E-065 SolitaireX 6X40 revascularization device for M2 segment thromboembolism: preliminary safety and effectiveness outcomes

Background The SolitaireX revascularization device (Medtronic, Irvine, CA) is deliverable through an 021 microcatheter and incorporates a parametric stent design resulting in lower radial force in smaller diameter vessels compared with Solitaire Platinum and Trevo (Stryker Neurovascular, Fremont, CA), in spite of its large 6 mm diameter. The combination of low radial force and ease of delivery make the device an attractive choice for (M2 segment) thromboembolism. Purpose To report our preliminary safety and effectiveness outcomes of the SolitaireX 6 × 40 mm (SX) for treatment of M2 segment thromboembolism. Methods Procedure data representing embolectomies performed at a comprehensive stroke center between 9/5/2019 and 2/7/2020 were reviewed for use of the SX. Collected data include location and size of treated arteries, utilization of balloon guide catheters (BGC) or distal aspiration (DAC), and revascularization success (M2 TICI ≥ 2B). Post procedure imaging and clinical data was reviewed for evidence of radiographic complications with the primary safety endpoint being SICH (ECAS definition). 90 day mRS were determined by phone interview by a trained nurse practitioner. Results 24 cases utilizing the SX were identified during the study period and an M2 segment was treated in 14 instances (7 representing primary M2 segment occlusions, 2 tandem cervical ICA/M2 occlusions, the remainder salvage following primary M1 segment occlusion). Completion M2 TICI ≥2B was 12/14 (86%). 90d mRS scores were available for 5 of the 14 cases representing treated M2 segment thromboemboli with mRS ≤ 2 recorded in 2/5 (40%). Additional clinical and outcome data is summarized below. Post procedure SAH was observed in 4/14 (28.6%) cases and was trace volume in all but one case where there was significant SAH and PH1 hemorrhage. This case represented the only SICH and was observed after two unsuccessful M2 passes of the SX (M2 TICI 0) as salvage following a M1 segment direct aspiration embolectomy. A fifth patient had non-symptomatic HT1 hemorrhagic conversion. Overall rate of any ICH 5/14 (36%), rate of SICH 1/14 (7.1%). Conclusion The SolitaireX 6 × 40 mm revascularization device can be used for M2 segment thromboembolism. The one significant complication in this cohort (SICH due to combined PH1 hemorrhagic conversion and SAH) may have been attributable to factors independent of the revascularization device. Treated arteries ranged from 1.5 – 2 mm and there was an overall good safety profile and high angiographic success rate. Disclosures B. Cristiano: None. K. Cicilioni: None. J. Dye: None. J. Jacobson: None. D. Hoss: None.