First multicenter experience with the SOFIA 88 super-large-bore aspiration catheter in mechanical thrombectomy.

Abstract

BACKGROUND Super-large-bore aspiration catheters are designed to improve clot engagement and aspiration efficiency during mechanical thrombectomy. However, multiple 0.088-inch platforms are now available, and device-specific clinical performance cannot be inferred from catheter size alone. We report the first multicenter real-world experience with SOFIA 88. METHODS This retrospective multicenter European registry included consecutive patients treated with SOFIA 88 for anterior circulation large vessel occlusion involving the internal carotid artery or M1. The primary outcome was successful catheter advancement to the thrombus-vessel interface. Angiographic outcomes included first-pass effect (extended Thrombolysis in Cerebral Infarction (eTICI)≥2c after one pass), final complete reperfusion (eTICI 2c-3), and final successful reperfusion (eTICI≥2b). Safety outcomes included procedural complications, embolization to new territory, intracranial hemorrhage, and symptomatic intracranial hemorrhage. RESULTS Eighty-one patients from eight centers were included. SOFIA 88 reached the thrombus-vessel interface in 67/81 cases (82.7%), most often using smaller-catheter support (57/81, 70.4%). SOFIA 88 standalone first-pass effect occurred in 32/81 patients (39.5%) using the full real-world cohort denominator and in 32/67 patients (47.8%) among cases with successful SOFIA 88 target access. Final complete and successful reperfusion was achieved in 67/81 (82.7%) and 79/81 (97.5%) patients, respectively. Procedural adverse events occurred in 3/81 (3.7%), embolization to new territory in 1/81 (1.2%), and symptomatic intracranial hemorrhage in 5/81 (6.2%). No device-related adverse events occurred. CONCLUSIONS SOFIA 88 showed feasible target access, high final reperfusion, favorable standalone first-pass performance after successful target access, and acceptable early safety. Further prospective studies are warranted to define optimal patient selection, delivery strategies, and the role of SOFIA 88 in contemporary thrombectomy practice.