PMID- 27590412
OWN - NLM
STAT- MEDLINE
DCOM- 20170623
LR  - 20181202
IS  - 1876-4738 (Electronic)
IS  - 0914-5087 (Linking)
VI  - 69
IP  - 1
DP  - 2017 Jan
TI  - Cardiac contractility modulation in heart failure patients: Randomized comparison 
      of signal delivery through one vs. two ventricular leads.
PG  - 326-332
LID - S0914-5087(16)30149-6 [pii]
LID - 10.1016/j.jjcc.2016.06.015 [doi]
AB  - BACKGROUND: Cardiac contractility modulation (CCM) is an electrical stimulation 
      treatment for symptomatic heart failure (HF) patients. The procedure involves 
      implantation of two ventricular leads for delivery of CCM impulses. The purpose 
      of this study is to compare the efficacy and safety of CCM when the signal is 
      delivered through one vs. two ventricular leads. METHODS: This prospective 
      blinded randomized trial enrolled 48 patients. Eligible subjects had symptoms 
      despite optimal HF medications, left ventricular ejection fraction <40% and 
      peakVO(2)>/=9ml O(2)/kg/min. All patients received a CCM system with two 
      ventricular leads, and were randomized to CCM active through both or just one 
      ventricular lead; 25 patients were randomized to receive signal delivery through 
      two leads (Group A) and 23 patients to signal delivery through one lead (Group 
      B). The study compared the mean changes from baseline to 6 months follow-up in 
      peakVO(2), New York Heart Association (NYHA) classification, and quality of life 
      (by MLWHFQ). RESULTS: Following 6 months, similar and significant (p<0.05) 
      improvements from baseline in NYHA (-0.7+/-0.5 vs. -0.9+/-0.7) and MLWHFQ (-14+/-20 vs. 
      -16+/-22) were observed in Group A and in Group B. PeakVO(2) showed improvement 
      trends in both groups (0.34+/-1.52 vs. 0.10+/-2.21ml/kg/min; p=ns). No patient died. 
      Serious adverse event rates (20 events in 10 subjects) were not different between 
      groups. No statistically significant difference was found in any of the study 
      endpoints. CONCLUSIONS: The efficacy and safety of CCM in this study were similar 
      when the signal was delivered through either one or two ventricular leads. These 
      results support the potential use of a single ventricular lead for delivery of 
      CCM.
CI  - Copyright (c) 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All 
      rights reserved.
FAU - Roger, Susanne
AU  - Roger S
AD  - Mannheim University Hospital, Mannheim, Germany; DZHK (German Centre for 
      Cardiovascular Research) partner site, Mannheim, Germany. Electronic address: 
      susanroeger@hotmail.com.
FAU - Said, Samir
AU  - Said S
AD  - Magdeburg University Hospital, Magdeburg, Germany.
FAU - Kloppe, Axel
AU  - Kloppe A
AD  - University Hospital of the Ruhr-University Bochum, Bochum, Germany.
FAU - Lawo, Thomas
AU  - Lawo T
AD  - Elisabeth Hospital, Recklinghausen, Germany.
FAU - Emig, Ulf
AU  - Emig U
AD  - Helios Klinikum Meiningen Medical Clinic, Meiningen, Germany.
FAU - Rousso, Benny
AU  - Rousso B
AD  - Impulse Dynamics, Hod Hasharon, Israel.
FAU - Gutterman, David
AU  - Gutterman D
AD  - Medical College of Wisconsin, Milwaukee, WI, USA.
FAU - Borggrefe, Martin
AU  - Borggrefe M
AD  - Mannheim University Hospital, Mannheim, Germany; DZHK (German Centre for 
      Cardiovascular Research) partner site, Mannheim, Germany.
FAU - Kuschyk, Jurgen
AU  - Kuschyk J
AD  - Mannheim University Hospital, Mannheim, Germany; DZHK (German Centre for 
      Cardiovascular Research) partner site, Mannheim, Germany.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160830
PL  - Netherlands
TA  - J Cardiol
JT  - Journal of cardiology
JID - 8804703
SB  - IM
MH  - Aged
MH  - Cardiac Pacing, Artificial/*methods
MH  - Female
MH  - Heart Failure/physiopathology/*therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Myocardial Contraction/*physiology
MH  - Prospective Studies
MH  - Quality of Life
MH  - Single-Blind Method
MH  - Stroke Volume
MH  - Time Factors
MH  - Treatment Outcome
MH  - Ventricular Function, Left/physiology
OTO - NOTNLM
OT  - Cardiac contractility modulation
OT  - Heart failure
OT  - Leads
EDAT- 2016/09/04 06:00
MHDA- 2017/06/24 06:00
CRDT- 2016/09/04 06:00
PHST- 2016/05/03 00:00 [received]
PHST- 2016/06/11 00:00 [revised]
PHST- 2016/06/16 00:00 [accepted]
PHST- 2016/09/04 06:00 [pubmed]
PHST- 2017/06/24 06:00 [medline]
PHST- 2016/09/04 06:00 [entrez]
AID - S0914-5087(16)30149-6 [pii]
AID - 10.1016/j.jjcc.2016.06.015 [doi]
PST - ppublish
SO  - J Cardiol. 2017 Jan;69(1):326-332. doi: 10.1016/j.jjcc.2016.06.015. Epub 2016 Aug 
      30.