Table 3.
Clinical trials investigating the effects of vagal neuromodulation on cardiovascular measures. – indicates value unspecified; n refers to intervention/control. AF, atrial fibrillation; CABG, coronary artery bypass grafting; LVEDV, left ventricular end diastolic volume; LVEF, left ventricular ejection fraction; LVESV, left ventricular end systolic volume; PCI, percutaneous coronary intervention; PMID, PubMed Identification Number; STEMI, ST elevation myocardial infarction; taVNS, transcutaneous auricular vagus nerve stimulation; tcVNS, transcutaneous cervical vagus nerve stimulation; VNS, vagus nerve stimulation.
| Authors, ref. no., year (PMID) | Study design | Subjects (n) | Age (yr) | Sex (% female) | Intervention | Start of intervention | Stimulation parameters |
Control | Outcome measured | Outcome time point | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| On/off period (s) | Duration (min) | Pulse width (μs) | Pulse frequency (Hz) | Intensity (mA) | ||||||||||
| Stavrakis and colleagues,49 2017 (29759717) | RCT | Surgical (26/28) | 43–72 | 29.6 | Transvenous VNS | On arrival in ICU (time point unspecified) | – | 4320 | 1000 | 20 | – | Sham | Postoperative AF occurrence (% of patients) | 24, 72 h |
| Yu and colleagues,52 2017 (28797427) | RCT | STEMI needing PCI (47/48) | 18–80 | 25.3 | taVNS | 35 min before reperfusion in catheterisation laboratory | 5 | 155 | 1000 | 20 | – | Sham | Reperfusion-related arrhythmia (number of events); creatine kinase-MB (ng m−1), myoglobin (μg L−1), N-terminal pro-B-type natriuretic peptide (ng L−1); echocardiographic parameters including LVEF (%), LVEDV and LVESV (ml) | 72 h |
| Stavrakis and colleagues,50 2015 (25744003) | RCT | Paroxysmal AF needing ablation (20/20) | 53–69 | 35 | taVNS | Pre-induction of general anaesthesia (time point unspecified) | – | 60 | 1000 | 20 | – | Sham | AF duration (min) | 20 min |
| Zamotrinsky and colleagues,53 2001 (11474540) | Non-RCT | Coronary artery disease needing CABG (8/10) | 48–58 | 0 | taVNS | Not clear | – | 15 | – | – | – | None | Cardiac noradrenergic nerve density (volume % in atrial tissue); LVEF (%) | – |
| Tran and colleagues,54 2019 (30560316) | RCT, crossover | Heart failure (24/group) | 57–80 | 46 | taVNS | 40 min before assessment | 10–20 | 60 | 200 | 20 | – | Sham | LV global longitudinal strain (% reduction on echocardiography) | 60 min |
| Clancy,92 2014 (25164906) | RCT | Volunteer (34/14) | 20–62 | 50 | taVNS | N/A | – | 15 | 200 | 30 | 10–50 | Sham | Muscle sympathetic nerve activity (μV) | – |