Clinical Research in Cardiology

https://doi.org/10.1007/s00392-023-02194-4

ORIGINAL PAPER

Multicenter comparison of transcatheter aortic valve implantation

with the self‑expanding ACU​RAT​E neo2 versus Evolut
PRO transcatheter heart valves
Tobias Rheude1 · Costanza Pellegrini1 · Martin Landt2 · Sabine Bleiziffer3 · Alexander Wolf4 · Matthias Renker5 ·
Jonas Neuser6 · Oliver Dörr7 · Abdelhakim Allali2 · Tanja K. Rudolph3 · Jan Martin Wambach4 · Julian D. Widder6 ·
Parminder Singh7 · Dominik Berliner6 · Hector A. Alvarez‑Covarrubias1,8 · Gert Richardt2 · Erion Xhepa1 ·
Won‑Keun Kim5 · Michael Joner1,9

Received: 20 October 2022 / Accepted: 27 March 2023

© The Author(s) 2023

Abstract
Background New-generation self-expanding transcatheter aortic heart valves (THV) were designed to overcome technical
constraints of their preceding generations. We sought to compare the efficacy and safety of the self-expanding ACU​RAT​E
neo2 (Neo2) versus Evolut PRO (PRO) devices.
Methods Seven hundred nine patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) with either
Neo2 (n = 496) or PRO (n = 213) were included. Propensity score matching (PSM) was performed to account for differences
in baseline characteristics. In-hospital and 30-day clinical outcomes were evaluated according to Valve Academic Research
Consortium-3 criteria.
Results Baseline characteristics were comparable between both groups after PSM (Neo2: n = 155, Evolut Pro: n = 155).
Technical success rates were high in both groups (Neo2: 94.8% vs PRO: 97.4%; p = 0.239). Need for permanent pacemaker
implantation was less frequent with Neo2 compared with PRO (7.5% vs 20.6%; p = 0.002), whereas major vascular
complications were more frequent with Neo2 (Neo2: 11.6% vs PRO: 4.5%; p = 0.022). Intended valve performance at
discharge was high in both groups without relevant differences among groups (Neo2: 97.4% vs. 95.3%; p = 0.328).
Conclusions Short-term outcomes after TAVI using latest-generation self-expanding THV were excellent, with overall low
rates of adverse events. However, Neo2 was associated with lower pacemaker rates and reduced the prevalence of moderate–
severe paravalvular leakage. Transprosthetic gradients after TAVI were higher with Neo2 compared with PRO.

Tobias Rheude and Costanza Pellegrini shared first authors.

Extended author information available on the last page of the article

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 Clinical Research in Cardiology

Graphical abstract

Keywords Transcatheter aortic valve implantation · Transcatheter heart valves · Self-expanding · ACU​RAT​E Neo2 · Evolut
PRO

Abbreviations showed excellent results even in younger patients at low

CHF Congestive heart failure surgical risk [5, 6].
EuroSCORE European System for Cardiac Operative Currently, both, self-expanding (SE) and balloon-
Risk Evaluation expandable (BE) THV platforms are used on a global scale
NYHA New York Heart Association based on excellent results from several randomized trials and
PPI Permanent pacemaker implantation large multicenter registries over the last years, supporting
PSM Propensity score matching their broad application [7, 8]. Among them, the SCOPE
PVL Paravalvular leakage 2 randomized trial assigned patients with severe aortic
TAVI Transcatheter aortic valve implantation valve stenosis to receive treatment with either ACU​RAT​E
THV Transcatheter heart valves neo (Neo, Boston Scientific, Marlborough, MA, USA) or
VARC​ Valve Academic Research Consortium Evolut (Medtronic Inc., Minneapolis, MN, USA) SE-THV
systems [7]. The Neo THV did not meet the prespecified
non-inferiority criteria with regard to all-cause mortality or
stroke at one year as compared to the Evolut THV platform
Introduction and was further associated with elevated rates of moderate
or severe aortic regurgitation at 30 days [7].
Transcatheter aortic valve implantation (TAVI) is an New iterations of both SE-THV platforms became
established treatment option for older patients with recently available, the ACU​RAT​E neo2 (Neo2) and the
symptomatic severe aortic valve stenosis across the entire Evolut PRO (PRO), to address limitations of earlier-
spectrum of surgical risk [1]. Refinement of procedural generation devices, mainly paravalvular leakage (PVL) and
techniques and continuous device iteration played major need for permanent pacemaker implantation (PPI). Despite
roles in improving efficacy and safety of TAVI procedures, their broad application and very promising early results
resulting in improved outcomes [2–4]. Recent studies [9–11], comparative data are scarce.

