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Wild, Mirjam G.; Kreidel, Felix; Hell, Michaela M.; Praz, Fabien; Mach, Markus; Adam, Matti; Reineke, David; Ruge, Hendrik; Ludwig, Sebastian; Conradi, Lenard; Rudolph, Tanja K.; Bleiziffer, Sabine; Kellermair, Jörg; Zierer, Andreas; Nickenig, Georg; Weber, Marcel; Petronio, Anna Sonia; Giannini, Cristina; Dahle, Gry; Rein, Kjell A.; Coisne, Augustin; Vincentelli, Andre; Dubois, Christophe; Duncan, Alison; Quarto, Cesare; Unbehaun, Axel; Amat-Santos, Ignacio; Cobiella, Javier; Dumonteil, Nicolas; Estevez-Loureiro, Rodrigo; Fumero, Andrea; Geisler, Tobias; Lurz, Philipp; Mangieri, Antonio; Monivas, Vanessa; Noack, Thilo; Franco, Luis Nombela; Pinon, Miguel A.; Stolz, Lukas; Tchetche, Didier; Walter, Thomas; Unsöld, Bernhard; Baldus, Stephan; Andreas, Martin; Hausleiter, Jörg und Bardeleben, Ralph Stephan von (2022): Transapical mitral valve implantation for treatment of symptomatic mitral valve disease: a real-world multicentre experience. In: European Journal of Heart Failure, Bd. 24, Nr. 5: S. 899-907 [PDF, 3MB]

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.

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