Effects of Left Atrial Appendage Resection and Marshall Ligament Amputation on Clinical Outcome in Patients Undergoing Off-pump Coronary Artery Bypass

Study Overview
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Brief Summary
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Surgical occlusion of the left atrial appendage (LAAO) is sometimes performed during the cardiac surgery to reduce long-term risk of stroke.A previous study found that LAAO may be associated with increased risk of postoperative atrial fibrillation.New-onset atrial fibrillation (NOAF) after coronary artery bypass graft is related to an increased short-term and long term risk of stroke and mortality.Marshall ligament amputation may reduce the occurence of atrial fibrillation. However, little is known whether this approach is justified during the coronary artery bypass graft.Therefore, this study aimed to investigate whether LAAO and Marshall ligament amputation during off-pump coronary artery bypass was associated with reduced risks of postoperative new-onset atrial fibrillation and stroke.

Official Title
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Fuwai Hospital, Chinese Academy of Medical Science

Conditions
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Stroke, Coronary Artery Disease, Atrial Fibrillation

Intervention / Treatment
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* Procedure: Left Atrial Appendage Resection and Marshall Ligament Amputation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: isolated first off-pump coronary artery bypass Exclusion Criteria: Preoperative atrial fibrillation or a history of atrial fibrillation; Concurrent cardiac or non-cardiac surgery Intraoperative convert to bypass bypass surgery Emergency surgery History of previous cardiac surgery Severe organ dysfunction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Left Atrial Appendage Resection<br> | Procedure: Left Atrial Appendage Resection and Marshall Ligament Amputation<br>* Left Atrial Appendage Resection and Marshall Ligament Amputation during the cardiac surgery<br>|
| No Intervention: off-pump coronary artery bypass<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative new-onset atrial fibrillation | Postoperative atrial fibrillation (POAF), defined as new-onset atrial fibrillation (AF) in the immediate period after surgery, is the most important type of secondary AF. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stroke | Stroke is caused by a disruption in the flow of blood to part of the brain either because of occlusion of a blood vessel in the case of acute ischemic stroke （AIS） or the rupture of a blood vessel causing bleeding in or around the brain： intracerebral hemorrhage （ICH）or subarachnoid hemorrhage （SAH）。 | 1 months,3 months, 1years, 3years, 5years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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off-pump coronary artery bypass, postoperative new-onset atrial fibrillation, left atrial appendage, Marshall ligament