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Observational Study
. 2025 Dec 16;14(24):e042785.
doi: 10.1161/JAHA.125.042785. Epub 2025 Dec 10.

Safety and Prognostic Implications of Mechanical Circulatory Support-Assisted Transcatheter Edge-to-Edge Repair: The OCEAN-Mitral Registry

Shuhei Tanaka  1 , Teruhiko Imamura  1 , Ryuichi Ushijima  1 , Makiko Nakamura  1 , Nobuyuki Fukuda  1 , Hiroshi Ueno  1 , Koichiro Kinugawa  1 , Masanori Yamamoto  2   3   4 , Shunsuke Kubo  5 , Yuki Izumi  6 , Mike Saji  6   7 , Masahiko Asami  8 , Yusuke Enta  9 , Shinichi Shirai  10 , Masaki Izumo  11 , Shingo Mizuno  12 , Yusuke Watanabe  13 , Makoto Amaki  14 , Kazuhisa Kodama  15 , Hisao Otsuki  16 , Toru Naganuma  17 , Hiroki Bota  18 , Yohei Ohno  19 , Masahiro Yamawaki  20 , Gaku Nakazawa  21 , Daisuke Hachinohe  22 , Toshiaki Otsuka  23 , Kentaro Hayashida  24 ; OCEAN‐Mitral investigators
Collaborators, Affiliations
Observational Study

Safety and Prognostic Implications of Mechanical Circulatory Support-Assisted Transcatheter Edge-to-Edge Repair: The OCEAN-Mitral Registry

Shuhei Tanaka et al. J Am Heart Assoc. .

Abstract

Background: Transcatheter edge-to-edge repair of the mitral valve (M-TEER) has demonstrated promising outcomes for patients with mitral regurgitation who are unsuitable for surgical intervention. However, the clinical implications of M-TEER in patients requiring mechanical circulatory support (MCS) for unstable hemodynamics remains unclear. This study aimed to evaluate the outcomes of MCS-assisted M-TEER in critically ill patients.

Methods: Consecutive patients who underwent M-TEER for significant mitral regurgitation were identified from the Japanese multicenter OCEAN-Mitral (Optimized Catheter Valvular Intervention-Mitral) registry. All-cause death was compared between the cohort undergoing MCS-assisted M-TEER and a virtual control group receiving MCS alone without undergoing M-TEER, estimated using the Seattle Heart Failure Model. Additionally, logistic regression analysis was conducted to identify factors associated with in-hospital death following MCS-assisted M-TEER.

Results: A total of 3764 patients were included in the analysis (mean age, 81 years; 54.9% men; 70.1% with secondary mitral regurgitation), of whom 105 underwent MCS-assisted M-TEER. Procedure success exceeded 95%, irrespective of MCS use. The 1-year mortality rate in the MCS-assisted M-TEER group was lower than the estimated mortality rate in the virtual control group (43.2% versus 69.5%). Factors associated with in-hospital death included frailty, inflammation, and hypoalbuminemia. In a landmark analysis starting from discharge date, there was no statistically significant difference in cardiovascular death or heart failure hospitalization between the groups with or without the use of MCS (hazard ratio, 1.45 [95% CI, 0.93-2.26]; P=0.10).

Conclusions: MCS-assisted M-TEER appears to be a viable and effective therapeutic strategy for carefully selected patients with significant mitral regurgitation and unstable hemodynamics.

Registration: URL: https://www.umin.ac.jp/ctr/; Unique identifier: UMIN-ID: UMIN000023653.

Keywords: mechanical circulatory support; mitral regurgitation; transcatheter edge‐to‐edge repair.

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Conflict of interest statement

The OCEAN–Mitral registry, which is part of OCEAN–Structural Heart Disease registry, is supported by Edwards Lifesciences, Medtronic Japan, Boston Scientific, Abbott Medical Japan, and Daiichi‐Sankyo Company. Drs Ueno, Kubo, Izumi, Saji, Izumo, Watanabe, Amaki, and Kodama are clinical proctors of transcatheter edge‐to‐edge repair for Abbott Medical and have received consultant fees from Abbott Medical. Drs Asami and Kodama are clinical proctors of transcatheter edge‐to‐edge repair for Abbott Medical and have received speaker fees from Abbott Medical. Dr Yamamoto is a clinical proctor of transcatheter edge‐to‐edge repair for Abbott Medical and has received lecture fees from Abbott Medical. Dr Otsuki has received lecture fees and a scholarship donation from Abbott Medical. Dr Ohno has received consultant, advisor, and speaker fees from Abbott Medical. Drs Enta, Shirai, Mizuno, Bota, and Hayashida are clinical proctors of transcatheter edge‐to‐edge repair for Abbott Medical. The other authors have no relationships relevant to the content of this article.

Figures

Figure 1
Figure 1. Comparison of 1‐ and 2‐year survival rates between the cohort undergoing MCS‐assisted M‐TEER and the rates predicted by SHFM for the same cohort.
MCS indicates mechanical circulatory support; M‐TEER, transcatheter edge‐to‐edge repair of mitral valve; OCEAN, Optimized Catheter Valvular Intervention; and SHFM, Seattle Heart Failure Model.
Figure 2
Figure 2. Kaplan–Meier curve for composite end point of cardiovascular death and heart failure hospitalization in the MCS and the non‐MCS groups after landmark time point.
MCS indicates mechanical circulatory support.
See this image and copyright information in PMC

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