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.
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).
Cardiac contractile therapy is a feasible, safe, and useful therapy for patients with HFrEF whose symptomatology is not improved with optimal standard therapy.