One-Year Outcome of Cardiac Contractility Modulation in Patients With Reduced Ejection Fraction, Atrial Fibrillation,
Diana Tint1,2, Sorin Micu2
1Faculty of Medicine, Transilvania University, Brasov, Romania; and.
Insights
Cardiac contractility modulation (CCM) therapy significantly improves heart failure outcomes, including ejection fraction and exercise capacity, over one year. This therapy offers long-term benefits for patients with heart failure with reduced ejection fraction (HFrEF).
Area of Science:
- Cardiology
- Medical Devices
- Heart Failure Management
Background:
- Cardiac contractility modulation (CCM) shows short-term benefits for heart failure with reduced left ventricular ejection fraction (HFrEF).
- Long-term data and randomized trials on CCM therapy for HFrEF are limited.
- Current understanding lacks comprehensive long-term efficacy and safety profiles.
Purpose of the Study:
- To evaluate the long-term benefits of CCM device implantation.
- To assess CCM therapy's impact on symptomatic patients with severe, optimally treated HFrEF.
- To determine sustained improvements in cardiac function and exercise tolerance.
Main Methods:
- A prospective trial was conducted involving HFrEF patients (NYHA Class III-IV, LVEF ≤35%) receiving CCM therapy.
- Twenty patients were followed for an average of 321.7 days.
- Optimized pharmacological treatment was administered to all participants.
Main Results:
- Left ventricular ejection fraction (LVEF) improved significantly from 24.68% to 34.6% (P < 0.0001) after one year.
- New York Heart Association (NYHA) class improved from 3.2 to 1.4 (P < 0.0001), and 6-Minute Walk Test distance increased significantly (P < 0.00001).
- Improvements were most pronounced within the first six months and sustained over the year, with no significant device-related issues.
Conclusions:
- CCM therapy demonstrates sustained one-year efficacy in improving LVEF and NYHA class in HFrEF patients.
- Significant improvements in exercise tolerance were observed, even in patients with atrial fibrillation or cardiac resynchronization therapy.
- CCM therapy appears safe and effective for long-term management of severe HFrEF, with no major device-related complications.
Background:
After 6 months of therapy, cardiac contractility modulation (CCM) has been shown to improve symptoms, exercise tolerance, and quality of life as well as reduce the rate of hospitalizations in patients with heart failure with reduced left ventricular ejection fraction (HFrEF), but long-term effects data are lacking, with no randomized trial to date.
Study Question:
What is the long-term benefit of the CCM device implantation in symptomatic patients with severe, optimally treated HFrEF?
Study Design:
We conducted a prospective trial involving patients with symptomatic HFrEF [New York Heart Association (NYHA) Class III or IV, left ventricular ejection fraction (LVEF) ≤35%] who were supported by a CCM device.
Results:
Twenty patients (19 men), aged 66.5 ± 6.9 years, were provided with CCM therapy and followed up for an average duration of 321.7 ± 113.5 days. The etiology of heart failure was ischemic in 16 patients (80%), 9 patients (45%) had atrial fibrillation, 6 patients (30%) had diabetes mellitus, and mean creatinine clearance value was 54.8 ± 13.0 mL/min. Eleven patients (60%) had LVEF ≤25%. Although all the patients had an implanted cardioverter-defibrillator, 6 of them (30%) also had resynchronization therapy. The pharmacological treatment has been optimized in all patients. One year after implantation, the LVEF increased from 24.68% ± 4.5 to 34.6 ± 5 ( P < 0.0001), NYHA class improved from 3.2 ± 0.5 to 1.4 ± 0.5 ( P < 0.0001), and exercise tolerance evaluated with a 6-Minute Walk Test increased (from 307.9 ± 74.1 m to 567 ± 99.5 m; P < 0.00001). These improvements were largely seen in the first 6 months.
Conclusions:
Over the course of a year, CCM therapy was associated with improved LVEF and NYHA class, as well as significantly better exercise tolerance, even in patients with atrial fibrillation and cardiac resynchronization therapy and did not seem to be associated with additional significant device-related problems.
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