TraNscutaneOus Electrical VAgus Nerve Stimulation to Suppress Premature Ventricular Contractions: A Crossover, Randomized Clinical Trial (NoVa-PVC).

IF 8 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Stefanos Zafeiropoulos, Kristie Coleman, Jonathan Kogan, Dimitrios Varrias, Jonas Leavitt, Alexandra Bekiaridou, Theodoros Zanos, Stavros Zanos, Stavros Stavrakis, Stavros Mountantonakis
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引用次数: 0

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 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].

经皮迷走神经电刺激抑制室性早搏:一项交叉随机临床试验(NoVa-PVC)。
导论:自主神经系统与特发性室性早搏的发生有关。低水平电刺激耳屏(LLTS)的抗肾上腺素能作用已被证明是无创的。目的:本研究评估LLTS减轻PVC负担的效果。方法:本研究为双中心前瞻性、假对照、单盲、交叉随机临床试验,研究对象为每日PVC负荷不低于5%且药物治疗难治性的症状性室性早衰患者。参与者接受了两个连续的,为期10天的活动LLTS (20 Hz,低于不适阈值1 mA)和假刺激(耳垂刺激)。每次治疗被8天的洗脱期打断。随机化决定了治疗的顺序。所有患者都佩戴了延长的动态心电图监护仪(ePatch;在研究期间的每日PVC计数。结果:36例随机患者中,35例(男性19例[59.4%];平均年龄(58.0±17.1岁)完成研究并纳入分析。中位基线PVC负担为12.00% (IQR: 11.4%)。与假刺激相比,LLTS显著降低了中位PVC负担13.4% (10.5% [IQR: 14.4%] vs 8.59% [IQR: 8.45%];P = 0.021)。两组间心率变异性无显著差异。探索性分析显示,在整个LLTS期间,慢心率依赖性室性早搏的减少更为明显,室性早搏负荷持续下降。结论:LLTS有效地减轻了药物治疗难治性症状性室性心动过速患者的PVC负担,突出了其作为辅助治疗选择的潜力。需要更大的、多中心的试验来证实这些发现并评估长期结果[无创迷走神经刺激治疗频繁早衰心室复合物(NoVa-PVC);NCT05341544]。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
JACC. Clinical electrophysiology
JACC. Clinical electrophysiology CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
10.30
自引率
5.70%
发文量
250
期刊介绍: JACC: Clinical Electrophysiology is one of a family of specialist journals launched by the renowned Journal of the American College of Cardiology (JACC). It encompasses all aspects of the epidemiology, pathogenesis, diagnosis and treatment of cardiac arrhythmias. Submissions of original research and state-of-the-art reviews from cardiology, cardiovascular surgery, neurology, outcomes research, and related fields are encouraged. Experimental and preclinical work that directly relates to diagnostic or therapeutic interventions are also encouraged. In general, case reports will not be considered for publication.
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