Clinical
Percutaneous Mitral Valve Repair Vs. Stand-Alone Medical Therapy in Patients with Functional Mitral Regurgitation and Heart Failure

https://doi.org/10.1016/j.carrev.2019.06.008Get rights and content

Highlights

  • Functional mitral regurgitation is a common finding among patients with heart failure and it is related to adverse events

  • Our meta-analysis show a statistically significant reduction in all-cause mortality favoring MitraClip

  • Our data show a significant reduction in heart failure hospitalizations and indication for advanced heart failure therapies

  • Our work supports the use of MitraClip in patients with functional mitral regurgitation and heart failure

Abstract

Background

Functional mitral regurgitation (FMR) is a common finding among patients with heart failure (HF) and it is related to adverse events. Outcomes in patients undergoing transcatheter mitral valve repair (TMVR) are still a matter of debate. We performed a meta-analysis to assess mid- and long-term outcomes of patients with FMR treated with MitraClip® compared to medical management.

Methods

We conducted an electronic database search of all published data PubMed Central, Embase, the Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and Google Scholar databases. The primary end-point was all-cause mortality. The secondary end-points were hospitalizations for HF, need for heart transplantation or left ventricular assist device, unplanned mitral valve surgery, myocardial infarction and stroke.

Results

Five studies (n = 1513 patients) were included in the analysis. The summary estimate including all the available studies showed a statistically significant reduction in all-cause mortality favoring MitraClip® (HR 0.56, CI 95% [0.38–0.84]) and HF hospitalizations (HR 0.65; CI 95% [0.46–0.92]). A significant reduction in the indication for advanced HF therapies (OR 0.48; CI 95% [0.25–0.90]) or the need for unplanned mitral valve surgery (OR 0.20; CI 95% [0.07–0.57]) was also found in the group of patients that underwent TMVR. No differences in the incidence of myocardial infarction or stroke were found between both groups of treatment. No publication bias was detected.

Conclusion

TMVR with MitraClip® system was related to a significant reduction in all-cause mortality, hospitalizations for HF and the need for HF transplant, left ventricular assist device or unplanned surgery beyond 1-year follow up.

Introduction

Transcatheter MV repair (TMVR) with MitraClip® (Abbott Vascular, Santa Clara, USA) has become a minimally invasive alternative therapy for patients with MR deemed either non-candidates or at high risk for conventional surgery [1]. TMVR has proved to effectively decrease MR, thus reducing volume overload [2], which leads to inverse remodeling in left cardiac chambers [3]. These changes have been related to improved clinical status and quality of life [4]. Furthermore, different observational series have pointed out a reduction in all-cause mortality in patients who underwent TMVR compared to those treated conservatively [5]. Nevertheless, two recent randomized controlled trials (RCT) [6,7] including only patients with FMR have shown conflicting results.

Our aim was to conduct a meta-analysis to compare survival outcomes between TMVR with MitraClip® system over optimal medical therapy (OMT) versus conservative stand-alone OMT in patients with symptomatic FMR not considered candidates for MV surgery.

Section snippets

Methods

The PRISMA [8] Preferred Reporting Items for Systematic Reviews and Meta-Analyses, and the MOOSE [9] statement for reporting systematic reviews and meta-analyses of observational studies were applied.

Literature search

The search strategy identified a total of 858 potential articles (Fig. 1). Duplicates, articles that did not meet inclusion criteria based on title or abstract, conference abstracts, and narrative or systematic reviews were removed. Thirteen reports were deeply evaluated for eligibility. Ultimately, five studies, two RCT [6,7] and three observational [[12], [13], [14]] series satisfied all inclusion criteria and were used in the qualitative appraisal and quantitative data extraction. Overall,

Discussion

We performed a meta-analysis of all the available evidence to address potential survival benefit of TMVR with MitraClip® device versus conservative stand-alone OMT in patients with FMR. Overall, more than fifteen hundred patients were analyzed within 2 RCT and 3 observational studies. The main finding of our study was a significant reduction in all-cause mortality, consistently beyond 1-year follow up. Furthermore, TMVR was related to a reduction in the incidence of HF hospitalizations and the

Conclusions

TMVR with MitraClip® system was related to a significant reduction in all-cause mortality, hospitalizations for HF and the need for HF transplant, left ventricular assist device or unplanned surgery. Differences in survival become significantly apparent beyond 1-year follow up. Given the heterogeneity in the enrolling criteria of included studies, these results support the use of the recommendations of the American Society of Echocardiography for defining severe FMR in patients evaluated for

Funding

This study was supported by a research grant (PdH) in interventional cardiology of the Spanish Society of Cardiology.

Declaration of Competing Interest

Dr. Estevez-Loureiro is proctor for MitraClip® and consultant for Abbott Vascular. The rest of authors have nothing to disclose.

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