North American clinical experience with the EKOS MicroLysUS infusion catheter for the treatment of embolic stroke

BACKGROUND AND PURPOSE: We present early experience with the EKOS MicroLysUS infusion catheter for acute embolic stroke treatment in North America. This study was designed to demonstrate the safety of the device and to determine if sonography accelerates thrombolysis and improves clinical outcomes. METHODS: Fourteen patients aged 40-77 years with anterior- or posterior-circulation occlusion presented with cerebral ischemia 3-6 or 4-13 hours after symptom onset, respectively. Patients were treated with the catheter and simultaneous intraarterial thrombolysis. Procedural and clinical information, including time to lysis, degree of recanalization, National Institute of Health Stroke Scale (NIHSS) score, and modified Rankin Scale (mRS) score was recorded before treatment and afterward (immediately and at 24 hours, 1 week, 1 month, and 3 months). RESULTS: Ten patients presented with acute anterior-circulation emboli; four patients, with posterior-circulation emboli (NIHSS score, 9-23 [mean. 18.2] and 11-27 [mean, 18.75], respectively). Three deaths occurred at 24 hours: two from hemorrhage and one from cerebral swelling. Deaths also occurred at 1 week and 1 month after treatment. Thrombolysis in Myocardial Ischemia grade 2-3 flow was achieved in eight patients in the first hour. Average time to recanalization was 46 minutes. Mean NIHSS scores in eight of nine survivors at 90 days were 5 in the anterior-circulation group and 3 in the posterior-circulation group; mean mRS scores at 90 days were 2 and 3, respectively. No catheter-related adverse events occurred. CONCLUSION: Use of the EKOS MicroLysUS infusion catheter is feasible in the treatment of acute ischemic stroke. Further studies to evaluate its efficacy are warranted.