Work

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

Year: 2025

Type: article

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.

Source: Journal of the Society for Cardiovascular Angiography & Interventions

DOI: 10.1016/j.jscai.2025.103608