First-in-Human Experience With the EnCompass F2 Filter, a Novel Cerebral Embolic Protection Device for TAVR

Figures

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  Figure 1. EnCompass F2 filter. (A) The F2 filter is comprised of a self-expanding nitinol frame and an electrospun polyurethane filter. (B) Microscopic appearance of the electrospun polyurethane filter demonstrating the distribution of pore sizes, averaging 30 μm and with maximum pore size of 80 μm. (C) The system is comprised of (1) F2delivery sheath for filter delivery and retrieval, (2) F2pusher assembly and 0.015” retention wire to facilitate filter placement and removal, and (3) F2filter.

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  Figure 2. F2 filter delivery. F2 filter deployment is demonstrated. (A) Delivery sheath is positioned proximal to the brachiocephalic artery origin. (B) The filter is withdrawn from the delivery sheath with a pin and pull technique. (C) The filter's distal portion is covering the left subclavian artery origin. (D) A fluoroscopic appearance of the final position of the filter, which is stabilized via its radial force within the aorta.

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  Figure 3. TAVR deployment and F2 filter retrieval. (A and B) The TAVR procedure is performed through the central lumen of the F2 filter. (C and D) Then the F2 filter is retrieved via resheathing. TAVR, transcatheter aortic valve replacement.

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  Figure 4. F2 DW-MRI results compared with historical data from SENTINEL and TriGUARD. Graphic demonstration comparing total lesion number, volume and individual lesion volume in the F2 with historical SENTINEL9 and TriGUARD10 studies. DW-MRI, diffusion-weighted magnetic resonance imaging.

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  Central Illustration. EnCompass F2 embolic filter device and FIH study findings. DW-MRI, diffusion-weighted magnetic resonance imaging; MACCE, major adverse cardiac and cerebrovascular event; mRS, modified Rankin scale; NIHSS, National Institutes of Health Stroke Scale.