Evidence map›Paper›PMID 34148125›Full record

ArticleClinical research in cardiology : official journal of the German Cardiac Society2021

The ACURATE neo2 valve system for transcatheter aortic valve implantation: 30-day and 1-year outcomes.

Helge Möllmann, David M Holzhey, Michael Hilker, Stefan Toggweiler, Ulrich Schäfer, Hendrik Treede, Michael Joner, Lars Søndergaard, Thomas Christen, Dominic J Allocco and 1 more

Open access · hybridAbstract readClinical StudyMulticenter Study
In one paragraph

Article in Clinical research in cardiology : official journal of the German Cardiac Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
7.1field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 59 citations in OpenAlex.

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  14. Five-year outcomes of transcatheter aortic valve implantation with the ACURATE neo2 valve system.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
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  16. Short-Term Outcomes of ACURATE neo2.Structural heart : the journal of the Heart Team · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 10 institutions in 4 countries.

Helge MöllmannDepartment of Internal Medicine I, St.-Johannes-Hospital Dortmund, Johannesstraße 9-13, 44137, Dortmund, Germany. Helge.Moellmann@joho-dortmund.de.
David M HolzheyDepartment of Cardiovascular Surgery, Heart Center Leipzig, Leipzig, Germany.
Michael HilkerKlinik Für Herz-, Thorax und Herznahe Gefäßchirurgie, Universität Regensburg, Regensburg, Germany.
Stefan ToggweilerDepartment of Cardiology, Luzerner Kantonsspital | LUKS, Luzern, Switzerland.
Ulrich SchäferCenter for Internal Medicine, Marienkrankenhaus, Hamburg, Germany.
Hendrik TreedeDepartment of Cardiovascular Surgery, University Hospital Mainz, Mainz, Germany.
Michael JonerDeutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Lars SøndergaardDepartment of Cardiology, Rigshospitalet, Copenhagen, Denmark.
Thomas ChristenBoston Scientific, Marlborough, MA, USA.
Dominic J AlloccoBoston Scientific, Marlborough, MA, USA.
Won-Keun KimDepartment of Cardiology/Cardiac Surgery, Kerckhoff Heart Centre, Bad Nauheim, Germany.
Boston Scientific (United States) · USKerckhoff Klinik · DELeipzig Heart Institute · DELuzerner Kantonsspital · CHMarienkrankenhaus Hamburg · DERigshospitalet · DKSt.-Johannes-Hospital Dortmund · DETechnical University of Munich · DEUniversity Medical Center of the Johannes Gutenberg University Mainz · DEUniversity of Regensburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTranscatheter aortic valve implantation (TAVI) has become standard treatment for elderly patients with symptomatic severe aortic valve stenosis. The ACURATE neo AS study evaluates 30-day and 1-year clinical and hemodynamic outcomes in patients treated with the ACURATE neo2 valve.

methodsThe primary endpoint of this single-arm multicenter study is 30-day all-cause mortality. Other key endpoints include device performance, echocardiographic measures assessed by an independent core laboratory, and VARC-2 clinical efficacy and safety endpoints through 12 months.

resultsThe study enrolled 120 patients (mean age 82.1 ± 4.0 years; 67.5% female, mean baseline STS score 4.8 ± 3.8%). The VARC-2 composite safety endpoint at 30 days occurred in 13.3% of patients. All-cause mortality was 3.3% at 30 days and 11.9% at 1 year. The 30-day stroke rate was 2.5% (disabling stroke 1.7%); there were no new strokes between 30 days and 12 months. The rate of permanent pacemaker implantation was 15.0% (18/120) at 30 days and 17.8% (21/120) at 1 year. No patients required re-intervention for valve-related dysfunction and there were no cases of valve thrombosis or endocarditis. Patients demonstrated significant improvement in mean aortic valve gradient (baseline 38.9 ± 13.1 mmHg, 1 year 7.8 ± 3.5 mmHg; P < 0.001 in a paired analysis). In the overall population, paravalvular leak was evaluated at 1 year as none/trace in 60.5%, mild in 37.0%, and moderate in 2.5%; no patients had severe PVL.

conclusionsOne-year outcomes from the ACURATE neo AS study support the safety and performance of TAVI with the ACURATE neo2 valve.

Indexed as

BioprosthesisAged, 80 and overAortic ValveAortic Valve StenosisEquipment DesignFemaleFollow-Up StudiesGermanyHeart Valve ProsthesisHumansMaleProspective StudiesProsthesis DesignRecovery of FunctionRisk FactorsSeverity of Illness IndexAortic valve stenosisParavalvular regurgitationTranscatheter aortic valve replacementTransfemoral aortic valve implantation

Identifiers

PMID34148125
PMCPMC8639565
OpenAlexW3175536133

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.