About this trial
In patients with valvular heart disease and atrial fibrillation (AF) undergoing surgical valve surgery, current guidelines recommend concomitant surgical management of the left atrial appendage (LAA) to prevent postoperative thromboembolic events, particularly neurologic embolic events. However, whether concomitant LAA management benefits patients without AF by reducing postoperative neurologic complications remains controversial.
Given these uncertainties, this study aims to evaluate whether concomitant LAA suture closure during surgical valve surgery is associated with a lower incidence of perioperative silent cerebral infarction.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (≥18 years) without atrial fibrillation who are scheduled to undergo open (direct-vision) surgical heart valve surgery and who are informed about the study and provide written informed consent to participate.
Disqualifiers
History of prior cardiac surgery
history of cerebral infarction (ischemic stroke)
emergency surgery
infective endocarditis
Trial population
This is a multicenter observational study conducted at four participating hospitals in China. Adult patients (≥18 years) without atrial fibrillation who are scheduled to undergo elective open surgical heart valve surgery and provide informed consent will be enrolled. Participants will be grouped according to whether concomitant left atrial appendage (LAA) suture closure is performed during the index operation. The primary outcome is perioperative silent brain infarction (SBI) assessed by brain MRI at approximately postoperative day 5. Secondary outcomes include stroke, myocardial infarction, all-cause death, cardiovascular death, and MACCE within 30 days after surgery, as well as SBI and MACCE (including rehospitalization for heart failure) within 1 year after surgery.
Trial design
Cohort
Prospective
Treatments tested in this trial
Left Atrial Appendage (LAA) Suture Closure
Procedure/SurgeryConcomitant suture closure of the LAA performed at the time of surgical valve surgery, at the discretion of the operating surgeon.
Surgical Valve Surgery
Procedure/SurgeryStandard surgical valve repair or replacement performed according to routine clinical practice.
Treatment groups
Trial outcomes
Primary outcomes
Silent brain infarction (SBI)
Occurrence of SBI assessed by postoperative brain magnetic resonance imaging (MRI) performed at approximately postoperative day 5.
Secondary outcomes
Perioperative stroke
Incidence of clinically overt stroke within 30 days after surgery.
Perioperative all-cause mortality
Death from any cause within 30 days after surgery.
Perioperative MACCE
Incidence of major adverse cardiovascular and cerebrovascular events (MACCE), defined as a composite of stroke, myocardial infarction, all-cause death, or cardiovascular death occurring within 30 days after surgery.
Silent brain infarction (SBI) at 1 year
1 year after surgery
Sponsors and contacts
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