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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valve surgery with concomitant LAA suture closure | Concomitant suture closure of the LAA performed during surgical valve surgery. |
| |
| Valve surgery alone (no LAA procedure) | Standard surgical valve surgery without concomitant LAA suture closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left Atrial Appendage (LAA) Suture Closure | Procedure | Concomitant suture closure of the LAA performed at the time of surgical valve surgery, at the discretion of the operating surgeon. |
| Measure | Description | Time Frame |
|---|---|---|
| Silent brain infarction (SBI) | Occurrence of SBI assessed by postoperative brain magnetic resonance imaging (MRI) performed at approximately postoperative day 5. | Approximately postoperative day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative stroke | Incidence of clinically overt stroke within 30 days after surgery. | Within 30 days after surgery |
| Perioperative all-cause mortality | Death from any cause within 30 days after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LIANXIN Chen | Contact | 01088322265 | chenlianx1@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D013537 | Sutures |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Surgical Valve Surgery | Procedure | Standard surgical valve repair or replacement performed according to routine clinical practice. |
|
| 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. | Within 30 days after surgery |
| Silent brain infarction (SBI) at 1 year | 1 year after surgery | Occurrence of SBI assessed by brain MRI at 1 year after surgery. |
| MACCE at 1 year | 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. | Within 1 year after surgery |
| Peking University First Hospita | Beijing | Beijing Municipality | China |
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| Qingdao Cardiovascular Hospital | Qingdao | China |
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| Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen | Shenzhen | China |
|