Mitral Transcatheter Edge-to-Edge Repair in Ventricular Functional Mitral Regurgitation and Very Severe Left Ventricular Dysfunction

BACKGROUND: Patients with functional mitral regurgitation (MR) and very severe left ventricular (LV) dysfunction (LV ejection fraction [LVEF] <20%) have been largely excluded from randomized trials of mitral transcatheter edge-to-edge repair (M-TEER), leaving a substantial knowledge gap regarding the role of M-TEER in this high-risk population. OBJECTIVES: This study aimed to evaluate the safety, feasibility, and 1-year outcomes of M-TEER in patients with functional MR and LVEF <20%. METHODS: The OCEAN (Optimized Catheter Valvular Intervention)-Mitral registry prospectively enrolled patients undergoing M-TEER. Among patients with functional MR and LVEF ≤40% (n = 1,538), outcomes were compared between those with LVEF <20% (n = 103) and 20%≤ LVEF ≤40% (n = 1,435). The primary endpoint was the composite of all-cause death and heart failure (HF) hospitalization at 1 year. Secondary endpoints included cardiovascular (CV) death and procedural outcomes. RESULTS: Acute procedural success was similar between groups (n = 103 [100%, LVEF <20%] vs n = 1,390 [97%, 20%≤ LVEF ≤40%]), with comparable residual MR and postprocedural transmitral pressure gradients. In-hospital mortality did not differ by LVEF category (n = 5 [5%] vs n = 58 [4%]). Both groups showed significant improvement in NYHA functional class at 1 year, although functional status remained worse in patients with LVEF <20%. After adjustment, the primary endpoint did not differ significantly between groups (LVEF <20% vs 20%≤ LVEF ≤40%; HR: 1.24; 95% CI: 0.82-1.88). However, LVEF <20% was independently associated with higher CV mortality (HR: 2.00; 95% CI: 1.08-3.68). CONCLUSIONS: In patients with ventricular functional MR and LVEF <20%, M-TEER was feasible and associated with meaningful symptomatic improvement without excess risk of death or HF hospitalization, although CV mortality remained higher, likely reflecting advanced myocardial disease.

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Journal
JACC Advances
Published
2026-08-14
DOI
https://doi.org/10.1016/j.jacadv.2026.103126
Primary Topic
Cardiac Valve Diseases and Treatments
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article
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article

Mitral Transcatheter Edge-to-Edge Repair in Ventricular Functional Mitral Regurgitation and Very Severe Left Ventricular Dysfunction

Mike Saji, Masahiko Asami, Hiroshi Ueno, Hiroki Bota et al.
JACC Advances
Cardiac Valve Diseases and Treatments
article

Mitral Transcatheter Edge-to-Edge Repair in Ventricular Functional Mitral Regurgitation and Very Severe Left Ventricular Dysfunction

Mike Saji, Masahiko Asami, Hiroshi Ueno, Hiroki Bota, Kentaro Hayashida, Hisao Otsuki, Kazunori Omote, Yusuke Enta, Makoto Amaki, Kazuhisa Kodama, Daisuke Hachinohe, Masahiro Yamawaki, Shinichi Shirai, Shunsuke Kubo, Shingo Mizuno, Gaku Nakazawa, Toru Naganuma, Atsushi Sugiura, Yohei Ohno, Yuki Izumi, Toshiaki Otsuka, Masanori Yamamoto, Tetsuro Shimura, Masaki Izumo, Yusuke Watanabe
article en

Abstract

BACKGROUND: Patients with functional mitral regurgitation (MR) and very severe left ventricular (LV) dysfunction (LV ejection fraction [LVEF] <20%) have been largely excluded from randomized trials of mitral transcatheter edge-to-edge repair (M-TEER), leaving a substantial knowledge gap regarding the role of M-TEER in this high-risk population. OBJECTIVES: This study aimed to evaluate the safety, feasibility, and 1-year outcomes of M-TEER in patients with functional MR and LVEF <20%. METHODS: The OCEAN (Optimized Catheter Valvular Intervention)-Mitral registry prospectively enrolled patients undergoing M-TEER. Among patients with functional MR and LVEF ≤40% (n = 1,538), outcomes were compared between those with LVEF <20% (n = 103) and 20%≤ LVEF ≤40% (n = 1,435). The primary endpoint was the composite of all-cause death and heart failure (HF) hospitalization at 1 year. Secondary endpoints included cardiovascular (CV) death and procedural outcomes. RESULTS: Acute procedural success was similar between groups (n = 103 [100%, LVEF <20%] vs n = 1,390 [97%, 20%≤ LVEF ≤40%]), with comparable residual MR and postprocedural transmitral pressure gradients. In-hospital mortality did not differ by LVEF category (n = 5 [5%] vs n = 58 [4%]). Both groups showed significant improvement in NYHA functional class at 1 year, although functional status remained worse in patients with LVEF <20%. After adjustment, the primary endpoint did not differ significantly between groups (LVEF <20% vs 20%≤ LVEF ≤40%; HR: 1.24; 95% CI: 0.82-1.88). However, LVEF <20% was independently associated with higher CV mortality (HR: 2.00; 95% CI: 1.08-3.68). CONCLUSIONS: In patients with ventricular functional MR and LVEF <20%, M-TEER was feasible and associated with meaningful symptomatic improvement without excess risk of death or HF hospitalization, although CV mortality remained higher, likely reflecting advanced myocardial disease.

JACC AdvancesVol. 5(9)
Kansai Medical University (JP), Toho University (JP), Tokai University (JP), St. Marianna University School of Medicine (JP), Kurashiki Central Hospital (JP), Sapporo Higashi Tokushukai Hospital (JP), New Tokyo Hospital (JP), Saiseikai Kumamoto Hospital (JP), Sapporo Science Center (JP), Cardiovascular Center Hokkaido Ohno Hospital (JP), National Cerebral and Cardiovascular Center (JP), Toyohashi Heart Center (JP), Sakakibara Hospital (JP), Mitsui Memorial Hospital (JP), Tokyo Women's Medical University (JP), Toyama University Hospital (JP), Nagoya Heart Center (JP), Shonan Kamakura General Hospital (JP), Naval Hospital Yokosuka Japan (JP), Gifu Heart Center (JP), Kokura Memorial Hospital (JP), Kanagawa Dental University (JP), Nippon Medical School (JP), Teikyo University (JP), Kindai University (JP)
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Cardiac Valve Diseases and Treatments
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