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

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 F₂ 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 F₂ 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. F₂ 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 F₂ 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 F₂ 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 mm³ (IQR: 13.1-159.8 mm³).

Conclusions

In this first-in-human series, cerebral embolic protection with the EnCompass F₂ during TAVR was feasible and safe with very low new brain DW-MRI lesion volumes and no strokes.