TraNscutaneOus Electrical VAgus Nerve Stimulation to Suppress Premature Ventricular Contractions: A Crossover, Randomized Clinical Trial (NoVa-PVC)
Abstract
INTRODUCTION
The autonomic nervous system has been implicated in the genesis of idiopathic premature ventricular complexes (PVCs). Antiadrenergic effects have been shown noninvasively by low-level electrical stimulation of the tragus (LLTS).
OBJECTIVES
This study evaluated the efficacy of LLTS in reducing PVC burden.
METHODS
This 2-center, prospective, sham-controlled, single-blinded, crossover randomized clinical trial was conducted in patients with symptomatic PVCs with at least 5% daily PVC burden and who were refractory to medical therapy. Participants received two sequential, 10-day sessions of active LLTS (20 Hz, 1 mA below the discomfort threshold) and sham stimulation (earlobe stimulation). Each treatment was interrupted by an 8-day washout period. Randomization determined the order of treatment. All patients wore an extended Holter monitor (ePatch; Philips) for daily PVC count during the study period.
RESULTS
Of the 36 randomized patients, 35 (19 [59.4%] male; mean age 58.0 ± 17.1 years) completed the study and were included in the analysis. The median baseline PVC burden was 12.00% (IQR: 11.4%). LLTS significantly reduced the median PVC burden by 13.4% compared with sham stimulation (10.5% [IQR: 14.4%] vs 8.59% [IQR: 8.45%]; P = 0.021). No significant differences in heart rate variability were observed between the 2 groups. Exploratory analyses revealed a more pronounced reduction in slow heart rate-dependent PVCs and a sustained decrease in PVC burden throughout…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 36 participants or records.
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