The Surpass Elite (Stryker Neurovascular) is a third-generation flow diverter featuring modified braid architecture with increased braid angle and novel surface charge neutralization treatment. This study presents the first clinical experience with the Surpass Elite globally. A retrospective analysis of 81 consecutive cases (78 unique patients) treated with the Surpass Elite across four centers by two operators from January to July 2025 was performed. Data collected included patient demographics, aneurysm characteristics, procedural details, technical success, complications, and angiographic/clinical outcomes. Primary endpoints were technical success rate, perioperative safety profile, and aneurysm occlusion rates at approximately 6-month follow-up. The cohort comprised 78 unique patients (76.9% female, mean age 59.2 ± 14.5 years) with 81 aneurysms treated using 112 total devices (mean 1.38 devices per case). Aneurysms were predominantly located in the internal carotid artery (75.3%). Technical success was achieved in 100% of cases regardless of access site. Balloon angioplasty was required in only 13.6% of cases. Among 61 aneurysms with complete angiographic follow-up at a mean of 6 months, complete occlusion (RROC Class I or OKM Grade D) was achieved in 78.7%. In-stent stenosis (< 50%) was observed in only 3.3% of cases with follow-up imaging, suggesting favorable vessel remodeling with minimal intimal hyperplasia. The immediate intraprocedural complication rate was 2.5% (2/81), including one device-related microperforation (complete recovery) and one intraoperative thrombosis (managed successfully intraprocedurally; delayed stroke from subsequent medication noncompliance). Delayed complications within 30 days included one stroke from antiplatelet noncompliance (fatal) and one access-site hematoma (recovered). One delayed adverse event beyond 30 days (delayed right temporal intraparenchymal hemorrhage at 10 months) was observed in a patient on dual antiplatelet therapy plus apixaban and was attributed to cerebral amyloid angiopathy; this event was not considered device- or procedure-related. Overall mortality was 7.4% (6/81): one death (1.2%) was procedure-related (stroke from medication noncompliance), one death occurred within 30 days from post-SAH vasospasm in a ruptured aneurysm case, and four deaths occurred after 30 days (recurrent ICH at 3 weeks, acute respiratory failure with acute on chronic heart failure at 5 months, homicide at approximately 6 months, and one of unknown cause), none of which were device- or procedure-related. This first published clinical experience with Surpass Elite flow diverter demonstrates reliable technical deliverability, favorable early occlusion rates comparable to established flow diverters, and a satisfactory safety profile. The low rates of required balloon angioplasty support the clinical benefit of the modified braid architecture. These preliminary findings support the continued clinical evaluation of the Surpass Elite in larger prospective cohorts.
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科技资讯 · 2026-05-08