Expanding the Spectrum of TEER Suitability: Evidence From the EXPAND G4 Post Approval Study.
Citation: Jacc: Cardiovascular Interventions. 16(12):1474-1485, 2023 06 26.PMID: 37380229Institution: MedStar Health Research InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | Multicenter Study | Research Support, Non-U.S. Gov'tSubject headings: *Cardiomyopathies | *Mitral Valve Insufficiency | Constriction, Pathologic | Humans | Mitral Valve Insufficiency/dg [Diagnostic Imaging] | Mitral Valve Insufficiency/su [Surgery] | Prospective Studies | Quality of Life | Reactive Oxygen Species | Treatment Outcome | Year: 2023Local holdings: Available online through MWHC library: 2008 - presentISSN:- 1936-8798
Item type | Current library | Collection | Call number | Status | Date due | Barcode |
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Journal Article | MedStar Authors Catalog | Article | 37380229 | Available | 37380229 |
Available online through MWHC library: 2008 - present
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.
CONCLUSIONS: Patients previously deemed TEER unsuitable can be safely and effectively treated with the mitral TEER fourth-generation device. Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.
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.
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.
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%).
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