Abstract
IntroductionHeart failure is a major cause of morbidity and mortality throughout the world. Despite advances in therapy, nearly half of patients receiving guideline-directed medical therapy remain limited by symptoms. Cardiac contractility modulation (CCM) can improve symptoms in this population, but efficacy and safety in prospective studies has been limited to 12 months of follow-up. We report on the first 2 year multi-site evaluation of CCM in patients with heart failure.MethodsOne hundred and forty-three subjects with heart failure and reduced ejection fraction were followed via clinical registry for 24 months recording NYHA class, MLWHFQ score, 6 min walk distance, LVEF, and peak VO2 at baseline and 6 month intervals as clinically indicated. Serious adverse events, and all cause as well as cardiovascular mortality were recorded. Data are presented stratified by LVEF (all subjects, LVEF <35%, LVEF ≥35%).ResultsOne hundred and six subjects from 24 sites completed the 24 month follow-up. Baseline parameters were similar among LVEF groups. NYHA and MLWHFQ improved in all 3 groups at each time point. LVEF in the entire cohort improved 2.5, 2.9, 5.0, and 4.9% at 6, 12, 18, and 24 months, respectively. Insufficient numbers of subjects had follow-up data for 6 min walk or peak VO2 assessment, precluding comparative analysis. Serious adverse events (n = 193) were observed in 91 subjects and similarly distributed between groups with LVEF <35% and LVEF ≥35%, and similar to other device trials for heart failure. Eighteen deaths (7 cardiovascularly related) over 2 years. Overall survival at 2 years was 86.4% (95% confidence intervals: 79.3, 91.2%).ConclusionCardiac contractility modulation provides safe and effective long-term symptomatic and functional improvement in heart failure. These benefits were independent of baseline LVEF and were associated with a safety profile similar to published device trials.
Highlights
IntroductionNearly half of patients receiving guideline-directed medical therapy remain limited by symptoms
Heart failure is a major cause of morbidity and mortality throughout the world
One hundred and forty-three subjects with heart failure and reduced ejection fraction were followed via clinical registry for 24 months recording NYHA class, MLWHFQ score, 6 min walk distance, LVEF, and peak VO2 at baseline and 6 month intervals as clinically indicated
Summary
Nearly half of patients receiving guideline-directed medical therapy remain limited by symptoms. In patients with moderate to severe chronic heart failure and reduced ejection fraction (HFrEF), the mainstay of guideline directed medical therapy (GDMT) includes use of beta-adrenergic blockers, angiotensin converting enzyme inhibitors (ACE-I) or angiotensin receptor blocking (ARB) agents, and aldosterone antagonists. The remaining 65% have a narrow QRS or RBBB and CRT is not less frequently indicated [3] For these patients, cardiac contractility modulation (CCM) offers functional improvement, greater exercise tolerance, and symptomatic benefit [4,5,6]. CCM therapy was reviewed in the European Society of Cardiology’s guidelines on acute and chronic heart failure (2016) where it was stated that ‘‘CCM may be considered in selected patients with HF’’ [1]
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