Does Capturing Debris during TAVR Prevent Strokes?

This editorial analyzes the PROTECTED TAVR trial, which investigated whether cerebral embolic protection (CEP) devices reduce stroke risk during transcatheter aortic-valve replacement (TAVR). Despite successful debris capture by the Sentinel device, stroke incidence within 72 hours or discharge was similar in both groups (2.3% with CEP vs. 2.9% without; absolute difference −0.6%). However, disabling stroke occurred less frequently with CEP (0.5% vs. 1.3%), suggesting a possible selective benefit. Limitations in stroke ascertainment, such as assessments by non-neurologists and inconsistent structured interviews, could influence detection accuracy. The trial’s results indicate that CEP use during TAVR may not significantly lower overall stroke rates, though its safety profile and potential to reduce disabling strokes remain promising. Regulatory and clinical adoption will hinge on future studies validating this benefit. The editorial urges caution in routine CEP use and highlights challenges of relying on surrogate markers like debris capture without clear clinical endpoints.

This editorial analyzes the PROTECTED TAVR trial, which investigated whether cerebral embolic protection (CEP) devices reduce stroke risk during transcatheter aortic-valve replacement (TAVR). Despite successful debris capture by the Sentinel device, stroke incidence within 72 hours or discharge was similar in both groups (2.3% with CEP vs. 2.9% without; absolute difference −0.6%). However, disabling stroke occurred less frequently with CEP (0.5% vs. 1.3%), suggesting a possible selective benefit. Limitations in stroke ascertainment, such as assessments by non-neurologists and inconsistent structured interviews, could influence detection accuracy. The trial’s results indicate that CEP use during TAVR may not significantly lower overall stroke rates, though its safety profile and potential to reduce disabling strokes remain promising. Regulatory and clinical adoption will hinge on future studies validating this benefit. The editorial urges caution in routine CEP use and highlights challenges of relying on surrogate markers like debris capture without clear clinical endpoints.