Clinical outcomes of transcatheter mitral valve replacement: two-year results of the CHOICE-MI Registry

DOI: 10.4244/EIJ-D-22-01037

Sebastian Ludwig
Sebastian Ludwig1,2,3, MD; Nils Perrin4, MD; Augustin Coisne3,5, MD, PhD; Walid Ben Ali4, MD, PhD; Jessica Weimann1, MSc; Alison Duncan6, MD; Mariama Akodad7, MD; Andrea Scotti3,8, MD; Daniel Kalbacher1,2, MD; Sabine Bleiziffer9, MD; Georg Nickenig10, MD; Jörg Hausleiter11, MD; Hendrik Ruge12,13, MD; Matti Adam14, MD; Anna Sonia Petronio15, MD; Nicolas Dumonteil16, MD; Lars Sondergaard17, MD; Marianna Adamo18, MD; Damiano Regazzoli19, MD; Andrea Garatti20, MD; Tobias Schmidt21, MD; Gry Dahle22, MD, PhD; Maurizio Taramasso23, MD; Thomas Walther24, MD; Joerg Kempfert25, MD; Jean-François Obadia26, MD; Omar Chehab27, MD; Gilbert H. L. Tang28, MD, MSc, MBA; Azeem Latib8, MD; Sachin S. Goel29, MD; Neil P. Fam30, MD; Martin Andreas31, MD, PhD; David W. Muller32, MD; Paolo Denti33, MD; Fabien Praz34, MD; Ralph Stephan von Bardeleben35, MD; Juan F. Granada3, MD; Thomas Modine36, MD, PhD; Lenard Conradi37, MD
1. Department of Cardiology, University Heart & Vascular Center Hamburg, Hamburg, Germany; 2. German Center for Cardiovascular Research (DZHK), Partner site Hamburg/Kiel/Lübeck, Hamburg, Germany; 3. Cardiovascular Research Foundation, New York, NY, USA; 4. Structural Valve Program, Montreal Heart Institute, Montreal, QC, Canada; 5. CHU Lille, Institut Pasteur de Lille, Lille, France; 6. Royal Brompton Hospital, London, UK; 7. St. Paul’s Hospital, Vancouver, BC, Canada; 8. Montefiore Einstein Center for Heart and Vascular Care, Montefiore Medical Center, New York, NY, USA; 9. Department of Cardiothoracic Surgery, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany and Ruhr University Bochum, Bochum, Germany; 10. Heart Center Bonn, Bonn, Germany; 11. Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany; 12. Department of Cardiovascular Surgery, German Heart Center Munich, Munich, Germany; 13. INSURE – Institute for Translational Cardiac Surgery, Department of Cardiovascular Surgery, German Heart Centre Munich, Germany; 14. Department of Cardiology, Heart Center, University Hospital Cologne, Cologne, Germany; 15. Cardiac Catheterization Laboratory, Cardiothoracic and Vascular Department, University of Pisa, Pisa, Italy; 16. Groupe CardioVasculaire Interventionnel, Clinique Pasteur Toulouse, Toulouse, France; 17. Rigshospitalet, Copenhagen, Denmark; 18. Cardiac Catheterization Laboratory and Cardiology, ASST Spedali Civili di Brescia, Brescia, Italy and Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy; 19. IRCCS Humanitas Research Hospital, Milan, Italy; 20. IRCCS Policlinico San Donato, Milan, Italy; 21. Medical Clinic II, University Heart Center Lübeck, Lübeck, Germany; 22. Oslo University Hospital, Rikshospitalet, Oslo, Norway; 23. HerzZentrum Hirslanden Zürich, Zürich, Switzerland; 24. Frankfurt University Hospital, Frankfurt, Germany; 25. German Heart Institute Berlin, Berlin, Germany; 26. Department of Cardiac Surgery, Hôpital Louis Pradel, Lyon, France; 27. St. Thomas’ Hospital, London, UK; 28. Department of Cardiovascular Surgery, Mount Sinai Health System, New York, NY, USA; 29. Department of Cardiovascular Medicine, Houston Methodist DeBakey Heart and Vascular Center, Houston, TX, USA; 30. St. Michael’s Hospital, University of Toronto, Toronto, ON, Canada; 31. Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria; 32. St. Vincent’s Hospital, Sydney, NSW, Australia; 33. Ospedale San Raffaele, Milan, Italy; 34. Universitätsklinik für Kardiologie, Inselspital Bern, Bern, Switzerland; 35. Heart Valve Center, Universitätsmedizin Mainz, Mainz, Germany; 36. Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France; 37. Department of Cardiovascular Surgery, University Heart and Vascular Center Hamburg, Hamburg, Germany

Background: Transcatheter mitral valve replacement (TMVR) using dedicated devices is an alternative therapy for high-risk patients with symptomatic mitral regurgitation (MR).

Aims: This study aimed to assess the 2-year outcomes and predictors of mortality in patients undergoing TMVR from the multicentre CHOICE-MI Registry.

Methods: The CHOICE-MI Registry included consecutive patients with symptomatic MR treated with 11 different dedicated TMVR devices at 31 international centres. The investigated endpoints included mortality and heart failure hospitalisation rates, procedural complications, residual MR, and functional status. Multivariable Cox regression analysis was applied to identify independent predictors of 2-year mortality.

Results: A total of 400 patients, median age 76 years (interquartile range [IQR] 71, 81), 59.5% male, EuroSCORE II 6.2% (IQR 3.8, 12.0), underwent TMVR. Technical success was achieved in 95.2% of patients. MR reduction to ≤1+ was observed in 95.2% at discharge with durable results at 1 and 2 years. New York Heart Association Functional Class had improved significantly at 1 and 2 years. All-cause mortality was 9.2% at 30 days, 27.9% at 1 year and 38.1% at 2 years after TMVR. Chronic obstructive pulmonary disease, reduced glomerular filtration rate, and low serum albumin were independent predictors of 2-year mortality. Among the 30-day complications, left ventricular outflow tract obstruction, access site and bleeding complications showed the strongest impact on 2-year mortality.

Conclusions: In this real-world registry of patients with symptomatic MR undergoing TMVR, treatment with TMVR was associated with a durable resolution of MR and significant functional improvement at 2 years. Two-year mortality was 38.1%. Optimised patient selection and improved access site management are mandatory to improve outcomes.

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Mitral valve replacement and repair
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