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Proportion of Patients Eligible for Cardiac Contractility Modulation: Real-Life Data from a Single-Center Heart
Dávid Pilecky1,2, Balázs Muk3, Zsuzsanna Majoros3
1Department of Cardiology, Medical Centre - Hungarian Defence Forces, Budapest, Hungary, pileckyd@gmail.com.
Insights
Cardiac contractility modulation (CCM) is a potential therapy for chronic heart failure (CHF). This study found only 5% of eligible CHF patients met criteria for CCM after treatment optimization, highlighting a narrow therapeutic window.
Area of Science:
- Cardiology
- Medical Devices
- Heart Failure Management
Background:
- Cardiac contractility modulation (CCM) is an emerging device-based therapy for symptomatic chronic heart failure (CHF).
- Randomized controlled trials suggest CCM is effective in improving outcomes for patients with reduced ejection fraction.
- Determining patient eligibility for CCM is crucial for its clinical application.
Purpose of the Study:
- To estimate the proportion of patients with CHF and left ventricular ejection fraction (LVEF) <50% eligible for CCM.
- To assess eligibility based on the inclusion criteria of the FIX-HF-5C trial.
- To evaluate CCM candidacy after a treatment optimization period.
Main Methods:
- Retrospective assessment of consecutive patients with HF and LVEF <50% at an HF clinic.
- Application of FIX-HF-5C trial inclusion criteria (NYHA class III/IV, 25% ≤ LVEF ≤45%, QRS <130 ms, sinus rhythm) after 3-6 months of optimized medical therapy.
- Calculation of the proportion of eligible patients at baseline and post-optimization.
Main Results:
- After treatment optimization, the proportion of patients in NYHA class III/IV decreased significantly (77.0% to 18.6%).
- Mean LVEF increased (29.0% to 36.3%), with 73.3% of patients meeting LVEF criteria (25-45%).
- Only 5.2% of patients met all FIX-HF-5C inclusion criteria for CCM candidacy post-optimization.
Conclusions:
- A small proportion (5.2%) of patients with CHF and reduced LVEF are eligible for CCM therapy based on FIX-HF-5C criteria after medical treatment optimization.
- Treatment optimization significantly improves symptoms and LVEF, but eligibility for CCM remains limited.
- This suggests a highly selected patient group may benefit from CCM.
Introduction:
Based on recently published randomized controlled trials, cardiac contractility modulation (CCM) seems to be an effective device-based therapeutic option in symptomatic chronic heart failure (HF) (CHF). The aim of the current study was to estimate what proportion of patients with CHF and left ventricular ejection fraction (LVEF) <50% could be eligible for CCM based on the inclusion criteria of the FIX-HF-5C trial.
Methods:
Consecutive patients referred and followed up at our HF clinic due to HF with reduced or mid-range LVEF were retrospectively assessed. After a treatment optimization period of 3-6 months, the inclusion criteria of the FIX-HF-5C trial (New York Heart Association (NYHA) class III/IV, 25% ≤ LVEF ≤45%, QRS <130 ms, and sinus rhythm) were applied to determine the number of patients eligible for CCM.
Results:
Of the 640 patients who were involved, the proportion of highly symptomatic patients in NYHA class III/IV decreased from 77.0% (n = 493) at baseline to 18.6% (n = 119) after the treatment optimization period (p < 0.001). Mean LVEF increased significantly from 29.0 ± 7.9% to 36.3 ± 9.9% (p < 0.001), while the proportion of patients with 25% ≤ LVEF ≤45% increased from 69.7% (n = 446) to 73.3% (n = 469) (p < 0.001). QRS duration was below 130 ms in 63.1% of patients, while 30.0% of patients had persistent or permanent atrial fibrillation. We found that the eligibility criteria for CCM therapy based on the FIX-HF-5C study were fulfilled for 23.0% (n = 147) of patients at baseline and 5.2% (n = 33) after treatment optimization.
Conclusion:
This single-center cohort study showed that 5% of patients with CHF and impaired LVEF immediately after treatment optimization fulfilled the inclusion criteria of the FIX-HF-5C study and would be candidates for CCM.
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