Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02087-y

Early outcomes of two mitral valve transcatheter leaflet approximation devices – A propensity score matched multicenter comparison

V. Mauri1, A. Sugiura2, M. Spieker3, C. Iliadis1, C. Besler4, M. Riebisch5, O. Al-Hammadis6, T. Ruf7, M. Gercek8, C. Grothusen9, M. Mehr10, M. U. Becher2, P. Horn3, C. Mues9, N. F. Boeder11, F. Kreidel12, K. Friedrichs8, R. Westenfeld3, D. Braun10, S. Baldus13, T. Rassaf5, H. Thiele4, G. Nickenig2, J. Hausleiter10, H. Möllmann9, M. Kelm3, V. Rudolph14, R. S. von Bardeleben15, H. Nef11, P. Lüdike5, P. Lurz4, R. Pfister1

1Klinik III für Innere Medizin, Herzzentrum der Universität zu Köln, Köln; 2Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Bonn; 3Klinik für Kardiologie, Pneumologie und Angiologie, Universitätsklinikum Düsseldorf, Düsseldorf; 4Klinik für Innere Medizin/Kardiologie, Herzzentrum Leipzig - Universität Leipzig, Leipzig; 5Klinik für Kardiologie und Angiologie, Universitätsklinikum Essen, Essen; 6Kardiologie und Angiologie, Justus-Liebig-Universität Giessen, Gießen; 7Kardiologie 1, Zentrum für Kardiologie, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz; 8Klinik für Kardiologie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen; 9Klinik für Innere Medizin I, Kath. St. Paulus Gesellschaft, Dortmund; 10Medizinische Klinik und Poliklinik I, LMU Klinikum der Universität München, München; 11Medizinische Klinik I - Kardiologie und Angiologie, Universitätsklinikum Gießen und Marburg GmbH, Gießen; 12Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Kiel; 13Klinik für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin, Herzzentrum der Universität zu Köln, Köln; 14Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen; 15Zentrum für Kardiologie im Herz- und Gefäßzentrum, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz;

Objectives Aim of this study was to compare procedural and short-term safety and efficacy of two leaflet-based transcatheter mitral valve repair systems. Background In addition to the edge-to-edge MitraClip repair system, the edge-to-spacer PASCAL repair system was approved for percutaneous treatment of severe mitral regurgitation (MR). Comparative data are lacking. Methods Procedural and 30 day outcomes were investigated in a propensity-score matched cohort of 307 PASCAL and 307 MitraClip patients at 10 sites. Matching criteria included sex, age, left ventricular ejection fraction (LVEF), NYHA class, MR etiology, left ventricular end-diastolic diameter, left atrial volume index, and vena contracta width. Primary efficacy endpoints were technical success and degree of residual MR at discharge. Primary safety endpoint was the rate of major adverse events (MAE). Results Technical success was 97% in the PASCAL group and 98% in the MitraClip group (P=0.624). MR ≤2+ at discharge was comparable in both groups (PASCAL: 93.8% vs. MitraClip: 92.4%, P=0.527) with more patients exhibiting MR ≤1+ in the PASCAL group (70.5% vs. 56.6%, P<0.001). Postprocedural mean gradient was significantly higher in the MitraClip group (3.3±1.5 vs. 3.9±1.7 mmHg; P<0.001). At 30 days, all-cause mortality and MAE rates were similar (mortality: 1.7% vs. 3.3%, P=0.299; MAE: 3.9 vs. 5.2%, P=0.562). Conclusions In this first large propensity-score matched comparison procedural success rates and MAE did not differ significantly between patients treated with the PASCAL or MitralClip valve repair system. Procedural results with less than moderate MR and no elevated transmitral gradient were more common in the PASCAL group which might have an impact on long-term outcome.

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