In patients with heart failure (HF), cardiac contractility modulation (CCM) may be safe, may improve exercise tolerance and quality of life and may lead to fewer hospitalizations, according to results of the FIX-HF-5 confirmatory study presented May 10 during the Heart Rhythm Society's 39th Annual Scientific Sessions in Boston, MA, and simultaneously published in JACC: Heart Failure.

William T. Abraham, MD, FACC, et al., conducted a subgroup analysis of the FIX-HF-5 study and looked at 160 patients with New York Heart Association (NYHA) functional class III or IV symptoms, QRS duration <130 ms, and ejection fraction between 25 percent and 45 percent, who were randomized to a control group of continued medical therapy (n=86) or treatment with CCM (n=74, unblinded) for 24 weeks.

Results showed that the difference in peak oxygen consumption between the two groups was 0.84 ml O2/kg/min. In addition, Minnesota Living With Heart Failure questionnaire (p<0.001), NYHA functional class (p<0.001), and 6-min hall walk (p=0.02) were all better in the treatment vs. control group.

The authors note that there were seven device-related events, yielding a lower bound of 80 percent of patients free of events, therefore satisfying the primary safety endpoint. Further, the composite of cardiovascular death and HF hospitalizations was reduced from 10.8 percent to 2.9 percent (p=0.048).

The authors conclude that their results "supplement and confirm results of prior studies." They add that moving forward, "future research can explore the impact of CCM in patients with prolonged QRS duration in addition to CRT, in particular in CRT nonresponders."

Keywords: Exercise Tolerance, Quality of Life, Stroke Volume, Myocardial Contraction, Heart Failure, Hospitalization, Oxygen Consumption, Arrhythmias, Cardiac

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