Key result
FLOWer filter in TAVI is linked to ~85% fewer 30-day major adverse events versus benchmarks.
Why the study?
Embolic events are life-threatening complications of TAVI with clinically relevant stroke rates of 2%-4%, prompting evaluation of the safety and effectiveness of the novel FLOWer embolic protection device.
Does the FLOWer embolic protection device safely capture debris and reduce major adverse events in patients undergoing TAVI?
Population
52 intention-to-treat patients undergoing TAVI
Comparison
FLOWer embolic protection device vs benchmark values from EPD literature
Design
CE-mark clinical trial
Follow-up
30 days
Authors
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Suggests low MAEs with high debris capture using FLOWer in TAVI; leaves open benefit versus controls in randomized trials.
Does the FLOWer embolic protection device safely capture debris and reduce major adverse events in patients undergoing TAVI?
The novel FLOWer embolic protection device is safe and feasible during TAVI, effectively capturing debris and demonstrating a low 30-day major adverse event rate compared to historical benchmarks.
Sorropago et al. (2026) studied this question. FLOWer filter in TAVI reduced 30-day major adverse events to 2.2% vs 14.3% (p=0.0082) and captured median 213 debris >60μm vs 46.1 in benchmarks (p<0.0001).
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