- Question
- Does the use of a cerebral embolic protection device during transfemoral transcatheter aortic-valve replacement (TAVR) reduce the risk of periprocedural stroke?
- Design
- Randomized 1:1, open-label (no masking), multicenter trial of 3000 patients in North America, Europe and Australia. A neurology professional examined all patients at baseline and after TAVR.
- Population
- Patients with aortic stenosis undergoing transfemoral TAVR.
- Intervention
- Transfemoral TAVR with the Sentinel cerebral protection system; the device was successfully deployed in 1406 of the 1489 patients (94.4%) in whom an attempt was made.
- Control
- Transfemoral TAVR without a cerebral embolic protection device.
- Primary outcome
- Stroke within 72 hours after TAVR or before discharge (whichever came first), in the intention-to-treat population.
- Results
- Stroke occurred in 2.3% with protection vs. 2.9% in the control group (difference, -0.6 percentage points; 95% CI, -1.7 to 0.5; P = 0.30). Disabling stroke occurred in 0.5% vs. 1.3%.
- Safety
- There were no substantial differences in death (0.5% vs. 0.3%), the composite of stroke, transient ischemic attack or delirium (3.1% vs. 3.7%), or acute kidney injury (0.5% vs. 0.5%). One patient (0.1%) had a vascular complication at the device access site.
- Conclusion
- Cerebral embolic protection did not significantly reduce periprocedural stroke, although the confidence interval does not rule out a benefit.
- Why it matters
- As the largest randomized trial of cerebral embolic protection in TAVR, it failed to show a significant reduction in overall stroke, tempering routine use of these devices and underscoring the need to identify which patients might benefit.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026