Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement

The PROTECTED TAVR trial, a multicenter, randomized study, evaluated whether cerebral embolic protection (CEP) using the Sentinel device during transcatheter aortic-valve replacement (TAVR) reduces periprocedural stroke risk in patients with aortic stenosis. A total of 3000 patients were assigned to undergo TAVR with or without CEP. Stroke within 72 hours or before discharge occurred in 2.3% of the CEP group vs. 2.9% in the control group (difference: −0.6 percentage points; 95% CI: −1.7 to 0.5; P=0.30), indicating no statistically significant difference. However, disabling stroke incidence favored CEP (0.5% vs. 1.3%). Neurologic and safety outcomes including acute kidney injury, delirium, and death were similar between groups. CEP was successfully deployed in 94.4% of cases and rarely caused complications (0.1% access site vascular injury). Although CEP did not significantly reduce overall stroke rates, the trend toward fewer disabling ischemic strokes may hold clinical relevance, and future trials could clarify its utility in selected populations.

The PROTECTED TAVR trial, a multicenter, randomized study, evaluated whether cerebral embolic protection (CEP) using the Sentinel device during transcatheter aortic-valve replacement (TAVR) reduces periprocedural stroke risk in patients with aortic stenosis. A total of 3000 patients were assigned to undergo TAVR with or without CEP. Stroke within 72 hours or before discharge occurred in 2.3% of the CEP group vs. 2.9% in the control group (difference: −0.6 percentage points; 95% CI: −1.7 to 0.5; P=0.30), indicating no statistically significant difference. However, disabling stroke incidence favored CEP (0.5% vs. 1.3%). Neurologic and safety outcomes including acute kidney injury, delirium, and death were similar between groups. CEP was successfully deployed in 94.4% of cases and rarely caused complications (0.1% access site vascular injury). Although CEP did not significantly reduce overall stroke rates, the trend toward fewer disabling ischemic strokes may hold clinical relevance, and future trials could clarify its utility in selected populations.