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Article Dans Une Revue JACC: Cardiovascular Interventions Année : 2023

Expanding the Spectrum of TEER Suitability: Evidence From the EXPAND G4 Post Approval Study

Federico Asch
  • Fonction : Auteur
Paul Sorajja
  • Fonction : Auteur
Paul Mahoney
  • Fonction : Auteur
Francesco Maisano
  • Fonction : Auteur
Paolo Denti
  • Fonction : Auteur
Michael Morse
  • Fonction : Auteur
Michael Rinaldi
  • Fonction : Auteur
Francesco Bedogni
  • Fonction : Auteur
Federico de Marco
William Rollefson
  • Fonction : Auteur
Bassem Chehab
  • Fonction : Auteur
Mathew Williams
  • Fonction : Auteur
Takao Morikawa
  • Fonction : Auteur
Anita Asgar
  • Fonction : Auteur
Evelio Rodriguez
  • Fonction : Auteur

Résumé

Background: Anatomical and clinical criteria to define mitral transcatheter edge-to-edge repair (TEER) "unsuitability" have been proposed on the basis of a Heart Valve Collaboratory consensus opinion from physician experience with early-generation TEER devices but lacked an evidence-based approach.Objectives: The aim of this study was to explore the spectrum of TEER suitability using echocardiographic and clinical outcomes from the EXPAND G4 real-world postapproval study.Methods: EXPAND G4 is a global, prospective, multicenter, single-arm study that enrolled 1,164 subjects with mitral regurgitation (MR) treated with the MitraClip G4 System. Three groups were defined using the Heart Valve Collaboratory TEER unsuitability criteria: 1) risk of stenosis (RoS); 2) risk of inadequate MR reduction (RoIR); and 3) subjects with baseline moderate or less MR (MMR). A TEER-suitable (TS) group was defined by the absence of these characteristics. Endpoints included independent core laboratory-assessed echocardiographic characteristics, procedural outcomes, MR reduction, NYHA functional class, Kansas City Cardiomyopathy Questionnaire score, and major adverse events through 30 days.Results: Subjects in the RoS (n = 56), RoIR (n = 54), MMR (n = 326), and TS (n = 303) groups had high 30-day MR reduction rates (≤1+: RoS 97%, MMR 93%, and TS 91%; ≤2+: RoIR 94%). Thirty-day improvements in functional capacity (NYHA functional class I or II at 30 days vs baseline: RoS 94% vs 29%, RoIR 88% vs 30%, MMR 79% vs 26%, and TS 83% vs 33%) and quality of life (change in Kansas City Cardiomyopathy Questionnaire score: RoS +27 ± 26, RoIR +16 ± 26, MMR +19 ± 26, and TS +19 ± 24) were safely achieved in all groups, with low major adverse events (<3%) and all-cause mortality (RoS 1.8%, RoIR 0%, MMR 1.5%, and TS 1.3%).Conclusions: Patients previously deemed TEER unsuitable can be safely and effectively treated with the mitral TEER fourth-generation device.

Dates et versions

hal-04167993 , version 1 (21-07-2023)

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Paternité - Pas d'utilisation commerciale - Pas de modification

Identifiants

Citer

Jason Rogers, Federico Asch, Paul Sorajja, Paul Mahoney, Matthew Price, et al.. Expanding the Spectrum of TEER Suitability: Evidence From the EXPAND G4 Post Approval Study. JACC: Cardiovascular Interventions, 2023, 16 (12), pp.1474-1485. ⟨10.1016/j.jcin.2023.05.014⟩. ⟨hal-04167993⟩
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