Safety and efficacy of endovascular sonolysis using the EkoSonic endovascular system in patients with acute stroke.

BACKGROUND AND PURPOSE: Sonolysis is a new therapeutic procedure for arterial recanalization. The aim of this study was to confirm the safety and efficacy of endovascular sonolysis by using the EkoSonic Endovascular System in subjects with acute ischemic stroke.

MATERIALS AND METHODS: Patients with acute ischemic stroke with occlusion of the middle cerebral artery or basilar artery were enrolled consecutively in this prospective study. The control group (44 MCA and 12 BA occlusions) was selected from historical controls. EkoSonic Endovascular System was started within 8 hours after stroke onset. The NIHSS score at hospital admission, after 24 hours, and at 7 days; arterial recanalization; early neurologic improvement; symptomatic intracerebral hemorrhage; and favorable 3-month clinical outcome defined as a modified Rankin Scale score of 0-2 were evaluated by statistical means.

RESULTS: Fourteen patients (10 men; mean age, 65.1 ± 11.2 years; median NIHSS score, 16.5) underwent EkoSonic endovascular sonolysis. Arterial recanalization after endovascular treatment was achieved in 6 of 7 (85.7%) patients with MCA occlusion (4 complete recanalizations) and in all 7 (100%) patients with BA occlusion (6 complete recanalizations). No (0%) symptomatic intracerebral hemorrhage or periprocedural complications occurred. Seven (50%) patients were independent at 3 months (median mRS score, 2). Early neurologic improvement and favorable clinical outcome were significantly more frequent in patients with MCA occlusion undergoing EkoSonic endovascular sonolysis than in controls (100% and 71.4% versus 4.6% and 13.6% of patients; P = .0001 and P = .003, respectively). Three-month mortality was significantly lower in patients with BA occlusion undergoing EkoSonic endovascular sonolysis than in controls (0% versus 66.7% patients, P = .013).

CONCLUSIONS: In this small study, EkoSonic endovascular sonolysis allowed safe and potentially effective revascularization in patients experiencing acute ischemic stroke.