PMID- 34002440
OWN - NLM
STAT- MEDLINE
DCOM- 20210810
LR  - 20210818
IS  - 1879-0844 (Electronic)
IS  - 1388-9842 (Print)
IS  - 1388-9842 (Linking)
VI  - 23
IP  - 7
DP  - 2021 Jul
TI  - Long-term clinical experience with cardiac contractility modulation therapy 
      delivered by the Optimizer Smart system.
PG  - 1160-1169
LID - 10.1002/ejhf.2202 [doi]
AB  - AIMS: We assessed long-term effects of cardiac contractility modulation delivered 
      by the Optimizer Smart system on quality of life, left ventricular ejection 
      fraction (LVEF), mortality and heart failure and cardiovascular hospitalizations. 
      METHODS AND RESULTS: CCM-REG is a prospective registry study including 503 
      patients from 51 European centres. Effects were evaluated in three terciles of 
      LVEF (</=25%, 26-34% and >/=35%) and in patients with atrial fibrillation (AF) and 
      normal sinus rhythm (NSR). Hospitalization rates were compared using a chi-square 
      test. Changes in functional parameters of New York Heart Association (NYHA) 
      class, Minnesota Living with Heart Failure Questionnaire (MLWHFQ) and LVEF were 
      assessed with Wilcoxon signed-rank test, and event-free survival by Kaplan-Meier 
      analysis. For the entire cohort and each subgroup, NYHA class and MLWHFQ improved 
      at 6, 12, 18 and 24 months (P < 0.0001). At 24 months, NYHA class, MLWHFQ and 
      LVEF showed an average improvement of 0.6 +/- 0.7, 10 +/- 21 and 5.6 +/- 8.4%, 
      respectively (all P < 0.001). LVEF improved in the entire cohort and in the LVEF 
      </=25% subgroup with AF and NSR. In the overall cohort, heart failure 
      hospitalizations decreased from 0.74 [95% confidence interval (CI) 0.66-0.82] 
      prior to enrolment to 0.25 (95% CI 0.21-0.28) events per patient-year during 
      2-year follow-up (P < 0.0001). Cardiovascular hospitalizations decreased from 
      1.04 (95% CI 0.95-1.13) events per patient-year prior to enrolment to 0.39 (95% 
      CI 0.35-0.44) events per patient-year during 2-year follow-up (P < 0.0001). 
      Similar reductions of hospitalization rates were observed in the LVEF, AF and NSR 
      subgroups. Estimated survival was significantly better than predicted by MAGGIC 
      at 1 and 3 years in the entire cohort and in the LVEF 26-34% and >/=35% subgroups. 
      CONCLUSIONS: Cardiac contractility modulation therapy improved functional status, 
      quality of life, LVEF and, compared to patients' prior history, reduced heart 
      failure hospitalization rates. Survival at 1 and 3 years was significantly better 
      than predicted by the MAGGIC risk score.
CI  - (c) 2021 The Authors. European Journal of Heart Failure published by John Wiley & 
      Sons Ltd on behalf of European Society of Cardiology.
FAU - Kuschyk, Jurgen
AU  - Kuschyk J
AD  - 1st Department of Medicine - Cardiology, University Medical Centre Mannheim, 
      Germany; Partner Site Heidelberg/Mannheim, German Center for Cardiovascular 
      Research (DZHK), Mannheim, Germany.
FAU - Falk, Peter
AU  - Falk P
AD  - Herzzentrum Bad Bevensen, Bad Bevensen, Germany.
FAU - Demming, Thomas
AU  - Demming T
AD  - Herzzentrum Bad Bevensen, Bad Bevensen, Germany.
FAU - Marx, Oliver
AU  - Marx O
AD  - Elbe Klinikum Stade, Klinik fur Innere Medizin, Kardiologie und Intensivmedizin, 
      Stade, Germany.
FAU - Morley, Deborah
AU  - Morley D
AD  - Impulse Dynamics, Inc, Marlton, NJ, USA.
FAU - Rao, Ishu
AU  - Rao I
AD  - Impulse Dynamics, Inc, Marlton, NJ, USA.
FAU - Burkhoff, Daniel
AU  - Burkhoff D
AD  - Cardiovascular Research Foundation, New York, NY, USA.
LA  - eng
PT  - Journal Article
DEP - 20210517
PL  - England
TA  - Eur J Heart Fail
JT  - European journal of heart failure
JID - 100887595
SB  - IM
MH  - *Heart Failure/epidemiology/therapy
MH  - Humans
MH  - *Quality of Life
MH  - Stroke Volume
MH  - Treatment Outcome
MH  - Ventricular Function, Left
PMC - PMC8360159
OTO - NOTNLM
OT  - CCM therapy
OT  - Heart failure
EDAT- 2021/05/19 06:00
MHDA- 2021/08/11 06:00
PMCR- 2021/08/12
CRDT- 2021/05/18 07:26
PHST- 2021/03/18 00:00 [revised]
PHST- 2021/02/04 00:00 [received]
PHST- 2021/04/27 00:00 [accepted]
PHST- 2021/05/19 06:00 [pubmed]
PHST- 2021/08/11 06:00 [medline]
PHST- 2021/05/18 07:26 [entrez]
PHST- 2021/08/12 00:00 [pmc-release]
AID - EJHF2202 [pii]
AID - 10.1002/ejhf.2202 [doi]
PST - ppublish
SO  - Eur J Heart Fail. 2021 Jul;23(7):1160-1169. doi: 10.1002/ejhf.2202. Epub 2021 May 
      17.