Transcutaneous (Tragus) Vagal Nerve Stimulation for Post-op Afib

About

Brief Summary

Patients undergoing cardiac surgery are at high risk of developing atrial fibrillation (AF), with estimated rates of 30-50% and occurs at approximately 2-4 days after surgery. The autonomic nervous system is known to play a key role in AF. Animal studies have indicated that duration and inducibility of AF can be decreased with intermittent vagus nerve stimulation (VNS). In humans, literature suggests that transcutaneous (tragus) VNS (tVNS) can serve as a potentially non-invasive therapy for treatment of post-operative AF (POAF) by reducing inflammation and increasing atrial refractory period. The purpose of this study is to determine the value of tVNS in reducing the burden of POAF and days of hospitalization after cardiac surgery.

Primary Purpose

Prevention

Study Type

Interventional

Phase

N/A

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

80 Years

Inclusion Criteria:

Patients scheduled to undergo coronary artery bypass surgery, major vascular/aneurysm repair requiring bypass, valvular replacement or repair, or both, for clinically indicated reasons.
Age ≥ 18 years.
Sinus rhythm at baseline.
Provision of signed informed consent and stated willingness to comply with all study procedures for duration of the study

Exclusion Criteria:

Emergent surgery
Anticipated amiodarone use
Patients with permanent or persistent atrial fibrillation
Planned concomitant atrial Maze procedure
Complex congenital heart disease
Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
Left ventricular assist device or status post orthotopic heart or lung transplantation
Unable or unwilling to comply with protocol requirements.
Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardia
Symptomatic sinus bradycardia or sinus node dysfunction at baseline without an implantable pacemaker.
Complete heart block or trifascicular block without an implantable pacemaker
Recurrent vasovagal syncope
Unilateral or bilateral vagotomy
Chronic amiodarone use