Transapical mitral valve implantation for treatment of symptomatic mitral valve disease: a real‐world multicentre experience
Creators: name: Wild, Mirjam G.
name: Kreidel, Felix
name: Hell, Michaela M.
name: Praz, Fabien
name: Mach, Markus
name: Adam, Matti
name: Reineke, David
name: Ruge, Hendrik
name: Ludwig, Sebastian
name: Conradi, Lenard
name: Rudolph, Tanja K.
name: Bleiziffer, Sabine
name: Kellermair, Jörg
name: Zierer, Andreas
name: Nickenig, Georg
name: Weber, Marcel
name: Petronio, Anna Sonia
name: Giannini, Cristina
name: Dahle, Gry
name: Rein, Kjell A.
name: Coisne, Augustin
name: Vincentelli, André
name: Dubois, Christophe
name: Duncan, Alison
name: Quarto, Cesare
name: Unbehaun, Axel
name: Amat‐Santos, Ignacio
name: Cobiella, Javier
name: Dumonteil, Nicolas
name: Estevez‐Loureiro, Rodrigo
name: Fumero, Andrea
name: Geisler, Tobias
name: Lurz, Philipp
name: Mangieri, Antonio
name: Monivas, Vanessa
name: Noack, Thilo
name: Franco, Luis Nombela
name: Pinon, Miguel A.
name: Stolz, Lukas
name: Tchétché, Didier
name: Walter, Thomas
name: Unsöld, Bernhard
name: Baldus, Stephan
name: Andreas, Martin
name: Hausleiter, Jörg
name: von Bardeleben, Ralph S.
Publisher: name: Universität Regensburg
Year: 2022
Subjects: subject: REPAIR; REGURGITATION; REPLACEMENT; OUTCOMES; FEASIBILITY; PROSTHESIS; Mitral valve disease; Mitral regurgitation; Transcatheter mitral valve implantation; Tendyne
subject: 610 Medizin

description: 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 &lt;= 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 &lt; 0.001), and tricuspid regurgitation severity (p = 0.013). Heart failure symptoms improved significantly (73% in NYHA class I/II, p &lt; 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.