Transapical mitral valve implantation for treatment of symptomatic mitral valve disease: a real-world multicentre experience
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Transapical mitral valve implantation for treatment of symptomatic mitral valve disease: a real-world multicentre experience. / 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, André; Dubois, Christophe; Duncan, Alison; Quarto, Cesare; Unbehaun, Axel; Amat-Santos, Ignacio; Cobiella, Javier; Dumonteil, Nicolas; Estevez-Loureiro, Rodrigo; Fumero, Andrea; Geisler, Tobias; Mangieri, Antonio; Monivas, Vanessa; Noack, Thilo; Franco, Luis Nombela; Pinon, Miguel A; Stolz, Lukas; Tchétché, Didier; Walter, Thomas; Unsöld, Bernhard; Baldus, Stephan; Andreas, Martin; Hausleiter, Jörg; von Bardeleben, Ralph S; TENDER Investigators.
in: EUR J HEART FAIL, Jahrgang 24, Nr. 5, 05.2022, S. 899-907.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Transapical mitral valve implantation for treatment of symptomatic mitral valve disease: a real-world multicentre experience
AU - Wild, Mirjam G
AU - Kreidel, Felix
AU - Hell, Michaela M
AU - Praz, Fabien
AU - Mach, Markus
AU - Adam, Matti
AU - Reineke, David
AU - Ruge, Hendrik
AU - Ludwig, Sebastian
AU - Conradi, Lenard
AU - Rudolph, Tanja K
AU - Bleiziffer, Sabine
AU - Kellermair, Jörg
AU - Zierer, Andreas
AU - Nickenig, Georg
AU - Weber, Marcel
AU - Petronio, Anna Sonia
AU - Giannini, Cristina
AU - Dahle, Gry
AU - Rein, Kjell A
AU - Coisne, Augustin
AU - Vincentelli, André
AU - Dubois, Christophe
AU - Duncan, Alison
AU - Quarto, Cesare
AU - Unbehaun, Axel
AU - Amat-Santos, Ignacio
AU - Cobiella, Javier
AU - Dumonteil, Nicolas
AU - Estevez-Loureiro, Rodrigo
AU - Fumero, Andrea
AU - Geisler, Tobias
AU - Lurz, Philipp
AU - Mangieri, Antonio
AU - Monivas, Vanessa
AU - Noack, Thilo
AU - Franco, Luis Nombela
AU - Pinon, Miguel A
AU - Stolz, Lukas
AU - Tchétché, Didier
AU - Walter, Thomas
AU - Unsöld, Bernhard
AU - Baldus, Stephan
AU - Andreas, Martin
AU - Hausleiter, Jörg
AU - von Bardeleben, Ralph S
AU - TENDER Investigators
N1 - © 2022 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.
PY - 2022/5
Y1 - 2022/5
N2 - 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.
AB - 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.
KW - Aged
KW - Aged, 80 and over
KW - Cardiac Catheterization/methods
KW - Female
KW - Heart Failure/etiology
KW - Heart Valve Diseases/etiology
KW - Heart Valve Prosthesis
KW - Heart Valve Prosthesis Implantation/methods
KW - Humans
KW - Male
KW - Mitral Valve/diagnostic imaging
KW - Mitral Valve Insufficiency
KW - Retrospective Studies
KW - Treatment Outcome
U2 - 10.1002/ejhf.2434
DO - 10.1002/ejhf.2434
M3 - SCORING: Journal article
C2 - 35064722
VL - 24
SP - 899
EP - 907
JO - EUR J HEART FAIL
JF - EUR J HEART FAIL
SN - 1388-9842
IS - 5
ER -