CLEAN-TAVI, which was presented at TCT this morning, indicates that the use of Claret Medical’s dual filter cerebral protection system (Montage) during transcatheter aortic valve implantation (TAVI) is associated with a significant reduction in the number of cerebral lesions after TAVI.
Study presenter Axel Linke (Leipzig, Germany) reported that ischaemic brain lesions are found in more than two thirds of TAVI patients, adding: “The presence of ischaemic brain infarcts increases the risk of major stroke by more than three-fold. Silent infarcts are well recognised to be associated with several adverse neurological and cognitive complications.” Therefore, Linke explained, the Montage dual filter cerebral protection was developed to protect the brain from embolic debris.
In the study, 100 high-risk patients undergoing TAVI with the CoreValve (Medtronic) device were randomised to undergo TAVI with the filter (50) or without the filter (50; control group). The primary endpoint was the numerical reduction in positive post-procedure diffusion-weighted MRI (DW-MRI) brain lesions relative to baseline at two days in the protected territories. Secondary endpoints included serial volumetric and numerical reductions in positive post-procedure DW-MRI perfused brain lesions at two, seven, 30, and 360 days. Linke said: “The study hypothesis was that there would be a reduction in the number of cerebral emboli of 50% at two days after TAVI by the use of the Claret Montage dual filter.”
At two days post procedure, as assessed by DW-MRI, there were four lesions in the Montage group in the protected regions compared with 10 lesions in the protected area in the control group at the same time point. This represented a significant 60% reduction (p=0.009). At seven says, there was a significant 57% reduction in brain lesions with the Montage device (three lesions vs. seven lesions in the control group; p=0.0023).
Linke reported that in a per-protocol analysis, the ataxia rate was significantly lower in the filter group compared with the control group (p<0.05). However, he added that there was not a significant difference in the ataxia rate between groups in the intention-to-treat analysis (p=0.118).
“Larger outcomes studies are necessary in order to validate the beneficial effects of the routine cerebral protection during TAVI in improving acute neurological outcome and reducing the stroke rate,” Linke concluded.