Key result
In five patients with HFrEF, the OPTIMIZER SMART cardiac contractility modulation device increased mean LVEF from 25.4% to 27% and six-minute walk distance from 310 m to 466 m over 6 months.
Why the study?
Heart failure mortality remains high despite existing therapies, prompting evaluation of the newest generation cardiac contractility modulation device across different clinical patterns of HFrEF.
Does cardiac contractility modulation improve LVEF and exercise capacity in patients with HFrEF?
Case Report (n=5)
No
Does cardiac contractility modulation improve LVEF and exercise capacity in patients with HFrEF?
The new generation OPTIMIZER SMART IPG CCMX10 device is feasible and may improve LVEF and exercise capacity in patients with HFrEF.
(1) Background: Heart failure (HF) is a major cause of morbidity and mortality throughout the world. Despite substantial progress in its prevention and treatment, mortality rates remain high. Device therapy for HF mainly includes cardiac resynchronization therapy (CRT) and the use of an implantable cardioverter-defibrillator (ICD). Recently, however, a new device therapy—cardiac contractility modulation (CCM)—became available. (2) Aim: The purpose of this study is to present a first case-series of patients with different clinical patterns of HF with a reduced ejection fraction (HFrEF), supported with the newest generation of CCM devices. (3) Methods and results: Five patients with a left ventricular ejection fraction (LVEF) ≤ 35% and a New York Heart Association (NYHA) class ≥ III were supported with CCM OPTIMIZER® SMART IPGCCMX10 at our clinic. The patients had a median age of 67 ± 8.03 years (47–80) and were all males—four with ischemic etiology dilated cardiomyopathy. In two cases, CCM was added on top of CRT (non-responders), and, in one patient, CCM was delivered during persistent atrial fibrillation (AF). After 6 months of follow-up, the LVEF increased from 25.4 ± 6.8% to 27 ± 9%, and the six-minute walk distance increased from 310 ± 65.1 m to 466 ± 23.6 m. One patient died 47 days after device implantation. (4) Conclusion: CCM therapy provided with the new model OPTIMIZER® SMART IPG CCMX10 is safe, feasible, and applicable to a wide range of patients with HF.
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Ţînţ et al. (2019) conducted a case report in Heart failure with reduced ejection fraction (n=5). CCM OPTIMIZER SMART IPG CCMX10 was evaluated on Change in left ventricular ejection fraction (LVEF) and six-minute walk distance (6MWT). In five patients with HFrEF, the OPTIMIZER SMART cardiac contractility modulation device increased mean LVEF from 25.4% to 27% and six-minute walk distance from 310 m to 466 m over 6 months.
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