A Pharmaco-surgical Approach to Reduce Postoperative Atrial Fibrillation After Cardiac Surgery

Mass General Brigham

Status: Completed

Conditions: Atrial Fibrillation New Onset

Treatments: Other: Prophylactic amiodarone and posterior pericardiotomy

Study type: Observational

Funder types: Other

Identifiers

NCT05780320

2004P001528

Details and patient eligibility

About

Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery with an estimated incidence around 35%. It has been found to be an independent predictor of 30-day and 6-month mortality, stroke, renal failure, respiratory failure, and need for permanent pacemaker among others. Previous studies including meta-analyses demonstrate a protective benefit of prophylactic amiodarone to decrease the risk of POAF. However, this has not been widely adopted, and recent society guidelines only give prophylactic amiodarone a Class IIA recommendation, citing risk of amiodarone-related toxicity and hypotension as reasons for the Class IIA recommendation. A meta-analysis comparing cumulative doses of amiodarone found that moderate to higher doses of amiodarone have a marginally increased benefit in reducing the incidence of postoperative atrial fibrillation over lower doses; however, the study did not assess risk of complications stratified by cumulative doses, which has been previously described. Finally, a recent meta-analysis showed that a posterior pericardiotomy was highly effective at reducing postoperative atrial fibrillation. Consequently, the investigators' institution has adopted a pharmaco-surgical approach (prophylactic amiodarone and posterior pericardiotomy) in an effort to reduce postoperative atrial fibrillation after coronary artery bypass cardiac surgery for all patients who meet inclusion/exclusion criteria.

Enrollment: 242 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preoperative normal sinus rhythm
• Procedures:
• CABG
• CABG + concomitant valve or aortic replacement/repair

Exclusion criteria

• Emergent operation

Procedures:

• MAZE or PVI performed
• Isolated valve replacement or repair
• Isolated aortic procedures
• Heart transplant
• Lung transplant Pre-existing atrial arrhythmias Pre-operative amiodarone use Contraindications to amiodarone use
• PR interval > 240 ms
• 2nd or 3rd degree heart block
• QTc > 550ms
• 2nd or 3rd degree heart block
• Liver impairment (INR > 1.7, AST/ALT > 2x normal)
• Uncontrolled hypothyroidism/hyperthyroidism
• Interstitial lung disease
• Allergy to amiodarone

Trial design

242 participants in 2 patient groups

Pharmaco-Surgical Arm

Treatment:

Other: Prophylactic amiodarone and posterior pericardiotomy

Standard of Care Arm