on October 28, 2004
Published online before print October 28, 2004, doi: 10.1161/01.STR.0000147718.12954.60
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Submitted on February 12, 2004
From the Division of Interventional Neuroradiology (Y.P.G.), Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY; the UCLA Stroke Study Network (S.S.), UCLA Fellowship in Stroke and Cerebrovascular Disorders, UCLA Emergency Medicine Center, Los Angeles, Calif; the Division of Interventional Neuroradiology (G.R.D.), Department of Radiological Sciences, University of California Los Angeles; Neurointerventional Surgery (T.G.), Saint Luke’s Hospital, Department of Radiology, Kansas City, Mo; the UCLA Stroke Unit and Comprehensive Stroke and Vascular Neurology Program (C.S.K.), Department of Neurology, UCLA School of Medicine, Reed Neurological Research Center, Los Angeles, Calif; the Division of Interventional Neuroradiology (R.J.), Department of Radiological Sciences, University of California Los Angeles; the Department of Radiology, Neurosurgery, and Neurology (J.P.-S.), Columbia University, Milstein Hospital, New York, NY; the Department of Neurology (A.S.), Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY; the Department of Radiological Sciences (F.V.), UCLA Medical Center, Los Angeles, Calif; the UCLA Stroke Unit and Comprehensive Stroke and Vascular Neurology Program (J.L.S.), Department of Neurology, UCLA School of Medicine, Los Angeles, Calif. * To whom correspondence should be addressed. E-mail: yvg2001{at}med.cornell.edu.
Background and Purpose--To report the result of the Mechanical Embolus Removal in Cerebral Ischemia (MERCI) 1 study, a phase 1 trial to evaluate the safety and efficacy of mechanical embolectomy in the cerebral vasculature. Methods--MERCI 1 enrolled 30 patients in 7 US centers. Main inclusion criteria were: National Institutes of Health Stroke Scale score (NIHSS) Results--Twenty-eight patients were treated. Median NIHSS was 22. Median time from onset to completion of treatment was 6 hours and 15 minutes. Successful recanalization with mechanical embolectomy only was achieved in 12 (43%) patients, and with additional intra-arterial tissue plasminogen activator in 18 (64%) patients. There was one procedure related technical complication, with no clinical consequence. Twelve asymptomatic and no symptomatic intracranial hemorrhages occurred. At 1 month, 9 of 8 revascularized patients and 0 of 10 nonrevascularized patients had achieved significant recovery. Conclusion--This phase 1 study shows that cerebral embolectomy with the Merci Retriever was safe and that successful recanalization could benefit a significant number of patients, even when performed in an extended 8-hour time window.
Accepted on September 17, 2004
MERCI 1. A Phase 1 Study of Mechanical Embolus Removal in Cerebral Ischemia
Y. Pierre Gobin MD*;
10; treatment performed within 8 hours from symptoms onset and contra-indication to intravenous thrombolysis; no large hypodensity on computed tomography; and occlusion of a major cerebral artery on the angiogram. Safety was defined by the absence of vascular injury or symptomatic intracranial hemorrhage. Efficacy was assessed by recanalization rate and clinical outcome at 1 month. Significant recovery was defined as 30-day modified Rankin of 0 to 2 in patients with baseline NIHSS 10 to 20 and 30-day modified Rankin of 0 to 3 in patients with baseline NIHSS >20. The procedures were performed with the Merci Retrieval System, a system specially designed for intracranial embolectomy.
Key words: embolectomy • stroke, ischemic • thrombectomy • thrombolytic therapy
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Stroke 2004 35: 2853-2854.
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