Background The benefits of mechanical thrombectomy for emergent large vessel occlusion (ELVO) have been established. Combined mechanical/aspiration (Solumbra) and a direct aspiration as a first pass technique (ADAPT) are valid procedures requiring an intermediate catheter for clot suction. Recently, SOFIA (Soft torqueable catheter Optimized For Intracranial Access) was developed as a single lumen flexible catheter with coil and braid reinforcement, but its suitability for mechanical thrombectomy had not been evaluated.
Objective To describe our initial experience with SOFIA in acute stroke intervention and evaluate its efficacy and safety.
Methods All patients with ELVO undergoing endovascular stroke intervention with SOFIA were identified. Demographic, presentation, treatment, and complication data were recorded. Primary outcome was Thrombolysis in Cerebral Infarction (TICI) 2b/3 revascularization rate and the number of passes required. Secondary outcomes included complication rates and discharge National Institute of Health Stroke Scale (NIHSS) score.
Results 33 patients with a mean age of 72 years were treated for ELVO with SOFIA and IV tissue plasminogen activator was administered in 67%. Vessel occlusion involved the internal carotid artery (15.2%), M1 (48.5%), and M2 (24.2%) segments, and posterior circulation (12.1%). Median presentation NIHSS score was 14 (IQR 11–19) and discharge NIHSS 4 (IQR 2–14). The Solumbra technique represented 94% of treatments and ADAPT 3%. The TICI 2b/3 revascularization rate was 94%, including 48.5% TICI 3 with an average of 1.6 passes. The symptomatic reperfusion hemorrhage rate was 6%. Procedural complications occurred in four patients, but were unrelated to SOFIA. Mortality was 21%, secondary to failed revascularization, hemorrhagic transformation, and baseline medical condition.
Conclusions Mechanical and aspiration thrombectomy with SOFIA is safe and effective with high revascularization rates. Its trackability, stability, and luminal size make SOFIA suitable for stroke intervention.
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Contributors JHYW, HMD and JJH conceived and designed the study. JHYW and JJH acquired the data and performed the statistical analyses. All authors participated in the interpretation of the data, the preparation and editing of the manuscript. The final version was approved by all authors.
Competing interests JJH and HMD received consulting fees from MicroVention, Inc.
Ethics approval This study was performed in accordance with the Stanford University's internal review board policies and is in compliance with the Health Insurance Portability and Accountability Act.
Provenance and peer review Not commissioned; internally peer reviewed.
Data sharing statement Published and unpublished data may be shared for additional publications pending the authors’ agreement to a research collaboration when appropriate.