The PROVE ACURATE neo2 Registry
A Prospective, multicenter registry of midterm outcomes with ACURATE neo2 in up to 30 EU centers enrolling N=~1000 patients
See below the main 30-day outcomes (VARC 3) presented at EuroPCR 2024 by Prof. Holger Thiele or Mohammad Abdel-Wahab
All-cause mortality
Transvalvular gradient at discharge (mmHg)
Pacemaker rates
ACURATE neo2 PMCF Post-market Registry | 1-year outcomes
A prospective multicenter single-arm post-market surveillance study for ACURATE neo2 in a routine clinical practice setting
8 mmHg
mean gradients
0.9%
>moderate PVL
5.1%
mortality rate
Early neo2 Registry core-lab results
First large, real-world clinical data on the ACURATE neo2™ Aortic Valve System*: The Early neo2 Registry
Independently studying 85% of the original study’s 554 patients, the Early neo2 Registry core-lab analysis confirmed minimized paravalvular leak rates with the ACURATE neo2 Valve and its Active PVsealTM sealing skirt.
6.0%
new permanent pacemaker
2.7%
moderate to severe PVL1
8.0mmHg
mean gradient
COMALIGN neo2 Study
A retrospective study of 900 patients implanted with ACURATE neo2 across 3 European sites. This is the largest study of commissural alignment to date, and one of the first assessments of TAVI valve performance based on the degree of commissural alignment
95%
Of cases avoided severe commisural misalignment 4
- Severe commissural misalignment is associated with an increased risk of severe Patient Prosthesis Mismatch (PPM).
- Total aortic regurgitation was significantly higher for patients with severe commissural misalignment.
COMALIGN Study
First real-world analysis of patient-specific implantation techniques using different devices. The COMALIGN study demonstrated that neo-commissural alignment and optimized valve design can improve procedural success.
Best-in-class commissural alignment: ACURATE neo2 was the only self-expanding valve to 100% avoid commissural misalignment.2
0% moderate or severe commissural misalignment
ACURATE neo2 Valve
20/20 successful consecutive cases
10% moderate or severe commissural misalignment
Evolut™ R/PRO Valve
17/20 successful consecutive cases; 3 cases with non-optimal rotations
25% moderate or severe commissural misalignment
PORTICO™ Valve
15/20 successful consecutive cases; 5 cases difficult to assess
RE-ACCESS 2 Study
This trial studied coronary re-engagement in patients undergoing transfemoral TAVI with Evolut R/PRO/PRO+ or ACURATE neo2 implanted with patient specific commissural alignment technique
Large cell frame design remains the most impactful factor in coronary re-engagement post TAVI.
5.5%
unsuccessful coronary cannulation (7 patients)
6 patients received Evolut5
RE-ACCESS Study
First systematically evaluated analysis of coronary access before and after TAVI in an all-comers’ population.
With zero incidences of unsuccessful coronary cannulation, ACURATE neo demonstrated an extremely high coronary access success rate.
100%
ACURATE neo™ Valve Platform
100% successful coronary cannulation
n = 723
82%
Evolut™ R/PRO
82% successful coronary cannulation
n = 1233
99%
SAPIEN Platform
99% successful coronary cannulation
n = 963
1. Möllmann H, Holzhey DM, Hilker M, et al. The ACURATE neo2 valve system for transcatheter aortic valve implantation: 30-day and 1-year outcomes. Clin Res Cardiol. 2021;110(12):1912–1920.
2. Bieliauskas G, Wong I, Bajoras V, et al. Patient-specific implantation technique to obtain neo-commissural alignment with self-expanding transcatheter aortic valves. J Am Coll Cardiol 2021;14(19):2097-2108.
3. Reobtain Coronary Ostia Cannulation Beyond Transcatheter Aortic Valve Stent (RE-ACCESS); NCT04026204 J Am Coll Cardiol Intv. 2020.
4. De Backer O. Commissural alignment & TAV performance: Results from the COMALIGN-neo 2 study. TCT 2023
5. Costa G. The REACCESS-2 Study. PCRLV 2023
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