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July 6, 2017Clinical Research in CardiologyOpen Access

Clinical effects of long-term cardiac contractility modulation (CCM) in subjects with heart failure caused by left ventricular systolic dysfunction

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Key result

Long-term cardiac contractility modulation significantly improved left ventricular ejection fraction by an estimated mean of 4.9% at 24 months in patients with heart failure.

Why the study?

Does cardiac contractility modulation (CCM) improve symptoms, quality of life, and left ventricular ejection fraction in patients with heart failure and reduced ejection fraction?

Population

143 subjects with heart failure and reduced ejection fraction on stable guideline-directed medical therapy…

Design

Cohort

Follow-up

24 months

Authors

ARAndrew RemppisPSPatrick SchauerteSSStephan Schmidt‐Schweda

Discussion

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Overview

Supports the potential for sustained functional benefits with device therapy in heart failure; leaves open.

Study Design

Type

Observational (n=143)

Multicenter

Yes

Structured PICO

Does cardiac contractility modulation (CCM) improve symptoms, quality of life, and left ventricular ejection fraction in patients with heart failure and reduced ejection fraction?

P
Population
143 adults with symptomatic heart failure and left ventricular ejection fraction <45% on stable medical therapy were followed in a prospective registry for 24 months after receiving a cardiac contractility modulation device.
I
Intervention
Cardiac contractility modulation (CCM) via the Optimizer system, delivering non-excitatory biphasic electrical signals to the right ventricular septum, active for an average of 7 ± 1 hours/day for 24 months.
O
Outcome
All-cause mortality (primary safety endpoint) and efficacy endpoints including NYHA classification, MLWHFQ score, and LVEF at 24 monthssafety

Main Result

Mean Difference: 4.9

p-value: p=<0.001

Long-term cardiac contractility modulation provides sustained symptomatic and functional improvement in heart failure patients over 2 years, independent of baseline LVEF being above or below 35%.

Limitations

  • Lack of a control group poses limitations on interpretation of findings.
  • Follow-up testing was performed based on clinical need, limiting the number of patients with outcomes data related to LVEF and exercise tolerance.
  • Small number of patients in the higher LVEF (≥35%) subgroup.
  • Insufficient numbers of subjects had follow-up data for 6 min walk or peak VO2 assessment, precluding comparative analysis
  • Inability to accurately determine changes in doses of each medication class
  • Observational registry design without a control group

Cite This Study

Remppis et al. (2017) conducted an observational in Heart failure with reduced ejection fraction (n=143). Cardiac contractility modulation (CCM) vs. Baseline (no control group) was evaluated on Change in left ventricular ejection fraction at 24 months (4.9% mean improvement, p=<0.001). Long-term cardiac contractility modulation significantly improved left ventricular ejection fraction by an estimated mean of 4.9% at 24 months in patients with heart failure.

synapsesocial.com/papers/6a81952d5feb15765cbf60b4https://doi.org/10.1007/s00392-017-1135-9
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Also Consider

Synapse has enriched 4 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Randomized, double blind study of non-excitatory, cardiac contractility modulation electrical impulses for symptomatic heart failure2008 · 240 citations
  2. 2First Human Chronic Experience with Cardiac Contractility Modulation by Nonexcitatory Electrical Currents for Treating Systolic Heart Failure:2004 · 94 citations
  3. 32016 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure2016 · 5,932 citations
  4. 4Prevalence, correlates, and prognostic significance of QRS prolongation in heart failure with reduced and preserved ejection fraction2012 · 157 citations