Five-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation: Results From the Tendyne Expanded Clinical Study
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.
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BibTeX
@article{muller2026fiveyear,
title = {{Five-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation: Results From the Tendyne Expanded Clinical Study}},
author = {David W Muller and Alison Duncan and Paul Sorajja and Gry Dahle and Vasilis Babaliaros and Edith Lubos and Vinay Badhwar and Paolo Denti and Marvin H Eng and Paul Grayburn and Brian Bethea and Darren Walters and Georg Nickenig and Anna Sonia Petronio and Erwan Donal and Vinod H Thourani and Mubashir Mumtaz and Thomas Modine and Nicolas Dumonteil and Jean-François Obadia and Samir R Kapadia and Mayra E Guerrero and Ricardo de Medeiros and Robert Mcnutt and Hong Nie and Michael Chuang and Philipp Blanke and Lenard Conradi},
journal = {ESC Heart Failure},
year = {2026},
month = jun,
doi = {10.1093/eschf/xvag175},
url = {https://hal.science/hal-05678853v1},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Five-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation: Results From the Tendyne Expanded Clinical Study
AU - David W Muller
AU - Alison Duncan
AU - Paul Sorajja
AU - Gry Dahle
AU - Vasilis Babaliaros
AU - Edith Lubos
AU - Vinay Badhwar
AU - Paolo Denti
AU - Marvin H Eng
AU - Paul Grayburn
AU - Brian Bethea
AU - Darren Walters
AU - Georg Nickenig
AU - Anna Sonia Petronio
AU - Erwan Donal
AU - Vinod H Thourani
AU - Mubashir Mumtaz
AU - Thomas Modine
AU - Nicolas Dumonteil
AU - Jean-François Obadia
AU - Samir R Kapadia
AU - Mayra E Guerrero
AU - Ricardo de Medeiros
AU - Robert Mcnutt
AU - Hong Nie
AU - Michael Chuang
AU - Philipp Blanke
AU - Lenard Conradi
PY - 2026
DA - 2026/06/27
JO - ESC Heart Failure
DO - 10.1093/eschf/xvag175
UR - https://hal.science/hal-05678853v1
AB - 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.
SN - 2055-5822
ER -