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Multicenter Study
. 2022 May;24(5):899-907.
doi: 10.1002/ejhf.2434. Epub 2022 Feb 10.

Transapical mitral valve implantation for treatment of symptomatic mitral valve disease: a real-world multicentre experience

Mirjam G Wild #  1   2 , Felix Kreidel #  3 , Michaela M Hell  3 , Fabien Praz  2 , Markus Mach  4 , Matti Adam  5 , David Reineke  6 , Hendrik Ruge  7 , Sebastian Ludwig  8 , Lenard Conradi  8 , Tanja K Rudolph  9 , Sabine Bleiziffer  9 , Jörg Kellermair  10 , Andreas Zierer  10 , Georg Nickenig  11 , Marcel Weber  12 , Anna Sonia Petronio  13 , Cristina Giannini  13 , Gry Dahle  14 , Kjell A Rein  14 , Augustin Coisne  15 , André Vincentelli  15 , Christophe Dubois  16 , Alison Duncan  17 , Cesare Quarto  18 , Axel Unbehaun  19 , Ignacio Amat-Santos  20 , Javier Cobiella  21 , Nicolas Dumonteil  22 , Rodrigo Estevez-Loureiro  23 , Andrea Fumero  24 , Tobias Geisler  25 , Philipp Lurz  26 , Antonio Mangieri  24 , Vanessa Monivas  27 , Thilo Noack  28 , Luis Nombela Franco  21 , Miguel A Pinon  23 , Lukas Stolz  1 , Didier Tchétché  22 , Thomas Walter  29 , Bernhard Unsöld  30 , Stephan Baldus  5 , Martin Andreas  4 , Jörg Hausleiter #  1 , Ralph S von Bardeleben #  3 ; TENDER Investigators
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Free article
Multicenter Study

Transapical mitral valve implantation for treatment of symptomatic mitral valve disease: a real-world multicentre experience

Mirjam G Wild et al. Eur J Heart Fail. 2022 May.
Free article

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: Mitral regurgitation; Mitral valve disease; Tendyne; Transcatheter mitral valve implantation.

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References

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