title: Nonexcitatory, cardiac contractility modulation electrical impulses: feasibility study for advanced heart failure in patients with normal QRS duration.
abstract: BACKGROUND
  Cardiac contractility modulation signals are associated with acutely improved hemodynamics, but chronic clinical impact is not defined.
  
  
  OBJECTIVE
  The purpose of this randomized, double-blind, pilot study was to determine the feasibility of safely and effectively delivering cardiac contractility modulation signals in patients with heart failure.
  
  
  METHODS
  Forty-nine subjects with ejection fraction <35%, normal QRS duration (105 +/- 15 ms), and New York Heart Association (NYHA) class III or IV heart failure despite medical therapy received a cardiac contractility modulation pulse generator. Patients were randomized to have their devices programmed to deliver cardiac contractility modulation signals (n = 25, treatment group) or to remain off (n = 24, control group) for 6 months. Evaluations included NYHA class, 6-minute walk, cardiopulmonary stress test, Minnesota Living with Heart Failure Questionnaire, and Holter monitoring.
  
  
  RESULTS
  Although most baseline features were balanced between groups, ejection fraction (31.4% +/- 7.4% vs 24.9% +/- 6.5%, P = .003), end-diastolic dimension (52.1 +/- 21.4 mm vs 62.5 +/- 6.2 mm, P = .01), peak VO(2) (16.0 +/- 2.9 mL O(2)/kg/min vs 14.3 +/- 2.8 mL O(2)/kg/min, P = .02), and anaerobic threshold (12.3 +/- 2.5 mL O(2)/kg/min vs 10.6 +/- 2.4 mL O(2)/kg/min, P = .01) were worse in the treatment group than in the control group. Nevertheless, one death occurred in the control group, and more patients in the treatment group were free of hospitalization for any cause at 6 months (84% vs 62%). No change in ectopy was observed. Compared with baseline, 6-minute walk (13.4 m), peak VO(2) (0.2 mL O(2)/kg/min), and anaerobic threshold (0.8 mL O(2)/kg/min) increased more in the treatment group than in control. None of these differences were statistically significant (small sample size). NYHA and Minnesota Living with Heart Failure Questionnaire changed similarly in the two groups.
  
  
  CONCLUSIONS
  Despite a sicker population in the treatment group, no specific safety concerns emerged with chronic cardiac contractility modulation signal administration. Further study is required to definitively define the safety and efficacy of cardiac contractility modulation signals.
authors.affiliation: Lone Star Arrhythmia and Heart Failure Center, Amarillo, Texas, USA.
authors.forename: Suresh B
authors.initials: SB
authors.lastname: Neelagaru
authors.forename: Javier E
authors.initials: JE
authors.lastname: Sanchez
authors.forename: Stanley K
authors.initials: SK
authors.lastname: Lau
authors.forename: Steven M
authors.initials: SM
authors.lastname: Greenberg
authors.forename: Nirav Y
authors.initials: NY
authors.lastname: Raval
authors.forename: Seth
authors.initials: S
authors.lastname: Worley
authors.forename: Jill
authors.initials: J
authors.lastname: Kalman
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Merliss
authors.forename: Steven
authors.initials: S
authors.lastname: Krueger
authors.forename: Mark
authors.initials: M
authors.lastname: Wood
authors.forename: Marc
authors.initials: M
authors.lastname: Wish
authors.forename: Daniel
authors.initials: D
authors.lastname: Burkhoff
authors.forename: Koonlawee
authors.initials: K
authors.lastname: Nademanee
mesh_terms: D000368:Aged; D017147:Defibrillators, Implantable; D004311:Double-Blind Method; D004554:Electric Countershock / Q000379:methods*; D015716:Electrocardiography, Ambulatory; D005080:Exercise Test; D017079:Exercise Tolerance / Q000502:physiology; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000503:physiopathology / Q000628:therapy*; D006339:Heart Rate / Q000502:physiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009200:Myocardial Contraction / Q000502:physiology*; D010865:Pilot Projects; D011446:Prospective Studies; D013318:Stroke Volume / Q000502:physiology; D016896:Treatment Outcome