PMID- 32111559
OWN - NLM
STAT- MEDLINE
DCOM- 20210125
LR  - 20210125
IS  - 1878-0938 (Electronic)
IS  - 1878-0938 (Linking)
VI  - 21
IP  - 6
DP  - 2020 Jun
TI  - Long-Term Survival Following Transcatheter Mitral Valve Repair: Pooled Analysis 
      of Prospective Trials with the Carillon Device.
PG  - 712-716
LID - S1553-8389(20)30082-8 [pii]
LID - 10.1016/j.carrev.2020.02.012 [doi]
AB  - PURPOSE: To report long-term survival and to identify potential determinants of 
      survival among patients receiving treatment for functional mitral regurgitation 
      (FMR) with the Carillon device. METHODS: This was a post hoc analysis in which we 
      pooled prospectively collected data from three studies of the Carillon device 
      with available long-term vital status data. Patient eligibility in these trials 
      specified symptomatic congestive heart failure despite guideline-directed medical 
      therapy, grade 2 to 4 FMR, left ventricular enlargement, and reduced ejection 
      fraction. Echocardiographic parameters were available through the 12-month visit 
      and vital status was available through 5 years. The association of patient 
      characteristics and changes in echocardiographic parameters at 6 and 12 months 
      with long-term survival was analyzed using Cox proportional hazards regression. 
      RESULTS: A total of 74 patients (mean age 67 years, 72% male, 59% MR grade 3 or 
      4) were treated with the Carillon device. Over 1 year of follow-up, the New York 
      Heart Association (NYHA) class decreased in 64% of patients, distance on the 
      6-minute walk test increased, and echocardiographic measures indicated 
      significant decreases in MR grade and favorable left ventricular remodeling. The 
      Kaplan-Meier survival rate was 83.6% at 1 year, 73.1% at 2 years, 67.9% at 
      3 years, and 56.2% at 4 and 5 years of follow-up. Primary determinants of 
      long-term survival were a decrease in NYHA class, an increase in 6-minute walk 
      test distance, and a decrease in regurgitant volume during the first year of 
      follow-up. CONCLUSIONS: Among patients with congestive heart failure and grade 2 
      to 4 FMR who were symptomatic despite guideline-directed medical therapy, 
      transcatheter mitral valve repair with the Carillon device resulted in a 
      favorable 5-year survival rate. The survival benefit was greatest among patients 
      with improvement in clinical and hemodynamic parameters during the first year of 
      follow-up.
CI  - Copyright (c) 2020. Published by Elsevier Inc.
FAU - Lipiecki, Janusz
AU  - Lipiecki J
AD  - Centre de Cardiologie Interventionnelle, Elsan, Pole Sante Republique, 
      Clermont-Ferrand, France. Electronic address: jlipiecki@polesanterepublique.com.
FAU - Kaye, David M
AU  - Kaye DM
AD  - Department of Cardiology, Alfred Hospital, Melbourne, Australia.
FAU - Witte, Klaus K
AU  - Witte KK
AD  - Leeds Institute for Cardiovascular and Metabolic Medicine, University of Leeds, 
      Leeds, United Kingdom.
FAU - Haude, Michael
AU  - Haude M
AD  - Medical Clinic I Stadtische Kliniken Neuss Lukaskrankenhaus, Neuss, Germany.
FAU - Kapadia, Samir
AU  - Kapadia S
AD  - Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, United 
      States of America.
FAU - Sievert, Horst
AU  - Sievert H
AD  - CardioVascular Center Sankt Katharinen, Frankfurt, Germany; Anglia Ruskin 
      University, Chelmsford, United Kingdom.
FAU - Goldberg, Steven L
AU  - Goldberg SL
AD  - Tyler Heart Institute at Community Hospital of the Monterey Peninsula, Monterey, 
      CA, United States of America; Cardiac Dimensions, Kirkland, WA, United States of 
      America.
FAU - Levy, Wayne C
AU  - Levy WC
AD  - Advanced Heart Failure, Division of Cardiology, University of Washington Heart 
      Institute, Seattle, WA, United States of America.
FAU - Siminiak, Tomasz
AU  - Siminiak T
AD  - Poznan University of Medical Sciences, HCP Medical Center, Poznan, Poland.
LA  - eng
PT  - Journal Article
DEP - 20200225
PL  - United States
TA  - Cardiovasc Revasc Med
JT  - Cardiovascular revascularization medicine : including molecular interventions
JID - 101238551
SB  - IM
MH  - Aged
MH  - Clinical Trials as Topic
MH  - Female
MH  - *Heart Valve Prosthesis
MH  - Heart Valve Prosthesis Implantation/adverse effects/*instrumentation/mortality
MH  - Hemodynamics
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Mitral Valve/diagnostic imaging/physiopathology/*surgery
MH  - Mitral Valve Insufficiency/diagnostic imaging/mortality/physiopathology/*surgery
MH  - Prospective Studies
MH  - Prosthesis Design
MH  - Recovery of Function
MH  - Risk Assessment
MH  - Risk Factors
MH  - Time Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Heart failure
OT  - Indirect annuloplasty
OT  - Secondary mitral regurgitation
OT  - Survival
EDAT- 2020/03/01 06:00
MHDA- 2021/01/26 06:00
CRDT- 2020/03/01 06:00
PHST- 2019/12/31 00:00 [received]
PHST- 2020/01/28 00:00 [revised]
PHST- 2020/02/12 00:00 [accepted]
PHST- 2020/03/01 06:00 [pubmed]
PHST- 2021/01/26 06:00 [medline]
PHST- 2020/03/01 06:00 [entrez]
AID - S1553-8389(20)30082-8 [pii]
AID - 10.1016/j.carrev.2020.02.012 [doi]
PST - ppublish
SO  - Cardiovasc Revasc Med. 2020 Jun;21(6):712-716. doi: 10.1016/j.carrev.2020.02.012. 
      Epub 2020 Feb 25.