Abstract
BACKGROUND: Stroke is a feared complication of transcatheter aortic valve replacement (TAVR), and effective cerebral embolic protection devices are an important innovation target. The EnCompass F(2) system is a novel cerebral embolic protection device consisting of a cylindrical, nitinol frame and an electrospun polyurethane deflection filter with 30-μm average pore size. It is deployed across the aortic arch from femoral access to provide complete cerebral embolic protection during TAVR. METHODS: This first-in-human study investigated the feasibility and safety of F(2) filter use during TAVR. Subjects had symptomatic severe aortic stenosis and met established clinical indications for TAVR. The primary safety end point was 30-day major adverse cardiac and cerebrovascular events, defined as all-cause death, stroke, major vascular complication, type 2 to 4 bleeding, or acute kidney injury stage 3 to 4. F(2) filter technical and procedure success and new ischemic brain lesion counts and volumes on diffusion-weighted magnetic resonance imaging (DW-MRI) were evaluated. RESULTS: Twelve patients underwent transfemoral TAVR with the F(2) device. Subjects were 58% female with mean age 73.4 ± 5.1 years and mean Society of Thoracic Surgeons score 3.2 ± 2.0%. A balloon-expandable valve was used in 75% (n = 9). A single F(2) device was used in all cases and was delivered ipsilateral to the TAVR sheath in 41.7% (n = 5). Technical and procedure success was achieved in 100% of cases. No major adverse cardiac and cerebrovascular events occurred within 30 days of TAVR, including no strokes. DW-MRI revealed median total new lesion volume 23.4 mm(3) (IQR: 13.1-159.8 mm(3)). CONCLUSIONS: In this first-in-human series, cerebral embolic protection with the EnCompass F(2) during TAVR was feasible and safe with very low new brain DW-MRI lesion volumes and no strokes.