Prognostic impact of MitraClip in patients with left ventricular dysfunction and functional mitral valve regurgitation: A comprehensive meta-analysis of RCTs and adjusted observational studies

Bertaina, Maurizio; Galluzzo, Alessandro; D’Ascenzo, Fabrizio; Conrotto, Federico; Marra, Walter Grosso; Frea, Simone; Alunni, Gianluca; Moretti, Claudio; Montefusco, Antonio; D’Amico, Maurizio; Perl, Leor; Rinaldi, Mauro; Giustetto, Carla; Ferrari, Gaetano M. De

doi:10.1016/j.ijcard.2019.05.015

Cited by 11 publications

(6 citation statements)

References 28 publications

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“…The global clinical improvement after Mitraclip ® in FMR remains under permanent study. While two recent observational studies showed worse outcomes in patients with lower LVEF [ 28 , 29 ], other reports have recently showed that the treatment with MitraClip ® for FMR in patients with different degrees of LV dysfunction is associated with a considerable reduction of death and HF hospitalization at mid-term follow-up [ 30 ].…”

Section: Discussionmentioning

confidence: 99%

Transcatheter Mitral Repair for Functional Mitral Regurgitation According to Left Ventricular Function: A Real-Life Propensity-Score Matched Study

Pascual

Carrasco-Chinchilla

Benito‐González

et al. 2020

JCM

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Background: Transcatheter mitral valve repair (TMVR) could improve survival in functional mitral regurgitation (FMR), but it is necessary to consider the influence of left ventricular ejection fraction (LVEF). Therefore, we compare the outcomes after TMVR with Mitraclip® between two groups according to LVEF. Methods: In an observational registry study, we compared the outcomes in patients with FMR who underwent TMVR with and without LVEF <30%. The primary endpoint was the combined one-year all-cause mortality and unplanned hospital readmissions due to HF. The secondary end-points were New York Heart Association (NYHA) functional class and mitral regurgitation (MR) severity. Propensity-score matching was used to create two groups with the same baseline characteristics, except for baseline LVEF. Results: Among 535 FMR eligible patients, 144 patients with LVEF <30% (group 1) and 144 with LVEF >30% (group 2) had similar propensity scores and were included in the analyses. The primary study endpoint was significantlly higher in group 1 (33.3% vs. 9.4%, p = 0.002). There was a maintained improvement in secondary endpoints without significant differences among groups. Conclusion: FMR patients with LVEF <30% treated with MitraClip® had higher mortality and readmissions than patients with LVEF ≥30% treated with the same device. However, both groups improved the NYHA functional class and MR severity.

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Section: Discussionmentioning

confidence: 99%

Transcatheter Mitral Repair for Functional Mitral Regurgitation According to Left Ventricular Function: A Real-Life Propensity-Score Matched Study

Pascual

Carrasco-Chinchilla

Benito‐González

et al. 2020

JCM

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“…Although many hypotheses have been suggested to account for trial differences [30][31][32][33] it remains unclear which patient categories benefit from PR and which do not, especially as baseline characteristics of enrolled patients are overall similar in the two trials (S2 Appendix in S1 File). Summarizing evidence across studies using meta-analysis of aggregate data appears inappropriate owing to the considerable heterogeneity between studies [34]. Indeed, such heterogeneity cannot be resolved satisfactorily with conventional meta-regression or subgroup analyses techniques.…”

Section: Plos Onementioning

confidence: 99%

Conflicting findings between the Mitra-Fr and the Coapt trials: Implications regarding the cost-effectiveness of percutaneous repair for heart failure patients with severe secondary mitral regurgitation

et al. 2020

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Purpose Two randomized controlled trials (RCTs), Mitra-Fr and Coapt, evaluating the benefit of percutaneous repair (PR) for heart failure (HF) patients with severe mitral regurgitation, have led to conflicting results. We aimed to evaluate the impact of these trial results on the cost-effectiveness of PR using effectiveness inputs from the two RCTs. Methods We developed a time varying Markov type model with three mutually exclusive health states: alive without HF hospitalisation, alive with HF hospitalisation, and dead. Clinically plausible extrapolations beyond observed data were obtained by developing parametric modelling for overall survival and HF hospitalisations using published data from each trial. We adopted the perspective of the French Health System and used a 30-year time horizon. Results were expressed as € / quality-adjusted life year (QALY) gained using utility inputs from literature. Findings Results are presented using treatment efficacy measures from Mitra-F and Coapt trials respectively. With the Mitra-Fr data, after annual discounting, the base case model generated an incremental 0.00387 QALY at a cost of €25,010, yielding an incremental cost effectiveness ratio (ICER) of €6,467,032 / QALY. The model was sensitive to changes made to model inputs. There was no potential of PR being cost-effective. With the Coapt data, the model generated 1.19 QALY gain at a cost of €26,130 yielding an ICER of €21,918 / QALY and at a threshold of >€50,000/QALY PR had a probability of 1 of being cost-effective. Implications Cost effectiveness results were conflicting; reconciling differences between trials is a priority and could promote optimal cost effectiveness analyses and resource allocation.

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“…A meta-analysis of six retrospective studies with a propensity-matched analysis showed that patients treated by MitraClip® for SMR had a better prognosis in term of mortality and re-hospitalization (median follow-up of 400 days), compared to patients treated by optimal medical treatment alone (11, 12, 13, 14). The COAPT trial showed for the first time, the clear benefit of MitraClip® therapy in SMR, when used in addition to optimal medical therapy (OMT): the primary endpoint (all hospitalizations for heart failure within 24 months) was significantly reduced in the MitraClip group (HR 0.53; 95 CI 0.40–0.70; P > 0.001), with an impressive number needed to treat (NNT) of 3.1.…”

Section: Secondary Mitral Regurgitation (Smr) Management: Interactionmentioning

confidence: 99%

The central role of the cardiac imager in heart valve disease

et al. 2019

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In this review, we discuss the central role of the imager in the heart team in the successful application of current guidelines for heart valve diseases to daily practice, and for improving patient care through new approaches, new techniques and new strategies for dealing with increasingly complex cases. This is an opportunity to emphasize the importance of having good imagers and the value of continuous learning in a modern heart team. It is essential to employ technological improvements and to appropriately adapt guidelines to the patients we see day to day.

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Prognostic impact of MitraClip in patients with left ventricular dysfunction and functional mitral valve regurgitation: A comprehensive meta-analysis of RCTs and adjusted observational studies

Cited by 11 publications

References 28 publications

Transcatheter Mitral Repair for Functional Mitral Regurgitation According to Left Ventricular Function: A Real-Life Propensity-Score Matched Study

Transcatheter Mitral Repair for Functional Mitral Regurgitation According to Left Ventricular Function: A Real-Life Propensity-Score Matched Study

Conflicting findings between the Mitra-Fr and the Coapt trials: Implications regarding the cost-effectiveness of percutaneous repair for heart failure patients with severe secondary mitral regurgitation

The central role of the cardiac imager in heart valve disease

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