Year: 2025
Type: article
Study design: Clinical Trial
Abstract: Background Subcutaneous nerve stimulation (ScNS) can reduce atrial arrhythmia in canine models. Objective To test the hypothesis that ScNS can reduce the burden of paroxysmal atrial fibrillation (AF) by a randomized, sham-controlled clinical trial. Methods Patients with drug-resistant symptomatic paroxysmal AF were randomized to receive ScNS (10 Hz, 3.5 mA output, 20 s ON, and 1 min OFF) for two weeks. The AF burden was determined by ePatch recordings. Results Of the 46 consented, 12 (8 men and 4 women, 60.9 ± 10.2 years) were randomized. The change in AF burden at week 1 from eligibility week was not significantly different between the groups (p=0.8102). The proportion of AF-free patients was 16.7% for each group (p=1.000). The difference in difference (DID) estimates for weeks 1, 2, 3, and 12 (estimate ± SE) were -2.04 ± 10.84 (p=0.8516), -2.44 ± 10.84 (p=0.8228), -0.20 ± 10.84 (p=0.986), and -18.11 ± 11.16 (p=0.1126), respectively. The Stimulation Group shows a slower increase in %AF burden over time than the Sham group (p=0.027 for group and time interaction) when time is modeled linearly as a continuous variable in the mixed model. In Week 3, the ventricular rate (VR) during AF in the Stimulation Group was faster than in the Sham Group (p=0.026). Conclusions Two weeks of ScNS did not reduce the AF burden or control the ventricular rate in patients with paroxysmal AF. However, there was a slower increase in %AF burden over time in the Stimulation group than in the Sham group.
Source: Heart Rhythm O2
Authors: Peng-Sheng Chen, Xiao Liu, Tiffany G. Perry, Robert J. Siegel, Alexander Tuchman, Anxhela Kote, Jewel N. Reaso, Kathleen A. Lane, Carine Rosenberg, K. Taiga Andersson, Susan Straka, Lan S. Chen, Thomas H. Everett, Michael M. Shehata, Ashkan Ehdaie, Xunzhang Wang, Eugenio Cingolani, Archana Ramireddy, Eric D. Braunstein, Xiaochun Li
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,150
Award: G9000107458
OpenAlex ID: W4416527897