Mitral Valve Surgery After Transcatheter Edge-to-Edge Repair: Mid-Term Outcomes From the CUTTING-EDGE International Registry.


Journal

JACC. Cardiovascular interventions
ISSN: 1876-7605
Titre abrégé: JACC Cardiovasc Interv
Pays: United States
ID NLM: 101467004

Informations de publication

Date de publication:
27 09 2021
Historique:
received: 13 07 2021
accepted: 20 07 2021
entrez: 24 9 2021
pubmed: 25 9 2021
medline: 3 11 2021
Statut: ppublish

Résumé

The aim of this study was to determine clinical and echocardiographic characteristics, mechanisms of failure, and outcomes of mitral valve (MV) surgery after transcatheter edge-to-edge repair (TEER). Although >100,000 mitral TEER procedures have been performed worldwide, longitudinal data on MV surgery after TEER are lacking. Data from the multicenter, international CUTTING-EDGE registry were retrospectively analyzed. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 9.0 months (interquartile range [IQR]: 1.2-25.7 months) after MV surgery, and follow-up was 96.1% complete at 30 days and 81.1% complete at 1 year. From July 2009 to July 2020, 332 patients across 34 centers underwent MV surgery after TEER. The mean age was 73.8 ± 10.1 years, median Society of Thoracic Surgeons risk for MV repair at initial TEER was 4.0 (IQR: 2.3-7.3), and primary/mixed and secondary mitral regurgitation were present in 59.0% and 38.5%, respectively. The median interval from TEER to surgery was 3.5 months (IQR: 0.5-11.9 months), with overall median Society of Thoracic Surgeons risk of 4.8% for MV replacement (IQR: 2.8%-8.4%). The primary indication for surgery was recurrent mitral regurgitation (33.5%), and MV replacement and concomitant tricuspid surgery were performed in 92.5% and 42.2% of patients, respectively. The 30-day and 1-year mortality rates were 16.6% and 31.3%, respectively. On Kaplan-Meier analysis, the actuarial estimates of mortality were 24.1% at 1 year and 31.7% at 3 years after MV surgery. In this first report of the CUTTING-EDGE registry, the mortality and morbidity risks of MV surgery after TEER were not negligible, and only <10% of patients underwent MV repair. These registry data provide valuable insights for further research to improve these outcomes.

Sections du résumé

OBJECTIVES
The aim of this study was to determine clinical and echocardiographic characteristics, mechanisms of failure, and outcomes of mitral valve (MV) surgery after transcatheter edge-to-edge repair (TEER).
BACKGROUND
Although >100,000 mitral TEER procedures have been performed worldwide, longitudinal data on MV surgery after TEER are lacking.
METHODS
Data from the multicenter, international CUTTING-EDGE registry were retrospectively analyzed. Clinical and echocardiographic outcomes were evaluated. Median follow-up duration was 9.0 months (interquartile range [IQR]: 1.2-25.7 months) after MV surgery, and follow-up was 96.1% complete at 30 days and 81.1% complete at 1 year.
RESULTS
From July 2009 to July 2020, 332 patients across 34 centers underwent MV surgery after TEER. The mean age was 73.8 ± 10.1 years, median Society of Thoracic Surgeons risk for MV repair at initial TEER was 4.0 (IQR: 2.3-7.3), and primary/mixed and secondary mitral regurgitation were present in 59.0% and 38.5%, respectively. The median interval from TEER to surgery was 3.5 months (IQR: 0.5-11.9 months), with overall median Society of Thoracic Surgeons risk of 4.8% for MV replacement (IQR: 2.8%-8.4%). The primary indication for surgery was recurrent mitral regurgitation (33.5%), and MV replacement and concomitant tricuspid surgery were performed in 92.5% and 42.2% of patients, respectively. The 30-day and 1-year mortality rates were 16.6% and 31.3%, respectively. On Kaplan-Meier analysis, the actuarial estimates of mortality were 24.1% at 1 year and 31.7% at 3 years after MV surgery.
CONCLUSIONS
In this first report of the CUTTING-EDGE registry, the mortality and morbidity risks of MV surgery after TEER were not negligible, and only <10% of patients underwent MV repair. These registry data provide valuable insights for further research to improve these outcomes.

