As transcatheter aortic valve implantation (TAVI) continues to expand toward younger patients with longer life expectancy, factors such as valve hemodynamic performance, durability, and the feasibility of future reintervention become increasingly important. Patients with a small aortic annulus (SAA) undergoing TAVI often experience suboptimal outcomes, including higher transprosthetic gradients, increased prosthesis–patient mismatch (PPM), and early bioprosthetic valve failure (BVF).
These outcomes may be influenced by transcatheter aortic valve design, particularly differences in leaflet position (supra-annular versus intra-annular) and overall valve architecture. However, currently available data on this topic remain conflicting.
The DurAVR transcatheter heart valve (THV; Anteris Technologies) is a novel balloon-expandable valve featuring a unique single-piece biomimetic leaflet design, unprecedented among currently available devices. Early experience from feasibility studies and first-in-human trials has demonstrated promising results.
The aim of this study was to report procedural, clinical, and hemodynamic outcomes at 30 days following TAVI in patients with SAA treated with the DurAVR valve.
This analysis, derived from early feasibility and first-in-human studies, included all patients with SAA (defined as an aortic annular area between 346 mm² and 452 mm²) treated with small-size DurAVR aortic valves. The mean aortic annular area, assessed by computed tomography (CT), was 404 ± 37 mm², with a mean annular diameter of 22.7 ± 1.0 mm. Thirty-day outcomes, including PPM assessment, were evaluated according to VARC-3 criteria, with independent adjudication of clinical events and post-implant echocardiographic analysis.
A total of 100 patients were analyzed. Mean age was 77.0 ± 7.3 years, and the majority were women (78%). The mean STS score was 4.7 ± 4.0%. Transfemoral access was used in 94% of cases.
Favorable 30-Day Hemodynamic Performance and Low Prosthesis–Patient Mismatch in Small Aortic Annulus
The overall technical success rate was 93%. At 30 days, device success was achieved in 91% of patients, with no reported deaths and a stroke rate of 2%. Echocardiographic hemodynamic assessment demonstrated a mean transprosthetic gradient of 8.2 ± 3.1 mmHg, a mean effective orifice area of 2.2 ± 0.3 cm², and a Doppler velocity index of 0.60 ± 0.10. The incidence of moderate or greater PPM was 3%, and no patient experienced more than mild paravalvular leak. The rate of new permanent pacemaker implantation was 6%.
Conclusion: DurAVR Balloon-Expandable Valve Shows High Device Success and Promising Short-Term Outcomes in Small Aortic Annulus
The balloon-expandable DurAVR aortic valve demonstrated high rates of technical and device success, along with favorable hemodynamic outcomes at 30 days, including a low incidence of PPM in patients with SAA. Further studies are needed to confirm its long-term durability.
Original Title: Thirty-day outcomes of a novel biomimetic balloon-expandable transcatheter heart valve in patients with small aortic annuli.
Reference: Ole De Backer et al EuroIntervention 2026;22:e -e160.
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