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Acute Hemodynamic Changes Induced by Cardiac Contractility Modulation Evaluated Using the NICaS® System: A Pilot
Andrea Madeo1, Silvana De Bonis2, Anna Lucia Cavaliere1
1Cardiology Department, Ferrari Hospital, ASP Cosenza, 87012 Castrovillari, Italy.
Insights
Cardiac contractility modulation (CCM) significantly improves stroke volume and reduces total peripheral resistance index in heart failure patients. The non-invasive NICaS system reliably tracks these hemodynamic changes, aiding treatment optimization.
Area of Science:
- Cardiology
- Biomedical Engineering
- Medical Devices
Background:
- Heart failure with reduced ejection fraction (HFrEF) is a major global health concern.
- Cardiac contractility modulation (CCM) offers a therapeutic option for HFrEF patients ineligible for cardiac resynchronization therapy (CRT).
- Accurate, non-invasive assessment of CCM's hemodynamic effects is crucial for patient management.
Purpose of the Study:
- To evaluate the acute hemodynamic impact of CCM on stroke volume (SV) and total peripheral resistance index (TPRI).
- To assess the utility of the non-invasive bioimpedance system NICaS® for monitoring these changes.
Main Methods:
- Eight HFrEF patients received Optimizer Smart Mini CCM device implantation.
- Stroke volume (SV) and total peripheral resistance index (TPRI) were measured using NICaS® at baseline and at 1 week, 1 month, and 3 months post-implantation.
- Non-parametric statistical tests were employed for data analysis.
Main Results:
- A significant increase in median SV was observed, from 40.02 mL at baseline to 69.83 mL at 3 months (p < 0.0001).
- A significant decrease in median TPRI was recorded, from 2537 dn·s/cm⁵·m² at baseline to 1307 dn·s/cm⁵·m² at 3 months (p < 0.0001).
- CCM therapy demonstrated significant improvements in SV and reductions in TPRI within three months.
Conclusions:
- CCM therapy effectively enhances stroke volume and reduces total peripheral resistance index in HFrEF patients.
- The NICaS® system provides a reliable, non-invasive method for monitoring acute hemodynamic changes induced by CCM.
- NICaS® supports the clinical application of CCM therapy for heart failure management.
Abstract:
Background/Objectives: Heart failure (HF) with reduced ejection fraction remains a significant global health challenge despite advances in medical therapy. Cardiac contractility modulation (CCM) is a promising treatment for symptomatic HF patients who are ineligible for cardiac resynchronization therapy (CRT). Non-invasive methods to assess the acute hemodynamic effects of CCM are critical to optimize care and guide treatment. This study aimed to evaluate the acute impact of CCM on stroke volume (SV) and total peripheral resistance index (TPRI) using the non-invasive bioimpedance-based system (NICaS®). Methods: Eight HF patients (median age: 64.6 years, median left ejection fraction (LVEF): 34.5%) underwent implantation of the Optimizer Smart Mini CCM device. Hemodynamic parameters, including SV and TPRI, were measured using NICaS® at baseline (pre-implantation) and at 1 week, 1 month, and 3 months post-implantation. Measurements were repeated eight times per session and analyzed using non-parametric statistical tests, including the Kruskal-Wallis test, Mann-Whitney test, and Kolmogorov-Smirnov test. Results: Median SV increased significantly from 40.02 mL (interquartile range (IQR): 32.62-78.16 mL) at baseline to 69.83 mL (IQR: 58.63-86.36 mL) at 3 months (p < 0.0001). Median TPRI decreased significantly from 2537 dn s/cm5 m2 (IQR: 1807-3084 dn s/cm5 m2) to 1307 dn s/cm5 m2 (IQR: 1119-1665 dn s/cm5 m2) over the same period (p < 0.0001). CCM therapy significantly improved SV and reduced TPRI in HF patients within three months of implantation. Conclusions: NICaS® provided a reliable, non-invasive tool for monitoring these acute hemodynamic changes, supporting its use in clinical practice.
