Evidence map›Paper›PMID 33074368›Full record

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

Early results of a real-world series with two transapical transcatheter mitral valve replacement devices.

S Ludwig, D Kalbacher, N Schofer, A Schäfer, B Koell, M Seiffert, J Schirmer, U Schäfer, D Westermann, H Reichenspurner and 3 more

Abstract read
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 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

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

8 citing papers in PubMed.

  1. Article
  2. Contemporary treatment of mitral valve disease with transcatheter mitral valve implantation.Clinical research in cardiology : official journal of the German Cardiac Society · 2023
    Article
  3. Article
  4. Review
  5. Review
  6. Management of patients with mitral regurgitation ineligible for standard therapy undergoing TMVI screening.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2022
    Article
  7. Article
  8. 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

13 authors.

S LudwigDepartment of Cardiology, University Heart and Vascular Center Hamburg, Martinistrasse 52, 20246, Hamburg, Germany. se.ludwig@uke.de.ORCID http://orcid.org/0000-0002-5752-4951
D KalbacherDepartment of Cardiology, University Heart and Vascular Center Hamburg, Martinistrasse 52, 20246, Hamburg, Germany.
N SchoferDepartment of Cardiology, University Heart and Vascular Center Hamburg, Martinistrasse 52, 20246, Hamburg, Germany.
A SchäferDepartment of Cardiovascular Surgery, University Heart and Vascular Center Hamburg, Hamburg, Germany.
B KoellDepartment of Cardiology, University Heart and Vascular Center Hamburg, Martinistrasse 52, 20246, Hamburg, Germany.
M SeiffertDepartment of Cardiology, University Heart and Vascular Center Hamburg, Martinistrasse 52, 20246, Hamburg, Germany.
J SchirmerDepartment of Cardiovascular Surgery, University Heart and Vascular Center Hamburg, Hamburg, Germany.
U SchäferMarienkrankenhaus Hamburg, Department of Cardiology, Angiology and Intensive Care, Hamburg, Germany.
D WestermannDepartment of Cardiology, University Heart and Vascular Center Hamburg, Martinistrasse 52, 20246, Hamburg, Germany.
H ReichenspurnerPartner Site Hamburg/Kiel/Lübeck, German Centre for Cardiovascular Research (DZHK), Hamburg, Germany.
S BlankenbergDepartment of Cardiology, University Heart and Vascular Center Hamburg, Martinistrasse 52, 20246, Hamburg, Germany.
E LubosDepartment of Cardiology, University Heart and Vascular Center Hamburg, Martinistrasse 52, 20246, Hamburg, Germany.
L ConradiPartner Site Hamburg/Kiel/Lübeck, German Centre for Cardiovascular Research (DZHK), Hamburg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTranscatheter mitral valve replacement (TMVR) with dedicated devices promises to fill the treatment gap between open-heart surgery and edge-to-edge repair for patients with severe mitral regurgitation (MR). We herein present a single-centre experience of a TMVR series with two transapical devices. METHODS AND

resultsA total of 11 patients were treated with the Tendyne™ (N = 7) or the Tiara™ TMVR systems (N = 4) from 2016 to 2020 either as compassionate-use procedures or as commercial implants. Clinical and echocardiographic data were collected at baseline, discharge and follow-up and are presented in accordance with the Mitral Valve Academic Research Consortium (MVARC) definitions. The study cohort [age 77 years (73, 84); 27.3% male] presented with primary (N = 4), secondary (N = 5) or mixed (N = 2) MR etiology. Patients were symptomatic (all NYHA III/IV) and at high surgical risk [logEuroSCORE II 8.1% (4.0, 17.4)]. Rates of impaired RV function (72.7%), severe pulmonary hypertension (27.3%), moderate or severe tricuspid regurgitation (63.6%) and prior aortic valve replacement (63.6%) were high. Severe mitral annulus calcification was present in two patients. Technical success was achieved in all patients. In 90.9% (N = 10) MR was completely eliminated (i.e. no or trace MR). Procedural and 30-day mortality were 0.0%. At follow-up NYHA class was I/II in the majority of patients. Overall mortality after 3 and 6 months was 10.0% and 22.2%.

conclusionsTMVR was performed successfully in these selected patients with complete elimination of MR in the majority of patients. Short-term mortality was low and most patients experienced persisting functional improvement.

Indexed as

Heart Valve ProsthesisAgedAged, 80 and overCardiac CatheterizationEchocardiographyEquipment DesignFemaleFollow-Up StudiesHeart Valve Prosthesis ImplantationHumansMaleMitral ValveMitral Valve InsufficiencyRetrospective StudiesRisk FactorsTime FactorsCompassionate useMitral regurgitationTranscatheter mitral valve replacement

Identifiers

PMID33074368
PMCPMC7907022

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Registered trials

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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.