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.
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.
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.
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.