Safety and efficacy of mechanical thrombectomy with the Solitaire device in large artery occlusion

Abstract

Intravenous tissue plasminogen activator (TPA) has limited efficacy in proximal large vessel occlusions. This study was to assess the safety and efficacy of mechanical thrombectomy with a retrievable Solitaire stent in acute large artery occlusions . This is a single center study enrolling patients treated with Solitaire-assisted thrombectomy between November 2010 and March 2011. Inclusion criteria were severe stroke of National Institutes of Health Stroke Scale (NIHSS) score ≥10, treatment initiation within 6 hours from onset, and an angiographically verified occlusion of proximal middle cerebral artery (MCA) or internal carotid artery (ICA). The primary outcome was recanalization defined as Thrombolysis in Cerebral Infarct (TICI) reperfusion grade 2b/3. Secondary outcomes were good functional outcome at 3 months (modified Rankin Scale [mRS] ≤2), early substantial neurological improvement (NIHSS score improvement ≥8 at 24 hours), and symptomatic hemorrhagic transformation (SHT). Ten patients were consecutively enrolled: Age: 72.4 ΁ 5.7 years; female: 70%; baseline median NIHSS score: 19.5; and ICA occlusion in 50% and M1 portion of MCA occlusion in 50%. Six patients received intravenous TPA before intra-arterial treatment, and five patients were treated with adjuvant intra-arterial urokinase. Successful recanalization was achieved in 7 (70%) patients. Four (40%) patients had a good functional outcome at 3 months, and three (30%) patients had an early substantial neurological improvement. SHT occurred in two patients (20%), and 3-month mortality rate was 30%. There was no procedure-related complication. Mechanical thrombectomy with the Solitaire device can effectively recanalize proximal large vessel occlusions, and potentially improves clinical outcome.