Left Atrial Appendage Closure
Conditions
Brief summary
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.
Interventions
PROCEDURESurgical Valve Surgery
Standard surgical valve repair or replacement performed according to routine clinical practice.
PROCEDURELeft Atrial Appendage (LAA) Suture Closure
Concomitant suture closure of the LAA performed at the time of surgical valve surgery, at the discretion of the operating surgeon.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* History of prior cardiac surgery * history of cerebral infarction (ischemic stroke) * emergency surgery * infective endocarditis * pregnancy * refusal or inability to provide informed consent/declines participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Silent brain infarction (SBI) | Approximately postoperative day 5 | Occurrence of SBI assessed by postoperative brain magnetic resonance imaging (MRI) performed at approximately postoperative day 5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative stroke | Within 30 days after surgery | Incidence of clinically overt stroke within 30 days after surgery. |
| Perioperative all-cause mortality | Within 30 days after surgery | Death from any cause within 30 days after surgery. |
| Perioperative MACCE | Within 30 days after surgery | 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 | Occurrence of SBI assessed by brain MRI at 1 year after surgery. | 1 year after surgery |
| MACCE at 1 year | Within 1 year after surgery | Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) within 1 year after surgery, defined as a composite of stroke, myocardial infarction, all-cause death, cardiovascular death, or rehospitalization for heart failure. |
Countries
China
Contacts
CONTACTLIANXIN Chen
Outcome results
None listed