Parasym™ neuromodulation device reveals promising developments in the treatment of heart failure patients with preserved ejection fraction: Clinical Trial Results

Reporter and Curator: Aviva Lev-Ari, PhD, RN

Neuromodulation of Inflammation to Treat Heart Failure With Preserved Ejection Fraction: A Pilot Randomized Clinical Trial

Stavros Stavrakis, 

Khaled Elkholey, 

Lynsie Morris, 

Monika Niewiadomska, 

Zain Ul Abideen Asad

 and 

Mary Beth Humphrey

Originally published 13 Jan 2022 https://doi.org/10.1161/JAHA.121.023582 Journal of the American Heart Association. 2022;11:e023582

 

Abstract

Background

A systemic proinflammatory state plays a central role in the development of heart failure with preserved ejection fraction. Low‐level transcutaneous vagus nerve stimulation suppresses inflammation in humans. We conducted a sham‐controlled, double‐blind, randomized clinical trial to examine the effect of chronic low‐level transcutaneous vagus nerve stimulation on cardiac function, exercise capacity, and inflammation in patients with heart failure with preserved ejection fraction.

Methods and Results

Patients with heart failure with preserved ejection fraction and at least 2 additional comorbidities (obesity, diabetes, hypertension, or age ≥65 years) were randomized to either active (tragus) or sham (earlobe) low‐level transcutaneous vagus nerve stimulation (20 Hz, 1 mA below discomfort threshold), for 1 hour daily for 3 months. Echocardiography, 6‐minute walk test, quality of life, and serum cytokines were assessed at baseline and 3 months. Fifty‐two patients (mean age 70.4±9.2 years; 70% female) were included (active, n=26; sham, n=26). Baseline characteristics were balanced between the 2 arms. Adherence to the protocol of daily stimulation was >90% in both arms (P>0.05). While the early mitral inflow Doppler velocity to the early diastolic mitral annulus velocity ratio did not differ between groups, global longitudinal strain and tumor necrosis factor‐α levels at 3 months were significantly improved in the active compared with the sham arm (−18.6%±2.5% versus −16.0%±2.4%, P=0.002; 8.9±2.8 pg/mL versus 11.3±2.9 pg/mL, P=0.007, respectively). The reduction in tumor necrosis factor‐α levels correlated with global longitudinal strain improvement (r=−0.73, P=0.001). Quality of life was better in the active arm. No device‐related side effects were observed.

Conclusions

Neuromodulation with low‐level transcutaneous vagus nerve stimulation over 3 months resulted in a significant improvement in global longitudinal strain, inflammatory cytokines, and quality of life in patients with heart failure with preserved ejection fraction.

Registration

URL: https://www.clinicaltrials.gov; Unique identifier: NCT03327649.

SOURCE

https://www.ahajournals.org/doi/10.1161/JAHA.121.023582

 

Press Release Announcement by Parasym™ is a neurotechnology company dedicated to shaping the future of bioelectric medicine. Founded in 2015 by Sophie and Nathan Dundovic, is focused on providing innovative neuromodulation products that restore health. The company has over 60 clinical partnerships across 4 continents, and over 1,000,000 treatment sessions completed. For more information about Parasym™’s latest products, visit nurosym.com

 

Parasym™ is the only company to have developed a device that utilises advances in electroceutical technology to provide ground-breaking non-invasive treatment for numerous health and wellness conditions ranging from mental to physical health including heart failure, without the need for heart failure medication. For further information about Parasym™ visit parasym.co.

Notes to editors:

• High-resolution imagery can be found here. 
• Full results of clinical trial
• Qualio nominated the device as one to watch 
• British Heart Foundation stats and figures

 

The neuromodulation device is non-invasive, patients are able to use it in addition to medication should they want to. Electroceuticals are set to revolutionise the treatment paradigm in heart failure, especially neuromodulation with its capacity to provide highly targeted treatment without drug interaction or side effects.

 

Clinical trial results

The study revealed significant improvements in levels of proinflammatory cytokines Interleukin-8 and Tumour Necrosis Factor alpha, indicating that the treatment had a significant anti-inflammatory effect, as well as in global longitudinal strain, a core indicator of cardiac mechanics. 

 

Dr Stavros Stavrakis MD, PhD, Associate Professor at University of Oklahoma College of Medicine commented: “We conducted a sham-controlled, double-blind, randomized clinical trial to examine the effect of chronic low-level transcutaneous vagus nerve stimulation on cardiac function, exercise capacity, and inflammation in a subgroup of patients with heart failure with preserved ejection fraction with a predominantly inflammatory-metabolic phenotype. In this patient population, neuromodulation with low-level transcutaneous vagus nerve stimulation over three months resulted in a significant improvement in global longitudinal strain, inflammatory cytokines, and quality of life. Our results support the emerging paradigm of noninvasive neuromodulation to treat selected patients with heart failure with preserved ejection fraction and provide the basis for further randomized trials.”

 

Parasym™️ is committed to supporting groundbreaking cardiac research and we are working to bring non-invasive electroceutical treatments to patients suffering from heart failure.

 

“The results published in the Journal of the American Heart Association highlight the brilliant work done by researchers at the University of Oklahoma and show the incredible potential that Parasym’s neuromodulatory technology can have in a condition where there is an urgent unmet clinical need for new treatment options. We are incredibly proud of the trial results and hope to continue to demonstrate the positive impact of neuromodulation in healthcare.”

SOURCE

 

From: Sofia Leadbetter <sofia@lem-uhn.com>
Date: Tuesday, February 22, 2022 at 9:56 AM
To: Aviva Lev-Ari <avivalev-ari@alum.berkeley.edu>
Subject: Re: A groundbreaking clinical trial using Parasym™ neuromodulation device reveals promising developments in the treatment of heart failure

 

Other related articles published in this Open Access Online Scientific Journal includes the following:

I. A related topic is Renal denervation for Hypertension control by a medical device

Single-Author Reporting on MedTech and Cardiac Medical Devices by

Aviva Lev-Ari, PhD, RN

Single-Author Reporting on MedTech and Cardiac Medical Devices by Aviva Lev-Ari, PhD, RN

II. All articles on preserved ejection fractions

Experimental Therapy (Left inter-atrial shunt implant device) for Heart Failure: Expert Opinion on a Preliminary Study on Heart Failure with preserved Ejection Fraction 

Article Curator: Aviva Lev-Ari, PhD, RN

Experimental Therapy (Left inter-atrial shunt implant device) for Heart Failure: Expert Opinion on a Preliminary Study on Heart Failure with preserved Ejection Fraction 

 

III. All articles on Heart Failure included in LPBI Group’s BioMed e-Series, Series A: Cardiovascular Diseases – Six Volumes

https://lnkd.in/e6WkMgF

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