TVT 2021

How ACURATE neo2 improves outcomes

W. Kim, MD
Kerckhoff Heart Center, Bad Nauheim, Germany
 Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a
financial interest/arrangement or affiliation with the organization(s)
listed below.
Affiliation/Financial Relationship Company
Consulting Fees/Honoraria Abbott
Boston Scientific
Edwards Lifesciences
Medtronic
Meril Life Sciences
Advisory Board Boston Scientific, Shockwave Med

Faculty disclosure information can be found on the app

Characteristics of the ACURATE neo platform
 ACURATE neo & PVL
PVL ≥moderate
SAPIEN PARTNER B (N=179) 10.5%
CoreValve CV HIGH RISK (N=299) 6.1%
Lotus RESPOND (N=545) 0.4%
CORELAB!
AS neo 2 AS NEO 2 (N=120) 3.0%
PROGRESS PVL (N=500) 5.0%
SCOPE I (N=361) 9.4%
SCOPE II (N=261) 9.6%

KIM ET AL (N=1000) 3.7%

ACURATE SAVI TF (N=1000) 4.1%
neo MAURI ET AL (N=92) 4.5%
KIM ET AL (N=500) 4.8%
MORENA (N=311) 4.8%
CE 89 (N=89) 4.9%
NEOPRO (N=251) 7.3%
RISPEVA (N=88) 19.0%
0.0% 2.0% 4.0% 6.0% 8.0% 10.0% 12.0% 14.0% 16.0% 18.0% 20.0%
 Limitations of first gen ACURATE neo
Aortic valve
calcification

Annulus range
19 20 21 22 23 24 25 26 27 29

Appropriate
Sizing

Kim et al, JACC Cardiovasc Interv 2019

It is possible to achieve good results using the ACURATE neo!
Variable Quartile 1 Quartile 2 Quartile 3 Quartile 4 p
(Case 1–250) (Case 251–500) (Case 501–750) (Case 751-1000)

Cover index (%) 3.87 [1.86; 5.13 [3.04; 5.38 [3.39; 6.17 [4.20; <0.001
6.37] 7.30] 7.52] 7.90]
Aortic valve calcium score 2395 [1646; 2049 [1494; 1955 [1385; 1989 [1280; <0.001
(AU) 3111] 2872] 2893] 2726]
Compact peri-annular Ca++ 64 (25.6%) 41 (16.4%) 42 (16.8%) 29 (11.6%) 0.001
formation
Implantation depth at LCC 5.0 [3.0; 6.0] 6.0 [5.0; 7.0] 6.0 [4.0; 6.0] 5.0 [4.0; 6.0] <0.001
(mm)
Device success (VARC-2) 171 (85.5%) 177 (88.5%) 181 (90.5%) 186 (93.0%) 0.002

≥moderate PVL 18/243 (7.4%) 7/241 (2.9%) 9/246 (3.7%) 2/246 (0.8%) 0.001

Permanent pacemaker 25 (10.0%) 26 (10.4%) 26 (10.4%) 17 (6.8%) 0.444

Kim et al. Am J Cardiol 2020

The Acurate neo2 valve
 The Early neo2 registry

• Investigator-initiated European registry

• 554 consecutive TAVI cases using Acurate neo2 from
September 2020 to March 2021
• Database at Karolinska
• Imaging core-lab at CORRIB, Galway, Ireland
• This is the first large dataset on the Acurate neo2 prosthesis
 Early neo2 registry centers
Center Site PI n
Kerkhoff Klinik, Bad Nauheim Won-Keun Kim 142
Karolinska, Stockholm Chris Meduri 86
Herzzentrum Leipzig Mohamed Abdel-Wahab 77
HDZ NRW, Bad Oeynhausen Tanja Rudolph 48
Elisabeth-Krankenhaus, Essen Alexander Wolf 40
Rigshospitalet, Copenhagen Ole de Backer 35
Medizinische Universität Wien Christian Hengstenberg 31
University Hospital Helsinki Mika Laine 28
SUS, Lund Henrik Bjursten 25
DHZ München Costanza Pellegrini 20
Kantonsspital Luzern Stefan Toggweiler 15
University Medical Center Groningen Joanna Wykrzykowska 7
 Baseline data
N=554
Age 82
Female % 66
Atrial fibrillation % 38
Prior pacemaker % 10
EuroScore II 4,5
STS score 3,7
LVEF % 56
Aortic mean gradient 43
Bicuspid % 3
Valve-in-valve % 2
 Procedural data

