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The aim of this study was to evaluate the impact of cerebral embolic protection with the Claret Sentinel device on stroke in different subgroups of patients undergoing transfemoral aortic valve replacement (TAVR). Imaging data on cerebral emboli protection devices have demonstrated a significant reduction in number and volume of cerebral lesion during TAVR.
A total of 802 consecutive patients were enrolled. The Sentinel cerebral embolic protection device (Claret Medical Inc. CA, USA) was used in 34.9% (N=280) of consecutive patients. In 65.1% (N=522) TAVR was performed in the identical setting with the same valve types except without cerebral embolic protection. Neurological follow-up was done within seven days post-procedure. The primary endpoint was a composite of all-cause mortality or all-stroke according to Valve Academic Research Consortium-2 criteria within seven days. Subgroup analyses were performed for the primary endpoint including gender, STS score for mortality and aortic valve calcification.
Both filters of the device were successfully positioned in 92%. With use of cerebral embolic protection rate of disabling and non-disabling stroke was significantly reduced from 4.2% to 1.4% (p=0.03, odds ratio 0.39, 95% confidence interval 0.16-0.98). The primary endpoint occurred significantly less frequent with 2.1% (N=6/280) in the protected group compared to 5.7% (N=30/522) in the control group (p=0.01; odds ratio 0.30, 95% confidence interval 0.12-0.77). A subgroup analysis for the primary endpoint in the total population confirmed the consistent reduction of death and stroke in all subgroups with use of the embolic protection device (rates for TAVR with protection device versus unprotected procedures for male patients 0.8% versus 5.9%, STS<8 4.4% versus 2.0%, STS>8 10.0% vs. 2.5%; severe aortic valve calcification 6.2% vs. 2.0%).
In patients undergoing TAVR use of a double-filter cerebral emboli protection device demonstrated a clinical benefit in all subgroup of patients with a lower rate of death and stroke compared with unprotected TAVR.
STRUCTURAL: Valvular Disease: Aortic