Key result
Cardiac contractility modulation in patients with HFrEF and wide QRS complex showed non-significant improvements in 6-minute walking distance (300 vs 305, p=0.093) and LVEF at 12 months.
Why the study?
Most CCM programming data concern patients with narrow QRS and limited follow-up, leaving an open question regarding device programming in the setting of wide QRS complex and fragmented ventricular local activation.
Is Cardiac contractility modulation (CCM) feasible and safe in patients with HFrEF and LBBB-related wide QRS complex?
Observational (n=11)
Is Cardiac contractility modulation (CCM) feasible and safe in patients with HFrEF and LBBB-related wide QRS complex?
CCM system implantation and programming is feasible and safe in HFrEF patients with LBBB-related wide QRS complex, though functional improvements at 12 months were non-significant in this small cohort.
Aim. Cardiac contractility modulation (CCM) is a device therapy for patients with heart failure with reduced ejection fraction (HFrEF), most of the data on its programming are concerned patients with narrow QRS and of limited follow up. Our aim was to propose programming approach for Optimizer device in setting of wide QRS complex and fragmented ventricular local activation. Methods. We enrolled 11 patients with HFrEF (median age, 8 males, median NYHA class 3) and LBBB-related wide QRS complex, who underwent Optimizer™ device implantation. Three patients got Optimizer™ IV system and eight patients were implanted Optimizer™ Smart. Ten patients were previously implanted with CRT-D due to HFrEF and LBBB; one patient received CRT-D after Optimizer™ implantation. Results. During the implantation procedure ventricular local sense (LS) channel signal fragmentation was detected in all patients. In five patients signal detection was optimized by lead relocation. In six patients LS signal sensitivity limitations were resolved by programming. At two-year follow-up survival 4 patients died of noncardiac causes (1 intracranial hemorrhage, 1 gastrointestinal bleeding and 2 - terminal kidney failure). At 12-month follow-up we observed a non-significant improvement in 6-minute walking distance (300 vs 305, p=0.093), NYHA class (2.75 vs 2, p=0.085), MLHF score (53 vs 42, p=0.109) and left ventricular ejection fraction (LVEF) (30 vs 33.5, p=0.212). Conclusion. CCM system implantation is feasible and safe in patients with HFrEF and LBBB-related wide QRS complex. Device programming maneuvers can resolve the challenges of ventricular local signal detection in these patients.
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Davtyan et al. (2023) conducted an observational in Heart failure with reduced ejection fraction (HFrEF) and LBBB-related wide QRS complex (n=11). Cardiac contractility modulation (Optimizer device) vs. Baseline was evaluated on 6-minute walking distance at 12 months (p=0.093). Cardiac contractility modulation in patients with HFrEF and wide QRS complex showed non-significant improvements in 6-minute walking distance (300 vs 305, p=0.093) and LVEF at 12 months.
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