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

Sebastian Ludwig, Nils Perrin, Augustin Coisne, Walid Ben Ali, Jessica Weimann, Alison Duncan, Mariama Akodad, Andrea Scotti, Daniel Kalbacher, Sabine Bleiziffer, Georg Nickenig, Jörg Hausleiter, Hendrik Ruge, Matti Adam, Anna Sonia Petronio, Nicolas Dumonteil, Lars Sondergaard, Marianna Adamo, Damiano Regazzoli, Andrea Garatti, Tobias Schmidt, Gry Dahle, Maurizio Taramasso, Thomas Walther, Joerg Kempfert, Jean-François Obadia, Omar Chehab, Gilbert H L Tang, Azeem Latib, Sachin S Goel, Neil P Fam, Martin Andreas, David W Muller, Paolo Denti, Fabien Praz, Ralph Stephan von Bardeleben, Juan F Granada, Thomas Modine, Lenard Conradi, Collaborators
Author Information
  1. Sebastian Ludwig: Department of Cardiology, University Heart & Vascular Center Hamburg, Hamburg, Germany.
  2. Nils Perrin: Structural Valve Program, Montreal Heart Institute, Montreal, QC, Canada.
  3. Augustin Coisne: Cardiovascular Research Foundation, New York, NY, USA.
  4. Walid Ben Ali: Structural Valve Program, Montreal Heart Institute, Montreal, QC, Canada.
  5. Jessica Weimann: Department of Cardiology, University Heart & Vascular Center Hamburg, Hamburg, Germany.
  6. Alison Duncan: Royal Brompton Hospital, London, UK
  7. Mariama Akodad: St. Paul’s Hospital, Vancouver, BC, Canada
  8. Andrea Scotti: Cardiovascular Research Foundation, New York, NY, USA.
  9. Daniel Kalbacher: Department of Cardiology, University Heart & Vascular Center Hamburg, Hamburg, Germany.
  10. Sabine Bleiziffer: Department of Cardiothoracic Surgery, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany and Ruhr University Bochum, Bochum, Germany
  11. Georg Nickenig: Heart Center Bonn, Bonn, Germany
  12. Jörg Hausleiter: Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany
  13. Hendrik Ruge: Department of Cardiovascular Surgery, German Heart Center Munich, Munich, Germany
  14. Matti Adam: Department of Cardiology, Heart Center, University Hospital Cologne, Cologne, Germany.
  15. Anna Sonia Petronio: Cardiac Catheterization Laboratory, Cardiothoracic and Vascular Department, University of Pisa, Pisa, Italy.
  16. Nicolas Dumonteil: Groupe CardioVasculaire Interventionnel, Clinique Pasteur Toulouse, Toulouse, France.
  17. Lars Sondergaard: Rigshospitalet, Copenhagen, Denmark.
  18. Marianna Adamo: 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. Damiano Regazzoli: IRCCS Humanitas Research Hospital, Milan, Italy.
  20. Andrea Garatti: IRCCS Policlinico San Donato, Milan, Italy.
  21. Tobias Schmidt: Medical Clinic II, University Heart Center Lübeck, Lübeck, Germany.
  22. Gry Dahle: Oslo University Hospital, Rikshospitalet, Oslo, Norway.
  23. Maurizio Taramasso: HerzZentrum Hirslanden Zürich, Zürich, Switzerland.
  24. Thomas Walther: Frankfurt University Hospital, Frankfurt, Germany.
  25. Joerg Kempfert: German Heart Institute Berlin, Berlin, Germany.
  26. Jean-François Obadia: Department of Cardiac Surgery, Hôpital Louis Pradel, Lyon, France.
  27. Omar Chehab: St. Thomas' Hospital, London, UK.
  28. Gilbert H L Tang: Department of Cardiovascular Surgery, Mount Sinai Health System, New York, NY, USA.
  29. Azeem Latib: Montefiore Einstein Center for Heart and Vascular Care, Montefiore Medical Center, New York, NY, USA.
  30. Sachin S Goel: Department of Cardiovascular Medicine, Houston Methodist DeBakey Heart and Vascular Center, Houston, TX, USA.
  31. Neil P Fam: St. Michael's Hospital, University of Toronto, Toronto, ON, Canada.
  32. Martin Andreas: Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
  33. David W Muller: St. Vincent's Hospital, Sydney, NSW, Australia.
  34. Paolo Denti: Ospedale San Raffaele, Milan, Italy.
  35. Fabien Praz: Universitätsklinik für Kardiologie, Inselspital Bern, Bern, Switzerland.
  36. Ralph Stephan von Bardeleben: Heart Valve Center, Universitätsmedizin Mainz, Mainz, Germany.
  37. Juan F Granada: Cardiovascular Research Foundation, New York, NY, USA.
  38. Thomas Modine: Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France.
  39. Lenard Conradi: Department of Cardiovascular Surgery, University Heart and Vascular Center Hamburg, Hamburg, Germany.

Abstract

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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MeSH Term

Humans
Male
Aged
Female
Mitral Valve
Heart Valve Prosthesis Implantation
Heart Valve Prosthesis
Cardiac Catheterization
Treatment Outcome
Risk Factors
Mitral Valve Insufficiency
Registries

Word Cloud

Created with Highcharts 10.0.0TMVRmortalityMRpatients2-year2%2 yearsmitralsymptomaticoutcomespredictorsCHOICE-MIRegistrycomplicationsvalvededicateddevicesundergoingincludedfunctionalindependent95results1improved381%accesssiteBACKGROUND:Transcatheterreplacementusingalternativetherapyhigh-riskregurgitationAIMS:studyaimedassessmulticentreMETHODS:consecutivetreated11 different31internationalcentresinvestigatedendpointsheartfailurehospitalisationratesproceduralresidualstatusMultivariableCoxregressionanalysisappliedidentifyRESULTS:A total400 patientsmedianage76yearsinterquartilerange[IQR]7181595%maleEuroSCOREII6IQR38120underwentTechnicalsuccessachievedreduction≤1+observeddischargedurableNewYorkHeartAssociationFunctionalClasssignificantlyAll-cause930 days279%1 yearChronicobstructivepulmonarydiseasereducedglomerularfiltrationratelowserumalbuminAmong30-dayleftventricularoutflowtractobstructionbleedingshowedstrongestimpactCONCLUSIONS:real-worldregistrytreatmentassociateda durableresolutionsignificantimprovementTwo-yearOptimisedpatientselectionmanagementmandatoryimproveClinicaltranscatheterreplacement:two-year

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