Five-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation: Results From the Tendyne Expanded Clinical Study
David W 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 ConradiAbstract
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.