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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 100
- Primary Endpoint
- Mortality
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
double blinded.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
group A.
surgical closure of the left atrial appendage.
Intervention: the left atrial appendage closure through surgery. (Procedure)
group B.
There was no surgical closure of the left atrial appendage.
Outcomes
Primary Outcomes
Mortality
Time Frame: 2 years post operative.
post-operative mortality rate.
Stroke.
Time Frame: 2 years post operative.
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.
Secondary Outcomes
- Hospital stay.(1 month)
- Postoperative arrhythmias.(1 year)
Investigators
Beshoy Allam Moris
Principal Investigator
Assiut University