Recanalization Devices Should Be Restricted to Clinical Trials

Abstract

Stephen M. Davis MD, FRACP Geoffrey A. Donnan MD, FRACP Section Editors: Yes, they work (sometimes)! However, “caveat emptor”—let the buyer beware. Both authors have encountered astonishing success stories with interventional recanalizations using them alone or in combination intravenous (IV) and intra-arterial (IA) lytics and devices. One of the authors (W.H.) did the ward rounds on their intensive care unit last Monday (first week of August); he found 2 patients next to each other, who, over the weekend, sustained a severe stroke with a M1/carotid T-occlusion. They both came within a 3-hour time window and presented with National Institutes of Health Stroke Scale (NIHSS) scores of 18 (right hemispheric) and 21 (left hemispheric). The initial CT showed a hyperdense middle cerebral artery sign in one and a T-occlusion (CTA) in the other case. Both were treated with IA devices after bridging lysis in one. One of them was included in a prospective clinical trial (Percutaneous Recanalization in Ischemic Stroke Management (Mindframe) [PRIISM] study); the other one could not be entered into the trial and was not treated with IV recombinant tissue plasminogen activator because of recent cardiac surgery and an international normalized ratio of 2.4. Following up with the patients on intensive care unit rounds, they were both on their way to the stroke unit. The 62 year old with the left middle cerebral artery occlusion presented with a NIHSS score of 4 (he was the one in the randomized trial); the other right hemispheric patient was down to a NIHSS of 2. The CT and MRI lesions were restricted to a central infarct pattern involving the basal ganglia and the insular ribbon, but not the internal capsule or cortical areas. One of the authors (P.D.S.) vividly remembers a 45-year-old patient with a proximal right-sided middle cerebral artery occlusion and …