Long-term clinical experience with cardiac contractility modulation therapy delivered by the Optimizer Smart system

Area of Science:

• Cardiology
• Medical Devices
• Heart Failure Management

Background:

• Heart failure (HF) remains a leading cause of morbidity and mortality worldwide.
• Current treatments aim to improve symptoms, reduce hospitalizations, and enhance survival.
• Cardiac contractility modulation (CCM) is an emerging therapy for specific HF populations.

Purpose of the Study:

• To evaluate the long-term effects of CCM therapy using the Optimizer Smart system.
• To assess CCM's impact on quality of life, left ventricular ejection fraction (LVEF), mortality, and hospitalizations.
• To analyze CCM's effectiveness across different LVEF subgroups and heart rhythm statuses (atrial fibrillation vs. normal sinus rhythm).

Main Methods:

• A prospective registry study (CCM-REG) involving 503 patients across 51 European centers.
• Patients were stratified by LVEF terciles (≤25%, 26-34%, ≥35%) and heart rhythm (AF, NSR).
• Outcomes including NYHA class, MLWHFQ, LVEF, hospitalization rates, and survival were assessed over 24 months using statistical tests and Kaplan-Meier analysis.

Main Results:

• CCM therapy led to significant improvements in NYHA class and MLWHFQ scores at 6, 12, 18, and 24 months (P<0.0001).
• At 24 months, average improvements were 0.6 in NYHA class, 10 points in MLWHFQ, and 5.6% in LVEF (all P<0.001).
• Significant reductions in heart failure (0.74 to 0.25 events/patient-year) and cardiovascular hospitalizations (1.04 to 0.39 events/patient-year) were observed (P<0.0001).
• LVEF improved across the cohort and in specific subgroups, including those with LVEF ≤25% and both AF and NSR.
• Survival at 1 and 3 years was significantly better than predicted by the MAGGIC risk score in several subgroups.

Conclusions:

• Cardiac contractility modulation therapy effectively improves functional status and quality of life in heart failure patients.
• CCM significantly reduces heart failure hospitalization rates compared to patients' baseline history.
• The therapy demonstrates a positive impact on LVEF and offers improved survival outcomes, outperforming risk score predictions.