Should HFrEF patients with NYHA class II expect benefit from CCM therapy? Results from the MAINTAINED observational
Christian Fastner1,2, Goekhan Yuecel1, Svetlana Hetjens3
1Department of Cardiology, Angiology, Haemostaseology and Medical Intensive Care, University Medical Centre Mannheim (UMM), Medical Faculty Mannheim, Heidelberg University, European Center for AngioScience (ECAS), and German Center for Cardiovascular Research (DZHK) Partner Site Heidelberg/Mannheim, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Insights
Cardiac contractility modulation (CCM) therapy significantly improved heart failure symptoms and ejection fraction in NYHA class III/IV patients. While NYHA class II patients showed less improvement, sustained LVEF benefits suggest CCM may be beneficial across a broader patient range.
Area of Science:
- Cardiology and device-based therapies for heart failure.
- Clinical outcomes and patient stratification in heart failure management.
Background:
- Cardiac Contractility Modulation (CCM) is an FDA-approved therapy for specific heart failure patients.
- Previous trials indicated CCM benefits primarily in severe heart failure (NYHA class II or higher).
Purpose of the Study:
- To compare the 5-year effects of CCM in patients with NYHA class II versus NYHA class III or ambulatory IV heart failure.
- To analyze individualized indications for CCM device therapy in a large clinical registry (MAINTAINED Observational Study).
Main Methods:
- Functional parameters including NYHA class, left ventricular ejection fraction (LVEF), tricuspid annular plane systolic excursion (TAPSE), and NT-proBNP levels were assessed.
- KDIGO chronic kidney disease stage was evaluated.
- 3-year mortality was compared against predictions from the Meta-Analysis Global Group in Chronic Heart Failure risk score.
Main Results:
- NYHA class III/IV patients showed significant NYHA class improvement over 5 years, unlike NYHA class II patients.
- Both groups experienced significant LVEF improvement, with comparable results over 5 years.
- NYHA class III/IV patients demonstrated significant TAPSE improvement and a significant survival benefit compared to predicted mortality.
Conclusions:
- Patients with NYHA class III/IV heart failure experienced greater functional improvements and survival benefits with CCM.
- Sustained LVEF improvements suggest potential benefits of CCM for NYHA class II patients as well.
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.
Related Concept Videos
01:30Heart Failure V: Medical Management
01:30Heart Failure IV: Classification and Diagnostic Evaluation
01:26Heart Failure Drugs: Inhibitors of Renin-Angiotensin System
01:28Acute Coronary Syndrome IV: Interprofessional Care
01:29Cardiomyopathy III: Hypertrophic Cardiomyopathy
01:22Heart Failure VI: Adjunct Therapies