Effect of Left Posterior Pericardiotomy for the Prevention of POAF

Study Overview
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Brief Summary
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This study is planned to evaluate the effect of left posterior pericardiotomy for the prevention of postoperative atrial fibrillation after coronary artery bypass grafting. Eligible patients will be randomized to be created or not to be created the left posterior pericardiotomy at the end of the operation, and the incidence of postoperative atrial fibrillation will be compared.

Detailed Description
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Postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery, particularly after coronary artery bypass grafting (CABG), and is associated with prolonged in-hospital stay and increased adverse outcomes, including death and stroke. There is evidence that pericardial effusion can trigger the occurence of POAF. Therefore, this study is aimed to evaluate the effect of left posterior pericardiotomy for the prevention of POAF after CABG. Patients who are planned to undergo off-pump CABG will be randomized to be created or not to be created the left posterior pericardiotomy at the end of the operation, and the incidence of postoperative atrial fibrillation will be compared as the primary outcome. Secondary outcomes will include early clinical outcomes and hospital stay.

Official Title
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Effect of Left Posterior Pericardiotomy for the Prevention of Postoperative Atrial Fibrillation in Coronary Artery Bypass Grafting: A Prospective Randomized Controlled Trial

Conditions
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Pericardial Effusion, Coronary Artery Disease, Atrial Fibrillation New Onset

Intervention / Treatment
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* Procedure: left posterior pericardiostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who are planned to undergo coronary artery bypass grafting patients aged ≥19 years Exclusion Criteria: patients who are planned to undergo other concomitant cardiac procedures (e.g. valve procedures, aorta procedures) patients who undergo coronary artery bypass grafting using cardiopulmonary bypass patients who are documented with paroxysmal, persistent, or permanent atrial fibrillation before operation patients who have a history of cardiac surgery patients who have a history of pericardial disease patients who have severe adhesion at left pleural cavity which precludes effective left posterior pericardiostomy patients who refuse to participate in this study

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pericardiostomy<br>The patients who were created with left posterior pericardiotomy during the operation | Procedure: left posterior pericardiostomy<br>* In patients assigned to the study group, a 4-5 cm vertical incision posterior to the phrenic nerve and extending from the left inferior pulmonary vein to the diaphragm is performed.<br>|
| No Intervention: No pericardiostomy<br>The patients who were not created with left posterior pericardiotomy during the operation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurence rate of postoperative atrial fibrillation | any short run of atrial fibrillation which occurred during postoperative period before discharge | From date of operation until postoperative day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative mortality | death occurred during the index admission or within 30 days after operation | at 30 days |