TRanscutaneous Electrical vAgus nerve sTimulation to suppress Atrial Fibrillation (TREAT AF): a randomized clinical trial
Abstract
Background Low-level transcutaneous electrical stimulation of the auricular branch of the vagus nerve at the tragus (LLTS) acutely suppresses atrial fibrillation (AF) in humans, but the chronic effect remains unknown. Objectives We conducted a sham-controlled, double-blind, randomized clinical trial to examine the effect of chronic LLTS in patients with paroxysmal AF. Methods LLTS (20Hz, 1mA below the discomfort threshold) was delivered using an ear clip attached to the tragus (active; n=26) or the ear lobe (sham control; n=27) for 1 hour daily over 6 months. AF burden over 2-week periods was assessed by noninvasive continuous ECG monitoring at baseline, 3 and 6 months. Five-minute ECG and serum were obtained at each visit to measure heart rate variability (HRV) and inflammatory cytokines, respectively. Results Baseline characteristics were balanced between the 2 groups. Adherence to the stimulation protocol (≤4 sessions lost per month), was 75% in the active and 83% in the control arm (p>0.05). At 6 months, the median AF burden was 85% lower in the active compared to the control arm (ratio of medians: 0.15, 95% CI: 0.03 to 0.65, p=0.011). Tumor necrosis factor-α was significantly decreased by 23% in the active relative to the control group (ratio of medians: 0.77, 95% CI: 0.63 to 0.94, p=0.0093). Frequency domain indices of HRV were significantly altered with active vs. control stimulation (p<0.01). No device-related side effects were observed. Conclusion Chronic,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 27 participants or records.
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