University of Pittsburgh researchers have designed a closed-loop multimodal artificial intelligence (AI) assisted neuromodulation device to treat heart failure (HF).
Description
This novel device, Calm Heart, based on a combination of spinal cord stimulation (SCS) and vagus nerve stimulation (VNS) will have the potential to provide novel therapeutic approaches to treating a variety of cardiac conditions. Assisted by artificial intelligence, this device aims to restore healthy autonomic balance in patients with HF with a view to halting progression of HF and improving the outcomes and quality of life for patients within this currently unmet clinical need.
Applications
• Ventricular Arrhythmias
• Heart Failure
• Myocardial Infarction
Advantages
HF is a chronic, life altering condition with nearly one million new cases in America each year. Frequent hospitalization is common. Along with the need for long-term treatment plans, innovative treatment approaches are needed to improve outcomes in HF patients.
During HF, cardiac neurons sense the failing heart and become hyperactive, requiring the cardiac nervous system to increase sympathetic tone and decrease parasympathetic tone to maintain cardiac output, resulting in autonomic imbalance. With time, this pull on the cardiac nervous system leads to worsening HF and can initiate fatal ventricular arrhythmias. This novel device will use closed-loop neuromodulation to control both sympathetic and parasympathetic tone. AI based on feedback from biomarkers, including ECG and blood pressure will be acquired and analyzed in real time, and will personalize the SCS and VNS parameters to provide autonomic balance, thereby reducing the risk of worsening HF or fatal ventricular arrhythmias.
Invention Readiness
Animal studies have shown SCS can decrease sympathetic response and the risk of ventricular arrhythmias. VNS has been shown to modulate parasympathetic tone. Open loop simultaneous SCS and VNS has also shown to be cardioprotective. Currently in the concept phase, a prototype closed-loop programmable device with the ability to collect and analyze biomarkers using AI now needs to be developed. The device will deliver controlled simultaneous SCS and VNS to HF patients to ensure autonomic balance. Further work to explore efficacy and safety in large animal models is also required.
IP Status
https://patents.google.com/patent/WO2025014855A2Related Publication(s)
Salavatian, S., Kuwabara, Y., Wong, B., Fritz, J. R., Howard-Quijano, K., Foreman, R. D., Armour, J. A., Ardell, J. L., & Mahajan, A. (2023). Spinal neuromodulation mitigates myocardial ischemia-induced sympathoexcitation by suppressing the intermediolateral nucleus hyperactivity and spinal neural synchrony. Frontiers in Neuroscience, 17. https://doi.org/10.3389/fnins.2023.1180294
Howard-Quijano, K., Yamaguchi, T., Gao, F., Kuwabara, Y., Puig, S., Lundquist, E., Salavatian, S., Taylor, B., & Mahajan, A. (2021). Spinal Cord Stimulation Reduces Ventricular Arrhythmias by Attenuating Reactive Gliosis and Activation of Spinal Interneurons. JACC: Clinical Electrophysiology, 7(10), 1211–1225. https://doi.org/10.1016/j.jacep.2021.05.016
