ArticleEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2022
Early outcomes of transcatheter mitral valve replacement with the Tendyne system in severe mitral annular calcification.
Article in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03539458 (Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects With Mitral Annular Calcification), which is not on this map. Cited by 33 papers, 1 of them a synthesis that pooled it.
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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.
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.
Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects With Mitral Annular Calcification
Who cites it
33 citing papers in PubMed, 1 synthesis or guideline pooled it, 54 citations in OpenAlex.
- Transcatheter mitral valve implantation with Tendyne System Ten Years since the First In-Human Implant A systematic review.Journal of cardiothoracic surgery · 2023Pooled it
- Prognostic Impact of Qualitative and Quantitative Mitral Valve Calcification in Transapical Transcatheter Mitral Valve Replacement: A Sub-Analysis of the TENDER Registry.Journal of clinical medicine · 2026Article
- Transcatheter Valve Replacement for Mitral Stenosis: A State of the Art Review.Journal of clinical medicine · 2026Review
- Early and mid-term outcomes of mitral annular calcification and transcatheter mitral therapy: a systematic review.Annals of cardiothoracic surgery · 2025Article
- Mitral annular calcification: implications on clinical outcomes and interventions.Annals of cardiothoracic surgery · 2025Review
- Transesophageal Echocardiography in Transcatheter Mitral Valve Replacement.Journal of clinical medicine · 2025Review
- The Emerging Role of Lithotripsy in Structural Heart Interventions.Current cardiology reports · 2025Review
- Functional Mitral Regurgitation in the Transcatheter Era: Diagnostic and Therapeutic Pathways.Journal of personalized medicine · 2025Review
- Mitral Annular Calcification: Natural History, Prognosis, and Clinical Outcomes.Journal of the Society for Cardiovascular Angiography & Interventions · 2025Article
- Mitral annular calcification in interventional cardiology: address all fears.AsiaIntervention · 2025Review
- Mitral Annular Calcification: Understanding the Disease and Treatment Options.Structural heart : the journal of the Heart Team · 2025Review
- An Imaging-Based Marker to Refine Risk Stratification for Transcatheter Mitral Valve Replacement.Journal of clinical medicine · 2025Article
- Evaluating the AltaValve as a novel method for transcatheter mitral valve replacement.Future cardiology · 2025Review
- Comparative midterm results of surgical mitral valve replacement and transcatheter mitral valve replacement with the Tendyne System.JTCVS structural and endovascular · 2025Article
- Modified left atrial cuff to treat severe mitral annular calcification.JTCVS techniques · 2025Article
- Lithotripsy-Facilitated or Conventional Percutaneous Mitral Balloon Valvuloplasty for Calcific Mitral Valve Disease: A Systematic Review.Journal of the Society for Cardiovascular Angiography & Interventions · 2025Article
- Back to the Future: Reviving Old Concepts to Advance Transcatheter Treatment of Calcific Mitral Valve Disease.Journal of the Society for Cardiovascular Angiography & Interventions · 2025Article
- Impact and limitations of 3D computational modelling in transcatheter mitral valve replacement-a two-centre Dutch experience.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2024Article
- Surgical or transcatheter mitral valve replacement with mitral annular calcification.JTCVS structural and endovascular · 2024Article
- Multiple Valvular Heart Disease in the Transcatheter Era: A State-of-the-Art Review.Structural heart : the journal of the Heart Team · 2024Review
Corrections and comments
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Authors and funding
14 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTreatment of mitral regurgitation (MR) associated with severe mitral annular calcification (MAC) is challenging due to the high risk of fatal atrioventricular groove disruption and significant paravalvular leak.
aimsThe aim of this study was to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) with the Tendyne valve (Abbott Structural) in patients with MR and MAC.
methodsTwenty patients (mean age 78 years; 11 women) who were treated with the Tendyne valve, either compassionate use (CU; closed) or as part of The Feasibility Study of Tendyne in MAC (NCT03539458), had reported outcomes in a median follow-up duration of 368 days.
resultsIn all patients, a valve was implanted with no procedural mortality and successful hospital discharge. Two embolic events occurred, including one with mesenteric ischaemia and one non-disabling stroke. At 30 days and one year, all-cause mortality occurred in one (5%) and eight patients (40%), respectively. At one year, six patients had been hospitalised for heart failure (30%). There was no prosthetic dysfunction, and MR remained absent in all patients at one year. Clinical improvement, measured by New York Heart Association Functional Class, occurred in 11 of 12 patients who were alive at one year. Among seven survivors with Kansas City Cardiomyopathy Questionnaire (KCCQ) data, mean increase in KCCQ score was 29.9±26.3 at one year with improvement of ≥10 points in five (71.4%) patients.
conclusionsIn patients with MR and severe MAC, TMVR with the Tendyne valve was associated with encouraging acute outcomes, midterm durability, and clinical improvement. Dedicated TMVR therapy may have a future role in these anatomically challenging, high-risk patients.
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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.