Enhancing Stroke Prevention in Transcatheter Aortic Valve Replacement: The Role of F2, a Novel Neuroprotection Device.

Abstract

Purpose: Transcatheter aortic valve replacement (TAVR) is an established treatment for severe aortic stenosis; however, it carries the risk of periprocedural strokes. Current cerebral embolic protection (CEP) devices, such as the Sentinel, provide partial protection but are limited by inadequate anatomical coverage and inability to capture smaller emboli effectively. This study aimed to evaluate the effectiveness of a novel CEP device, the F2 filter with a 28 μm pore size and full cervical vessel coverage, in preventing emboli from entering the cerebral circulation.

Methods: The Sentinel and F2 filter were evaluated for the ability to prevent embolic particles of various sizes (45-300 µm) from entering cerebral arteries using two in vitro flow models, incorporating standard and tortuous aortic anatomies. Additionally flow rates were also measured to confirm that normal perfusion was maintained while the devices were in place.

Results: The F2 filter maintained normal cerebral arterial flow and significantly reduced the number of particles across all sizes compared to the Sentinel and control groups. This reduction was observed in all four cerebral branches and across both standard and tortuous aorta models.

Conclusions: The F2 filter showed superior neuroprotective effectiveness to prevent embolic debris from entering the cerebral circulation in the in vitro models. By offering comprehensive coverage to all cervical arteries and with a smaller mesh size, this filter has the potential to improve cerebral protection during TAVR.