Abstract
Background & purpose: To evaluate safety and efficacy of the Solitaire FR in the treatment of patients with acute ischemic stroke (AIS) secondary to large artery occlusion. Methods: Retrospective study of consecutive patients presenting with AIS treated with Solitaire FR as the first choice device to restore blood flow in 6 experienced European sites according to the hospitals’ stroke protocols (direct IA, bridging IV t-PA/IA and failed or contraindicated IV t-PA). Sites provided patient information at pre-procedure, procedure, 24hrs, discharge and 90 days. An independent Core Lab evaluated TICI scores on the pre-procedure and post-procedure angiograms. Recanalization was defined as TICI 2 or 3 post Solitaire FR device use and prior to any rescue therapy. Baseline and post-treatment brain CT or MRI were also centrally reviewed for symptomatic ICH classification (PH2 + death or neurologic deterioration). Good early neurological outcome was defined as NIHSS score improvement of ≥10 points or NIHSS 0,1 at discharge, and favourable functional outcome as modified Rankin Scale (mRS) score ≤ 2 at day 90. Patients with missing mRS data were judged to have worst possible outcome for data analysis. Results: Of the 206 patients treated with Solitaire FR, the device was used as first line treatment in 141 patients (mean age, 66; median NIHSS, 18): 74 patients were treated with IV t-PA prior to endovascular treatment, 56 had contra indication to IV t-PA and 11 were directly treated IA. Safety and efficacy results in the overall and IV t-PA treated patients are shown in the table . The mean number of recoveries was 1.8 and median time from groin puncture to successful revascularization was 45 minutes. Conclusions: This retrospective, uncontrolled study shows that Solitaire FR is safe and achieves good revascularization rates and functional outcomes in patients with AIS and large artery occlusion.
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