Update From the First-in-Human Study With the Novel DurAVR Biomimetic Transcatheter Heart Valve—Coverage of SCAI Scientific Sessions 2024 | SCAI

Why is this study important? 

The Anteris DurAVR represents new technology in the transcatheter aortic space. The DurAVR valve is on a balloon-expandable platform and utilizes a single leaflet, which is hypothesized to aid in the flow characteristics of the valve. This study represents the FIH (first in human data). Patients were followed for up to one year. 

What did the study show? 

The prospective non-randomized, single-arm, single-center study was designed to evaluate safety and feasibility in patients with severe symptomatic aortic stenosis (AS) treated with the DurAVR Transcatheter Heart Valve System.

What question was this study supposed to answer?   

The small sample size of 28 patients all had successful implantation of the valve, with no valve-related complications at one year. The flow characteristics at the implant were maintained for one year with no moderate or severe paravalvular leak. Additionally, flow characteristics were stable out to one year, evaluated by cardiac MRI. Transvalvular gradients (8.34 mmHg on implant and 9.2 mmHg at one year) remained consistent, and there were no valve-related complications, strokes, life-threatening bleeding, or reoperations. 

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