Identifiants

pubmed: 34556275
pii: S1936-8798(21)01401-1
doi: 10.1016/j.jcin.2021.07.029
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT04198870']

Types de publication

Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

2010-2021

Investigateurs

Keti Vitanova (K)
Markus Krane (M)
Serdar Akansel (S)
Oliver D Bhadra (OD)
Shekhar Saha (S)
Erik Bagaev (E)
Thilo Noack (T)
Florian Fahr (F)
Guido Ascione (G)
Ana Paula Tagliari (AP)
Alejandro Pizano (A)
Marissa Donatelle (M)
Kashish Goel (K)
John J Squiers (JJ)
Pinak B Shah (PB)
Guillaume Leurent (G)
Herve Corbineau (H)
Anita W Asgar (AW)
Philippe Demers (P)
Michel Pellerin (M)
Denis Bouchard (D)
Chawannuch Ruaengsri (C)
Lin Wang (L)
George A Petrossian (GA)
Chad A Kliger (CA)
Lionel Leroux (L)
Muhanad Algadheeb (M)
Shahar Lavi (S)
Paul Werner (P)
Michele Flagiello (M)
Antonio L Bartorelli (AL)
Angie Ghattas (A)
Nicholas Dumonteil (N)
Moritz Wyler von Ballmoos (MW)
Marvin D Atkins (MD)
Augusto D'Onofrio (A)
Chiara Tessari (C)
Arnar Geirsson (A)
Ryan K Kaple (RK)
Francesco Massi (F)
Michele Triggiani (M)
Eric Van Belle (E)
Flavien Vincent (F)
Tom Denimal (T)
Christina Brinkmann (C)
Joachim Schöfer (J)
Marco Di Eusanio (M)
Filippo Capestro (F)
Rodrigo Estevez-Loureiro (R)
Miguel A Pinon (MA)
Neal S Kleiman (NS)
Michael J Reardon (MJ)
Molly I Szerlip (MI)
J Michael DiMaio (JM)
Michael J Mack (MJ)
D Scott Lim (DS)
Volkmar Falk (V)
Francesco Maisano (F)
Isaac George (I)
Rebecca T Hahn (RT)

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures Dr Kaneko is a speaker for Edwards Lifesciences, Medtronic, Abbott, and Baylis Medical; and is a consultant for 4C Medical. Dr Lange is an advisory board member for and has received royalties and speaker honoraria from Medtronic; has received speaker honoraria from Abbott; and is a shareholder in Highlife. Dr Kempfert has served as a physician proctor for Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Conradi is a physician proctor, consultant, and speaker for Edwards Lifesciences and Medtronic. Dr Hagl has received speaker honoraria from Edwards Lifesciences. Dr Borger has received speaker honoraria and/or consulting fees to his hospital from Edwards Lifesciences, Medtronic, Abbott, and CryoLife. Dr Taramasso has been a consultant for Abbott Vascular, Boston Scientific, Edwards Lifesciences, 4Tech, Mitraltech, Simulands, MTEx, Occlufit, CoreMedic, and Shenqi Medical. Dr Nguyen has received speaker honoraria from Edwards Lifesciences, CryoLife, and Abbott. Dr Ailawadi is a consultant for Abbott, Edwards Lifesciences, Medtronic, and AtriCure. Dr Smith has received grant support from Edwards Lifesciences; and has received speaker honoraria from Edwards Lifesciences, Abbott, and CryoLife. Dr Anselmi is a physician proctor and consultant for Abbott and Edwards Lifesciences. Dr Ben Ali has received research grants from Edwards Lifesciences and Medtronic. Dr Ramlawi is a consultant for Boston Scientific, Medtronic, LivaNova, and Atricure. Dr Grubb is a physician proctor for Medtronic, Edwards Lifesciences, and Boston Scientific; and has served as a consultant for Medtronic, Boston Scientific, Ancora, HLT, and BioVentrics. Dr Pirelli is a physician proctor for and has received speaker honoraria from Edwards Lifesciences; and is a consultant for Medtronic. Dr Chu has received speaker honoraria from Medtronic, Edwards Lifesciences, and Terumo Aortic. Dr Andreas is a physician proctor and consultant for and has received speaker honoraria from Edwards Lifesciences, Abbott, and Medtronic; and has received institutional research grants from Edwards Lifesciences, Abbott, Medtronic, and LSI Solutions. Dr Obadia is a consultant for Abbott, Carmat, Delacroix-Chevalier, Landanger, and Medtronic. Dr Gennari is a consultant for Medtronic. Dr Garatti is a physician proctor for Abbott. Dr Nazif has equity in Venus Medtech; and has received consulting fees or honoraria from Keystone Heart, Edwards Lifesciences, Medtronic, and Boston Scientific. Dr Bapat has served as a consultant for Medtronic, Edwards Lifesciences, 4C Medical, and Boston Scientific. Dr Modine is a physician proctor and consultant for Medtronic, Edwards Lifesciences, and Abbott. Dr Denti receives speaker honoraria from Abbott and Edwards Lifesciences; and is a consultant for InnovHeart. Dr Tang is a physician proctor for Medtronic; is a consultant for Medtronic, NeoChord, and Abbott; and is a physician advisory board member for Abbott and JenaValve. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Auteurs

