Using subcutaneous nerve stimulation to control atrial fibrillation.

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.