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Against this background, the purpose of this multicenter data collection per local practice. The study was approved
real-world study was to compare the performance of the by local ethics committees of the participating centers and
latest-generation self-expanding Neo2 versus PRO THV complied with the Declaration of Helsinki.
systems.
Device description

Methods The THVs used in this study have been described in detail
previously [10]. In brief, ACU​RAT​E Neo2 was granted
Study population and procedures Conformité Européenne (CE) mark in April 2020 based
on the results of the Neo2 CE-mark study [10]. Like its
In this analysis, a total of 709 patients with symptomatic, predecessor, Neo2 is composed of a nitinol frame with
severe native aortic valve stenosis undergoing transfemoral axial, self-aligning stabilization arches and featuring supra-
TAVI using Neo2 (n = 496) or PRO (n = 213) at seven annular porcine pericardium leaflets. This new iteration was
centers in Germany (German Heart Center Munich; Heart designed with a revised annular sealing technology designed
Center, Segeberger Kliniken, Bad Segeberg; Heart and to conform to irregular, calcified anatomies and an extended
Diabetes Center North Rhine-Westphalia, Bad Oeynhausen; sealing skirt covering the entire waist of the stent, with the
Kerckhoff Heart Center, Bad Nauheim; Hannover Medical purpose to further reduce PVL. Moreover, a new radiopaque
School, Hannover; Department of Cardiology, Elisabeth positioning marker was implemented to help navigate during
Hospital Essen; Department of Cardiology and Angiology, valve positioning. Similar to its predecessor, the Neo2 valve
University of Giessen) between August 2017 and September is available in 3 sizes (small, medium and large), covering
2021 were retrospectively selected (Fig. 1). All patients an annulus range from 21 to 27 mm.
were discussed by a local multidisciplinary heart team and The Evolut PRO THV is fabricated from porcine
found eligible for transfemoral TAVI. Patients underwent pericardial tissue, sutured in a supra-annular position into
off-line analysis of multi-slice computed tomography a self-expanding Nitinol frame. It adds an outer porcine
(MSCT) using 3-mensio software (Pie Medical, Maastricht, pericardial wrap over the first 1.5 cells to enhance annular
Netherlands). Patients were treated in a hybrid operation sealing and further reduce the incidence of PVL. It is
theatre either in conscious sedation or general anesthesia. repositionable and can be partially or fully recaptured until
Procedures were performed according to international released from the delivery system to assist with optimal
standards. Valve selection was left to the discretion of the positioning [12]. The valve is available in 3 sizes (23, 26
operators performing the procedure. All patients provided and 29 mm), covering an annulus range from 18 to 26 mm.
written informed consent for the procedure and subsequent

Fig. 1  Study flow chart. LVEF

left ventricular ejection fraction,
NYHA New York Heart
Association, TAVI transcatheter
aortic valve implantation, eGFR
estimated glomerular filtration
rate

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Definition of endpoints glomerular filtration rate (eGFR), left ventricular ejection

