Author + information
- Received May 15, 2019
- Revision received June 12, 2019
- Accepted June 17, 2019
- Published online October 28, 2019.
- Klaus K. Witte, MDa,∗ (, )
- Janusz Lipiecki, MDb,
- Tomasz Siminiak, MDc,
- Ian T. Meredith, MDd,
- Christopher J. Malkin, MDa,
- Steven L. Goldberg, MDe,f,
- Matthew A. Stark, PhDf,
- Ralph Stephan von Bardeleben, MDg,
- Paul C. Cremer, MDh,
- Wael A. Jaber, MDh,
- David S. Celermajer, MDi,
- David M. Kaye, MDj and
- Horst Sievert, PhD, MDk,l
- aLeeds Institute for Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, United Kingdom
- bClinique Pôle Sanioyté République, Clermont Ferrand, France
- cPoznan University of Medical Sciences, HCP Medical Center, Poznan, Poland
- dFaculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia
- eTyler Heart Institute at Community Hospital of the Monterey Peninsula, Monterey, California
- fCardiac Dimensions, Kirkland, Washington
- gDepartment of Cardiology, University Medical Centre Mainz, Mainz, Germany
- hDepartment of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
- iFaculty of Medicine and Health, University of Sydney, New South Wales, Australia
- jDepartment of Cardiology, Alfred Hospital, Melbourne, Victoria, Australia
- kCardioVascular Center Sankt Katherinen, Frankfurt, Germany
- lAnglia Ruskin University, Chelmsford, United Kingdom
- ↵∗Address for correspondence:
Dr. Klaus Witte, Leeds Institute of Cardio-Metabolic Medicine, University of Leeds, Clarendon Way, Leeds LS2 9JT, United Kingdom.
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)
- functional mitral regurgitation
- heart failure
- percutaneous mitral annuloplasty
- transcatheter mitral valve repair
The REDUCE-FMR trial was sponsored by Cardiac Dimensions. Dr. Witte has been recipient of a National Institute for Health Research (UK) Clinician Scientist Award; has received speaker fees and honoraria from Medtronic, Cardiac Dimensions, Novartis, Abbott, Bristol-Myers Squibb, Pfizer, and Bayer; and has received research grants from Medtronic. Dr. Lipiecki has been a proctor for Cardiac Dimensions. Dr. Siminiak has received proctoring fees from Cardiac Dimensions. Dr. Malkin has been a proctor for Medtronic and Boston Scientific. Dr. Goldberg holds stock options in and is a consultant for Cardiac Dimensions; and has received honoraria from Abbott. Dr. Stark is an employee of Cardiac Dimensions. Dr. Celermajer holds stock options in and serves on the Investment Committee of an investor in Cardiac Dimensions. Dr. von Bardeleben is a steering committee member and/or investigator for Abbott, Cardiac Dimensions, and Edwards; and has received honoraria from Abbott, Cardiac Dimensions, GE Healthcare, Edwards, Philips, and Siemens Healthineers. Dr. Kaye is a cofounder of and holds stock in Cardiac Dimensions. Dr. Sievert has received grants from Cardiac Dimensions; and has received grants, fees, and nonfinancial support from 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Carag, Celonova, Comed BV, Contego, CVRx, Dinova, Edwards, Endologix, Hemoteq, Hangzhou Nuomao Medtech, Lifetech, Maquet Getinge Group, Medtronic, Mitralign, Mokita, Occlutech, pfm Medical, Recor, Renal Guard, Rox Medical, Terumo, Vascular Dynamics, Vectorious Medtech, Venus, and Vivasure Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received May 15, 2019.
- Revision received June 12, 2019.
- Accepted June 17, 2019.
- 2019 The Authors