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

BACKGROUND Anatomical and clinical criteria to define mitral transcatheter edge-to-edge repair (TEER) "unsuitabil-ity" 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 (& LE;1+: RoS 97%, MMR 93%, and TS 91%; & LE;2+: RoIR 94%). Thirty-day improvements in functional ca-pacity (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 & PLUSMN; 26, RoIR +16 & PLUSMN; 26, MMR +19 & PLUSMN; 26, and TS +19 & PLUSMN; 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. (J Am Coll Cardiol Intv 2023;16:1474-1485)& COPY; 2023 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).