fraction (LVEF), mean transvalvular gradient and severe
Data were acquired during hospital stay and visits at the aortic valve calcification.
outpatient clinic, review of hospital records, contact of A 2-sided p value < 0.05 was considered statistically
primary care physician, or by direct contact with the significant. Statistical analyses were performed using R
patient or her/his relatives at each center and collected in (Version 4.1.3, R Foundation for Statistical Computing,
individual institutional databases. Data were consolidated in Vienna, Austria) and IBM SPSS Statistics (Version 28.0 for
a joined database for statistical analyses. Collection involved Macintosh, IBM Corp., Armonk, NY, USA).
demographic information, symptoms and co-morbidities,
procedural data, as well as clinical and imaging assessment
(echocardiography and computed tomography). Adverse Results
clinical events were recorded throughout the follow-up
period of 30 days after TAVI and procedural data, in-hospital Baseline patient characteristics
complications and clinical endpoints were categorized
according to Valve Academic Research Consortium A total of 709 patients undergoing transfemoral TAVI with
(VARC)-3 criteria [13]. Transthoracic echocardiography was either self-expanding Neo2 (n = 496) or PRO (n = 213)
conducted after TAVI prior to discharge. PVL was graded THVs were included in this analysis. Baseline characteristics
based on transthoracic echocardiography according to a are displayed in Table 1. In the entire cohort, patients treated
3-class scheme as follows: none or trace, mild, moderate with Neo2 presented more frequently with NYHA class
or severe. Aortic valve calcification was visually graded III/IV (68.5% vs. 60.6%; p = 0.046), had higher rates of
as mild, moderate or severe based on baseline computed diabetes (34.3% vs. 23.9%; p = 0.006) and peripheral artery
tomography. disease (14.5% vs. 5.6%; p = 0.001), a better renal function
(eGFR: 65 ml vs. 53 ml; p < 0.001), a better LVEF (60%
Statistical analysis vs. 55%; p < 0.001) and lower mean transvalvular gradients
(42 mmHg vs. 47 mmHg; p < 0.001). Rates of severe aortic
Continuous variables are presented as mean with valve calcification were significantly higher with PRO
standard deviation or median with interquartile range and compared with Neo2 (46.0% vs. 10.7%; p < 0.001), whereas
compared using Student’s t test or Mann–Whitney U test, bicuspid valves were equally distributed (Neo2: 3.6% vs.
as appropriate. Categorical variables are expressed as PRO: 2.8%; p = 0.658). A 1-to-1 propensity-score-matching
frequencies and proportions and compared using the Chi- analysis resulted in a total of 155 matched pairs (n = 310
square or Fisher’s exact test, as appropriate. Adverse events patients in total). As shown in Table 1, there was no relevant
are reported as crude rates up to 30 days after TAVI. Event difference in any baseline characteristic among both groups.
probabilities were compared for patients treated with Neo2
versus PRO using Cox proportional hazard regression Procedural characteristics and clinical outcomes
analysis. Hazard ratios (HR) with their corresponding 95%
confidence interval (CI) were computed. Procedural characteristics and VARC-3 defined clinical
To account for differences in baseline characteristics outcomes of the matched cohort are depicted in Table 2. Pre-
and the effect of a potential selection bias, propensity dilatation prior to valve implantation was more frequently
score matching (PSM) was performed using the R package performed with Neo2 compared with PRO (94.2% vs.
“MatchIt” (Version 4.1.0, R Foundation for Statistical 56.1%; p < 0.001). Moreover, contrast agent volume was
Computing, Vienna, Austria). A one-to-one nearest neighbor significantly lower with Neo2 compared with PRO (40 ml
matching algorithm was used to identify one control case vs. 97 ml; p < 0.001).
treated with Neo2 (n = 155) for each case treated with PRO Technical success rates were high in both groups (Neo2:
(n = 155). Missing baseline data were imputed using the 94.8% vs. PRO: 97.4%; p = 0.239; Figs. 2 and 3). Need
predictive mean matching function (R package “Mice”, for PPI was significantly lower in patients treated with
version 3.13.0). Baseline, electrocardiographic and imaging Neo2 compared with PRO (7.5% vs. 20.6%; p = 0.002;
characteristics (echocardiography or computed tomography) Figs. 2 and 3). Third-degree atrioventricular block was
showing significant univariate differences between both the most frequent indication in 78% of cases (29/37).
groups or with known influence on outcome were included Of note, cusp overlap technique was only used in one-
in the matching algorithm. These variables were: logistic third of patients treated with PRO (48/153). Moreover,
European System for Cardiac Operative Risk Evaluation major vascular complications were more frequent with
(Euro-)SCORE, New York Heart Association (NYHA) class Neo2 (Neo2: 11.6% vs. PRO: 4.5%; p = 0.022). Rates of
III/IV, diabetes mellitus, peripheral artery disease, estimated

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Table 1  Baseline characteristics

Entire cohort (n = 709) Matched cohort (n = 310)
Neo2 (n = 496) PRO p value Neo2 (n = 155) PRO (n = 155) p value
(n = 213)

