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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