Valvular & structural heart disease
Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice: one-yearresults of the ACURATE neo2 PMCF Study
Authors' conclusion
The study outcomes confirm favourable performance and safety up to 1 year in patients treated with ACURATE neo2 in routine clinical practice.
Study context
- Population
- Patients with severe AS in routine clinical practice246 implanted
- Participants
- 250 patients
- Outcome
- Clinical outcomes (VARC-2 safety events) and valve performance
- Follow-up
- Up to 1 year
Methodological detailssingle-arm, independent core laboratories
- Single-arm
- Independent core laboratories
Main finding
As reported in the abstract
VARC-2 clinical outcomes
All-cause mortality at 30 days
0.8%
All-cause mortality at 1 year
5.1%
Stroke at 1 year
3.0%
Disabling stroke at 1 year
1.3%
Further findings
Hypoattenuated leaflet thickening (HALT) >50% involvement of ≥1 leaflet (4D CT)
- HALT at 30 days
- 9%
- HALT at 1 year
- 12%
- No association between HALT and 1-year clinical or haemodynamic outcomes
Mean aortic valve gradient · up to 1 year
- Baseline (mmHg)
- 47.6±14.5
- 1 year (mmHg)
- 7.6±3.2
Mean aortic valve area · up to 1 year
- Baseline (cm²)
- 0.7±0.2
- 1 year (cm²)
- 1.7±0.4
Paravalvular leakage (PVL) · up to 1 year
- Mild or no/trace PVL
- 99%
- Moderate PVL
- <1%
- Severe PVL
- 0
Original publication
Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice: one-yearresults of the ACURATE neo2 PMCF Study. EuroIntervention. Published 1 January 2024. doi:10.
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