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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, Vol. 24, No. 5, 05.2022, p. 899-907.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Wild, MG, Kreidel, F, Hell, MM, Praz, F, Mach, M, Adam, M, Reineke, D, Ruge, H, Ludwig, S, Conradi, L, Rudolph, TK, Bleiziffer, S, Kellermair, J, Zierer, A, Nickenig, G, Weber, M, Petronio, AS, Giannini, C, Dahle, G, Rein, KA, Coisne, A, Vincentelli, A, Dubois, C, Duncan, A, Quarto, C, Unbehaun, A, Amat-Santos, I, Cobiella, J, Dumonteil, N, Estevez-Loureiro, R, Fumero, A, Geisler, T, Mangieri, A, Monivas, V, Noack, T, Franco, LN, Pinon, MA, Stolz, L, Tchétché, D, Walter, T, Unsöld, B, Baldus, S, Andreas, M, Hausleiter, J, von Bardeleben, RS & TENDER Investigators 2022, 'Transapical mitral valve implantation for treatment of symptomatic mitral valve disease: a real-world multicentre experience', EUR J HEART FAIL, vol. 24, no. 5, pp. 899-907. https://doi.org/10.1002/ejhf.2434

APA

Wild, M. G., Kreidel, F., Hell, M. M., Praz, F., Mach, M., Adam, M., Reineke, D., Ruge, H., Ludwig, S., Conradi, L., Rudolph, T. K., Bleiziffer, S., Kellermair, J., Zierer, A., Nickenig, G., Weber, M., Petronio, A. S., Giannini, C., Dahle, G., ... TENDER Investigators (2022). Transapical mitral valve implantation for treatment of symptomatic mitral valve disease: a real-world multicentre experience. EUR J HEART FAIL, 24(5), 899-907. https://doi.org/10.1002/ejhf.2434

Vancouver

Wild MG, Kreidel F, Hell MM, Praz F, Mach M, Adam M et al. Transapical mitral valve implantation for treatment of symptomatic mitral valve disease: a real-world multicentre experience. EUR J HEART FAIL. 2022 May;24(5):899-907. https://doi.org/10.1002/ejhf.2434

Bibtex

@article{39303f865ec44385890ffb8524730fb6,
title = "Transapical mitral valve implantation for treatment of symptomatic mitral valve disease: a real-world multicentre experience",
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.",
keywords = "Aged, Aged, 80 and over, Cardiac Catheterization/methods, Female, Heart Failure/etiology, Heart Valve Diseases/etiology, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation/methods, Humans, Male, Mitral Valve/diagnostic imaging, Mitral Valve Insufficiency, Retrospective Studies, Treatment Outcome",
author = "Wild, {Mirjam G} and Felix Kreidel and Hell, {Michaela M} and Fabien Praz and Markus Mach and Matti Adam and David Reineke and Hendrik Ruge and Sebastian Ludwig and Lenard Conradi and Rudolph, {Tanja K} and Sabine Bleiziffer and J{\"o}rg Kellermair and Andreas Zierer and Georg Nickenig and Marcel Weber and Petronio, {Anna Sonia} and Cristina Giannini and Gry Dahle and Rein, {Kjell A} and Augustin Coisne and Andr{\'e} Vincentelli and Christophe Dubois and Alison Duncan and Cesare Quarto and Axel Unbehaun and Ignacio Amat-Santos and Javier Cobiella and Nicolas Dumonteil and Rodrigo Estevez-Loureiro and Andrea Fumero and Tobias Geisler and Philipp Lurz and Antonio Mangieri and Vanessa Monivas and Thilo Noack and Franco, {Luis Nombela} and Pinon, {Miguel A} and Lukas Stolz and Didier Tch{\'e}tch{\'e} and Thomas Walter and Bernhard Uns{\"o}ld and Stephan Baldus and Martin Andreas and J{\"o}rg Hausleiter and {von Bardeleben}, {Ralph S} and {TENDER Investigators}",
note = "{\textcopyright} 2022 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.",
year = "2022",
month = may,
doi = "10.1002/ejhf.2434",
language = "English",
volume = "24",
pages = "899--907",
journal = "EUR J HEART FAIL",
issn = "1388-9842",
publisher = "Oxford University Press",
number = "5",

}

RIS

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 -