Key result
Cardiac contractility modulation therapy is linked to a ~66% reduction in heart failure hospitalizations.
Why the study?
Long-term effects of cardiac contractility modulation delivered by the Optimizer Smart system on quality of life, LVEF, mortality, and hospitalizations required evaluation.
Does cardiac contractility modulation therapy improve functional status, LVEF, and reduce hospitalizations in patients with heart failure?
Observational (n=503)
Yes
Does cardiac contractility modulation therapy improve functional status, LVEF, and reduce hospitalizations in patients with heart failure?
Absolute Event Rate: 0.25% vs 0.74%
p-value: p=<0.0001
Cardiac contractility modulation therapy is associated with improved functional status, LVEF, and reduced heart failure hospitalizations compared to pre-enrolment history in a real-world European registry.
May reduce hospitalizations in real-world HF; extends observational data but leaves open randomized confirmation.
Aims We assessed long‐term effects of cardiac contractility modulation delivered by the Optimizer Smart system on quality of life, left ventricular ejection fraction (LVEF), mortality and heart failure and cardiovascular hospitalizations. Methods and results CCM‐REG is a prospective registry study including 503 patients from 51 European centres. Effects were evaluated in three terciles of LVEF (≤25%, 26–34% and ≥35%) and in patients with atrial fibrillation (AF) and normal sinus rhythm (NSR). Hospitalization rates were compared using a chi‐square test. Changes in functional parameters of New York Heart Association (NYHA) class, Minnesota Living with Heart Failure Questionnaire (MLWHFQ) and LVEF were assessed with Wilcoxon signed‐rank test, and event‐free survival by Kaplan–Meier analysis. For the entire cohort and each subgroup, NYHA class and MLWHFQ improved at 6, 12, 18 and 24 months ( P < 0.0001). At 24 months, NYHA class, MLWHFQ and LVEF showed an average improvement of 0.6 ± 0.7, 10 ± 21 and 5.6 ± 8.4%, respectively (all P < 0.001). LVEF improved in the entire cohort and in the LVEF ≤25% subgroup with AF and NSR. In the overall cohort, heart failure hospitalizations decreased from 0.74 [95% confidence interval (CI) 0.66–0.82] prior to enrolment to 0.25 (95% CI 0.21–0.28) events per patient‐year during 2‐year follow‐up ( P < 0.0001). Cardiovascular hospitalizations decreased from 1.04 (95% CI 0.95–1.13) events per patient‐year prior to enrolment to 0.39 (95% CI 0.35–0.44) events per patient‐year during 2‐year follow‐up ( P < 0.0001). Similar reductions of hospitalization rates were observed in the LVEF, AF and NSR subgroups. Estimated survival was significantly better than predicted by MAGGIC at 1 and 3 years in the entire cohort and in the LVEF 26–34% and ≥35% subgroups. Conclusions Cardiac contractility modulation therapy improved functional status, quality of life, LVEF and, compared to patients' prior history, reduced heart failure hospitalization rates. Survival at 1 and 3 years was significantly better than predicted by the MAGGIC risk score.
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Kuschyk et al. (2021) conducted an observational in Heart failure (n=503). Cardiac contractility modulation (Optimizer Smart system) vs. Patients' prior history was evaluated on Heart failure hospitalizations (events per patient-year) (p=<0.0001). Cardiac contractility modulation therapy reduced heart failure hospitalizations from 0.74 to 0.25 events per patient-year (P<0.0001) compared to patients' prior history.
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