Temporal trends in mitral edge-to-edge repair for primary mitral regurgitation

Benedikt Koell¹^,², MD; Sebastian Ludwig¹^,², MD; Jessica Weimann¹, MSc; Dhairya Patel³, MD; Lukas Stolz⁴^,⁵, MD; Tetsu Tanaka⁶, MD; Teresa Trenkwalder⁷, MD; Felix Rudolph⁸, MD; Daryoush Samim⁹, MD; Philipp von Stein¹⁰, MD; Cristina Giannini¹¹, MD; Julien Dreyfus¹², MD; Andrea Scotti¹³, MD; Jean-Michel Paradis¹⁴, MD; Marianna Adamo¹⁵, MD; Nicole Karam¹⁶, MD; Yohann Bohbot¹⁷, MD; Anne Bernard¹⁸, MD; Bruno Melica¹⁹, MD; Yusuke Kobari²⁰, MD; Yoan Lavie-Badie²¹, MD; Mirjam Kessler²², MD; Omar Chehab²³, MD; Simon Redwood²³, MD; Edith Lubos²⁴, MD; Ole De Backer²⁰, MD; Marco Metra¹⁵, MD; Azeem Latib¹³, MD; Chiara Primerano¹¹, MD; Christos Iliadis¹⁰, MD; Fabien Praz⁹, MD; Muhammed Gerçek⁸, MD; Erion Xhepa⁷, MD; Marcel Weber⁶, MD; Raj Makkar³, MD; Juan Granada²⁵, MD; Thomas Modine²⁶, MD; Erwan Donal²⁷, MD; Jörg Hausleiter⁴^,⁵, MD; Augustin Coisne²⁸, MD; Daniel Kalbacher¹^,², MD; on behalf of the PRIME-MR investigators

1. Department of Cardiology, University Heart & Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; 2. German Centre for Cardiovascular Research (DZHK), partner site Hamburg/Kiel/Lübeck, Hamburg, Germany; 3. Department of Cardiology, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA; 4. Medizinische Klinik und Poliklinik I, LMU Klinikum, LMU München, Munich, Germany; 5. German Centre for Cardiovascular Research (DZHK), partner site Munich Heart Alliance, Munich, Germany; 6. Department of Internal Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany; 7. Department of Cardiology, German Heart Center Munich, Technical University of Munich, Munich, Germany; 8. Clinic for General and Interventional Cardiology/Angiology, Heart and Diabetes Center NRW, Bad Oeynhausen, Germany; 9. Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland; 10. Department III of Internal Medicine, Faculty of Medicine, University Hospital Cologne, University of Cologne, Cologne, Germany; 11. Cardiothoracic and Vascular Department, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy; 12. Cardiology Department, Centre Cardiologique du Nord, Paris, France; 13. Montefiore Einstein Center for Heart and Vascular Care, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA; 14. Department of Structural Interventional Cardiology, Quebec Heart and Lung Institute, Quebec City, QC, Canada; 15. Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy; 16. Department of Cardiology, European Hospital Georges Pompidou, Paris, France; 17. Department of Cardiology, Amiens University Hospital, Amiens, France; 18. Cardiology Department, CHRU de Tours, Tours, France; 19. Centro Hospitalar Vila Nova de Gaia, Espinho, Portugal; 20. Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; 21. Department of Cardiology, Rangueil University Hospital, Toulouse, France; 22. Department of Internal Medicine II, Ulm University Heart Center, Ulm, Germany; 23. Department of Cardiology, St. Thomas’ Hospital, London, United Kingdom; 24. Marienkrankenhaus, Hamburg, Germany; 25. Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA; 26. Department of Cardiology and Cardiovascular Surgery, Heart Valve Center, Institut Cœur Poumon, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France; 27. Cardiology Department, Université de Rennes 1, CHU de Rennes, Rennes, France; 28. Department of Clinical Physiology and Echocardiography, Heart Valve Clinic, CHU Lille, Lille, France

Abstract

Background: The evolving landscape of mitral valve transcatheter edge-to-edge repair (M-TEER) for mitral regurgitation (MR) has seen continuous advancements, driving improvements in therapeutic efficacy. Particularly in primary MR (PMR), contemporary device iterations of M-TEER offer technical advantages for improved management of complex anatomies. However, data on temporal trends in M-TEER for PMR are limited.

Aims: The primary objective of our study was to analyse temporal trends in the safety, efficacy, and stability of M-TEER treatment.

Methods: The PRIME-MR registry, a retrospective multicentre study, enrolled consecutive patients undergoing M-TEER for PMR at 27 centres in Europe and North America. M-TEER procedures were categorised into four time periods (2009-2013, 2014-2016, 2017-2019, and 2020-2023), to align with major device updates.

Results: The analysis included 3,082 consecutive patients (median age 82 years [interquartile range 76.0-85.0], 45.1% female). Patients treated were highly symptomatic (New York Heart Association [NYHA] Class ≥III in 80.4%). Patient characteristics showed a decline in symptomatic severity (NYHA Class ≥III 85.9% in 2009-2013 vs 71.8% in 2020-2023), accompanied by lower mean Society of Thoracic Surgeons scores (5.6% [2009-2013] vs 4.6% [2020-2023]; p for trend<0.0001), and less severe MR. Over time, complication rates decreased (procedures with complications: 42.4% [2009-2013] vs 23.1% [2020-2023]; p for trend<0.0001), whereas technical efficacy increased (residual MR ≤1+: 54.0% [2009-2013] vs 68.4% [2020-2023]; p for trend<0.001). There was an increased occurrence of stable results without any deterioration at one-year follow-up (63.6% [2009-2013] vs 74.4% [2020-2023]; p for trend=0.03).

Conclusions: Findings from the PRIME-MR registry highlight substantial reductions in residual MR severity and complication rates over time in PMR patients undergoing M-TEER.

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Coronary interventions Interventions for valvular disease Interventions for heart failure Peripheral interventions Interventions for hypertension Interventions for stroke STEMI NSTEMI Stable CAD Stents and scaffolds Left main and multivessel disease Bifurcation lesions CTO TAVI Mitral valve replacement and repair Tricuspid / Pulmonary valve Acute heart failure Chronic heart failure Below the knee AAA Iliac / Femoral / Popliteal Renal artery angioplasty Renal denervation Carotid stenting LAA closure Ischaemic stroke

mitral regurgitation mitral valve transcatheter edge-to-edge repair primary mitral regurgitation

Volume 22 Number 12

Jun 15, 2026