Safety and effectiveness assessment of the surpass evolve (SEASE): a post-market international multicenter study

Juan Vivanco-Suarez; Mahmoud Dibas; Demetrius Klee Lopes; Ricardo A Hanel; Mario Martínez-Galdámez; Aaron Rodriguez-Calienes; Gustavo M Cortez; Johanna T Fifi; Alex Devarajan; Gabor Toth; Thomas Patterson; David Altschul; Vitor M Pereira; Eileen Liu; Ajit S Puri; Anna Luisa Kuhn; Waldo R Guerrero; Priyank Khandelwal; Ivo Bach; Peter Kan; Gautam Edhayan; Curtis Given; Sandra Narayanan; Bradley A Gross; Mudassir Farooqui; Milagros Galecio-Castillo; Shahram Derakhshani; Santiago Ortega-Gutierrez

doi:10.1136/jnis-2024-021503

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Safety and effectiveness assessment of the surpass evolve (SEASE): a post-market international multicenter study

Journal article

Peer reviewed

Safety and effectiveness assessment of the surpass evolve (SEASE): a post-market international multicenter study

Juan Vivanco-Suarez, Mahmoud Dibas, Demetrius Klee Lopes, Ricardo A Hanel, Mario Martínez-Galdámez, Aaron Rodriguez-Calienes, Gustavo M Cortez, Johanna T Fifi, Alex Devarajan, Gabor Toth, …

Journal of neurointerventional surgery, Vol.17(3), pp.277-283

03/2025

DOI: 10.1136/jnis-2024-021503

PMID: 38663997

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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

Hemorrhagic stroke

Subarachnoid

Details

Title: Subtitle: Safety and effectiveness assessment of the surpass evolve (SEASE): a post-market international multicenter study
Creators: Juan Vivanco-Suarez - Department of Neurology, Neurosurgery & Radiology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA
Mahmoud Dibas - University of Iowa
Demetrius Klee Lopes - Advocate Health Care
Ricardo A Hanel - Department of Neurosurgery, Lyerly Neurosurgery, Jacksonville, Florida, USA
Mario Martínez-Galdámez - Hospital Clínico Universitario de Valladolid
Aaron Rodriguez-Calienes - University of Iowa
Gustavo M Cortez - Department of Neurosurgery, Lyerly Neurosurgery, Jacksonville, Florida, USA
Johanna T Fifi - Mount Sinai Health System
Alex Devarajan - Mount Sinai Health System
Gabor Toth - Cleveland Clinic
Thomas Patterson - Cleveland Clinic
David Altschul - Montefiore Medical Center
Vitor M Pereira - St. Michael's Hospital
Eileen Liu - St. Michael's Hospital
Ajit S Puri - University of Massachusetts Chan Medical School
Anna Luisa Kuhn - University of Massachusetts Chan Medical School
Waldo R Guerrero - University of South Florida
Priyank Khandelwal - Robert Wood Johnson University Hospital
Ivo Bach - Robert Wood Johnson University Hospital
Peter Kan - The University of Texas Medical Branch at Galveston
Gautam Edhayan - The University of Texas Medical Branch at Galveston
Curtis Given - Central Baptist Hospital
Sandra Narayanan - Pacific Heart Institute
Bradley A Gross - University of Pittsburgh
Mudassir Farooqui - University of Iowa
Milagros Galecio-Castillo - University of Iowa
Shahram Derakhshani - Queen's Medical Center
Santiago Ortega-Gutierrez - Department of Neurology, Neurosurgery & Radiology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA
Resource Type: Journal article
Publication Details: Journal of neurointerventional surgery, Vol.17(3), pp.277-283
DOI: 10.1136/jnis-2024-021503
PMID: 38663997
NLM abbreviation: J Neurointerv Surg
ISSN: 1759-8478
eISSN: 1759-8486
Publisher: BMJ Publishing Group Ltd
Grant note: 2021-HEM-034 / Stryker (http://dx.doi.org/10.13039/100008894)
Language: English
Electronic publication date: 04/25/2024
Date published: 03/2025
Academic Unit: Neurology; Radiology; Iowa Neuroscience Institute; Neurosurgery
Record Identifier: 9984618196002771

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