Five-year outcomes of transcatheter mitral valve replacement in patients with severe symptomatic mitral regurgitation: results from the Tendyne Expanded Clinical Study
Year: 2026
Type: article
Study design: Clinical Trial
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% New York Heart Association Class (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.
Source: ESC Heart Failure
Authors: David W M Muller, Alison Duncan, Paul Sorajja, Gry Dahle, Vasilis Babaliaros, Edith Lubos, Vinay Badhwar, Paolo Denti, Marvin H Eng, Paul Grayburn, Brian Bethea, Darren Walters, Georg Nickenig, Anna Sonia Petronio, Erwan Donal, Vinod H Thourani, Mubashir Mumtaz, Thomas Modine, Nicolas Dumonteil, Jean-Francois Obadia, Samir R Kapadia, Mayra E Guerrero, Ricardo De Medeiros, Robert McNutt, Hong Nie, Michael Chuang, Philipp Blanke, Lenard Conradi
Institutions: St Vincent's Hospital Sydney, Royal Brompton Hospital, Abbott Northwestern Hospital, Banner Health, Banner - University Medical Center Phoenix, Oslo University Hospital, Emory University Hospital, Universität Hamburg, West Virginia University, IRCCS Ospedale San Raffaele, University of Nebraska Medical Center, The University of Texas Southwestern Medical Center, MedStar Union Memorial Hospital, Prince Charles Hospital, University Hospital Bonn, Azienda Ospedaliera Universitaria Pisana, Inserm, Laboratoire Traitement du Signal et de l'Image, Centre Hospitalier Universitaire de Rennes, Université de Rennes, Piedmont Atlanta Hospital, Harrisburg Hospital, UPMC Central Pa, University of Pittsburgh Medical Center, Centre Hospitalier Universitaire de Lille, Clinique Pasteur, Hôpital Louis Pradel, Cleveland Clinic, Mayo Clinic, Beth Israel Deaconess Medical Center, St. Paul's Hospital
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $4,850
Funder: Abbott Laboratories
OpenAlex ID: W7166359952