Novel clinical data on cardiac contractility modulation in NYHA II patients – Results from the MAINTAINED Observational Study

Abstract

Abstract Background Cardiac contractility modulation (CCM) is an FDA-approved device therapy for patients with medication refractory systolic heart failure and normal QRS width. Pivotal trials have been performed primarily in patients with advanced heart failure (NYHA class III or ambulatory IV). As observed in clinical practice, CCM might also be beneficial in patients with low-grade but persistent heart failure that limits daily activity (NYHA class II). Purpose To facilitate an individualized indication in these patients, we evaluated the long-term effects of CCM in patients with baseline NYHA class II versus baseline NYHA class III or ambulatory IV from our large clinical registry (MAINTAINED Observational Study). Methods CCM effectiveness was measured by changes in functional parameters (i.e., NYHA class, left ventricular ejection fraction (LVEF), tricuspid annular plane systolic excursion (TAPSE), NT-proBNP levels, and KDIGO CKD stage). In addition, mortality within 3 years was compared with the prediction of the Meta-Analysis Global Group in Chronic (MAGGIC) heart failure survival risk score. Results 172 patients were included (10% with NYHA class II). 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 contrast, LVEF improved significantly in each group (II: 4.7±8.3; p=0.0072 vs. III/IV: 7.0±10.7%; p<0.0001; p=0.67 for the comparison of changes between both groups). 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). 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=0.48). KDIGO CKD stage did not experience significant improvement in any group. Actual 3-year mortality was 17 and 26% vs. a predicted mortality of 31 and 42%, respectively (p=0.0038 for NYHA III/IV). Conclusions In clinical practice, CCM was infrequently performed in NYHA class II patients. No significant improvement in NYHA class/dyspnea was observed in these patients over 5 years. Because of the improvement in LVEF, sustainable positive effects on long-term cardiac reverse remodeling might be expected in young patients. Patients with advanced heart failure showed improvements in NYHA class, LVEF, and TAPSE also in clinical practice. Funding Acknowledgement Type of funding sources: None.