Novel treatment offers non-pharmacological approach for treating common blood circulation disorder

NEW ORLEANS, LA, May 20, 2023 – New data from a randomized clinical trial show a novel ear-clip effectively uses nerve stimulation to treat postural tachycardia syndrome (POTS). The self-administered therapy offers a noninvasive solution for patients who do not respond to existing treatment options. Findings will be presented today as a late-breaking clinical trial at Heart Rhythm 2023.

POTS is a clinical syndrome usually characterized by frequent symptoms that occur when standing such as lightheadedness or fatigue, an increased heart rate when moving from a seated to a standing position, and the absence of orthostatic hypotension.¹ More common in women than men, POTS can cause debilitating symptoms that are often exacerbated by everyday activities, and many patients suffering from POTS experience a decrease in quality of life.² Today, there are no uniformly successful therapies for POTS.

This sham-controlled, double-blind, randomized, first-in-human, clinical trial sought to examine the effect of low-level transcutaneous stimulation (LLTS) on POTS over a 2-month period relative to sham stimulation. LLTS (20Hz, 1mA below the discomfort threshold) was delivered using an ear clip attached to either the tragus (active; n=12) or the ear lobe (sham; n=14) for 1 hour daily over a 2-month period. Patients attached the ear clips themselves after individual training. Of the 26 enrolled patients (active; n=12; sham; n=14), the mean age was 34±11 years (100% female; 81% Caucasian). Heart rates were monitored daily using wearable devices. Postural tachycardia was assessed during the baseline and 2-month visit. Heart rate variability (HRV) based on 5 min electrocardiogram, serum cytokines, and anti-autonomic autoantibodies were measured at the respective time points.

Postural tachycardia (in the absence of blood pressure drop) was significantly less in the active arm compared to the sham arm at 2 months (postural increase in heart rate 18±10bpm vs. 32±14bpm, respectively, p=0.016). Anti-autonomic autoantibodies (α1-AR and β1-AR) were lower in the active arm compared to the sham at 2 months (p<0.05). No device-related side effects were observed.

"Treatment options that mitigate POTS symptoms can be hard to determine and are often unsuccessful. For patients who are suffering and looking for answers, it can be frustrating. Our trial set out to better understand whether noninvasive vagus nerve stimulation could be a novel solution that improves overall quality of life," said Stavros Stavrakis, MD, PhD, FACC, FHRS, University of Oklahoma Health Sciences Center. "We are pleased to show the success of this novel noninvasive therapy and hope this trial offers an important step forward in considering this emerging treatment option."

The authors of this study would like to note that continuous heart rate monitoring, HRV, and cytokine analysis are currently underway. The authors also note that further studies are needed to examine the long-term effects and optimize patient selection.

¹ Sheldon RS, Grubb BP, Olshansky B, et al. 2015 heart rhythm society expert consensus statement on the diagnosis and treatment of postural tachycardia syndrome, inappropriate sinus tachycardia, and vasovagal syncope. Heart Rhythm. 2015;12(6):e42-e43. doi:10.1016/j.hrthm.2015.03.029

² Benrud-Larson LM, Dewar MS, Sandroni P, Rummans TA, Haythornthwaite JA, Low PA. Quality of life in patients with postural tachycardia syndrome. Mayo Clin Proc. 2002;77:531-537.

Session Details

"Late Breaking Clinical Trials and Science - Innovations: Randomized Clinical Trials: Noninvasive Vagus Nerve Stimulation in Postural Tachycardia Syndrome: A Randomized Clinical Trial" [Saturday, May 20, 2023 at 2:00 pm CT]

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About the Heart Rhythm Society

The Heart Rhythm Society (HRS) is a 501(c)(3) international nonprofit organization and the preeminent leader in science, education, and advocacy for cardiac arrhythmia professionals and patients. HRS continues to be the primary information resource on heart rhythm disorders with a mission to improve the care of patients by promoting research, education, and optimal health care policies and standards, and a mission to eliminate death and suffering due to heart rhythm disorders. Incorporated in 1979 and based in Washington, D.C., it has a membership of more than 8,000 heart rhythm professionals from 94 countries. For more information, visit www.HRSonline.org.

About Heart Rhythm 2023

The Heart Rhythm Society's annual Heart Rhythm meeting convenes 7,000+ of the world’s finest clinicians, scientists, researchers, and innovators in the field of cardiac pacing and electrophysiology. More than 1,500 international experts in the field will serve as faculty and presenters for the 200+ educational sessions, forums, symposia, and ceremonies, while 120+ exhibitors will showcase innovative products and services. For more information, visit www.HeartRhythm.com.