TCT 2020 | Efficacy of Cerebral Protection Device TriGUARD 3 During TAVR

Cerebral protection device TriGUARD 3, designed to cover all supra-aortic vessels during transcatheter aortic valve replacement (TAVR), is safe to use, according to the outcomes of the REFLECT II study.

TCT 2020 | Eficacia del dispositivo de protección cerebral TriGUARD 3 durante el TAVI

The technical feasibility of the device, which requires transfemoral access, does not seem to have an impact over clinical events.

The primary safety endpoint was a VARC-2-defined composite of all-cause mortality, all stroke, life-threatening bleeding, acute kidney injury, coronary artery obstruction requiring intervention, and valve dysfunction requiring a repeat procedure. The 30-day rate was 15.9%, showing non-inferiority compared to previous studies.

The device failed to provide a clinical benefit in terms of stroke and burden of cerebral lesions. Diffusion-weighted magnetic resonance imaging analysis suggests that bigger lesions–most likely to cause symptoms–could be reduced.

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TriGUARD 3 bears the CE mark but has not yet been approved by the United States Food and Drug Administration (FDA) for use in said country. This device consists in a micromesh that covers all three supra-aortic vessels to deflect any debris created during TAVR or other structural intervention. It is inserted through a transfemoral access and its release system is similar to that of TAVR; consequently, its use is intuitive.

The REFLECT II study was conducted in 25 sites in the United States, where patients were randomized 2:1 to TAVR plus protection device or TAVR without protection. The valve was implanted in all patients, and TriGUARD 3 was deployed and retrieved in all cases.

At 30 days, the safety endpoint was more common in the TriGUARD group, although the difference did not reach statistical significance (15.9% vs. 7.0%; p = 0.11). Authors explained that the higher amount of events in the TriGUARD arm was due to bleeding at the TAVR access site and not to the device in itself.

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There was also a numeric trend towards more stroke events in the TriGUARD arm (8.3% vs. 5.3%; p = 0.57). Once more, authors explained that there were no differences as regards immediate stroke; events were accumulated throughout 30 days and may not be related to the TriGUARD device.

Original Title: A randomized evaluation of the TriGUARD3 cerebral embolic protection device to reduce the impact of cerebral embolic lesions after transcatheter aortic valve implantation: the REFLECT II trial.

Reference: Moses JW. Presentado en el congreso TCT 2020 virtual.

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