Atrial Fibrillation New Onset, Coronary Artery Disease, Pericardial Effusion
Conditions
Brief summary
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
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.
Interventions
PROCEDUREleft posterior pericardiostomy
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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| occurence rate of postoperative atrial fibrillation | From date of operation until postoperative day 7 | any short run of atrial fibrillation which occurred during postoperative period before discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| operative mortality | at 30 days | death occurred during the index admission or within 30 days after operation |
Countries
South Korea
Outcome results
None listed