May 1, 2012EuroIntervention
First-in-man experience with a new embolic deflection device in transcatheter aortic valve interventions
Key result
The SMT Embolic Deflection Device was successfully placed in all patients during TAVI, resulting in 3.2 new cerebral lesions per patient on DW-MRI compared to 7.2 in those without the filter.
Why the study?
Does the SMT Embolic Deflection Device reduce cerebral lesions and procedural complications in patients undergoing TAVI?
Population
15 patients with severe aortic stenosis undergoing percutaneous transfemoral or transapical aortic valve…
Comparison
SMT Embolic Deflection Device deployed in the… vs 20 patients previously undergoing TAVI without a…
Design
Cohort
Follow-up
4 days (± 2 days)
Authors
Discussion
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Implication
May reduce new cerebral lesions during TAVI; hypothesis-generating pending randomized confirmation.
Study Design
Type
Cohort (n=35)
Structured PICO
Does the SMT Embolic Deflection Device reduce cerebral lesions and procedural complications in patients undergoing TAVI?
P
Population
15 patients (mean age 79 years) with severe aortic stenosis undergoing TAVI with the SMT Embolic Deflection Device, compared retrospectively to 20 patients without a protection device.
E
Exposure
SMT Embolic Deflection Device deployed in the aortic arch during transcatheter aortic valve implantation (TAVI).
C
Comparator
20 patients previously undergoing TAVI without a protection device (retrospective comparison for DW-MRI).
O
Outcome
Feasibility (successful placement) and safety (procedural complications, neurological symptoms).safety
Main Result
Absolute Event Rate: 3.2% vs 7.2%
This first-in-man study demonstrates the feasibility of the SMT Embolic Deflection Device during TAVI, with preliminary evidence suggesting a reduction in new cerebral lesions on DW-MRI.
Limitations
- Larger randomised, prospective studies are required to confirm these findings and prove safety and efficacy
- Small sample size
- Retrospective comparison group for MRI findings
- Requires larger randomised, prospective studies to confirm safety and efficacy
Cite This Study
Onsea et al. (2012) conducted a cohort in severe aortic stenosis (n=35). SMT Embolic Deflection Device vs. TAVI without a protection device was evaluated on new cerebral lesions per patient on DW-MRI. The SMT Embolic Deflection Device was successfully placed in all patients during TAVI, resulting in 3.2 new cerebral lesions per patient on DW-MRI compared to 7.2 in those without the filter.