Age (years) 82 [79–85] 82 [79–85] 0.395 82 [78–85] 82 [79–85] 0.677

Female gender 240 (48.4) 115 (54.0) 0.190 85 (54.8) 87 (56.1) 0.909
Body Mass Index (kg/m2) 26.5 [23.7–29.7] 26.5 [23.8– 0.827 25.7 [23.2–29.0] 26.5 [23.6–29.9] 0.127
29.9]
Logistic EuroSCORE (%) 14.4 [8.1–23.1] 12.0 0.102 11.4 [6.7–20.3] 11.4 [8.0–20.0] 0.730
[8.0–21.2]
NYHA class III/IV 340 (68.5) 129 (60.6) 0.046 91 (58.7) 101 (65.2) 0.292
Arterial hypertension 432 (87.1) 189 (88.7) 0.620 128 (82.6) 137 (88.4) 0.197
Diabetes mellitus 170 (34.3) 51 (23.9) 0.006 37 (23.9) 39 (25.2) 0.895
Coronary artery disease 303 (61.1) 122 (57.3) 0.358 93 (60.0) 91 (58.7) 0.908
Previous percutaneous coronary 172 (34.7) 73 (34.3) 0.932 52 (33.5) 50 (32.3) 0.904
intervention
Previous coronary artery bypass 36 (7.3) 14 (6.6) 0.873 11 (7.1) 11 (7.1) > 0.99
grafting
Previous myocardial infarction 44 (8.9) 16 (7.5) 0.659 12 (7.7) 10 (6.5) 0.826
Previous stroke 63 (12.7) 17 (8.0) 0.071 16 (10.3) 12 (7.7) 0.553
Chronic obstructive pulmonary disease 64 (12.9) 20 (9.4) 0.206 10 (6.5) 14 (9.0) 0.525
Peripheral artery disease 72 (14.5) 12 (5.6) 0.001 9 (5.8) 10 (6.5) > 0.99
eGFR (ml/min/1.73m2)* 65 [48–84] 53 [39–71] < 0.001 56 [43–75] 55 [42–74] 0.743
Previous pacemaker 58 (11.7) 26 (12.2) 0.899 21 (13.5) 24 (15.5) 0.747
Atrial fibrillation 203 (40.9) 79 (37.1) 0.358 69 (44.5) 54 (34.8) 0.104
Left bundle branch block 49 (9.9) 18 (8.6) 0.674 22 (14.2) 14 (9.0) 0.214
Right bundle branch block 52 (10.5) 19 (9.0) 0.681 17 (11.0) 13 (8.4) 0.565
Mean transvalvular gradient (mmHg) 42 [32–50] 47 [39–57] < 0.001 46 [39–56] 45 [37–56] 0.924
Left ventricular ejection fraction (%) 60 [55–65] 55 [52–60] < 0.001 60 [54–65] 56 [55–60] 0.055
Bicuspid valve 18 (3.6) 6 (2.8) 0.658 10 (6.5) 4 (2.6) 0.170
Mean aortic annulus diameter (mm) 23.6 [22.3–24.8] 24.0 [23.0– 0.555 23.6 [22.4–24.8] 23.8 [23.0–24.2] 0.748
25.0]
Severe aortic valve calcification 53 (10.7) 98 (46.0) < 0.001 47 (30.3) 51 (32.9) 0.714

Data are median [interquartile range] or n (%)

eGFR estimated glomerular filtration rate, EuroSCORE European System for Cardiac Operative Risk Evaluation, NYHA New York Heart
Association
*Available in n = 655

further peri-procedural complications were overall low The VARC-3 defined composite endpoint device
and comparable with both devices (Fig. 3). success at 30 days was overall high in both THVs, without
Intended valve performance at discharge was high in significant differences (Neo2: 91.6% vs. PRO: 91.6%;
both groups without relevant differences (Neo2: 97.4% p > 0.99; Table 2).
vs. 95.3%; p = 0.328; Figs. 2 and 3). Of note, rates of
moderate–severe PVL were higher with PRO as compared
Discussion
with Neo2 (4.6% vs. 0.6%; p = 0.036). Consistently, rates of
none or trace PVL were also higher with Neo2 compared This multicentric study compared new-generation self-
with PRO (67.5% vs. 49.0%; p = 0.001). However, slightly expanding transcatheter heart valves for transcatheter aortic
increased mean transprosthetic gradients were found with valve implantation. The main results can be summarized
Neo2 (Neo2: 9 [7–12] mmHg vs. PRO: 8 [6–11] mmHg; as follows: (1) Technical success rate was high with Neo2
p = 0.001), with higher rates of elevated mean transprosthetic and PRO THVs, (2) Permanent pacemaker rates after TAVI
gradients ≥ 20 mmHg (Neo2: 1.9% (3/153) vs. PRO: 0% were higher after PRO implantation, whereas major vascular
(0/148); p = 0.055). complications were more frequent with Neo2, (3) Intended

