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

医学 动脉瘤 闭塞 外科 多中心研究 改良兰金量表 颈内动脉 内科学 随机对照试验 缺血性中风 缺血
作者
Juan Vivanco‐Suarez,Mahmoud Dibas,Demetrius K. Lopes,Ricardó A. Hanel,Mario Martínez‐Galdámez,Aarón Rodríguez-Calienes,Gustavo M Cortez,Johanna T Fifi,Alex Devarajan,Gábor Tóth,Thomas E. Patterson,David Altschul,Vítor Mendes Pereira,Eileen Liu,Ajit S Puri,Anna Luisa Kühn,Waldo R. Guerrero,Priyank Khandelwal,Ivo Bach,Peter Kan,Gautam Edhayan,Curtis A. Given,Sandra Narayanan,Bradley A. Gross,Mudassir Farooqui,Milagros Galecio‐Castillo,Shahram Derakhshani,Santiago Ortega‐Gutiérrez
出处
期刊:Journal of NeuroInterventional Surgery [BMJ]
卷期号:: jnis-021503 被引量:1
标识
DOI:10.1136/jnis-2024-021503
摘要

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.
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