Evidence map›Paper›PMID 30003366›Full record

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

Transcatheter valve-in-valve implantation (VinV-TAVR) for failed surgical aortic bioprosthetic valves.

Bernhard Wernly, Ann-Katrin Zappe, Axel Unbehaun, Jan-Malte Sinning, Christian Jung, Won-Keun Kim, Stephan Fichtlscherer, Michael Lichtenauer, Uta C Hoppe, Brunilda Alushi and 8 more

Erratum issued Registry-linked trialAbstract readMulticenter Study
PubMed Publisher
In one paragraph

Article 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. An erratum has been issued. It is linked to trial NCT05459233 (Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–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.

NCT05459233 narecruitingnot on this mapstarted 2023, after this paper: background citation

Valve Hemodynamic Optimization Based on Doppler-Echocardiography Versus Catheterization Measurements Following Valve-in-Valve TAVR: A Prospective Randomized Trial

TypeinterventionalSponsorInstitut universitaire de cardiologie et de pneumologie de Québec, University LavalRan2023 to 2029Enrolled310ConditionsAortic Valve Stenosis, Aortic Valve Regurgitation, Prosthesis FailureArmsDoppler-echocardiography, Invasive hemodynamic measurements
3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Machine learning-based risk prediction of intrahospital clinical outcomes in patients undergoing TAVI.Clinical research in cardiology : official journal of the German Cardiac Society · 2021
    Article
  8. Metabolomic profiling of patients with high gradient aortic stenosis undergoing transcatheter aortic valve replacement.Clinical research in cardiology : official journal of the German Cardiac Society · 2021
    Article
  9. Kidney injury as post-interventional complication of TAVI.Clinical research in cardiology : official journal of the German Cardiac Society · 2021
    Review
  10. Periprocedural embolisation of a Sapien 3 TAVI prosthesis: failure and success.Clinical research in cardiology : official journal of the German Cardiac Society · 2020
    Article
  11. Review
  12. Article
  13. Bioprosthetic Valve Thrombosis.Cardiology research · 2018
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors.

Bernhard WernlyClinic of Internal Medicine II, Department of Cardiology, Paracelsus Medical University of Salzburg, Salzburg, Austria.ORCID http://orcid.org/0000-0003-4024-0220
Ann-Katrin ZappeDepartment of Cardiology, Charité-Universitaetsmedizin Berlin, Hindenburgdamm 30,, 12203, Berlin, Germany.
Axel UnbehaunGerman Heart Center Berlin, Berlin, Germany.
Jan-Malte SinningDepartment of Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
Christian JungDivision of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, University Duesseldorf, Düsseldorf, Germany.
Won-Keun KimDepartment of Cardiology and Cardiac Surgery, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany.
Stephan FichtlschererDivision of Cardiology, Department of Medicine III, Goethe University Hospital Frankfurt, Frankfurt am Main, Germany.
Michael LichtenauerClinic of Internal Medicine II, Department of Cardiology, Paracelsus Medical University of Salzburg, Salzburg, Austria.
Uta C HoppeClinic of Internal Medicine II, Department of Cardiology, Paracelsus Medical University of Salzburg, Salzburg, Austria.
Brunilda AlushiDepartment of Cardiology, Charité-Universitaetsmedizin Berlin, Hindenburgdamm 30,, 12203, Berlin, Germany.
Frederik BeckhoffDepartment of Cardiology, Charité-Universitaetsmedizin Berlin, Hindenburgdamm 30,, 12203, Berlin, Germany.
Charlotte WewetzerDepartment of Cardiology, Charité-Universitaetsmedizin Berlin, Hindenburgdamm 30,, 12203, Berlin, Germany.
Marcus FranzDepartment of Cardiology, Universitätsherzzentrum Thüringen, Friedrich Schiller University Jena, Jena, Germany.
Daniel KretzschmarDepartment of Cardiology, Universitätsherzzentrum Thüringen, Friedrich Schiller University Jena, Jena, Germany.
Eliano NavareseInova Center for Thrombosis Research and Drug Development, Inova Heart and Vascular Institute, Fairfax, VA, USA.
Ulf LandmesserDepartment of Cardiology, Charité-Universitaetsmedizin Berlin, Hindenburgdamm 30,, 12203, Berlin, Germany.
Volkmar FalkGerman Heart Center Berlin, Berlin, Germany.
Alexander LautenDepartment of Cardiology, Charité-Universitaetsmedizin Berlin, Hindenburgdamm 30,, 12203, Berlin, Germany. alexander.lauten@charite.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveWe sought to investigate the procedural and hemodynamic outcome after valve-in-valve transcatheter aortic valve replacement (VinV-TAVR) for different surgical (SBV) and transcatheter (TAVR) bioprosthetic valves. METHODS AND

results223 patients (76 ± 11years, STS-Score 8.3 ± 10.1) suffering from SBV failure treated with VinV-TAVR were enrolled at 6 centers across Germany. At time of the intervention, the majority of patients were in NYHA-class ≥ III (88%, n = 180). Failure mode of the SBVs was either stenosis, regurgitation (AR) or a combination of both in 85 (38%), 76 (34%) and 62 (28%) patients, respectively. 138 (62%) patients were treated with first generation TAVR valves (Edwards Sapien XT or CoreValve). Second generation valves were implanted in 85 (38%) patients (Sapien 3, Medtronic CoreValve Evolut, SJM-Portico, JenaValve). VinV-TAVR was associated with high procedural success rate, conversion to surgery was necessary in 3 (2%) patients. After VinV-TAVR procedure, 4 (2%) patients suffered from ≥ moderate AR. In 6 (3%) patients a second valve was implanted due to mispositioning of the first valve and subsequent severe paravalvular AR. Coronary obstruction was observed in 4 (2%) patients. Major bleeding and cerebrovascular complications (according to VARC) were reported in 3 (1%) and 4 (2%) patients at 30 days. Post-interventionally, 44/178 (25%) patients evidenced a mean pressure gradient (mPG) ≥ 20 mmHg. Residual stenosis was not associated with increased mortality (HR 0.39; 95% CI 0.13-1.22; p = 0.11).

conclusionIn VinV-TAVR for SBV-failure is a safe procedure resulting in hemodynamic improvement in the majority of patients. Residual stenosis is a common finding which can be observed in 1/4 of patients undergoing VinV-TAVR. However, this condition is not associated with increased 1-year-mortality.

Indexed as

AgedAortic ValveAortic Valve StenosisBioprosthesisFemaleGermanyHemodynamicsHumansIncidenceMalePostoperative ComplicationsProsthesis DesignReoperationRisk FactorsSeverity of Illness IndexSurvival RateResidual stenosisTAVITAVRTranscatheter aortiv valve implantationValve-in-valve

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Registered trials

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.