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Table 2  Procedural Neo2 Evolut PRO p value

characteristics and clinical
outcomes of the matched cohort Procedural characteristics
Valve size
Small 31 (20.0)
Medium 74 (47.7)
Large 50 (32.3)
23 mm –
26 mm 40 (25.8)
29 mm 115 (74.2)
Conscious sedation 154 (99.4) 115/117 (98.3) 0.579
Pre-dilatation 146 (94.2) 87 (56.1) < 0.001
Post-dilatation 81 (52.3) 63 (40.6) 0.040
Procedural time (min) 48 [37–62] 53 [45–66] 0.003
Fluoroscopy time (min) 10.7 [8.1–14.2] 9.5 [7.1–13.1] 0.045
Contrast agent (ml) 40 [24–145] 97 [82–128] < 0.001
Clinical outcomes
Technical success (VARC-3) 147 (94.8) 151 (97.4) 0.239
Intended valve performance (VARC-3) 149 (97.4) 141 (95.3) 0.328
Device success (VARC-3) 142 (91.6) 142 (91.6) > 0.99
Procedural mortality 0 0 –
Correct implant position 154 (99.4) 154 (99.4) > 0.99
Second THV implanted 0 2 (1.3) 0.498
Annular rupture 0 0 –
Coronary obstruction 1 (0.6) 0 > 0.99
Conversion to open heart surgery 0 0 –
Major vascular complications 18 (11.6) 7 (4.5) 0.022
All stroke 3 (1.9) 6 (3.9) 0.501
New permanent pacemaker implantation* 10/134 (7.5) 27/131 (20.6) 0.002
Bleeding type 3/4 (VARC-3) 9 (5.8) 4 (2.6) 0.157
Myocardial infarction 0 0 –
Acute kidney injury stage 2/3 9 (5.8) 5 (3.2) 0.274
Echocardiographic outcomes
Mean transvalvular gradient 9 [7–12] 8 [6–11] 0.001
Mean gradient ≥ 20 mmHg 3/153 (1.9) 0/148 (0) 0.055
Moderate to severe PVL 1/154 (0.6) 7/153 (4.6) 0.036

Data are median [interquartile range] or n (%)

PCI percutaneous coronary intervention, PVL paravalvular leakage, THV transcatheter heart valve, VARC​
Valve Academic Research Consortium
*Excluding patients with pacemaker at baseline

valve performance at discharge was high with both THVs. In in a supra-annular position display several advantages,
this regard, rates of moderate–severe PVL after TAVI were especially in certain subgroups of patients [14]; nevertheless
higher, whereas transprosthetic gradients were lower with elevated rates of significant PVL compared with balloon-
PRO compared with Neo2. expandable platforms belong to the drawbacks of earlier-
Accumulating evidence with different THV platforms for generation SE-THVs [15, 16]. Both new iterations, Neo2
the treatment of patients with severe aortic stenosis across and PRO were designed with a revised annular sealing skirt
the entire risk spectrum led to a continuous increase of aiming at further reduction of PVL rates after TAVI. Indeed,
TAVI procedures on a global scale. Widespread use of TAVI recent data from large multicenter registries demonstrated
has been paralleled by technical refinement of available that improved annular sealing properties of the Neo2 were
THVs aimed at improving procedural safety and efficacy associated with a threefold lower frequency of moderate
[3, 4, 9, 11]. Self-expanding THVs with their deployment or greater PVL compared with the preceding Neo THV [3,

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Fig. 2  Major findings after transcatheter aortic valve implantation with ACU​RAT​E neo2 versus Evolut PRO

Fig. 3  VARC-3 defined procedural complications and clinical outcomes. PVL paravalvular leakage, PPI permanent pacemaker implantation,
VARC Valve Academic Research Consortium

9]. Of note, the aforementioned advantage with regard to The VARC-3 defined composite endpoint technical
PVL was not counterbalanced by an elevated pacemaker success was high with both self-expanding THVs. The
rate, which was numerically even lower in patients treated majority of peri-procedural and in-hospital complications
with Neo2 [3, 9]. Likewise, technical refinements with were overall low and consistent with previous studies [3,
Medtronic’s latest-generation THV, the Evolut PRO valve, 9, 11, 18], without relevant differences between the two
resulted in very low rates of relevant PVL, while maintaining treatment groups. However, the need for PPI after TAVI
excellent hemodynamic performance as compared to remains one of the major obstacles, even with current-
the preceding generations in a large analysis with 18,874 generation devices, with a pooled incidence of 19%
patients from the Society of Cardiac Surgeons (STS)/ according to a recent meta-analysis [19, 20]. In our analysis,
American College of Cardiology (ACC) TVT Registry [17]. PPI rates after TAVI were significantly higher with PRO

