Evidence map›Paper›PMID 30737532›Full record

SynthesisClinical research in cardiology : official journal of the German Cardiac Society2019

Transcatheter aortic valve replacement for pure aortic valve regurgitation: "on-label" versus "off-label" use of TAVR devices.

Bernhard Wernly, Sarah Eder, Eliano P Navarese, Daniel Kretzschmar, Marcus Franz, Brunilda Alushi, Frederik Beckhoff, Christian Jung, Michael Lichtenauer, Christian Datz and 5 more

Abstract readMeta-AnalysisReview
PubMed Publisher
In one paragraph

Synthesis in Clinical research in cardiology : official journal of the German Cardiac Society, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Structural Valve Deterioration after Transcatheter Aortic Valve Implantation Using J-Valve: A Long-Term Follow-Up.Annals of thoracic and cardiovascular surgery : official journal of the Association of Thoracic and Cardiovascular Surgeons of Asia · 2020
    Trial
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Eight-Year Clinical Outcomes of Transcatheter Aortic Valve Replacement with J-Valve System.Annals of thoracic and cardiovascular surgery : official journal of the Association of Thoracic and Cardiovascular Surgeons of Asia · 2025
    Article
  11. Multiple Valvular Heart Disease in the Transcatheter Era: A State-of-the-Art Review.Structural heart : the journal of the Heart Team · 2024
    Review
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Contemporary Evaluation and Clinical Treatment Options for Aortic Regurgitation.Journal of cardiovascular development and disease · 2023
    Review
  18. Article
  19. Article
  20. 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

15 authors.

Bernhard WernlyDepartment of Cardiology, Clinic of Internal Medicine II, Paracelsus Medical University of Salzburg, Salzburg, Austria.ORCID http://orcid.org/0000-0003-4024-0220
Sarah EderDepartment of Internal Medicine, Hospital Oberndorf, Teaching Hospital of Paracelsus Medical University Salzburg, Oberndorf, Austria.
Eliano P NavareseInterventional Cardiology and Cardiovascular Medicine Research, Inova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, Falls Church, VA, USA.
Daniel KretzschmarDepartment of Cardiology, Clinic of Internal Medicine I, Universitaetsherzzentrum Thüringen, Friedrich Schiller University Jena, Jena, Germany.
Marcus FranzDepartment of Cardiology, Clinic of Internal Medicine I, Universitaetsherzzentrum Thüringen, Friedrich Schiller University Jena, Jena, Germany.
Brunilda AlushiDepartment of Cardiology, University Heart Center Berlin and Charité University Medicine Berlin, Campus Benjamin-Franklin, Berlin, Germany.
Frederik BeckhoffDepartment of Cardiology, University Heart Center Berlin and Charité University Medicine Berlin, Campus Benjamin-Franklin, Berlin, Germany.
Christian JungDivision of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, University Duesseldorf, Düsseldorf, Germany.
Michael LichtenauerDepartment of Cardiology, Clinic of Internal Medicine II, Paracelsus Medical University of Salzburg, Salzburg, Austria.
Christian DatzDepartment of Internal Medicine, Hospital Oberndorf, Teaching Hospital of Paracelsus Medical University Salzburg, Oberndorf, Austria.
Paul Christian SchulzeDepartment of Cardiology, Clinic of Internal Medicine I, Universitaetsherzzentrum Thüringen, Friedrich Schiller University Jena, Jena, Germany.
Ulf LandmesserDepartment of Cardiology, University Heart Center Berlin and Charité University Medicine Berlin, Campus Benjamin-Franklin, Berlin, Germany.
Uta C HoppeDepartment of Cardiology, Clinic of Internal Medicine II, Paracelsus Medical University of Salzburg, Salzburg, Austria.
Volkmar FalkDepartment of Cardiovascular Surgery, Charite Berlin, Berlin, Germany.
Alexander LautenDepartment of Cardiology, University Heart Center Berlin and Charité University Medicine Berlin, Campus Benjamin-Franklin, Berlin, Germany. alexander.lauten@charite.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTranscatheter aortic valve replacement (TAVR) has become the mainstay of treatment for aortic stenosis in patients with high surgical risk. Pure aortic regurgitation (PAR) is considered a relative contraindication for TAVR; however, TAVR is increasingly performed in PAR patients with unfavorable risk profile. Herein, we aim to summarize available data on TAVR for PAR with special emphasis on "on-label" versus "off-label" TAVR devices. METHODS AND

resultsPubmed was searched for studies of patients undergoing TAVR for PAR. Primary outcome was 30 day-mortality. Pooled estimated event rates were calculated. Twelve studies including a total of 640 patients were identified until December 2017. Among these, 208 (33%) patients were treated with devices with CE-mark approval for PAR ("on-label"; JenaValve and J valve). Overall, the procedural success rate was 89.9% (95% CI 81.1-96.1%; I

conclusionBased on this summary of available observational data TAVR for PAR is feasible and safe in patients deemed inoperable. First-generation TAVR devices are associated with inferior outcome and should be avoided. The "on-label" use of PAR-certified TAVR devices is associated with a significantly higher procedural success rate and might be favorable compared to other second-generation devices.

Indexed as

Aortic ValveAortic Valve InsufficiencyEquipment DesignHumansTranscatheter Aortic Valve ReplacementAortic insufficiencyAortic regurgitationTAVITAVRTranscatheter aortic valve implantationTranscatheter aortic valve replacement

Identifiers

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.