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

Massachusetts General Hospital242 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

242

Conditions

Atrial Fibrillation New Onset

Interventions

Patients after the implementation of the protocol receive postoperative prophylactic amiodarone and a posterior pericardiotomy. The amiodarone regimen consists of amiodarone 1mg/min x 10 hours (600 mg total) via central line upon arrival to the intensive care unit followed by 400 mg PO BID on postoperative days 1 and 2 followed by 200 mg PO BID on postoperative days 3 and 4 or until discharge, whichever occurs first. The posterior pericardiotomy occurs during the cardiac procedure.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Postoperative atrial fibrillation

At least 1 minute duration detected by continuous telemetry or 12-lead electrocardiogram.

Time frame: Prior to patient discharge or within 30 days after surgery.

Secondary Outcomes

Operative mortality

Operative mortality as defined by either in-hospital death or death within 30 days of discharge.

Time frame: Either in-hospital death or death within 30 days of discharge

Stroke

Characterized by deficits lasting \> 24 hours and/or imaging findings of infarction

Time frame: Either in-hospital or within 30 days of procedure

Transient ischemic attack

Characterized by examination findings lasting \< 24 hours without associated imaging findings

Time frame: Either in-hospital or within 30 days of procedure

Initiation of systemic anticoagulation

New indication of systemic anticoagulation for stroke prophylaxis due to atrial fibrillation

Time frame: Either in-hospital or within 30 days of procedure

Persistence of atrial fibrillation at discharge

Atrial fibrillation as diagnosed by final ECG

Time frame: At postoperative surgical visit (around 4-6 weeks)

Postoperative hospital length of stay

The postoperative length of stay will be calculated starting from the end of the procedure to time of discharge

Time frame: Up to 90 days

Readmission

Rates of hospital readmission will be estimated for patients in each of the study intervention groups. Readmissions will be counted in this calculation if patients are admitted to the hospital. Emergency room visits without admission and outpatient visits will not count toward this calculation of readmission rates.

Time frame: Within 30 days of procedure

Symptomatic bradycardia

Symptomatic bradycardia (HR \< 55 bpm) requiring intervention

Time frame: Either in-hospital or within 30 days of procedure

Number of patients with Amiodarone-related pulmonary toxicity

Clinical diagnosis of amiodarone-related pulmonary toxicity that uses a combination of x-ray findings consistent with known amiodarone-related pulmonary toxicity and clinical findings including shortness of breath, non-productive cough, and other diagnoses have been excluded.

Time frame: Either in-hospital or within 30 days of procedure

Postoperative pleural effusions requiring intervention

Postoperative pleural effusions requiring interventions including thoracostomy drainage or surgical drainage

Time frame: Either in-hospital or within 30 days of procedure

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes