PMID- 33619896
OWN - NLM
STAT- MEDLINE
DCOM- 20210701
LR  - 20210701
IS  - 2055-5822 (Electronic)
IS  - 2055-5822 (Linking)
VI  - 8
IP  - 2
DP  - 2021 Apr
TI  - Functional outcomes with Carillon device over 1 year in patients with functional 
      mitral regurgitation of Grades 2+ to 4+: results from the REDUCE-FMR trial.
PG  - 872-878
LID - 10.1002/ehf2.13273 [doi]
AB  - AIMS: The objective of this study was to compare functional outcomes through 
      1 year in patients with core-lab verified moderate to severe (Grades 2+ to 4+) 
      functional mitral regurgitation (FMR) treated with the Carillon device or control 
      in the blinded sham-controlled REDUCE-FMR (Carillon Mitral Contour System for 
      Reducing Functional Mitral Regurgitation) study. METHODS AND RESULTS: The main 
      outcomes of this analysis were the change in 6 min walk test (6MWT) distance, 
      incidence of heart failure hospitalization or death, change in New York Heart 
      Association (NYHA) class, and change in Kansas City Cardiomyopathy Questionnaire 
      (KCCQ) score through 1 year of follow-up. The minimum clinically important 
      difference (MCID) was defined as a >/=30 m increase in 6MWT distance, an NYHA 
      decrease in >/=1 class, and a >/=3 point increase in KCCQ score. The proportion of 
      patients achieving the MCID in each treatment group was compared using Fisher's 
      exact test, and the number needed to treat (NNT) with the Carillon device was 
      calculated. Among 83 patients (62 Carillon and 21 sham), no statistically 
      significant group differences were observed in the baseline characteristics. All 
      outcomes at 1 year numerically favoured the Carillon group, including MCID for 
      the 6MWT distance (59% vs. 23%, P = 0.029; NNT = 2.8), NYHA class (48% vs. 33%, 
      P = 0.38; NNT = 6.9), KCCQ score (69% vs. 47%, P = 0.14; NNT = 4.5), and freedom 
      from heart failure hospitalization or death (60% vs. 48%, P = 0.45; NNT = 8.3). 
      CONCLUSIONS: REDUCE-FMR was the first blinded sham-controlled trial to report 
      outcomes with percutaneous therapy for the treatment of FMR. Trends towards 
      improvement in mean 6MWT distance, KCCQ score, and NYHA class were observed with 
      the Carillon device. A substantially higher number of patients achieved MCID for 
      all patient-centred outcomes with the Carillon device compared with the sham 
      procedure.
CI  - (c) 2021 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on 
      behalf of European Society of Cardiology.
FAU - Khan, Muhammad Shahzeb
AU  - Khan MS
AD  - Department of Medicine, University of Mississippi, Jackson, MS, USA.
FAU - Siddiqi, Tariq Jamal
AU  - Siddiqi TJ
AD  - Department of Medicine, Dow University of Health Sciences, Karachi, Pakistan.
FAU - Butler, Javed
AU  - Butler J
AD  - Department of Medicine, University of Mississippi, Jackson, MS, USA.
FAU - Friede, Tim
AU  - Friede T
AD  - Department of Medical Statistics, University Medical Center Gottingen, Gottingen, 
      Germany.
AD  - DZHK (German Center for Cardiovascular Research), partner site Gottingen, 
      Gottingen, Germany.
FAU - Levy, Wayne C
AU  - Levy WC
AD  - UW Heart Institute, University of Washington, Seattle, WA, USA.
FAU - Witte, Klaus K
AU  - Witte KK
AD  - Leeds Institute for Cardiovascular and Metabolic Medicine, University of Leeds, 
      Leeds, UK.
FAU - Lipiecki, Janusz
AU  - Lipiecki J
AD  - Centre de Cardiologie Interventionnelle, Pole Sante Republique, Clermont-Ferrand, 
      France.
FAU - Sievert, Horst
AU  - Sievert H
AD  - CardioVascular Center Frankfurt, Frankfurt, Germany.
AD  - Anglia Ruskin University, Chelmsford, UK.
FAU - Coats, Andrew J Stewart
AU  - Coats AJS
AD  - Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
LA  - eng
PT  - Journal Article
DEP - 20210222
PL  - England
TA  - ESC Heart Fail
JT  - ESC heart failure
JID - 101669191
SB  - IM
MH  - Humans
MH  - Incidence
MH  - *Mitral Valve Insufficiency/diagnosis
MH  - Treatment Outcome
PMC - PMC8006711
OTO - NOTNLM
OT  - Heart failure
OT  - Percutaneous device
OT  - Quality of life
OT  - Secondary mitral regurgitation
COIS- J.B. reports consulting fees from BI, Cardior, CVRx, Foundry, G3 Pharma, Imbria, 
      Impulse Dynamics, Innolife, Janssen, LivaNova, Luitpold, Medtronic, Merck, 
      Novartis, NovoNordisk, Relypsa, Roche, Sanofi, Sequana Medical, V-Wave Ltd., and 
      Vifor. K.W. held a National Institute for Health Research (NIHR) (UK) Clinician 
      Scientist Award 2012-2017; has received speaker fees and honoraria from 
      Medtronic, Cardiac Dimensions, Novartis, Abbott, Bristol-Myers Squibb, Pfizer, 
      and Bayer; and has received unconditional research grants from Medtronic UK 
      (managed by the University of Leeds) for a PhD fellowship program. He has also 
      acted as a proctor for Cardiac Dimensions. T.F. reports personal fees from 
      Novartis, Bayer, Janssen, SGS, Roche, Boehringer Ingelheim, Daiichi-Sankyo, 
      Galapagos, Penumbra, Parexel, Vifor, BiosenseWebster, CSL Behring, Fresenius 
      Kabi, Coherex Medical, and LivaNova. A.J.S.C. reports honoraria and/or lecture 
      fees from AstraZeneca, Bayer, Menarini, Novartis, Nutricia, Servier, Vifor, 
      Actimed, Cardiac Dimensions, CVRx, Enopace, Faraday, Gore, Impulse Dynamics, 
      Respicardia, Stealth Peptides, V-Wave, Corvia, Arena, and ESN Cleer. W.C.L. is a 
      consultant for Abbott and Medtronic. EBR Systems, Baim Institute, Respicardia, 
      PharmIN, and Cardiac Dimensions. J.L. has been a proctor for Cardiac Dimensions. 
      H.S. has received grants from Cardiac Dimensions and has received grants, fees, 
      and non-financial 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 
      no conflicts of interest to declare.
EDAT- 2021/02/24 06:00
MHDA- 2021/07/02 06:00
PMCR- 2021/02/22
CRDT- 2021/02/23 06:21
PHST- 2021/02/08 00:00 [received]
PHST- 2021/02/09 00:00 [accepted]
PHST- 2021/02/24 06:00 [pubmed]
PHST- 2021/07/02 06:00 [medline]
PHST- 2021/02/23 06:21 [entrez]
PHST- 2021/02/22 00:00 [pmc-release]
AID - EHF213273 [pii]
AID - 10.1002/ehf2.13273 [doi]
PST - ppublish
SO  - ESC Heart Fail. 2021 Apr;8(2):872-878. doi: 10.1002/ehf2.13273. Epub 2021 Feb 22.