CLEAN-TAVI

1
CLEAN-TAVI
Trial design Patients undergoing TAVR were
randomized in 11 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

• 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 0.0023
• 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