January 27, 2026EuroIntervention4 citationsOpen Access
Thirty-day outcomes of a novel biomimetic balloon-expandable transcatheter heart valve in patients with small aortic annuli
Key Result
The DurAVR transcatheter heart valve demonstrated promising 30-day outcomes in patients with small aortic annuli, with a 3% incidence of moderate or greater prosthesis-patient mismatch.
Study Design
Type
Observational
Structured PICO
Does the DurAVR THV provide acceptable 30-day clinical and echocardiographic outcomes in patients with small aortic annuli?
P
Population
Patients with small aortic annuli (SAA), mean diameter 22.7±1.0 mm
I
Intervention
DurAVR transcatheter heart valve (THV) (novel balloon-expandable with single-piece biomimetic leaflet design)
O
Outcome
30-day performance including prosthesis-patient mismatch (PPM) evaluated per Valve Academic Research Consortium 3 criteriasurrogate
The novel DurAVR THV demonstrates promising early echocardiographic and clinical outcomes, with low rates of prosthesis-patient mismatch and paravalvular leak in patients with small aortic annuli.
Limitations
- Longer-term follow-up in larger cohorts is needed to confirm these encouraging early results
Abstract
BACKGROUND: Transcatheter aortic valve implantation (TAVI) in patients with small aortic annuli (SAA) is associated with an increased risk of prosthesis-patient mismatch (PPM). AIMS: This study assesses the 30-day performance of the novel balloon-expandable DurAVR transcatheter heart valve (THV), which features a unique single-piece biomimetic leaflet design, in patients with SAA. METHODS: , with a mean diameter of 22.7±1.0 mm. Outcomes at 30 days, including PPM, were evaluated per Valve Academic Research Consortium 3 criteria, with independent adjudication of clinical events and core laboratory analysis of post-implant transthoracic echocardiograms. RESULTS: , and a Doppler velocity index of 0.60±0.10. The incidence of moderate or greater PPM was 3%, and no patients experienced more than mild paravalvular leak. The rate of new permanent pacemaker implantation was 6%. CONCLUSIONS: In patients with SAA, the DurAVR THV demonstrated promising clinical and echocardiographic outcomes at 30 days. Longer-term follow-up in larger cohorts is needed to confirm these encouraging early results.