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compared with Neo2. The 8% PPI rate with Neo2 in our greater PVL adversely impacts on prognosis, including
study confirms recent data from other registries [3, 9]. The elevated rates of heart failure-related re-hospitalizations,
rate of new PPI after PRO implantation observed in our valve re-interventions and mortality up to seven years
study is by trend higher as compared with previous studies after TAVI [29–31]. As the impact of mild PVL remains
ranging from 11.8 to 13.2% [18, 21]. Of note, continuous a matter of debate and might have detrimental effects
decrease of PPI rates was observed with device iterations in certain subgroups of patients [29, 32], and the given
of Medtronic’s THV platform with up to 38% in first- expansion to treat younger, lower-risk patients, post-
generation CoreValve [16], up to 20% in second-generation procedural PVL should be eliminated completely to
Evolut R [22] and up to 12% in latest-generation generation compete with surgical aortic valve replacement. In this
Evolut PRO in the Evolut PRO US Clinical Study [21]. This regard, significantly more patients treated with Neo2
might not only be explained by technical refinements, but had none or trace PVL after TAVI. Post-procedural
also by improved implantation techniques, such as the cusp transprosthetic gradients were overall low with both self-
overlap technique aimed at high valve implantation relative expanding THV platforms, although mean transprosthetic
to the membranous septum in proximity to the non-coronary gradients and rates of elevated transprosthetic gradients
cusp [23]. This technique helped to minimize conduction (≥ 20 mmHg) were lower after PRO implantation as
disturbances and indeed resulted in significantly reduced compared to Neo2. Our results are consistent with previous
PPI rates after TAVI when compared with the classical studies investigating the hemodynamic performance of the
implantation technique [24, 25]. However, it was only preceding generation of the given SE-THV platforms with
used in one-third of patients treated with Evolut PRO in lowest gradients after implantation of Medtronic’s THV
this multi-center all-comers study. Although pacemaker platform [33]. Bioprosthetic valve dysfunction with or
dependency rates among patients receiving PPI after TAVI without hemodynamic changes is complex with various
were just around 33–36% at one year [26], adverse effects underlying pathologies and mechanisms, as illustrated by
have been reported in these patients including reduced left updated VARC-3 criteria [13], and the impact of elevated
ventricular function as well as an increased risk for heart post-procedural transprosthetic gradients with regard to
failure hospitalizations and all-cause mortality at 1 year clinical outcomes and valve durability remains a matter
[27]. As even new left bundle branch block after TAVI has of debate and should be investigated in further studies
already been associated with an increased risk of all-cause [34–36].
death and heart failure hospitalization at 1-year follow-up
in a large meta-analysis, further research is required to
overcome this limitation of current-generation devices,
especially in certain subgroups with an elevated risk for Limitations
PPI after TAVI [27]. Rates of major vascular complications
were more frequent in the Neo2-group. Previous studies This observational, multicenter study exhibits the inherent
investigating the Neo2 THV system reported lower rates limitations of a retrospective, non-randomized study design.
of major vascular complication rates up to 6.0% [3, 9, 10]. Severe aortic valve calcification was more frequent in the
Peripheral artery disease was significantly more common PRO-group of the entire population and well balanced
in the entire population and balanced between both groups between both groups after propensity score matching.
after matching. As adverse events were site reported in this Nevertheless, details regarding certain characteristics of
multicenter registry, individual data are not available to calcification patterns, such as distribution of calcification
further illuminate this finding. (symmetric versus asymmetric, valvular versus LVOT
Intended valve performance at discharge was high with calcification), degree of oversizing or implantation depth
both devices, without relevant differences. As depicted were not available and might have impacted on results,
in Fig. 3, rates of moderate or greater PVL after TAVI especially rates of residual PVL. Pre-procedural CT imaging
were lower with Neo2 compared to Evolut PRO. The low data of the access vasculature regarding diameters of the
rates of moderate or greater PVL in the Neo2 group are in ilio-femoral arteries, tortuosity and calcification were not
line with recent data from several international registries available to further illuminate the different vascular
ranging from 0.6 to 3.5% [9–11, 28], with convincing complication rates. Moreover, the influence of additional
data even in more challenging calcific anatomies [3]. unknown confounders cannot be excluded, despite rigorous
This indicates that other risk factors beyond calcification matching algorithms. There was no core laboratory analysis
might impact on residual PVL after successful THV of echocardiographic findings. A dedicated implantation
implantation. The fact that technical refinements translate approach (SLIM) was used at one center only and might have
into better valve performance is of utmost clinical introduced bias with regard to significantly lower contrast
relevance as there is clear evidence that moderate or amount in the Neo2-group, as it was predominantly used

