Key result
Six months after implantation of a cardiac contractility modulation device, patients with HFrEF experienced a significant increase in left ventricular ejection fraction from 25.93% to 35.5%.
Why the study?
To report the initial Romanian experience using the newest-generation cardiac contractility modulation device in patients with heart failure with reduced ejection fraction.
Does cardiac contractility modulation improve LVEF, NYHA class, and exercise tolerance in patients with HFrEF who remain symptomatic despite optimal standard therapy?
Observational (n=16)
No
Does cardiac contractility modulation improve LVEF, NYHA class, and exercise tolerance in patients with HFrEF who remain symptomatic despite optimal standard therapy?
Cardiac contractility modulation therapy is feasible and significantly improves LVEF, NYHA class, and exercise tolerance in HFrEF patients who remain symptomatic despite optimal medical and device therapy.
Aim The purpose of this study is to present the first Romanian case-series of patients with heart failure with reduced ejection fraction (HFrEF), supported with the newest generation of cardiac contractility modulation (CCM) device. Methods and results 16 patients (15 men), aged 66.6±7.49 years, were supported with OPTIMIZER® smart IPG CCMX10 device and followed-up for an average duration of 385.75±326.32 days. The etiology of HF was ischemic in 13 patients (81%), 8 patients (50%) had atrial fibrillation, mean creatinine clearance value was 55.8±13.87 ml/min, and 5 patients (31,2%) had diabetes mellitus. All patients were supported with an implanted cardio verter-defibrillator (ICD), while 5 patients (31.2%) had cardiac resynchronization therapy (CRT) on top. The pharma cological treatment has been optimized in all patients. Six months after implantation, the LVEF has increased from 25.93%±6.21 to 35.5%±4.31 (p=0.00002), NYHA class improved from 3.18±0.4 to 1.83±0.38 (p<0.0001), and exercise tolerance evaluated with 6-minute walking test (6MWT) increased (from 321.87±70.63m to 521.41±86.43m; p<0,00001). Three patients (18,7%) died during the follow-up period after 48, 108 and 545 days (one non-cardiac death). Conclusions Cardiac contractile therapy is a feasible, safe, and useful therapy for patients with HFrEF whose symptomatology is not improved with optimal standard therapy.
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Ţînţ et al. (2021) conducted an observational in Heart failure with reduced ejection fraction (HFrEF) (n=16). Cardiac contractility modulation (CCM) device vs. Baseline was evaluated on Left ventricular ejection fraction (LVEF) at 6 months (p=0.00002). Six months after implantation of a cardiac contractility modulation device, patients with HFrEF experienced a significant increase in left ventricular ejection fraction from 25.93% to 35.5%.
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