Temporary Autonomic Blockade to Prevent Atrial Fibrillation After Cardiac Surgery
Atrial Fibrillation
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Cardiac Surgery, Postoperative Complications, Autonomic Nerve Block
Eligibility Criteria
Inclusion Criteria:
- Undergoing cardiac surgery with cardiopulmonary bypass via median sternotomy
- coronary artery bypass graft (CABG)
- valve surgery
- CABG + valve surgery
Exclusion Criteria:
- < 50years of age
- > 90years of age
- chronic AF or AF at the time of screening
- preoperative heart block (second degree or greater)
- LVEF < 25%
- renal failure
- hepatic failure
- known sensitivity to Botulinum toxin
- debilitating neuromuscular disease
- preoperative need for inotropes/vasopressors or intra-aortic balloon pump
- planned MAZE procedure
- history of catheter ablation for AF
- use of Vaughan-Williams class I or III drugs within 5 elimination half lives (or within 2 months for amiodarone)
- undergoing minimally-invasive cardiac surgery
- prior cardiac surgery
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Epicardial Botulinum
Epicardial Placebo
After instituting cardiopulmonary bypass (CPB), botulinum toxin injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 50U (1mL) of botulinum toxin (OnabotulinumtoxinA, Botox®). After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge.
After instituting cardiopulmonary bypass (CPB), placebo (normal saline) injections will be performed by the surgeon as follows: Using a standard sterile insulin syringe with a 27g needle, surgeons will inject each of the epicardial fat pads with 1mL of normal saline. After completion of surgery and separation from CPB, patients will proceed along the institutional Cardiac Surgical Caremap. All patients will be monitored with continuous ECG (telemetry) until hospital discharge. POAF will be diagnosed by telemetry or 12-lead ECG, and will be defined as new-onset if it occurs postoperatively at any time before hospital discharge.