The Left Atrial Appendage Closure by Surgery and the Incidence of Stroke in Patients Undergoing Open-heart Surgery.

Study Overview
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Brief Summary
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This study aims to assess the efficacy and safety of prophylactic surgical closure of the left atrial appendage for stroke and cardiovascular death prevention in patients undergoing open heart surgery, regardless of their preoperative AF status and stroke risk.

Detailed Description
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Cerebrovascular complications following cardiac surgical procedures are a significant source of morbidity and mortality. The etiology of postoperative stroke is multifactorial and may include carotid artery stenosis, hypotension, cardiac arrhythmia, aortic atherosclerosis, and transient hypercoagulable state. Most strokes complicating cardiac surgery occur in patients without significant carotid disease and are acquired after the patient awakens neurologically intact. The high incidence of postoperative AF in these patients suggests a possible embolic cause for some strokes. As such, some postoperative strokes may be preventable. Previous studies report incident AF in 10 to 65% of patients after open heart surgery, with the highest incidences after a combination of coronary artery bypass grafting (CABG) and valve surgery. In patients with non-operative AF, the risk of ischemic stroke is markedly reduced by adequate OAC. However, the management of postoperative AF is still a challenge and is, by some, regarded as a transient phenomenon not requiring intervention. The risk of bleeding poses a significant limitation to the use of OAC, which consequently increases focus on left atrial appendage (LAA) closure, as the LAA is a predilection site for thrombus formation during AF. Based on previous studies, ≥90% of AF-related left atrial thrombi are located in the left atrial appendage (LAA), and therefore, LAA occlusion is a tempting method for AF-related stroke prevention. Current recommendations regarding surgical left atrial appendage (LAA) closure to prevent thromboembolisms lack high-level evidence.

Official Title
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The Left Atrial Appendage Closure by Surgery and the Incidence of Stroke in Patients Undergoing Open-heart Surgery Irrespective of Preoperative Atrial Fibrillation Status and Stroke Risk.

Conditions
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Left Atrial Appendage Thrombosis

Intervention / Treatment
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* Procedure: the left atrial appendage closure through surgery.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years scheduled for first-time planned open-heart surgery. Exclusion Criteria: Pediatric population >18 years. Emergent open heart surgery. Patients with current endocarditis. Where follow-up is not possible. The patient refused to sign the informed consent to participate in the research.

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Randomized control trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A.<br>surgical closure of the left atrial appendage. | Procedure: the left atrial appendage closure through surgery.<br>* Surgical closure of the left atrial appendage during the set of an elective open heart surgery with the inclusion criteria fulfilled.<br>* Other names: LAACS;|
| No Intervention: group B.<br>There was no surgical closure of the left atrial appendage. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke. | the incidence of stroke in patients undergoing open-heart surgery, including transient ischemic attack, as assigned by two independent neurologists blinded to the treatment allocation. | 2 years post operative. | 
| Mortality | post-operative mortality rate. | 2 years post operative. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative arrhythmias. | Incidence of postoperative arrhythmias with special regard to post-operative AF. | 1 year | 
| Hospital stay. | Number of inpatient hospital stay days. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surgical closure of the left atrial appendage., stroke, Post operative atrial fibrillation.