JACC. Clinical electrophysiology · 2025
Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Premature Ventricular Contractions: A Crossover, Randomized Clinical Trial (NoVa-PVC).
СтатьяРандомизированное исследованиеМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Zafeiropoulos Stefanos, Coleman Kristie, Kogan Jonathan, Varrias Dimitrios, Leavitt Jonas, Bekiaridou Alexandra, Zanos Theodoros, Zanos Stavros, Stavrakis Stavros, Mountantonakis Stavros
Аннотация
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 the LLTS period.
CONCLUSIONS: LLTS effectively reduced PVC burden in patients with symptomatic PVCs refractory to medical therapy, highlighting its potential as an adjuvant therapeutic option. Larger, multicenter trials are warranted to confirm these findings and evaluate long-term outcomes [Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes (NoVa-PVC); NCT05341544].
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 the LLTS period.
CONCLUSIONS: LLTS effectively reduced PVC burden in patients with symptomatic PVCs refractory to medical therapy, highlighting its potential as an adjuvant therapeutic option. Larger, multicenter trials are warranted to confirm these findings and evaluate long-term outcomes [Non-invasive Vagal Stimulation for Frequent Premature Ventricular Complexes (NoVa-PVC); NCT05341544].