SENTINEL-BVF (NCT05093764) enrolled 20 patients undergoing VIV-TAVR with
BVF at Saint Luke's Mid America Heart Institute, every one with SENTINEL
cerebral embolic protection in place. Each filter was sent for
histopathology, compared against 49 native-valve TAVR patients from the
SENTINEL Low-Intermediate Risk registry.
→ Debris was captured in 100% of cases — acute thrombus, organizing
thrombus, calcium, valve tissue, arterial wall, foreign material.
→ More particles were captured than in native-valve TAVR: 70.9 ± 32.9 vs 42.6 ± 40.7
particles ≥150 µm per patient (p<0.001).
→ The excess was almost entirely small particles, 150 to <500 µm. No
difference in intermediate or large particles.
→ Different composition, not just more of it: more organizing thrombus,
more foreign material, less valve tissue. The foreign material was mostly
gauze — an unexpected finding that points toward device preparation
rather than the fracture itself.
→ One in-hospital stroke (5%), no other major adverse cardiac events.
Comparable to the SENTINEL trial (5.6%) and the SENTINEL-LIR registry (4%).