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

Autor: C Fastner, G Yuecel, S Hetjens, B Rudic, G Schmiel, M Toepel, V Liebe, M Kruska, M Borggrefe, D Burkhoff, I Akin, D Duerschmied, J Kuschyk
Rok vydání: 2022
Předmět:
Zdroj: European Heart Journal. 43
ISSN: 1522-9645
0195-668X
Popis: 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 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.
Databáze: OpenAIRE