Frontline ADAPT therapy to treat patients with symptomatic M2 and M3 occlusions in acute ischemic stroke: initial experience with the Penumbra ACE and 3MAX reperfusion system.

BACKGROUND: After a series of positive studies for mechanical thrombectomy in large vessel occlusion acute ischemic stroke, the question remains, can symptomatic patients with distal vessel occlusion benefit from mechanical thrombectomy?

PURPOSE: To assess the safety and efficacy of the 3MAX reperfusion system as frontline therapy for M2 and M3 occlusions.

METHODS: This study retrospectively collected data on 58 patients treated for M2 and M3 occlusions between January and September 2016. Of these 58 patients, 31 had an isolated M2 or M3 occlusion. Eligible patients were treated with 3MAX by adirect first pass aspiration (ADAPT) technique within 6 hours following stroke onset. Effectiveness was defined by functional independence (90-day modified Rankin Scale core 0-2) and revascularization to modified Thrombolysis in Cerebral Infarction (mTICI) 2b-3 scores adjudicated by a core laboratory, while complication rates were used to determine safety of the device and the procedure.

RESULTS: Patients with an isolated M2 or M3 occlusion had a mean age of 68.6±13.3 years (range 18-90 years), a median National Institutes of Health Stroke Score of 15 (IQR 9-19), and ASPECTS score of 9 (IQR 8-10). After intervention, 100% (31/31) of patients were revascularized to mTICI 2b-3; 77.4% (24/31) of patients showed revascularization to mTICI 3. Aspiration alone led to revascularization in 83.9% (26/31) of patients. At 90 days, 96.8% (30/31) of patients had achieved functional independence. The incidence of symptomatic intracranial hemorrhage was 0% (0/31).

CONCLUSIONS: Results suggest that the 3MAX reperfusion system is safe and effective in achieving successful revascularization and functional independence for patients with acute ischemic stroke secondary to M2 and M3 occlusions using ADAPT, either as frontline monotherapy, or in combination with adjunctive devices.