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. 2022 Jun 24;18(3):213-223.
doi: 10.4244/EIJ-D-21-00708.

Management of patients with mitral regurgitation ineligible for standard therapy undergoing TMVI screening

Sebastian Ludwig  1   2 , Roya Sedighian  1 , Jessica Weimann  1 , Benedikt Koell  1   2 , Lara Waldschmidt  1 , Andreas Schäfer  3 , Moritz Seiffert  1   2 , Dirk Westermann  1   2 , Hermann Reichenspurner  2   3 , Stefan Blankenberg  1   2 , Niklas Schofer  1 , Edith Lubos  1   2 , Lenard Conradi  3 , Daniel Kalbacher  1   2
Affiliations

Management of patients with mitral regurgitation ineligible for standard therapy undergoing TMVI screening

Sebastian Ludwig et al. EuroIntervention. .

Abstract

Background: Transcatheter mitral valve implantation (TMVI) represents a novel treatment alternative for patients with severe mitral regurgitation (MR) considered ineligible for standard therapies. Data on the management of patients after TMVI screening are scarce.

Aims: We aimed to investigate outcomes of patients with severe MR undergoing TMVI evaluation treated with either TMVI, bailout-transcatheter edge-to-edge repair (bailout-TEER) or medical therapy (MT).

Methods: Between May 2016 and February 2021, 121 patients with MR considered ineligible for standard therapy were screened for TMVI. Outcomes were assessed for the subgroups of patients treated with TMVI, bailout-TEER and MT. The primary composite endpoint was all-cause death or heart failure hospitalisation after one year.

Results: The subgroups of TMVI (N=38), bailout-TEER (N=28) and MT (N=44) differed significantly with regard to MR aetiology (secondary MR: TMVI 68.4%, bailout-TEER 39.3%, MT 38.6%, p=0.014) and left ventricular ejection fraction (TMVI 37.0% [31.4-51.2], bailout-TEER 48.0% [35.3-58.3], MT 54.5% [40.8-60.0], p<0.001). At discharge and after one year, MR was reduced to ≤mild residual MR in all patients undergoing TMVI, while ≥moderate residual MR was present in 25.9% and 20.0% of patients, respectively, after bailout-TEER, and in 100.0% of patients on MT at one year. The primary endpoint occurred in 72.2% of patients remaining on MT, in 51.6% of patients undergoing TMVI and in 40.2% of those receiving bailout-TEER.

Conclusions: In MR patients considered ineligible for standard therapy, TMVI provided acceptable clinical outcomes and MR elimination in the majority of patients. In screen-failed patients, bailout-TEER represented a reasonable alternative while MT was associated with poor outcomes.

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Figures

Figure 1
Figure 1. Study flow chart.
MR: mitral regurgitation; MT: medical therapy; MV: mitral valve; TEER: transcatheter edge-to-edge repair; TMVI: transcatheter mitral valve implantation
Figure 2
Figure 2. TMVI screening failure reasons.
annulus (-): small annulus size; annulus (+): large annulus size; LV: left ventricle; LVOTO: left ventricular outflow tract obstruction; MAC: mitral annular calcification; MT: medical therapy; TEER: transcatheter edge-to-edge repair; TMVI: transcatheter mitral valve implantation
Figure
Figure. Echocardiographic and functional outcomes.
A. Echocardiographic outcome at discharge and at one year. B. Functional outcome after one year. MR: mitral regurgitation; NYHA: New York Heart Association; TEER: transcatheter edge-to-edge repair; TMVI: transcatheter mitral valve implantation
Figure 4
Figure 4. Kaplan-Meier analyses for the primary endpoint of all-cause death or HF rehospitalisation after one year, and the secondary endpoints of all-cause death and cardiovascular death after one year.
CV: cardiovascular; HF: heart failure; MT: medical therapy; TEER: transcatheter edge-to-edge repair; TMVI: transcatheter mitral valve implantation
Figure 5
Figure 5. Univariate Cox regression analysis.
Combined endpoint (all-cause death or heart failure rehospitalisation after one year). COPD: chronic obstructive pulmonary disease; EROA: effective regurgitant orifice area; LV: left ventricular; LVEDV: left ventricle end-diastolic volume; LVEF: left ventricular ejection fraction; MT: medical therapy; MVPG: mitral valve pressure gradient; NYHA: New York Heart Association; PASP: pulmonary artery systolic pressure; RV: right ventricular; TAPSE: tricuspid annular plane systolic excursion; TEER: transcatheter edge-to-edge repair; TMVI: transcatheter mitral valve implantation
Central illustration
Central illustration. Management of patients with mitral regurgitation ineligible for standard therapy undergoing TMVI screening; a single-centre experience.
HF: heart failure; LV: left ventricular; LVOT: left ventricular outflow tract; MAC: mitral annular calcification; MR: mitral regurgitation; TEER: transcatheter edge-to-edge repair; TMVI: transcatheter mitral valve implantation
See this image and copyright information in PMC

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