Evidence map›Paper›PMID 36250307›Full record

ArticleEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2023

ACURATE neo2 versus SAPIEN 3 Ultra for transcatheter aortic valve implantation.

Costanza Pellegrini, Tobias Rheude, Matthias Renker, Alexander Wolf, Jan Martin Wambach, Hector A Alvarez-Covarrubias, Oliver Dörr, Parminder Singh, Efstratios Charitos, Erion Xhepa and 2 more

Open access · greenAbstract read
In one paragraph

Article in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
6.1field-weighted citation impact, top 3% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Predictors of pacemaker implantation in aortic regurgitation patients treated with a dedicated transcatheter heart valve.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025
    Article
  7. Short-Term Outcomes of ACURATE neo2.Structural heart : the journal of the Heart Team · 2024
    Review
  8. Article
  9. Real-world evidence with the ACURATE neo2: a prelude to the ACURATE IDE trial.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
    Article
  10. Article
  11. Rocky II, Rambo II, and the ACURATE neo2.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023
    Article
  12. Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicenter, observational, post-market surveillance study.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2022
    Article
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

12 authors at 4 institutions in 2 countries.

Costanza PellegriniKlinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.
Tobias RheudeKlinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.
Matthias RenkerDepartment of Cardiology, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany.
Alexander WolfDepartment of Cardiology, Elisabeth Hospital Essen, Essen, Germany.
Jan Martin WambachDepartment of Cardiology, Elisabeth Hospital Essen, Essen, Germany.
Hector A Alvarez-CovarrubiasKlinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.
Oliver DörrDepartment of Cardiology and Angiology, Justus-Liebig University of Giessen and Marburg, Giessen, Germany.
Parminder SinghDepartment of Cardiology and Angiology, Justus-Liebig University of Giessen and Marburg, Giessen, Germany.
Efstratios CharitosDepartment of Cardiology, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany.
Erion XhepaKlinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.
Michael JonerKlinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany.
Won-Keun KimDepartment of Cardiology, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany.
Deutsches Herzzentrum München · DEKerckhoff Klinik · DEElisabeth-Krankenhaus Essen · DECentro Medico Nacional Siglo XXI · MX

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNo comparative data exist with the latest generation self-expanding ACURATE neo2 (Neo2) and the balloon-expandable SAPIEN 3 Ultra (Ultra) transcatheter heart valves (THV).

aimsWe aimed to compare the outcomes after transcatheter aortic valve implantation (TAVI) using the Neo2 and the Ultra THV.

methodsA total of 1,356 patients at 4 centres were treated either with the Neo2 (n=608) or the Ultra (n=748). The primary endpoint was device success according to the latest Valve Academic Research Consortium definitions. The association of the THV used and the primary endpoint was assessed using inverse probability treatment weighting (IPTW) and 1:1 propensity score matching (PSM), which identified 472 matched pairs.  Results: After PSM, there were no relevant differences between the groups. While rates of moderate to severe paravalvular leakage (PVL) were overall low (0.6% vs 1.1%; p=0.725), elevated transvalvular gradients (≥20 mmHg) were less frequent with the Neo2 (2.4% vs 7.7%; p<0.001), which translated into a significantly higher rate of device success with the Neo2 compared with the Ultra (91.9% vs 85.0%; p<0.001). Consistently, the Neo2 was associated with higher rates of device success in the IPTW analysis (odds ratio [OR] 1.961, 95% confidence interval [CI]: 1.269-3.031; p=0.002). Rates of mild PVL were significantly lower with the Ultra compared with the Neo2 (20.0% vs 32.8%; p<0.001). Clinical events at 30 days were comparable between the 2 groups.

conclusionsShort-term outcomes after TAVI using the Neo2 or Ultra THV were excellent and, overall, comparable. However, transvalvular gradients were lower with the Neo2, which translated into higher rates of device success. Rates of mild PVL were significantly lower with the Ultra THV.

Indexed as

Aortic Valve StenosisHeart Valve ProsthesisTranscatheter Aortic Valve ReplacementAortic ValveHumansProsthesis DesignTreatment Outcome

Identifiers

PMID36250307
PMCPMC9853033
OpenAlexW4306670022

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.