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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