Evidence map›Paper›PMID 31150455›Full record

Observational studyPloS one2019

Early versus newer generation transcatheter heart valves for transcatheter aortic valve implantation: Echocardiographic and hemodynamic evaluation of an all-comers study cohort using the dimensionless aortic regurgitation index (AR-index).

Anja Stundl, Hannah Lucht, Jasmin Shamekhi, Marcel Weber, Alexander Sedaghat, Fritz Mellert, Eberhard Grube, Georg Nickenig, Nikos Werner, Jan-Malte Sinning

Open access · goldAbstract readComparative StudyObservational Study
In one paragraph

Observational study in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 14% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Transcatheter aortic valve replacement in heavily calcified aortic valve stenosis: a multicenter comparison.Clinical research in cardiology : official journal of the German Cardiac Society · 2025
    Article
  3. Article
  4. Observational
  5. Short-term outcome after transcatheter aortic valve replacement with a novel balloon-expandable valve.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2023
    Article
  6. Article
  7. Mid-term outcomes of patients with Lotus and Evolut transcatheter valves.Postepy w kardiologii interwencyjnej = Advances in interventional cardiology · 2022
    Article
  8. Article
  9. Article
  10. 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

10 authors at 1 institution in 1 country.

Anja StundlDepartment of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.ORCID 0000-0001-9634-5908
Hannah LuchtDepartment of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
Jasmin ShamekhiDepartment of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
Marcel WeberDepartment of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
Alexander SedaghatDepartment of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
Fritz MellertDepartment of Cardiothoracic Surgery, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
Eberhard GrubeDepartment of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
Georg NickenigDepartment of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
Nikos WernerDepartment of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
Jan-Malte SinningDepartment of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
University Hospital Bonn · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsMore than mild paravalvular aortic regurgitation (pAR) negatively impacts prognosis after transcatheter aortic valve implantation (TAVI). "Newer generation" transcatheter heart valves (THVs) including Direct Flow Medical, Medtronic Evolut R, Boston Lotus, and Edwards SAPIEN 3 valve system promise to improve outcome by reducing the rate of TAVI-related issues such as pAR. Aim was to evaluate and compare the hemodynamic performance with AR index of "early" vs. "newer generation" THVs and its impact on outcome. METHODS AND

resultsIn 805 patients undergoing TAVI, the degree of pAR was assessed using imaging modalities (angiography, echocardiography) and hemodynamic measurements (aortic regurgitation index, ARI ratio). Severity of pAR and outcome were assessed according to the VARC-2 criteria. 805 patients underwent TAVI with use of the CoreValve (n = 400), SAPIEN XT (n = 48), Direct Flow Medical (n = 38), Evolut R (n = 114), Lotus (n = 104), or SAPIEN 3 (n = 101) prosthesis. TTE post TAVI revealed that a total of 7.3% of the patients showed moderate/severe pAR. The occurrence of greater than mild pAR occurred less frequently in patients treated with "newer generation" THVs (p<0.001): CoreValve (11.3%), SAPIEN XT (12.5%), Direct Flow Medical (5.3%), Evolut R (5.3%), Lotus (0.0%), and SAPIEN 3 (0.0%). The AR index was significantly higher (p<0.001) in patients receiving "newer generation" prostheses compared to those in whom "earlier generation" THVs were used. However, the ARI was only predictive of cumulative all-cause mortality at 1 and 3 years in "early generation", but not in "newer generation" THVs. In the overall cohort, 30-day and 1-year mortality was 4.8% and 20.1%, respectively. In patients treated with "newer generation" devices, the respective mortality rates remained substantially below those of patients treated with "earlier generation" THVs (30-day mortality: 2.5% vs. 6.7%, p< 0.001; 1-year mortality: 11.2% vs. 27.2%, p<0.001).

conclusionTAVI with use of "newer generation" THVs showed significantly reduced pAR and improved outcomes compared to "early generation" devices that could at least in part be explained by more favorable hemodynamics.

Indexed as

AgedAged, 80 and overAngiographyAortic ValveAortic Valve InsufficiencyAortic Valve StenosisEchocardiographyFemaleHeart Valve ProsthesisHumansKaplan-Meier EstimateMaleProsthesis DesignRetrospective StudiesSeverity of Illness IndexTranscatheter Aortic Valve Replacement

Identifiers

PMID31150455
PMCPMC6544262
OpenAlexW2947527791

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.