Transapical mitral valve implantation for treatment of symptomatic mitral valve disease: a real‐world multicentre experience
Mirjam G. Wild, Felix Kreidel, Michaela Hell, Fabien Praz, Markus Mach, Matti Adam, David Reineke, Hendrik Ruge, Sebastian Ludwig, Lenard Conradi, Tanja K. Rudolph, Sabine Bleiziffer, Joerg Kellermair, Andreas Zierer, Georg Nickenig, Marcel Weber, Anna Sonia Petronio, Cristina Giannini, Gry Dahle, Kjell Arne Rein, Augustin Coisne, André Vincentelli, Christophe Dubois, Alison Duncan, Cesare Quarto, Axel Unbehaun, Ignacio J. Amat‐Santos, Javier Cobiella, Nicolas Dumonteil, Rodrigo Estévez‐Loureiro, R. Fumero, Tobias Geisler, Philipp Lurz, Antonio Mangieri, Vanessa Moñivas, Thilo Noack, Luis Nombela‐Franco, Miguel Piñón, Lukas Stolz, Didier Tchétché, Thomas Walter, Bernhard Unsöld, Stephan Baldus, Martin Andreas, Jörg Hausleiter, Ralph Stephan von Bardeleben, on behalf of the TENDER Investigators
Abstract
AIMS: Transcatheter mitral valve implantation (TMVI) is a new treatment option for patients with symptomatic mitral valve (MV) disease. Real-world data have not yet been reported. This study aimed to assess procedural and 30-day outcomes of TMVI in a real-world patient cohort. METHOD AND RESULTS: All consecutive patients undergoing implantation of a transapically delivered self-expanding valve at 26 European centres from January 2020 to April 2021 were included in this retrospective observational registry. Among 108 surgical high-risk patients included (43% female, mean age 75 ± 7 years, mean STS-PROM 7.2 ± 5.3%), 25% was treated for an off-label indication (e.g. previous MV intervention or surgery, mitral stenosis, mitral annular calcification). Patients were highly symptomatic (New York Heart Association [NYHA] functional class III/IV in 86%) and mitral regurgitation (MR) was graded 3+/4+ in 95% (38% primary, 37% secondary, and 25% mixed aetiology). Technical success rate was 96%, and MR reduction to ≤1+ was achieved in all patients with successful implantation. There were two procedural deaths and 30-day all-cause mortality was 12%. At early clinical follow-up, MR reduction was sustained and there were significant reductions of pulmonary pressure (systolic pulmonary artery pressure 52 vs. 42 mmHg, p < 0.001), and tricuspid regurgitation severity (p = 0.013). Heart failure symptoms improved significantly (73% in NYHA class I/II, p < 0.001). Procedural success rate according to MVARC criteria was 80% and was not different in patients treated for an off-label indication (74% vs. 81% for off- vs. on-label, p = 0.41). CONCLUSION: In a real-world patient population, TMVI has a high technical and procedural success rate with efficient and durable MR reduction and symptomatic improvement.