Tragus Stimulation to Prevent Atrial Fibrillation After Cardiac Surgery

Study Overview
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Brief Summary
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Patients undergoing cardiac surgery, specifically a coronary artery bypass graft and/or heart valve replacement surgery, are at a higher risk for post-procedure atrial fibrillation (AF). AF is a condition in which the upper chambers of the heart do not contract normally and results in an irregular heartbeat. Recent studies have shown that tragus stimulation decreases the likelihood of AF in animals and humans. It has also been shown to reduce inflammation which may be related to post-procedure AF. Tragus stimulation involves stimulating a part of the outer ear, called the tragus, by sending a microcurrent through a small alligator clip. It is believed that tragus stimulation can affect the nervous system, which may reduce heart rate and lead to prevention of AF. The purpose of this study is to determine whether tragus stimulation in subjects undergoing cardiac surgery will lead to shorter occurrences, or even prevention, of AF.

Detailed Description
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This was a single-blind study where patients were randomized tragus stimulation versus sham procedure and remained blinded to their treatment allocation. Both treatment options utilized similar equipment, namely the use of alligator clips which will be placed on the tragus and earlobe of the right ear for patients. Prior to cardiac surgery, the discomfort threshold of both left and right tragus stimulation was determined for all participating patients. Intermittent electrode signals, or microcurrents, were delivered at 20 Hz with100 µsec pulse width with variable microampere (mA) output. The discomfort threshold was defined as the stimulation intensity in mA at which point patients experience discomfort. The stimulation intensity used in the study was set below the sensation and discomfort threshold. The clip was placed on the patient's ear at the end of surgery. Stimulation then continued, one ear alternating with the other, every 4 hours for a total of 48 hours. If the patient showed any sign of discomfort from stimulation, the intensity of stimulation was reduced to a level at which signs of discomfort disappears. Follow-up was performed with a 14-day event monitor at the time of discharge, as clinically indicated. Echocardiography were assessed prior to study initiation and when clinically available in follow-up.

Official Title
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Tragus Stimulation to Prevent Atrial Fibrillation After Cardiac Surgery: The TraP-AF Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Parasym


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥18 years of age, <90 years of age Estimated life expectancy of at least 1 year at the time of enrollment History of sinus rhythm or paroxysmal atrial fibrillation Exclusion Criteria: Patients ≥90 years of age, <18 years Patients with known prior history of persistent or permanent AF Atrial Fibrillation occurrence within the last 24 hours of procedure Urgent or Emergency cases Pregnant patients Patients undergoing the following cardiac procedures: heart transplant, pulmonary thromboendarterectomy, isolated aortic arch procedures, congenital hear disease, ventricular assist device insertion, extracorporeal membrane oxygenation insertion, and surgical AF ablation Antiarrhythmics prior to surgery (Class I and Class III) High degree atrioventricular block requiring temporary pacing Prior maze procedure for the treatment of AF

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Sham Group<br>At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, but the Parasym was not turned on and the subject did not receive any stimulation. The clip was switched to the other ear every 4 hours for a total of 48 hours. | |
| Experimental: Stimulation Group<br>At the end of cardiac surgery, the Parasym alligator clip was placed on the subject's tragus, and the subject received continuous stimulation for 48 hours. The clip was switched to the other ear every 4 hours. | Device: Parasym<br>* Tragus stimulation was done using the Parasym device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the First Episode of Atrial Fibrillation (AF) >30 Seconds | Time to the first episode of atrial fibrillation (AF) that was greater than 30 seconds in patients who had AF. This was assessed on the review of patient chart and inpatient telemetry. | From end of surgery to end of hospitalization, up to 1 month. | 
| Number of Participants Hospitalized for >5 Days | Number of participants with an overall length of hospitalization greater than five days. | From end of surgery to end of hospitalization, up to 1 month. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Atrial Fibrillation (AF) Burden | The total number of hours of atrial fibrillation (AF) burden as an inpatient. | From end of surgery to end of hospitalization, up to 1 month. | 
| Number of Participants With Rate Control Medications Used for AF | Number of participants that the management of their postoperative atrial fibrillation (AF) utilized the use of rate-controlling medications such as beta-blockers, calcium-channel blockers, or the use of digoxin. | From end of surgery to end of hospitalization, up to 1 month. | 
| Number of Participants With Antiarrhythmic Used to Treat AF | Number of participants that antiarrhythmic was use to treat atrial fibrillation (i.e., use of amiodarone) | From end of surgery to end of hospitalization, up to 1 month. | 
| Number of Participants With Inotropes Used for Blood Pressure Support During AF | The number of participants who management of their postoperative atrial fibrillation (AF) required the use of inotropic vasoactive or pressor medications for blood pressure (BP) support | From end of surgery to end of hospitalization, up to 1 month. | 
| Number of Participants With Stroke or Transient Ischemic Attack (TIA) | The number of participants who suffered from a cerebral vascular accident (CVA) or transient ischemic attacks (TIA) for any cause during hospitalization was recorded. | From end of surgery to end of hospitalization, up to 1 month. | 
| All-cause Mortality | Number of participants who suffered from mortality due to any cause during the inpatient period | From end of surgery to end of hospitalization, up to 1 month. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Atrial Fibrillation, Tragus Stimulation