Using subcutaneous nerve stimulation to control atrial fibrillation

Abstract

Background: Subcutaneous nerve stimulation (ScNS) can reduce atrial arrhythmia in canine models. Objective: This study aimed 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 2 weeks. The AF burden was determined by ePatch recordings. Results: Of the 46 patients who consented, 12 patients (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 = .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 = .8516), -2.44 ± 10.84 (P = .8228), -0.20 ± 10.84 (P = .986), and -18.11 ± 11.16 (P = .1126), respectively. The Stimulation Group shows a slower increase in %AF burden over time than the Sham Group (P = .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 = .026). Conclusion: 2 weeks of ScNS did not reduce the AF burden or control the VR 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.