1. Total lesions on MRI at 48 hours
CLEAN-TAVI
Trial design: Patients undergoing TAVR were randomized in 1:1 fashion to receive either a cerebral embolic protection device (CEPD), Claret-Montage, or routine management during the procedure. Patients were followed for 7 days.
Results
(p = )
At 2 days, there was a significant reduction in the total number of lesions on MRI in the CEPD vs. no filter arms: 8 vs. 16, p =
Similar results were noted on 7-day MRI: 5 vs. 10, p = 0.012
Clinical strokes were similar
No. of lesions
Conclusions
Embolic protection with Claret-Montage CEPD results in fewer cerebral embolic events vs. routine management using no filter in transfemoral TAVR; results are interesting given the high cerebral embolism rate in TAVR patients
Further studies powered for clinical endpoints in TAVR patients are necessary
Total lesions on MRI at 48 hours
CEPD
(n = 50)
No filter
(n = 50)
Presented by Dr. Axel Linke at TCT 2014