Atrial Fibrillation, Surgery, Cardiac
Conditions
Keywords
Postoperative atrial fibrillation, POAF
Brief summary
Postoperative atrial fibrillation is quite common after cardiac surgery with up to 1 in 3 patients experiencing this abnormal heart rhythm. Amiodarone, a medication commonly used to treat atrial fibrillation, has been previously shown to be an effective prophylactic agent at decreasing the occurrence of postoperative atrial fibrillation in patients who underwent coronary artery bypass surgery. However, despite many studies which have demonstrated its effectiveness, it has not been widely used due to the concern of side effects that can occur such as slow heart rate, low blood pressure, and lung toxicity. We have designed a study to test the effectiveness and safety of a short course of postoperative prophylactic amiodarone for patients undergoing non-coronary artery bypass cardiac surgery. We hypothesize that patients who receive the prophylactic amiodarone will have decreased rates of postoperative atrial fibrillation without significantly increased side effects compared to patients who receive the standard postoperative care after non-coronary artery bypass cardiac surgery.
Interventions
DRUGAmiodarone
Patients randomized to the Amiodarone Arm will receive a 5-day course of amiodarone after surgery.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>= 18 years of age * All genders * All non-coronary artery bypass cardiac surgery patients * Preoperative normal sinus rhythm
Exclusion criteria
* Pre-existing atrial fibrillation or atrial arrhythmias * Pre-existing heart block * Cardiogenic shock * Sick sinus syndrome * Marked sinus bradycardia * Preoperative amiodarone use * Contraindication to amiodarone use * PR interval \> 240 ms * QTc \> 550 ms * 2nd or 3rd degree heart block * Liver impairment (INR \> 1.7, AST/ALT \> 2x normal) * Uncontrolled hyperthyroidism or hypothyroidism * Interstitial lung disease * Pregnancy and/or breastfeeding * Known hypersensitivity to any components of amiodarone, including iodine * Emergent operation * Planned MAZE or Pulmonary Vein Isolation procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative atrial fibrillation | At least 1 minute duration, occurring before or on postoperative day 7 | The occurrence of postoperative atrial fibrillation detected by continuous telemetry, 12-lead electrocardiogram, and/or continuous ambulatory monitoring device through postoperative day 7. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative mortality | Either in-hospital or within 30 days of procedure | Operative mortality as defined by either in-hospital death or death within 30 days of discharge. |
| Stroke | Either in-hospital or within 30 days of procedure | characterized by deficits lasting \> 24 hours and/or imaging findings of infarction |
| Transient ischemic attack | Either in-hospital or within 30 days of procedure | characterized by examination findings lasting \< 24 hours without associated imaging findings |
| Electrical cardioversion | Either in-hospital or within 30 days of procedure | Whether the patient required electrical cardioversion for hemodynamically unstable atrial fibrillation |
| Hemodynamic instability | Either in-hospital or within 30 days of procedure | New hemodynamic instability (mean arterial pressure \< 65 mmHg) after surgery |
| Initiation of systemic anticoagulation | Either in-hospital or within 30 days of procedure | New indication of systemic anticoagulation for stroke prophylaxis due to atrial fibrillation |
| Myocardial infarction | Either in-hospital or within 30 days of procedure | Myocardial infarction diagnosed based on ECG and laboratory testing including pursued intervention and/or findings from subsequent angiography will be compared between intervention groups. To be considered a myocardial infarction, the diagnosis will have to be confirmed and documented in the chart by a board-certified cardiologist. |
| Persistence of atrial fibrillation at discharge | Up to 90 days | Atrial fibrillation as diagnosed by final ECG |
| Postoperative hospital length of stay | Up to 90 days | The postoperative length of stay will be calculated starting from the end of the procedure to time of discharge. |
| Readmission | Within 30 days of procedure | 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. |
| Symptomatic bradycardia | Either in-hospital or within 30 days of procedure | Symptomatic bradycardia (HR \< 55 bpm) requiring intervention |
| Number of patients with Amiodarone-related pulmonary toxicity | Either in-hospital or within 30 days of procedure | 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. |
Contacts
CONTACTAsishana A Osho, MD, MPH
PRINCIPAL_INVESTIGATORAsishana A Osho, MD, MPH
Massachusetts General Hospital
Outcome results
None listed