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


Journal

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
ISSN: 1969-6213
Titre abrégé: EuroIntervention
Pays: France
ID NLM: 101251040

Informations de publication

Date de publication:
21 08 2023
Historique:
pmc-release: 21 08 2024
medline: 23 8 2023
pubmed: 26 5 2023
entrez: 26 5 2023
Statut: ppublish

Résumé

Transcatheter mitral valve replacement (TMVR) using dedicated devices is an alternative therapy for high-risk patients with symptomatic mitral regurgitation (MR). This study aimed to assess the 2-year outcomes and predictors of mortality in patients undergoing TMVR from the multicentre CHOICE-MI Registry. 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. 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. 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.

Sections du résumé

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.

Identifiants

pubmed: 37235388
pii: EIJ-D-22-01037
doi: 10.4244/EIJ-D-22-01037
pmc: PMC10436071
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

512-525

Investigateurs

Stefan Blankenberg (S)
Benedikt Koell (B)
Niklas Schofer (N)
André Vincentelli (A)
Arnaud Sudre (A)
John G. Webb (JG)
Philipp Blanke (P)
Marcel Weber (M)
Tetsu Tanaka (T)
Johanna Vogelhuber (J)
Mirjam G. Wild (MG)
Rüdiger Lange (R)
Laurin Ochs (L)
Elmar Kuhn (E)
Cristina Giannini (C)
Marco De Carlo (M)
Didier Tchétché (D)
Marco Metra (M)
Francesco Bedogni (F)
Christian Frerker (C)
Kjell A. Rein (KA)
Axel Unbehaun (A)
Christoph Klein (C)
Matteo Pozzi (M)
Michele Flagiello (M)
Simon R. Redwood (SR)
Neil S. Kleiman (NS)
Mark D. Peterson (MD)
Geraldine Ong (G)
Djeven Deva (D)
Markus Mach (M)
Tillmann Kerbel (T)
Sara Hungerford (S)
Francesco Maisano (F)
Michaela Hell (M)
Jaqueline Da Rocha e Silva (J)
Lionel Leroux (L)
Tanja K. Rudolph (TK)
Kai Friedrichs (K)
Pierre Berthoumieu (P)
Alberto Pozzoli (A)
Michael J. Reardon (MJ)

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Auteurs

Sebastian Ludwig (S)

Department of Cardiology, University Heart & Vascular Center Hamburg, Hamburg, Germany.
German Center for Cardiovascular Research (DZHK), Partner site Hamburg/Kiel/Lübeck, Hamburg, Germany.
Cardiovascular Research Foundation, New York, NY, USA.

Nils Perrin (N)

Structural Valve Program, Montreal Heart Institute, Montreal, QC, Canada.

Augustin Coisne (A)

Cardiovascular Research Foundation, New York, NY, USA.
CHU Lille, Institut Pasteur de Lille, Lille, France.

Walid Ben Ali (W)

Structural Valve Program, Montreal Heart Institute, Montreal, QC, Canada.

Jessica Weimann (J)

Department of Cardiology, University Heart & Vascular Center Hamburg, Hamburg, Germany.

Alison Duncan (A)

Royal Brompton Hospital, London, UK

Mariama Akodad (M)

St. Paul’s Hospital, Vancouver, BC, Canada

Andrea Scotti (A)

Cardiovascular Research Foundation, New York, NY, USA.
Montefiore Einstein Center for Heart and Vascular Care, Montefiore Medical Center, New York, NY, USA.

Daniel Kalbacher (D)

Department of Cardiology, University Heart & Vascular Center Hamburg, Hamburg, Germany.
German Center for Cardiovascular Research (DZHK), Partner site Hamburg/Kiel/Lübeck, Hamburg, Germany.

Sabine Bleiziffer (S)

Department of Cardiothoracic Surgery, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany and Ruhr University Bochum, Bochum, Germany

Georg Nickenig (G)

Heart Center Bonn, Bonn, Germany

Jörg Hausleiter (J)

Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany

Hendrik Ruge (H)

Department of Cardiovascular Surgery, German Heart Center Munich, Munich, Germany
INSURE – Institute for Translational Cardiac Surgery, Department of Cardiovascular Surgery, German Heart Centre Munich, Germany

Matti Adam (M)

Department of Cardiology, Heart Center, University Hospital Cologne, Cologne, Germany.

Anna Sonia Petronio (AS)

Cardiac Catheterization Laboratory, Cardiothoracic and Vascular Department, University of Pisa, Pisa, Italy.

Nicolas Dumonteil (N)

Groupe CardioVasculaire Interventionnel, Clinique Pasteur Toulouse, Toulouse, France.

Lars Sondergaard (L)

Rigshospitalet, Copenhagen, Denmark.

Marianna Adamo (M)

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.

Damiano Regazzoli (D)

IRCCS Humanitas Research Hospital, Milan, Italy.

Andrea Garatti (A)

IRCCS Policlinico San Donato, Milan, Italy.

Tobias Schmidt (T)

Medical Clinic II, University Heart Center Lübeck, Lübeck, Germany.

Gry Dahle (G)

Oslo University Hospital, Rikshospitalet, Oslo, Norway.

Maurizio Taramasso (M)

HerzZentrum Hirslanden Zürich, Zürich, Switzerland.

Thomas Walther (T)

Frankfurt University Hospital, Frankfurt, Germany.

Joerg Kempfert (J)

German Heart Institute Berlin, Berlin, Germany.

Jean-François Obadia (JF)

Department of Cardiac Surgery, Hôpital Louis Pradel, Lyon, France.

Omar Chehab (O)

St. Thomas' Hospital, London, UK.

Gilbert H L Tang (GHL)

Department of Cardiovascular Surgery, Mount Sinai Health System, New York, NY, USA.

Azeem Latib (A)

Montefiore Einstein Center for Heart and Vascular Care, Montefiore Medical Center, New York, NY, USA.

Sachin S Goel (SS)

Department of Cardiovascular Medicine, Houston Methodist DeBakey Heart and Vascular Center, Houston, TX, USA.

Neil P Fam (NP)

St. Michael's Hospital, University of Toronto, Toronto, ON, Canada.

Martin Andreas (M)

Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.

David W Muller (DW)

St. Vincent's Hospital, Sydney, NSW, Australia.

Paolo Denti (P)

Ospedale San Raffaele, Milan, Italy.

Fabien Praz (F)

Universitätsklinik für Kardiologie, Inselspital Bern, Bern, Switzerland.

Ralph Stephan von Bardeleben (RS)

Heart Valve Center, Universitätsmedizin Mainz, Mainz, Germany.

Juan F Granada (JF)

Cardiovascular Research Foundation, New York, NY, USA.

Thomas Modine (T)

Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France.

Lenard Conradi (L)

Department of Cardiovascular Surgery, University Heart and Vascular Center Hamburg, Hamburg, Germany.

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