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in Neo2 cases. Although clinical events were categorized 3. Scotti A, Pagnesi M, Kim W-K et al (2022) Haemodynamic
according to standardized VARC-3 definitions, events performance and clinical outcomes of transcatheter aortic
valve replacement with the self-expanding ACU​RAT​E neo2.
were not adjudicated by an independent event adjudication EuroIntervention 18:804–811
committee. Event numbers were overall low; thus the 4. Rheude T, Pellegrini C, Lutz J et al (2020) Transcatheter aortic
results of this analysis should be interpreted with caution valve replacement with balloon-expandable valves: comparison
and should be confirmed in adequately powered prospective, of SAPIEN 3 ultra versus SAPIEN 3. JACC Cardiovasc Interv
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Short-term outcomes after TAVI with latest-generation 7. Tamburino C, Bleiziffer S, Thiele H et al (2020) Comparison
self-expanding THVs were excellent with overall low of self-expanding bioprostheses for transcatheter aortic valve
rates of adverse events. Implantation of ACU​RAT​E neo2 replacement in patients with symptomatic severe aortic stenosis:
SCOPE 2 randomized clinical trial. Circulation 142:2431–2442
was associated with lower pacemaker rates and reduced 8. Lanz J, Kim W-K, Walther T et al (2019) Safety and efficacy
prevalence of moderate-severe paravalvular leakage. Evolut of a self-expanding versus a balloon-expandable bioprosthesis
PRO showed lower transprosthetic gradients compared to for transcatheter aortic valve replacement in patients with
ACU​RAT​E neo2. symptomatic severe aortic stenosis: a randomised non-inferiority
trial. Lancet 394:1619–1628
9. Buono A, Gorla R, Ielasi A et al (2022) Transcatheter aortic valve
Declarations replacement with self-expanding ACU​RAT​E neo2: postprocedural
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AstraZeneca. AA is a proctor and consultant for Boston Scientific. 10. Möllmann H, Holzhey DM, Hilker M et al (2021) The ACU​RAT​
TKR: Speaker’ honoraria from Medtronic and Boston Scientific. E neo2 valve system for transcatheter aortic valve implantation:
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Authors and Affiliations

Tobias Rheude1 · Costanza Pellegrini1 · Martin Landt2 · Sabine Bleiziffer3 · Alexander Wolf4 · Matthias Renker5 ·
Jonas Neuser6 · Oliver Dörr7 · Abdelhakim Allali2 · Tanja K. Rudolph3 · Jan Martin Wambach4 · Julian D. Widder6 ·
Parminder Singh7 · Dominik Berliner6 · Hector A. Alvarez‑Covarrubias1,8 · Gert Richardt2 · Erion Xhepa1 ·
Won‑Keun Kim5 · Michael Joner1,9

5
* Michael Joner Department of Cardiology, Kerckhoff Heart Center,
[email protected] Bad Nauheim, Germany
6
1 Department of Cardiology and Angiology, Hannover Medical
Klinik für Herz- und Kreislauferkrankungen, Deutsches
School, Hannover, Germany
Herzzentrum München, Technische Universität München,
7
Lazarettstr. 36, 80636 Munich, Germany Medical Clinic I, Department of Cardiology and Angiology,
2 University of Giessen, Giessen, Germany
Heart Center, Segeberger Kliniken, Bad Segeberg, Germany
8
3 Hospital de Cardiología, Centro Médico Nacional Siglo XXI,
Heart and Diabetes Center North Rhine-Westphalia,
IMSS, Cd. de México, México
Bad Oeynhausen, Germany
9
4 DZHK (German Center for Cardiovascular Research),
Department of Cardiology, Elisabeth Hospital Essen, Essen,
Partner Site Munich Heart Alliance, Munich, Germany
Germany

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