May 1, 2015EuroIntervention
Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study
Why the study?
Does the TriGuard Embolic Deflection Device safely reduce cerebral ischemic lesions in patients undergoing TAVR?
Population
37 consecutive subjects undergoing transcatheter aortic valve replacement (TAVR)
Comparison
TriGuard Embolic Deflection Device, a nitinol… vs Historical controls (for DW-MRI outcomes)
Design
Cohort
Follow-up
30 days
Authors
Discussion
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Member takes
Implication
TriGuard appears safe in TAVR with fewer lesions under complete coverage; leaves open randomized confirmation of clinical benefit.
Structured PICO
Does the TriGuard Embolic Deflection Device safely reduce cerebral ischemic lesions in patients undergoing TAVR?
P
Population
37 consecutive subjects undergoing transcatheter aortic valve replacement (TAVR)
I
Intervention
TriGuard Embolic Deflection Device (EDD), a nitinol mesh filter positioned in the aortic arch across all three major cerebral artery take-offs
C
Comparator
Historical controls (for DW-MRI outcomes)
O
Outcome
In-hospital EDD device- or EDD procedure-related cardiovascular mortality, major stroke disability, life-threatening bleeding, distal embolisation, major vascular complications, or need for acute cardiac surgerysafety
The TriGuard Embolic Deflection Device appears safe during TAVR and may reduce cerebral ischemic burden when complete vessel coverage is achieved.
Cite This Study
Baumbach et al. (2015) studied this question.