consultant: Microvention, Stryker, and Von Vascular Inc. Pereira – Consultant: Stryker, Medtronic, Penumbra, Neurovasc, and Balt. Liu – None; Puri – Consultant: Medtronic, Stryker, Cerenovus, Microvention, Agile, Merit, Corindus, Q’apel, Arsenal, and Imperative Care. Grants: Medtronic, Stryker, and Cerenovus. Kühn – None; Guerrero – None; Khandelwal – Consultant: Stryker and Medtronic. Bach – None; Kan – Consultant: Stryker, Imperative Care, Cerenovus, and Microvention. Grants: NIH, Siemens, Joe Niekro, and Medtronic. Editorial board: Journal of NeuroInterventional Surgery. Edhayan – None; Given – Consultant: Stryker and Medtronic. Gross – Consultant: Medtronic, Microvention, and Stryker. Farooqui – None; Galecio-Castillo – None; Derakhshani – None; Ortega-Gutierrez – Grants: NIH-NINDS (R01NS127114-01, RO3NS126804-01), Stryker, Medtronic, Microvention, Methinks, Viz.ai. Consulting fees: Medtronic, Stryker Neurovascular.

    • 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.