Tsuyoshi Kaneko (T)

Brigham and Women's Hospital, Boston, Massachusetts, USA. Electronic address: tkaneko2@partners.org.

Sameer Hirji (S)

Brigham and Women's Hospital, Boston, Massachusetts, USA.

Syed Zaid (S)

Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas, USA.

Rudiger Lange (R)

German Heart Center Munich, Munich, Germany.

Jörg Kempfert (J)

German Heart Center Berlin, Berlin, Germany.

Lenard Conradi (L)

University Heart and Vascular Center Hamburg, Hamburg, Germany.

Christian Hagl (C)

LMU Klinikum Munich, Munich, Germany.

Michael A Borger (MA)

Leipzig Heart Center, Leipzig, Germany.

Maurizio Taramasso (M)

HerzZentrum Hirslanden, Zurich, Switzerland.

Tom C Nguyen (TC)

University of California San Francisco Medical Center, San Francisco, California, USA.

Gorav Ailawadi (G)

University of Michigan, Ann Arbor, Michigan, USA.

Ashish S Shah (AS)

Vanderbilt University Medical Center, Nashville, Tennessee, USA.

Robert L Smith (RL)

Baylor, Scott & White The Heart Hospital, Plano, Texas, USA.

Amedeo Anselmi (A)

CHU Rennes, Inserm, LTSI-UMR 1099, Université de Rennes 1, Rennes, France.

Matthew A Romano (MA)

University of Michigan, Ann Arbor, Michigan, USA.

Walid Ben Ali (W)

Montreal Heart Institute, Montreal, Quebec, Canada.

Basel Ramlawi (B)

Lankenau Heart Institute, Philadelphia, Pennsylvania, USA.

Kendra J Grubb (KJ)

Emory University, Atlanta, Georgia, USA.

Newell B Robinson (NB)

St. Francis Hospital, Roslyn, New York, USA.

Luigi Pirelli (L)

Lenox Hill Hospital, New York, New York, USA.

Michael W A Chu (MWA)

London Health Sciences Center, Western University, London, Ontario, Canada.

Martin Andreas (M)

Medical University of Vienna, Vienna, Austria.

Jean-Francois Obadia (JF)

Hospices Civils de Lyon, Lyon, France.

Marco Gennari (M)

Centro Cardiologico Monzino, IRCCS, University of Milan, Milan, Italy.

Andrea Garatti (A)

IRCCS Policlinico San Donato, Milan, Italy.

Didier Tchetche (D)

Clinique Pasteur, Toulouse, France.

Tamim M Nazif (TM)

Columbia University Irving Medical Center, New York, New York, USA.

Vinayak N Bapat (VN)

Abbott Northwestern Hospital, Minneapolis, Minnesota, USA.

Thomas Modine (T)

CHU Bordeaux, Bordeaux, France.

Paolo Denti (P)

San Raffaele University Hospital, Milan, Italy.

Gilbert H L Tang (GHL)

Mount Sinai Health System, New York, New York, USA. Electronic address: gilbert.tang@mountsinai.org.

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