The Revolve Study: A Multicenter Registry Using the Flow Diverter Surpass Evolve® Device for the Endovascular Treatment of Intracranial Aneurysms.

Abstract

Flow diverter devices have revolutionized the treatment of intracranial aneurysms, but evidence on newer-generation devices remains limited. The Surpass Evolve (SE) was designed to improve deliverability and vessel wall apposition compared with its predecessors. This registry aimed to evaluate the feasibility, safety, and efficacy of SE in a large, real-world multicenter cohort with long-term follow-up. Between May 2019 and December 2022, 275 consecutive aneurysms in 272 patients were treated with the SE flow diverter across 28 Italian centers. Clinical and imaging follow-up was completed by January 2024. Mid-term (≤6 months) and long-term (≤24 months) follow-ups, including clinical assessment, angiography, and cross-sectional imaging (computed tomography/magnetic resonance), were systematically collected and independently reviewed by a central Core Lab. The mean maximum diameter of the aneurysm was 11.2 mm, and the mean neck size was 5.4 mm. A total of 258 aneurysms were unruptured (93.8%), and 17 (6.2%) were ruptured. The majority arose from the anterior circulation (87.6%), with 12.4% in the posterior circulation. Device deployment was unsuccessful in 5/278 procedures (1.8%), and misdeployment occurred in 28/278 (10%). The overall device-related mortality was 0.7%, and the morbidity was 5.4%. At mid-term follow-up, complete or near-complete occlusion was achieved in 66% of aneurysms, increasing to 92% at long-term. According to mass criteria, 82% of aneurysms were considered cured, whereas sac enlargement occurred in 0.5% and 17% remained unchanged in volume. Our experience using SE for endovascular treatment of intracranial aneurysms showed a high safety and efficacy profile, substantially equivalent to that of the other flow diverter devices commonly used.