New Generation Cardiac Contractility Modulation Device-Filling the Gap in Heart Failure Treatment

Area of Science:

• Cardiology
• Medical Devices
• Heart Failure Management

Background:

• Heart failure (HF) remains a significant global health challenge with high mortality rates despite advances in treatment.
• Current device therapies for HF include cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillators (ICDs).
• Cardiac contractility modulation (CCM) represents a novel device-based therapeutic option for HF management.

Purpose of the Study:

• To present the first case series evaluating the newest generation of CCM devices in patients with diverse heart failure with reduced ejection fraction (HFrEF) clinical patterns.
• To assess the safety, feasibility, and efficacy of CCM therapy in a small cohort of HFrEF patients.

Main Methods:

• Five patients with left ventricular ejection fraction (LVEF) ≤ 35% and New York Heart Association (NYHA) class ≥ III received CCM therapy with the OPTIMIZER® SMART IPG CCMX10.
• The patient cohort included individuals with ischemic cardiomyopathy, those with non-responsive CRT, and one patient with persistent atrial fibrillation (AF).
• Outcomes were assessed after a 6-month follow-up period.

Main Results:

• The mean LVEF increased from 25.4 ± 6.8% to 27 ± 9% over 6 months.
• The six-minute walk distance significantly improved from a baseline of 310 ± 65.1 m to 466 ± 23.6 m.
• One patient experienced mortality 47 days post-implantation; the remaining patients tolerated the therapy.

Conclusions:

• The OPTIMIZER® SMART IPG CCMX10 device demonstrates safety, feasibility, and applicability in a wide range of heart failure patients.
• CCM therapy offers a potential new therapeutic avenue for managing HFrEF, including in challenging patient subgroups.