Illustration of the ACURATE neo2 Aortic Valve System in anatomy. Supra-annular TAVI. Illustration of the ACURATE neo2 Aortic Valve System in anatomy. Supra-annular TAVI.

Clinical data

The Neo2 BAV Registry

Retrospective, multicenter study evaluating the safety & effectiveness of ACURATE neo2 in patients with severe symptomatic bicuspid aortic valve (BAV) stenosis.

30 day device

30-day device success was achieved in 90.6% .

PPI rate

New PPI rate of 6.5% .

gradient

Mean gradient of 6.5mmHg.

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Clinical Impact of Frame Under Expansion following TAVR using a Self-Expanding Valve

Clinical impact of transcather heart valve (THV) mid-frame under expansion among patients treated with the ACURATE neo2 device in a European patient population.

expansion

Majority of ACURATE neo2 implants were appropriately expanded with a mid-frame under expansion identified in a small proportion of patients 9.4% (n=57) vs. the ACURATE IDE trial (21.3%).

92%

When post dilation was carried out, it was effective in reducing the rate of mid-frame under expansion in 92% of cases (45/49).

composite rate

The composite rate at one year was 37.6% in the mid frame under expansion arm 10.2% in the expanded arm. (p<0.01).

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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

1.4% All-cause mortality

All-cause mortality 

6.8+3.2 Transvalvular gradient at discharge (mmHg)

Transvalvular gradient at discharge (mmHg) 

9.3 % Pacemaker rates

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

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8 mmHg

mean gradients

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0.9%

>moderate PVL

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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.

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6.0%

new permanent pacemaker

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2.7%

moderate to severe PVL1

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8.0mmHg

mean gradient

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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.

Download the COMALIGN neo2 TCT 2023 presentation

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

0% moderate or severe commissural misalignment
ACURATE neo2 Valve

20/20 successful consecutive cases

10% moderate or severe commissural misalignment 
Evolut R™/PRO Valve

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

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

AN2 chart

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

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REFERENCES

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

The ACURATE IDE LBCT, TCCT 2024, Dr. M. Reardon

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