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Observational Study
. 2025 Sep;13(9):102565.
doi: 10.1016/j.jchf.2025.102565. Epub 2025 Jun 27.

Transcatheter Edge-to-Edge Repair in Secondary Mitral Regurgitation With Extended Non-COAPT-Like Features: From the EXPANDed Studies

Gilbert H L Tang  1 , Matthew J Price  2 , Wolfgang Rottbauer  3 , Paul D Mahoney  4 , Jorg Hausleiter  5 , Philip W Raake  6 , William A Rollefson  7 , Philipp Lurz  8 , Paolo Denti  9 , Bassem K Chehab  10 , Melody Dong  11 , Rong Huang  11 , Federico M Asch  12 , Jose Luis Zamorano  13 , Ralph Stephan von Bardeleben  8 , Francesco Maisano  14 , Saibal Kar  15 , Evelio Rodriguez  16
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Free article
Observational Study

Transcatheter Edge-to-Edge Repair in Secondary Mitral Regurgitation With Extended Non-COAPT-Like Features: From the EXPANDed Studies

Gilbert H L Tang et al. JACC Heart Fail. 2025 Sep.
Free article

Abstract

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: Of the 967 SMR patients in EXPANDed, 197 were categorized as COAPT-like and 81 as non-COAPT-like. Both groups were elderly (74.4 ± 10.1 vs 73.6 ± 10.2 years) with a high prevalence of prior heart failure hospitalizations (HFH; 63% and 64%, respectively). Non-COAPT-like patients had larger left ventricular end-diastolic volumes (183 mL COAPT-like, 220 non-COAPT-like) and effective regurgitant orifice areas (0.33 cm2; 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).

Keywords: MitraClip; heart failure; mitral transcatheter edge-to-edge repair; mitral valve repair; secondary mitral regurgitation.

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Conflict of interest statement

Funding Support and Author Disclosures The EXPAND and EXPAND G4 studies are funded and sponsored by Abbott Structural Heart (Santa Clara, California, USA). Dr Tang has received speaker honoraria and served as a physician proctor, consultant, advisory board member, TAVR publications committee member, RESTORE study steering committee member, APOLLO trial screening committee member and IMPACT MR steering committee member for Medtronic; has received speaker honoraria and served as a physician proctor, consultant, advisory board member, and TRILUMINATE trial anatomic eligibility and publications committee member for Abbott Structural Heart; has served as an advisory board member for Boston Scientific and JenaValve; a consultant and physician screening committee member for Shockwave Medical; a consultant for NeoChord, Peija Medical, and Shenqi Medical Technology; and has received speaker honoraria from Siemens Healthineers. Dr Price has received consulting fees and honoraria from Abbott, Boston Scientific, InnovHeart, Medtronic, Philips Medical, W.L. Gore and Associates, and Shockwave Medical. Dr Rottbauer has received consulting fees/speaker honoraria from Abbott, Bayer Healthcare, Boston Scientific, Daiichi Sankyo, Edwards Lifesciences, and Medtronic; and is a member of the steering committee of the EXPAND G4 study for Abbott and Encourage AF study for Daiichi Sankyo. Dr Mahoney is a consultant and proctor for Medtronic, Edwards Lifesciences, and Boston Scientific; is a consultant for Abbott; and has been awarded research grants from Edwards Lifesciences, Medtronic Abbott, and Boston Scientific. Dr Lurz has received institutional fees and research grants from Abbott Vascular, Edwards, Lifesciences, and ReCor; has received honoraria from Edwards Lifesciences, Abbott Medical, Innoventric, ReCor, and Bhoehringer Lingelheim; and owns stock options in Innoventric. Dr Denti has received speaker honoraria from Abbott and Edwards Lifesciences; and has been a consultant to InnovHeart, Artiness, and Pi-Cardia. Dr Chehab has received study grants and consulting fees from Abbott, Edwards Lifesciences, and BioTronics. Dr Dong and Ms Huang are employees of Abbott Structural Heart. Dr Asch’s work as an academic core laboratory director is performed through institutional research grants (MedStar Health) with Abbott, Boston Scientific, Medtronic, Edwards Lifesciences, Neovasc, Ancora Heart, LivaNova, MVRx, InnovHeart, Polares Medical, and Aria CV. Dr Zamorano has received speaker honoraria from Pfizer, Amgen, and Daiichi Sankyo; and research grants from Abbott and Edwards Lifesciences. Dr Maisano has received grants and/or institutional research support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, NVT, and Terumo; has received honoraria and consulting fees (personal and institutional) from Abbott, Medtronic, Edwards Lifesciences, Xeltis, and Cardiovalve; has received royalty income and intellectual property rights from Edwards Lifesciences; and is a shareholder (including stock options) of CardioGard, Magenta, SwissVortex, Transseptal Solutions, Occlufit, 4Tech, and Perifect. Dr von Bardeleben has performed nonpaid trial activities for Abbott, Edwards Lifesciences, Medtronic, and the University of Göttingen (IIT); and serves as an advisory board or speaker bureau member for Abbott Cardiovascular Edwards Lifesciences, Medtronic, and NeoChord. Dr Kar has received grants and institutional research support from Abbott, Boston Scientific, and Edwards Lifesciences; has received consulting fees/honoraria from Abbott, Boston Scientific, W.L. Gore, and Medtronic; and served as a steering committee member of the TRILUMINATE study (Abbott) and as national principal investigator of the EXPAND study and the REPAIR MR study for Abbott. Dr Rodriguez has been awarded grants and support for research from Abbott, Edwards Lifesciences, Boston Scientific, AtriCure, and CardioMech; and has received honoraria or consulting fees from Abbott, Edwards Lifesciences, Philips, Teleflex, and CardioMech. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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