Witte, KK orcid.org/0000-0002-7146-7105, Lipiecki, J, Siminiak, T et al. (10 more authors) (2019) The REDUCE FMR Trial: A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation. JACC: Heart Failure, 7 (11). pp. 945-955. ISSN 2213-1779
Abstract
Objectives
This study sought to evaluate the effects of the Carillon device on mitral regurgitation severity and left ventricular remodeling.
Background
Functional mitral regurgitation (FMR) complicates heart failure with reduced ejection fraction and is associated with a poor prognosis.
Methods
In this blinded, randomized, proof-of-concept, sham-controlled trial, 120 patients receiving optimal heart failure medical therapy were assigned to a coronary sinus-based mitral annular reduction approach for FMR or sham. The pre-specified primary endpoint was change in mitral regurgitant volume at 12 months, measured by quantitative echocardiography according to an intention-to-treat analysis.
Results
Patients (69.8 ± 9.5 years of age) were randomized to either the treatment (n = 87) or the sham-controlled (n = 33) arm. There were no significant differences in baseline characteristics between the groups. In the treatment group, 73 of 87 (84%) had the device implanted. The primary endpoint was met, with a statistically significant reduction in mitral regurgitant volume in the treatment group compared to the control group (decrease of 7.1 ml/beat [95% confidence interval [CI]: −11.7 to −2.5] vs. an increase of 3.3 ml/beat [95% CI: −6.0 to 12.6], respectively; p = 0.049). Additionally, there was a significant reduction in left ventricular volumes in patients receiving the device versus those in the control group (left ventricular end-diastolic volume decrease of 10.4 ml [95% CI: −18.5 to −2.4] vs. an increase of 6.5 ml [95% CI: −5.1 to 18.2]; p = 0.03 and left ventricular end-systolic volume decrease of 6.2 ml [95% CI: −12.8 to 0.4] vs. an increase of 6.1 ml [95% CI: −1.42 to 13.6]; p = 0.04).
Conclusions
The Carillon device significantly reduced mitral regurgitant volume and left ventricular volumes in symptomatic patients with functional mitral regurgitation receiving optimal medical therapy. (Carillon Mitral Contour System for Reducing Functional Mitral Regurgitation [REDUCE FMR]; NCT02325830)
Metadata
Item Type: | Article |
---|---|
Authors/Creators: |
|
Copyright, Publisher and Additional Information: | © 2019 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation, under the terms of the CC-BY-NC-ND 4.0 licence: https://creativecommons.org/licenses/by-nc-nd/4.0/ |
Keywords: | functional mitral regurgitation; heart failure; percutaneous mitral annuloplasty; transcatheter mitral valve repair |
Dates: |
|
Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Leeds Institute of Cardiovascular and Metabolic Medicine (LICAMM) > Clinical & Population Science Dept (Leeds) |
Funding Information: | Funder Grant number NIHR National Inst Health Research NIHR-CS--012-032 |
Depositing User: | Symplectic Publications |
Date Deposited: | 04 Sep 2019 09:05 |
Last Modified: | 25 Jun 2023 21:58 |
Status: | Published |
Publisher: | Elsevier |
Identification Number: | 10.1016/j.jchf.2019.06.011 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:150065 |