Abstract
Background
Cardiac contractility modulation (CCM) is an FDA-approved device therapy for patients with refractory systolic heart failure and normal QRS width. Randomized trials demonstrated benefits of CCM primarily for patients with severe heart failure (> NYHA class II).
Purpose
To better understand individualized indication in clinical practice, we compared the effect of CCM in patients with baseline NYHA class II vs. NYHA class III or ambulatory IV over the 5-year period in our large clinical registry (MAINTAINED Observational Study).
Methods
Changes in NYHA class, left ventricular ejection fraction (LVEF), tricuspid annular plane systolic excursion (TAPSE), NT-proBNP level, and KDIGO chronic kidney disease stage were compared as functional parameters. In addition, mortality within 3 years was compared with the prediction of the Meta-Analysis Global Group in Chronic heart failure risk score.
Results
A total of 172 patients were included in the analyses (10% with NYHA class II). Only patients with NYHA class III/IV showed a significant improvement in NYHA class over 5 years of CCM (II: 0.1 ± 0.6; p = 0.96 vs. III/IV: − 0.6 ± 0.6; p < 0.0001). In both groups, LVEF improved significantly (II: 4.7 ± 8.3; p = 0.0072 vs. III/IV: 7.0 ± 10.7%; p < 0.0001), while TAPSE improved significantly only in NYHA class III/IV patients (II: 2.2 ± 1.6; p = 0.20 vs. III/IV: 1.8 ± 5.2 mm; p = 0.0397). LVEF improvement was comparable in both groups over 5 years of CCM (p = 0.83). NYHA class II patients had significantly lower NT-proBNP levels at baseline (858 [175/6887] vs. 2632 [17/28830] ng/L; p = 0.0044), which was offset under therapy (399 [323/1497] vs. 901 [13/18155] ng/L; p = 0.61). Actual 3-year mortality was 17 and 26% vs. a predicted mortality of 31 and 42%, respectively (p = 0.0038 for NYHA class III/IV patients).
Conclusions
NYHA class III/IV patients experienced more direct and extensive functional improvements with CCM and a survival benefit compared with the predicted risk. However, our data suggest that NYHA class II patients may also benefit from the sustained positive effects of LVEF improvement.
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Abbreviations
- CCM:
-
Cardiac contractility modulation
- CKD:
-
Chronic kidney disease
- CRT:
-
Cardiac resynchronization therapy
- ESC:
-
European society of cardiology
- FDA:
-
Food and drug administration
- IPG:
-
Implanted pulse generator
- KDIGO:
-
Kidney disease improving global Outcomes
- (LV) EF:
-
(Left ventricular) ejection fraction
- MAGGIC:
-
Meta-analysis global group in chronic [heart failure]
- MAINTAINED:
-
Mannheim cardiac contractility modulation observational study
- NT-proBNP:
-
NT-proB-type natriuretic peptides
- NYHA:
-
New York heart association
- OMT:
-
Optimal medical therapy
- RV:
-
Right ventricular
- TAPSE:
-
Tricuspid annular plane systolic excursion
- vs.:
-
Versus
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BR received lecture fees from Impulse Dynamics Germany GmbH (Stuttgart, Germany). CF received travel allowance and lecture fees from Impulse Dynamics Germany GmbH (Stuttgart, Germany). DB is a paid consultant to Impulse Dynamics (Marlton, NJ, USA). JK works as a consultant for Impulse Dynamics (Marlton, NJ, USA) and received honoraria and lecture fees from this company.
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Fastner, C., Yuecel, G., Hetjens, S. et al. Should HFrEF patients with NYHA class II expect benefit from CCM therapy? Results from the MAINTAINED observational study. Clin Res Cardiol 111, 1286–1294 (2022). https://doi.org/10.1007/s00392-022-02089-w
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DOI: https://doi.org/10.1007/s00392-022-02089-w