Percutaneous mitral valve repair vs. stand-alone medical therapy in patients with functional mitral regurgitation and heart failure Tomás Benito-González a , Rodrigo Estévez-Loureiro a, ⁎, Pedro A. Villablanca b , Patrizio Armeni c , Ignacio Iglesias-Gárriz a , Carlos Minguito a , Carmen Garrote a , Armando Pérez de Prado a , Elena Tundidor-Sanz a , Javier Gualis d , Felipe Fernández-Vázquez a a Department of Cardiology, University Hospital of León, León, Spain b Department of Cardiology, Center for Structural Heart Disease, Henry Ford Hospital, Detroit, United States of America c SDA Bocconi School of Management/CERGAS SDA Bocconi, Italy d Department of Cardiac Surgery, University Hospital of León, León, Spain abstract article info Article history: Received 10 April 2019 Received in revised form 12 June 2019 Accepted 20 June 2019 Available online xxxx 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 trans- plantation 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 indica- tion 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, hospital- izations for HF and the need for HF transplant, left ventricular assist device or unplanned surgery beyond 1-year follow up. © 2019 Elsevier Inc. All rights reserved. Keywords: Functional mitral regurgitation MitraClip Optimal medical therapy 1. 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 im- proved clinical status and quality of life [4]. Furthermore, different ob- servational series have pointed out a reduction in all-cause mortality in patients who underwent TMVR compared to those treated conserva- tively [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 out- comes 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. 2. Methods The PRISMA [8] Preferred Reporting Items for Systematic Reviews and Meta-Analyses, and the MOOSE [9] statement for reporting system- atic reviews and meta-analyses of observational studies were applied. Cardiovascular Revascularization Medicine xxx (xxxx) xxx ⁎ Corresponding author at: Department of Cardiology, University Hospital Puerta de Hierro-Majadahonda, Madrid, Spain. E-mail address: rodrigo.estevez.loureiro@sergas.es (R. Estévez-Loureiro). CARREV-01625; No of Pages 9 https://doi.org/10.1016/j.carrev.2019.06.008 1553-8389/© 2019 Elsevier Inc. All rights reserved. Contents lists available at ScienceDirect Cardiovascular Revascularization Medicine Please cite this article as: T. Benito-González, R. Estévez-Loureiro, P.A. Villablanca, et al., Percutaneous mitral valve repair vs. stand-alone medical therapy in patients with functional mitral ..., Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.06.008