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Effect of a Cerebral Protection Device on Brain Lesions Following Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis: The CLEAN-TAVI Randomized Clinical Trial
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In this study the investigators aimed to study whether a cerebral protection device during TAVI reduced the number of cerebral lesions in patients undergoing TAVI.
In total, 100 patients undergoing TAVI between April 2013 and June 2014 were randomized to either the filter or control group. The number of new lesions at 2 days after TAVI, as measured by diffusion-weighted magnetic resonance imaging (DWMRI), was lower in the filger group (4.00 versus 10.00 in the control group, p<0.001). Also lesion volume was lower in the filter group. Adverse events were similar in the filter and control group.
This small randomized study shows that a cerebral protection device reduced the frequency of ischemic cerebral lesions after TAVI. Further larger studies are needed to assess the beneficial effect on neurological and cognitive functioning.
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