Transcatheter Edge-to-Edge Repair in Secondary Mitral Regurgitation With Extended Non–COAPT-Like Features

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BACKGROUND: Mitral transcatheter edge-to-edge repair (MTEER) is approved for patients with secondary mitral regurgitation (SMR) and heart failure based on COAPT (The Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy) eligibility criteria. Outcomes in patients beyond COAPT criteria with more advanced heart disease remain unclear. OBJECTIVES: This study aimed to assess the outcomes of MTEER in SMR patients beyond COAPT trial criteria from the global, post-market EXPANDed studies. METHODS: Analyses were performed with the EXPANDed data set, including 2,205 patients treated with the 3rd/4th-generation MitraClip MTEER System. Non-COAPT-like patients were classified by baseline ≥3+ SMR and at least 1 of the following: left ventricular ejection fraction <20%, left ventricular end-systolic diameter >70 mm, or systolic pulmonary artery pressure >70 mm Hg. Echocardiographic outcomes were assessed by an echocardiographic core laboratory. RESULTS: ; 0.36). One-year mortality and HFH rates were similar between groups and comparable or lower to those in the MITRA-FR (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients with Severe Secondary Mitral Regurgitation) and COAPT trials. HFH was reduced by 56% in COAPT-like and 74% in non-COAPT-like patients from pre- to post-MTEER. At 1 year, both groups achieved significant MR reduction (90% MR ≤1+ COAPT-like and non-COAPT-like). CONCLUSIONS: In the EXPANDed studies, non-COAPT-like patients experienced significant improvements in MR, HFH, and quality-of-life at 1 year, comparable with those observed in COAPT-like patients. These findings suggest that MTEER may be an effective therapeutic option in appropriately selected patients outside COAPT eligibility. (The MitraClip EXPAND Study of the Next Generation of MitraClip Devices [EXPAND]; NCT03502811) (MitraClip EXPAND G4 Study [EXPAND G4]; NCT04177394).

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