Procedural data N=554 Acurate neo2 size

General anesthesia % 0.2
Small
Femoral access % 99.6 (23 mm)
21%
Predilatation % 87.0

Postdilatation % 36.0
Large Medium
Anulus size mm (average) 23.7 (27 mm) (25 mm)
38% 41%
 Procedural complications

Complications N=554

Second valve implanted % 0.9

Annular rupture % 0

Coronary obstruction % 0

Intraprocedural death % 0.2

Major vascular complication (in-hospital) % 3.4

Major or life-threatening bleeding (in-hospital) % 4.8

Acute kidney injury (AKIN grade 3) % 0.2

 Primary outcomes
Paravalvular leak
Primary outcomes 100% 2.7
Paravalvular leak >mild % * 2.7 90%
80% 37.6
Postoperative mean gradient (mmHg) * 8 70%
60% 2
New pacemaker % 6.0
50% 1
Mortality 30 days % 1.3 40% 0
30% 59.6
Stroke in-hospital % ** 2.1 20%
10%
* 85% of patients had echo available to core-lab
0%
** Major and minor stroke
 A glimpse from 4 German centers: Neo2 vs. Ultra
Neo 2 Ultra P-value
n=146 N=477
Pre-dilatation 106 (72.6) 165 (34.6) <0.001
Post-dilatation 56 (38.4) 67 (14.0) <0.001
AR II+ at angiography 2 (1.4) 6 (1.3) 0.072
Procedural mortality 0 (0) 0 (0) -
Conversion to surgery 1 (0.7) 3 (0.6) 0.999
Mean transvalvular gradient 8.8±3.3 13.3±4.8 <0.001
Elevated gradients (≥20mmHg) 1 (0.7) 44 (9.4) 0.001
Major vascular complication 8 (5.5) 57 (12.0) 0.026
All stroke 6 (4.1) 16 (3.4) 0.658
New pacemaker implantation 8 (6.1) 39 (9.0) 0.286
 ACURATE neo2 - Kerckhoff experience (n=256)
Increasing
calcification

p<0.001
First half Second half
(n=128) (n=128)

Moderate paravalvular 2 (1.6%) 1 (0.8%)

leakage

Device success (VARC-2) 124 (96.9%) 122 (95.3%)

Suitability of ACURATE neo vs. neo2

Limiting factors:
Limiting factors:
Extreme
Calcification
Calcification (?)
Annulus size
Annulus size

PVL ≥moderate PVL ≥moderate

5 - 10% 2 - 5%

PVL ≥moderate PVL ≥moderate

<1% <1%
Ongoing/upcoming studies with ACURATE neo2
ACURATE IDE trial
Study Study Status Description
cohort
ACURATE IDE n=1500 Enroling (n=543) 1:1 randomization vs. Evolut
trial R/PRO or SAPIEN 3 device

ASneo2 PMCF n=200 Enroling (n=50) Post TAVR CT at 30 days and 1

registry year

ACURATE neo2 n=2000 Study initiation in Investigator initiiated study

European registry Q4 2021
 Key learnings for the ACURATE neo2
• The ACURATE neo2 demonstrates promising results. The „Achilles`
heel“ of the first generation has been addressed without
compromising the other favorable attributes – including
• ease of use
• hemodynamic stability throughout deployment
• flexible delivery system
• suitable for horizontal aorta
• low pacemaker rates
• low gradients
• low risk of coronary obstruction
• easy coronary reaccess

=> This and future iterations could make it the most promising THV
system!
Thank you!
 Cases with moderate PVL
1

Echo 3 months
2