{
  "abstract": "Aims: Transcatheter mitral valve replacement (TMVR) with the Tendyne Mitral Valve System is a treatment option for patients with severe symptomatic mitral regurgitation (MR) unsuitable for conventional mitral valve surgery or transcatheter edge-to-edge repair (TEER). This study sought to evaluate the safety and effectiveness of TMVR through 5-year follow-up. Methods and results: The Tendyne Expanded Clinical Study is a prospective, single-arm, multicentre study that enrolled patients between November 2014 and June 2020. The study enrolled 191 patients (mean age 74.1±8.0 years, 62.8% male, 70.2% NYHA class III/IV, 88.5% secondary MR), of whom 186 (97.4%) underwent TMVR with Tendyne. MR grade decreased from ≥ 3+ in 99.5% patients at baseline to grade ≤ 1+ in 95.3% at 5 years. In those patients surviving to 5 years (n=49), durable symptomatic improvement was evidenced by 73.5% patients being in NYHA class I/II at 5 years. The Kansas City Cardiomyopathy Questionnaire overall summary score increased from 48.5±22.5 points at baseline to 67.6±21.5 points at 5 years. Serious adverse events that occurred through 5 years included life-threatening bleeding (11.5%), fatal bleeding (2.6%), renal insufficiency/failure (28.8%), endocarditis (7.3%), device thrombosis (5.8%) and new onset atrial fibrillation (13.1%). No structural device degeneration or device embolism occurred through 5 years. Conclusions: The Tendyne TMVR was effective at achieving immediate and sustainable elimination of MR, which was associated with symptomatic improvement and absence of structural valve degeneration in a high-risk cohort over 5 years. These findings support TMVR with the Tendyne System as an alternative for patients with appropriate mitral valve anatomy and symptomatic secondary MR unsuitable for mitral surgery or TEER.",
  "abstract_shown": true,
  "affiliations": [],
  "article_type": null,
  "arxiv": null,
  "author_total": 28,
  "authors": [
    {
      "name": "David W Muller"
    },
    {
      "name": "Alison Duncan"
    },
    {
      "name": "Paul Sorajja"
    },
    {
      "name": "Gry Dahle"
    },
    {
      "name": "Vasilis Babaliaros"
    },
    {
      "name": "Edith Lubos"
    },
    {
      "name": "Vinay Badhwar"
    },
    {
      "name": "Paolo Denti"
    },
    {
      "name": "Marvin H Eng"
    },
    {
      "name": "Paul Grayburn"
    },
    {
      "name": "Brian Bethea"
    },
    {
      "name": "Darren Walters"
    },
    {
      "name": "Georg Nickenig"
    },
    {
      "name": "Anna Sonia Petronio"
    },
    {
      "name": "Erwan Donal"
    },
    {
      "name": "Vinod H Thourani"
    },
    {
      "name": "Mubashir Mumtaz"
    },
    {
      "name": "Thomas Modine"
    },
    {
      "name": "Nicolas Dumonteil"
    },
    {
      "name": "Jean-François Obadia"
    },
    {
      "name": "Samir R Kapadia"
    },
    {
      "name": "Mayra E Guerrero"
    },
    {
      "name": "Ricardo de Medeiros"
    },
    {
      "name": "Robert Mcnutt"
    },
    {
      "name": "Hong Nie"
    },
    {
      "name": "Michael Chuang"
    },
    {
      "name": "Philipp Blanke"
    },
    {
      "name": "Lenard Conradi"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/4vt6k6e5g535n.bib",
  "cited_by": 0,
  "doi": "10.1093/eschf/xvag175",
  "fulltext_url": null,
  "id": "4vt6k6e5g535n",
  "issns": [
    "2055-5822"
  ],
  "landing_url": "https://hal.science/hal-05678853v1",
  "language": "en",
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "hal",
      "0.sdv"
    ],
    [
      "hal",
      "1.sdv.ib"
    ],
    [
      "openalex",
      "2705|Cardiac Valve Diseases and Treatments"
    ]
  ],
  "openalex": "W7166359952",
  "pdf_url": "https://hal.science/hal-05678853/document",
  "pmcid": null,
  "pmid": "42363737",
  "published": "2026-06-27",
  "publisher": "Wiley",
  "ris": "https://research.draconitic.com/paper/4vt6k6e5g535n.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:17:57Z",
      "native_id": "hal-05678853",
      "source": "hal",
      "url": "https://hal.science/hal-05678853v1"
    }
  ],
  "subjects": [
    {
      "field": "biology",
      "origin": "hal:1.sdv.ib",
      "subfield": "systems-synthetic"
    }
  ],
  "title": "Five-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation: Results From the Tendyne Expanded Clinical Study",
  "title_text": "Five-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation: Results From the Tendyne Expanded Clinical Study",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:17:57Z",
  "url": "https://research.draconitic.com/paper/4vt6k6e5g535n",
  "venue": "ESC Heart Failure",
  "versions": []
}