Valvular & structural heart disease
Effect of cerebral embolic protection device on new cerebral embolism during transcatheter aortic valve replacement: A prospective sentinel registry
Authors' conclusion
Among patients who are at high risk for stroke undergoing TAVR, the use of CEP was associated with a significant reduction of new cerebral embolism in protected brain territories. Because the study was underpowered to detect clinically relevant events, the results cannot be considered clinically directive.
Study context
- Population
- Patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) who were considered at high risk for strokepatients included
- Participants
- 219 patients
- Exposure
- Cerebral embolic protection (CEP) group vs control group
- CEP groupn = 49
- Control groupn = 170
- Outcome
- Number and volume of new cerebral lesions on brain magnetic resonance imaging (MRI) compared to baseline in protected brain territories
- Follow-up
- Postprocedure (2 to 7 days)
Methodological detailsimaging study, external control group from the ADAPT-TAVR trial
- Imaging study
- External control group from the ADAPT-TAVR trial
Main finding
As reported in the abstract
Difference
−4
P < 0.001
number of lesions; IQR, −6 to −3
Difference
−145.9
P < 0.001
volume of lesions; IQR, −296.7 to −67.1
CEP group
- No. of lesions
- 1 (IQR, 1 to 2)
- Volume of lesions
- 113.5 mm³ (IQR, 42.4-206.9)
Control group
- No. of lesions
- 6 (IQR, 3 to 10)
- Volume of lesions
- 283.5 mm³ (IQR, 129.7-682.4)
No. of lesions
CEP group1 (IQR, 1 to 2)
Control group6 (IQR, 3 to 10)
Volume of lesions
CEP group113.5 mm³ (IQR, 42.4-206.9)
Control group283.5 mm³ (IQR, 129.7-682.4)
Observational data: associations, not effects.
Safety
Strokes · 30 days
P = 0.64
Original publication
Effect of cerebral embolic protection device on new cerebral embolism during transcatheter aortic valve replacement: A prospective sentinel registry. Am Heart J. Published 14 August 2025. doi:10.
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