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. 2024 Nov 18;20(22):1430-1441.
doi: 10.4244/EIJ-D-23-01092.

Predictors and clinical impact of worsening left ventricular ejection fraction after mitral transcatheter edge-to-edge repair

Sachiyo Ono  1 , Shunsuke Kubo  1 , Takeshi Maruo  1 , Naoki Nishiura  1 , Kazunori Mushiake  1 , Kohei Osakada  1 , Kazushige Kadota  1 , Masanori Yamamoto  2   3   4 , Mike Saji  5   6 , Masahiko Asami  7 , Yusuke Enta  8 , Shinichi Shirai  9 , Masaki Izumo  10 , Shingo Mizuno  11 , Yusuke Watanabe  12 , Makoto Amaki  13 , Kazuhisa Kodama  14 , Junichi Yamaguchi  15 , Yoshifumi Nakajima  16 , Toru Naganuma  17 , Hiroki Bota  18 , Yohei Ohno  19 , Masahiro Yamawaki  20 , Hiroshi Ueno  21 , Kazuki Mizutani  22 , Toshiaki Otsuka  23 , Kentaro Hayashida  24 , Ocean-Mitral Investigators
Affiliations

Predictors and clinical impact of worsening left ventricular ejection fraction after mitral transcatheter edge-to-edge repair

Sachiyo Ono et al. EuroIntervention. .

Abstract

Background: Little is known about the effects of left ventricular ejection fraction (LVEF) worsening after transcatheter edge-to-edge valve repair (TEER) for mitral regurgitation (MR).

Aims: This study investigated the predictors and clinical impact of LVEF worsening after TEER for primary MR (PMR) and secondary MR (SMR).

Methods: This study included 2,019 patients (493 with PMR and 1,526 with SMR) undergoing successful TEER (postprocedural MR grade ≤2+) in the OCEAN-Mitral registry. The patients were categorised into worsened LVEF (wEF), defined as a relative decrease of >12.9% in LVEF at discharge, and preserved LVEF (pEF). The serial changes in left ventricular (LV) function at 1 year were also evaluated.

Results: Following TEER, 657 (32%) patients demonstrated wEF. The pEF group demonstrated both decreased left ventricular end-diastolic volumes (LVEDV) and end-systolic volumes (LVESV), and the wEF group showed significantly increased LVESV at discharge. Higher LVEF, larger LVEDV, higher B-type natriuretic peptide levels, and moderate/severe aortic regurgitation predicted wEF. Compared with baseline, the wEF group still demonstrated lower LVEF (46% to 43%; p<0.001) but significantly increased stroke volume (48 mL to 53 mL; p=0.001) at 1 year. The incidence of death or heart failure hospitalisation was similar between the wEF and pEF groups (hazard ratio 1.14, 95% confidence interval: 0.72-1.80; p=0.84) and also in patients with PMR and SMR.

Conclusions: LVEF worsening after TEER was not uncommon and was caused by the increased LVESV. LV volumes and some patient-specific factors predicted worsened LVEF which was not associated with long-term clinical outcomes. OCEAN-Mitral registry: UMIN-CTR ID: UMIN000023653.

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Conflict of interest statement

S. Kubo, M. Saji, M. Izumo, Y. Watanabe, M. Amaki, Y. Nakajima, Y. Enta, S. Shirai, S. Mizuno, H. Bota, and M. Yamamoto are clinical proctors of transcatheter edge-to-edge repair for Abbott; and have received speaker fees from Abbott. M. Asami and K. Kodama have received speaker fees from Abbott. J. Yamaguchi is a clinical proctor of transcatheter edge-to-edge repair for Abbott; and has received a lecture fee and a scholarship donation from Abbott. Y. Ohno has received consultant, advisor, and speaker fees from Abbott. The other authors have no conflicts of interest relevant to the content of this article to declare.

Figures

Figure 1
Figure 1. The degree of MR reduction in wEF and pEF groups.
LVEF: left ventricular ejection fraction; MR: mitral regurgitation; pEF: patients with preserved LVEF; wEF: patients with worsened LVEF
Figure 2
Figure 2. Serial changes in LVEF, stroke volume, and LV volumes.
LVEF, stroke volume, LVEDV, and LVESV at baseline, discharge, and 1 year in the pEF groups (A,B) and wEF (C,D). LVEDV: left ventricular end-diastolic volume; LVEF: left ventricular ejection fraction; LVESV: left ventricular end-systolic volume; pEF: patients with preserved LVEF; wEF: patients with worsened LVEF
Figure 3
Figure 3. Time-to-first event curves for the primary and secondary endpoints.
Kaplan-Meier curves of (A) all-cause mortality or hospitalisation for heart failure, (B) all-cause mortality, and (C) hospitalisation for heart failure, stratified according to LVEF changes after TEER. CI: confidence interval; HR: hazard ratio; LVEF: left ventricular ejection fraction; pEF: patients with preserved LVEF; TEER: transcatheter edge-to-edge repair; wEF: patients with worsened LVEF
Figure 4
Figure 4. NYHA Functional Class at baseline and 1 year.
NYHA Functional Class at baseline (A) and 1 year (B) in the wEF and pEF groups. LVEF: left ventricular ejection fraction; NYHA: New York Heart Association; pEF: patients with preserved LVEF; wEF: patients with worsened LVEF
Central illustration
Central illustration. Outcomes of patients undergoing TEER according to LVEF change: predictors and clinical impact of LVEF worsening.
The OCEAN-Mitral registry observed worsened LVEF after TEER in approximately 30% of patients with MR mainly due to the increased LV end-systolic volume, but LVEF tended to improve after 1 year with reverse remodelling (the red, orange, and green arrows indicate adverse change, positive change, and no change in the left ventricle, respectively). Worsened LVEF was predicted by LV volume and patient-specific factors, and was not associated with long-term outcomes regardless of MR aetiology. AR: aortic regurgitation; BNP: B-type natriuretic peptide; CI: confidence interval; HR: hazard ratio; LV: left ventricular; LVEF: left ventricular ejection fraction; MR: mitral regurgitation; TEER: transcatheter edge-to-edge valve repair
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