Early Outcomes of Two Large Mitral Valve Transcatheter Edge-to-Edge Repair Devices—A Propensity Score Matched Multicenter Comparison

Author:

von Stein Philipp1ORCID,Wienemann Hendrik1ORCID,von Stein Jennifer1,Sugiura Atsushi2ORCID,Tanaka Tetsu2ORCID,Kavsur Refik2,Öztürk Can2,Weber Marcel2,Haurand Jean Marc3ORCID,Horn Patrick3,Kister Tobias4ORCID,Mahabadi Amir Abbas5ORCID,Boeder Niklas6ORCID,Ruf Tobias7ORCID,Gerçek Muhammed8ORCID,Mues Christoph9,Grothusen Christina910,Novotny Julia11,Weckbach Ludwig11,Guthoff Henning1ORCID,Rudolph Felix8,Polzin Amin3ORCID,Baldus Stephan1,Rassaf Tienush5ORCID,Thiele Holger4ORCID,Möllmann Helge9,Kelm Malte3,Rudolph Volker8,von Bardeleben Ralph Stephan7,Nef Holger6,Luedike Peter5ORCID,Lurz Philipp4,Hausleiter Jörg11,Pfister Roman1ORCID,Mauri Victor1

Affiliation:

1. Department of Cardiology, Heart Center, Faculty of Medicine, University of Cologne, 50937 Cologne, Germany

2. Department of Internal Medicine II, Heart Center Bonn, University Hospital Bonn, 53127 Bonn, Germany

3. Department of Cardiology, Pulmonology and Vascular Medicine, University Hospital Düsseldorf, Medical Faculty of the Heinrich Heine University Düsseldorf, 40225 Düsseldorf, Germany

4. Department of Cardiology, Heart Center Leipzig at University of Leipzig, 04289 Leipzig, Germany

5. Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen, 45122 Essen, Germany

6. Department of Cardiology and Angiology, Justus-Liebig-University Giessen, 35392 Giessen, Germany

7. Department of Cardiology, University Medical Center of the Johannes Gutenberg-University Mainz, 55131 Mainz, Germany

8. Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, 32545 Bad Oeynhausen, Germany

9. Medical Clinic I, Department of Cardiology, St. Johannes Hospital, 44137 Dortmund, Germany

10. Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Campus Kiel, 24105 Kiel, Germany

11. Medizinische Klinik und Poliklinik I, Ludwig-Maximilians-Universität München, 81377 Munich, Germany

Abstract

Background/Objectives: Previous trials reported comparable results with PASCAL and earlier MitraClip generations. Limited comparative data exist for more contemporary MitraClip generations, particularly the large MitraClip XT(R/W). We aimed to evaluate acute and 30-day outcomes in patients undergoing mitral valve transcatheter edge-to-edge repair (M-TEER) with one of the large devices, either PASCAL P10 or MitraClip XT(R/W) (3rd/4th generation). Methods: A total of 309 PASCAL-treated patients were matched by propensity score to 253 MitraClip-treated patients, resulting in 200 adequately balanced pairs. Procedural, clinical, and echocardiographic outcomes were collected for up to 30 days, including subgroup analysis for mitral regurgitation (MR) etiologies. Results: PASCAL and MitraClip patients were comparable regarding age (80 vs. 79 years), sex (female: 45.5% vs. 50.5%), and MR etiology (degenerative MR: n = 94, functional MR [FMR]: n = 96, mixed MR: n = 10 in each group). Technical success rates were comparable (96.5% vs. 96.0%; p > 0.999). At discharge, the mean gradient was higher (3.3 mmHg vs. 3.0 mmHg; p = 0.038), and the residual mitral valve orifice area was smaller in MitraClip patients (3.0 cm2 vs. 2.3 cm2; p < 0.001). At discharge, the reduction to MR ≤ 2+ was comparable (92.4% vs. 87.8%; p = 0.132). However, reduction to MR ≤ 1+ was more frequently observed in PASCAL patients (67.7% vs. 56.6%; p = 0.029), driven by the FMR subgroup (74.0% vs. 60.0%; p = 0.046). No difference was observed in 30-day mortality (p = 0.204) or reduction in NYHA-FC to ≤II (p > 0.999). Conclusions: Both M-TEER devices exhibited high and comparable rates of technical success and MR reduction to ≤2+. PASCAL may be advantageous in achieving MR reduction to ≤1+ in patients with FMR.

Publisher

MDPI AG

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