The Anteris DurAVR biomimetic transcatheter heart valve (THV) demonstrated outstanding hemodynamic performance in patients with severe, symptomatic aortic stenosis (AS) who received the device in an early feasibility study (EFS). These data were presented by Thomas Waggoner, DO, of the Cleveland Clinic, Cleveland, in a Late-Breaking Trial session at Cardiovascular Research Technologies (CRT) 2024 in Washington, D.C. Patients with severe, symptomatic AS can benefit from treatment with THVs. The DurAVR THV (Anteris Technologies) is a biomimetic THV with features including single-piece leaflet geometry and a tissue-engineering calcification process to reduce bioprosthetic structural valve deterioration (SVD). Included in the device is also a balloon-expandable platform with large open-cell geometry to assist in coronary access. The investigators in this prospective, multi-center, non-randomized, early feasibility study examined the safety and feasibility of the DurAVR THV in patients who had severe symptomatic AS. Assessments included clinical, echocardiography, computed tomography (CT) and cardiac magnetic resonance imaging and are planned to be performed for up to 10 years post-procedure. Core labs independently analyzed the data. A total of 15 patients (mean age=81 years; 67% female; New York Heart Association [NYHA] Class II=53%, NYHA Class III=47%; mean CT annulus diameter=22.2 mm). All patients had successful implantation of the DurAVR THV. At 30 days, excellent hemodynamic results were shown by transthoracic echocardiography, even though the aortic annuli were small: the effective orifice area was 2.2±0.5 cm2, mean pressure gradient was 7.8±2.0 mmHg and dimensionless index was 0.63±0.1. A favorable safety profile was also shown in all patients at 30 days. Device related complications, strokes, bleeding or reoperations occurred in no of patients. Due to pre-existing conduction abnormalities, one patient received a pacemaker. No moderate or severe paravalvular leak nor cases of moderate or severe prosthesis-patient mismatch were observed. Overall, the DurAVR biomimetic THV was found to be a beneficial treatment for patients with severe AS and showed favorable hemodynamic stability through 30 days. Photo Credit: Bailey Salimes/CRTonline.org Photo Caption: Thomas Waggoner, DO, presents early feasibility study results of the DurAVR device Sunday at CRT 2024 in Washington, D.C.