Safety and effectiveness assessment of the surpass evolve (SEASE): A post-market international multicenter study
Authors
Juan Vivanco-Suarez, Department of Neurology, Neurosurgery & Radiology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA.
Mahmoud Dibas, Department of Neurology, Neurosurgery & Radiology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA.
Demetrius Klee Lopes, Advocate Health - MidwestFollow
Ricardo A. Hanel, Department of Neurosurgery, Lyerly Neurosurgery, Jacksonville, Florida, USA.
Mario Martínez-Galdámez, Department of Interventional Neuroradiology, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.
Aaron Rodriguez-Calienes, Department of Neurology, Neurosurgery & Radiology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA.
Gustavo M. Cortez, Department of Neurosurgery, Lyerly Neurosurgery, Jacksonville, Florida, USA.
Johanna T. Fifi, Department of Neurosurgery, Mount Sinai Health System, New York, New York, USA.
Alex Devarajan, Department of Neurosurgery, Mount Sinai Health System, New York, New York, USA.
Gabor Toth, Cerebrovascular Center, Cleveland Clinic, Cleveland, Ohio, USA.
Thomas Patterson, Cerebrovascular Center, Cleveland Clinic, Cleveland, Ohio, USA.
David Altschul, Department of Neurosurgery, Montefiore Medical Center, New York, New York, USA.
Vitor M. Pereira, Department of Neurosurgery, St Michael's Hospital, Toronto, Ontario, Canada.
Eileen Liu, Department of Neurosurgery, St Michael's Hospital, Toronto, Ontario, Canada.
Ajit S. Puri, Department of Radiology, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA.
Anna Luisa Kuhn, Department of Radiology, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA.
Waldo R. Guerrero, Department of Neurology and Brain Repair, University of South Florida, Tampa, Florida, USA.
Priyank Khandelwal, Department of Neurosurgery, Robert Wood Johnson University Hospital, New Brunswick, New Jersey, USA.
Ivo Bach, Department of Neurosurgery, Robert Wood Johnson University Hospital, New Brunswick, New Jersey, USA.
Peter Kan, Department of Neurosurgery, The University of Texas Medical Branch at Galveston, Galveston, Texas, USA.
Gautam Edhayan, Department of Neurosurgery, The University of Texas Medical Branch at Galveston, Galveston, Texas, USA.
Curtis Given, Department of Radiology, Baptist Health Lexington, Lexington, Kentucky, USA.
Sandra Narayanan, Neurointerventional Program and Comprehensive Stroke Program, Pacific Neuroscience Institute, Santa Monica, California, USA.
Bradley A. Gross, Department of Neurosurgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Mudassir Farooqui, Department of Neurology, Neurosurgery & Radiology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA.
Milagros Galecio-Castillo, Department of Neurology, Neurosurgery & Radiology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA.
Shahram Derakhshani, Department of Diagnostic and Therapeutic Neuroradiology, Queen's University Hospital, Romford, UK.
Santiago Ortega-Gutierrez, Department of Neurology, Neurosurgery & Radiology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA santy-ortega@uiowa.edu.
Recommended Citation
Vivanco-Suarez J, Dibas M, Lopes DK, et al. Safety and effectiveness assessment of the surpass evolve (SEASE): a post-market international multicenter study. J Neurointerv Surg. Published online April 25, 2024. doi:10.1136/jnis-2024-021503
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.
