1. The number and volume of new brain lesions was lower in patients with an implanted cerebral protection device following transcatheter aortic valve implantation
2. There was no difference in the rate of complications in patients with the cerebral protection device compared to controls.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Stroke is a major complication following transcatheter aortic valve implantation (TAVI), and new brain lesions can be found in up to 80% of patients on post-procedure MRI scans. Several devices have been marketed in an effort to reduce the incidence of embolic events during this procedure. The purpose of this randomized clinical trial was to determine if the use of a specific cerebral protection device (Claret Montage Dual Filter System, Claret Medical Inc.) reduced the amount of ischemic brain injury on MRI. The authors determined that the device significantly reduced the number and total volume of new cerebral lesions.
Overall, this study supports the use of this cerebral protection device to reduce the burden of neurological complications following TAVI. This study’s methodology was superior to prior studies of other cerebral protection devices in that it implanted the same heart valves in all patients, used a higher MRI scanner strength field, and provided consistent baseline MRIs. However, the generalizability of this study may be limited as all procedures were performed by the same experienced team and all patients underwent valve repair for severe aortic stenosis. What’s more, the clinical relevance of reduced cerebral lesions on MRI is uncertain at this time. Going forward, this device does not protect the left vertebral circulation and requires refinement for complete cerebral protection.
In-Depth [randomized clinical trial]: This study was completed at the Heart Center at the University of Leipzig, Germany between April 2013 and June 2014. In order to determine brain lesion burden, brain MRI was performed at baseline, 2 days, and 7 days after TAVI. Patients were randomly assigned to either receive cerebral protection with the Claret Montage Dual Filter System device (Claret Medical Inc., Santa Rosa, California, USA) or no device. Among a total of 100 patients, the number of new lesions was lower in the device group, 4.00 (IQR 3.00-7.25) vs 10.00 (IQR 6.75-17.00) in the control group (difference 5.00; p < 0.001). New lesion volume after TAVI was lower in the device group (242 mm3; 95%CI 159-353) vs in the control group (527 mm3; 95%CI 364-830) (difference 234 mm3 ; p = 0.001). In terms of complications, major vascular complications occurred in 5 patients in the device group and 6 patients in the control group.
©2016 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.