Transcutaneous low-level vagus nerve stimulation for the prevention of postoperative atrial fibrillation after cardiac valve surgery with cardiopulmonary bypass: protocol for a randomized controlled trial.
4 affiliations
- 1Department of Anesthesiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 Qingchun East Road, Hangzhou, 310016, Zhejiang, China.
- 2Department of Nutrition and Food Hygiene, School of Public Health, Zhejiang University, Hangzhou, Zhejiang, 310058, China.
- 3Department of Cardiac Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 Qingchun East Road, Hangzhou, Zhejiang, 310016, China. [email protected].
- 4Department of Anesthesiology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, 3 Qingchun East Road, Hangzhou, 310016, Zhejiang, China. [email protected].
Abstract
Background
Atrial fibrillation (AF) is one of the most common complications following cardiac surgery, with reported incidence rates reaching up to 44%. Transcutaneous low-level vagus nerve stimulation (TLL-VNS) has shown potential in reducing the risk of postoperative AF by modulating autonomic nervous system activity, suppressing inflammation, and regulating atrial ganglionic function.Methods
The Vagus-Heart Trial is a prospective, randomized, double-blind, sham-controlled study designed to evaluate the efficacy of TLL-VNS in preventing postoperative AF. A total of 140 patients undergoing elective cardiac valve surgery with cardiopulmonary bypass (CPB) are randomly assigned to receive either active TLL-VNS or sham stimulation. The primary endpoint is the incidence of AF within the first week after surgery. Secondary endpoints include the duration of AF within the first week after surgery, surgical parameters, vital signs, inflammatory markers, renal function, surgical prognosis, and stress response biomarkers.Discussion
This trial is the first large-scale, randomized, sham-controlled study to evaluate TLL-VNS for the prevention of postoperative AF in patients undergoing cardiac valve surgery with CPB. If proven effective, TLL-VNS could represent a novel, non-invasive, and cost-effective strategy to enhance postoperative recovery and reduce the burden of AF in this high-risk population.Trial registration
Chictr.org.cn Identifer: ChiCTR2400080750. Registered on 6 February 2024.
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BibTeX
@article{bian2026transcutaneous,
title = {{Transcutaneous low-level vagus nerve stimulation for the prevention of postoperative atrial fibrillation after cardiac valve surgery with cardiopulmonary bypass: protocol for a randomized controlled trial.}},
author = {Lindi Bian and Yuwei Shi and Tieshuai Liu and Ying Zhang and Jiwen Li and Jun Zhang},
journal = {BMC complementary medicine and therapies},
year = {2026},
month = aug,
doi = {10.1186/s12906-026-05510-3},
url = {https://europepmc.org/article/MED/42972365},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Transcutaneous low-level vagus nerve stimulation for the prevention of postoperative atrial fibrillation after cardiac valve surgery with cardiopulmonary bypass: protocol for a randomized controlled trial.
AU - Lindi Bian
AU - Yuwei Shi
AU - Tieshuai Liu
AU - Ying Zhang
AU - Jiwen Li
AU - Jun Zhang
PY - 2026
DA - 2026/08/06
JO - BMC complementary medicine and therapies
DO - 10.1186/s12906-026-05510-3
UR - https://europepmc.org/article/MED/42972365
AB - Background Atrial fibrillation (AF) is one of the most common complications following cardiac surgery, with reported incidence rates reaching up to 44%. Transcutaneous low-level vagus nerve stimulation (TLL-VNS) has shown potential in reducing the risk of postoperative AF by modulating autonomic nervous system activity, suppressing inflammation, and regulating atrial ganglionic function.Methods The Vagus-Heart Trial is a prospective, randomized, double-blind, sham-controlled study designed to evaluate the efficacy of TLL-VNS in preventing postoperative AF. A total of 140 patients undergoing elective cardiac valve surgery with cardiopulmonary bypass (CPB) are randomly assigned to receive either active TLL-VNS or sham stimulation. The primary endpoint is the incidence of AF within the first week after surgery. Secondary endpoints include the duration of AF within the first week after surgery, surgical parameters, vital signs, inflammatory markers, renal function, surgical prognosis, and stress response biomarkers.Discussion This trial is the first large-scale, randomized, sham-controlled study to evaluate TLL-VNS for the prevention of postoperative AF in patients undergoing cardiac valve surgery with CPB. If proven effective, TLL-VNS could represent a novel, non-invasive, and cost-effective strategy to enhance postoperative recovery and reduce the burden of AF in this high-risk population.Trial registration Chictr.org.cn Identifer: ChiCTR2400080750. Registered on 6 February 2024.
SN - 2662-7671
ER -