Evidence map›Paper›PMID 39007829›Full record

ArticleEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2024

Clinical outcomes and predictors of transapical transcatheter mitral valve replacement: the Tendyne Expanded Clinical Study.

Lenard Conradi, Sebastian Ludwig, Paul Sorajja, Alison Duncan, Brian Bethea, Gry Dahle, Vasilis Babaliaros, Mayra Guerrero, Vinod Thourani, Nicolas Dumonteil and 8 more

Abstract 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, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Article
  2. Article
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  5. Review
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  7. Article
  8. Current and future applications of robotics in structural heart interventions.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025
    Review
  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

18 authors.

Lenard ConradiDepartment of Cardiovascular Surgery, University Heart & Vascular Center Hamburg, Hamburg, Germany.
Sebastian LudwigGerman Center for Cardiovascular Research (DZHK), partner site Hamburg/Kiel/Lübeck, Hamburg, Germany.
Paul SorajjaMinneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN, USA.
Alison DuncanRoyal Brompton Hospital, London, United Kingdom.
Brian BetheaMedStar Union Memorial Hospital, Baltimore, MD, USA.
Gry DahleOslo University Hospital, Oslo, Norway.
Vasilis BabaliarosEmory University Hospital, Atlanta, GA, USA.
Mayra GuerreroMayo Clinic, Rochester, MN, USA.
Vinod ThouraniDepartment of Cardiovascular Surgery, Marcus Heart Valve Center, Piedmont Heart Institute, Atlanta, GA, USA.
Nicolas DumonteilGroupe Cardiovasculaire Interventionnel, Clinique Pasteur, Toulouse, France.
Thomas ModineUnité Médico Chirurgicale de Valvulopathie, Hôpital Haut Lévêque, CHU de Bordeaux, Pessac, France.
Andrea GarattiIRCCS Policlinico San Donato, San Donato Milanese, Italy.
Paolo DentiCardiac Surgery Department, San Raffaele University Hospital, Milan, Italy.
Jonathon LeipsicSt Paul's Hospital, Vancouver, BC, Canada.
Michael L ChuangBeth Israel Deaconess Medical Center, Boston, MA, USA.
Philipp BlankeSt Paul's Hospital, Vancouver, BC, Canada.
David W MullerCardiology Department, St Vincent's Hospital Sydney, Darlinghurst, NSW, Australia.
Vinay BadhwarDepartment of Cardiovascular & Thoracic Surgery, West Virginia University, Morgantown, WV, USA.

Funding

Network for Cardiothoracic Surgical Investigations in Cardiovascular MedicineUM1HL088925 · NHLBI · UNIVERSITY OF VIRGINIA · PI BADHWAR, VINAY, KRON, IRVING L. · 2013 to 2025
$6.8M
NHLBI NIH HHS UM1 HL088925
6 · The paper itself

Abstract

backgroundTranscatheter mitral valve replacement (TMVR) is a therapeutic option for patients with severe mitral regurgitation (MR) who are ineligible for conventional surgery. There are limited data on the outcomes of large patient cohorts treated with TMVR.

aimsThis study aimed to investigate the outcomes and predictors of mortality for patients treated with transapical TMVR.

methodsThis analysis represents the clinical experience of all patients enrolled in the Tendyne Expanded Clinical Study. Patients with symptomatic MR underwent transapical TMVR with the Tendyne system between November 2014 and June 2020. Outcomes and adverse events up to 2 years, as well as predictors of short-term mortality, were assessed.

resultsA total of 191 patients were treated (74.1±8.0 years, 62.8% male, Society of Thoracic Surgeons Predicted Risk of Mortality 7.7±6.6%). Technical success was achieved in 96.9% (185/191), and there were no intraprocedural deaths. At 30-day, 1- and 2-year follow-up, the rates of all-cause mortality were 7.9%, 30.8% and 40.5%, respectively. Complete MR elimination (MR <1+) was observed in 99.3%, 99.1% and 96.3% of patients, respectively. TMVR treatment resulted in consistent improvement of New York Heart Association Functional Class and quality of life up to 2 years (both p<0.001). Independent predictors of early mortality were age (odds ratio [OR] 1.11; p=0.003), pulmonary hypertension (OR 3.83; p=0.007), and institutional experience (OR 0.40; p=0.047).

conclusionsThis study investigated clinical outcomes in the full cohort of patients included in the Tendyne Expanded Clinical Study. The Tendyne TMVR system successfully eliminated MR with no intraprocedural deaths, resulting in an improvement in symptoms and quality of life. Continued refinement of clinical and echocardiographic risks will be important to optimise longitudinal outcomes.

Indexed as

Cardiac CatheterizationHeart Valve Prosthesis ImplantationMitral ValveMitral Valve InsufficiencyAgedAged, 80 and overFemaleHeart Valve ProsthesisHumansMaleMiddle AgedRisk FactorsTreatment Outcome

Identifiers

PMID39007829
PMCPMC11228541

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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.