Valvular & structural heart disease
Early safety and feasibility of a first-in-class biomimetic transcatheter aortic valve - DurAVR
Authors' conclusion
Preliminary results from the FIH study with DurAVR THV demonstrate a good safety profile with promising haemodynamic performance sustained at 1 year and restoration of near-normal flow dynamics.
Study context
- Population
- Patients with severe symptomatic aortic stenosis (AS) of any surgical risk eligible for DurAVR transcatheter heart valve (THV)
- Participants
- 13 patients
- Outcome
- Safety and feasibility (implant success, haemodynamic performance, safety)
- Follow-up
- 30 days, 6 months, 1 year
Methodological detailsnon-randomised, single-centre
- Non-randomised
- Single-centre
Main finding
As reported in the abstract
Implant success
DurAVR THV
100%
Observational data: associations, not effects.
Further findings
Haemodynamics: EOA (mean annulus 22.95±1.09 mm) · 30 days
- EOA
- 2.00±0.17 cm²
- MPG
- 9.02±2.68 mmHg
Haemodynamics: EOA and MPG · 1 year
- EOA
- 1.96±0.11 cm²
- MPG
- 8.82±1.38 mmHg
- Patients with any degree of prosthesis-patient mismatch
- 0
CMR valve performance
- Mean coaptation length
- 8.3±1.7 mm
- Restoration of laminar flow, consistent with a predisease state
Safety
Procedural and follow-up safety · up to 1 year
- Implant success
- 100%
- Device-related complications
- 0
- Access site complication
- 1
- Permanent pacemaker implantation
- 1
- Moderate aortic regurgitation
- 1
- Deaths, stroke, bleeding, reinterventions or MI
- 0
Original publication
Early safety and feasibility of a first-in-class biomimetic transcatheter aortic valve - DurAVR. EuroIntervention. Published 17 July 2023. doi:10.
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