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‘Reassuring’ signal over long-term cardiac contractility modulation mortality

Heart Failure 2016 Congress News

Daniel Burkhoff (Columbia University Medical Center, New York, USA)
Clinical Forum; 21 May, 08:30–17:30; Poster Area

Long-term mortality with a cardiac contractility modulation (CCM) device is comparable to that seen with standard therapies in chronic heart failure, reassuring clinicians and indicating that further study of the therapy is warranted, conclude US researchers.

Daniel Burkhoff (Columbia University Medical Center, New York, USA) told Heart Failure Congress News that while findings, which were presented earlier this week, should be interpreted with caution, they are “encouraging” and reassuring for clinicians.

The researchers examined data on patients from the FIX-HF-5 study, in which 428 heart failure patients with an ejection fraction (EF) <45%, a normal QRS duration and New York Heart Association (NYHA) class III or IV symptoms were randomised to continued medical therapy alone or in combination with CCM. The device was associated with improvements in peak Vo₂ levels, particularly in patients with an EF of ≥25%. [1]

As many of the patients were followed up for more than 10 years, Dr Burkhoff and colleagues compared the long-term mortality with CCM with that seen in the benchmark PARADIGM-HF study. [2]

Dr Burkhoff explained that PARADIGM-HF was chosen because “it’s the most recent, most comprehensive, largest study of patients with heart failure…and has among the lowest mortality rates for any ambulatory group of heart failure patients”.

Kaplan-Meier analysis of FIX-HF-5 showed patients that the probability of death from any cause after 3.4 years was 24.6%, while the probability of the composite of death from any cause, left ventricular assist device implant or heart transplant was 28.9%.

The mortality rate across the FIX-HF-5 cohort lay between that of the treatment and controls groups of PARADIGM-HF on Kaplan-Meier analysis, at approximately 24$ and 28%, respectively. This was despite the FIX-HF-5 patients having more serve heart failure at baseline.

When the analysis was restricted to patients with an EF of ≥25%, the probability of all-cause mortality among FIX-HF-5 patients was 20.6%, while the probability of the composite endpoint was 22.3%.

Dr Burkhoff says that further study of the device is planned, with data drawn from several databases to allow a propensity matched analysis and thus more robust results. Nevertheless, he noted that “one should appreciate the importance of a prospective study of clinical outcomes”.


  1. Kadish A, Nademanee K, Volosin K et al. A randomized controlled trial evaluating the safety and efficacy of cardiac contractility modulation in advanced heart failure. Am Heart J. 2011;161:329-337.e1.
  2. McMurray JJ, Packer M, Desai AS et al. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014;371:993-1004.

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