Safety and Efficacy of Aortic Root Reinforcement Combined With Vascular Grafts Eversion and built-in Procedure (XJ-procedure) in Patients With Acute Type A Aortic Dissection (ADVANCED-XJ )

Study Overview
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Brief Summary
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This is a retrospective study based on the data available in our hospital database for ATAAD patients from January 2020 to December 2021. These patients were divided into two groups according to the surgical procedures of aortic root. This study compared baseline data, perioperative and short-term follow-up results between the two groups to evaluate the efficacy and safety of XJ-procedure in ATAAD.

Detailed Description
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Acute type A aortic dissection (ATAAD) is a life-threatening disease with high mortality. Surgery remains the gold standard for the treatment of ATAAD. In recent years, ATAAD is still a persistent challenge for cardiovascular surgeons. This is a retrospective study based on the data available in our hospital database for ATAAD patients undergoing total aortic arch replacement with elephant trunk stent under cryogenic stop circulation from January 2020 to December 2021. These patients were divided into two groups according to the surgical procedures of aortic root: continuous aortic root suture group (CARS group); aortic root reinforcement combined with vascular grafts eversion and built-in, which was created by our group and to be named as XJ-procedure (XJ-procedure group, XJ is an acronym for Xi'an Jiaotong University). The main outcome was defined as 30-day mortality. Secondary outcomes included the postoperative bleeding necessitating re-operation and the incidence of anastomotic pseudoaneurysm, residual aortic root dissection and severe aortic regurgitation before discharge and at 3 and 6 months after the operation. This study compared baseline data, perioperative and short-term follow-up results between the two groups to evaluate the efficacy and safety of XJ-procedure in ATAAD.

Official Title
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Safety and Efficacy of Aortic Root Reinforcement Combined With Vascular Grafts Eversion and built-in Procedure (XJ-procedure) in Patients With Acute Type A Aortic Dissection (ADVANCED-XJ ): an Investigator-initiated, Single-center, Cohort Study

Conditions
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Type A Aortic Dissection

Intervention / Treatment
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* Other: No Intervention.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with ATAAD by computed tomography angiography (CTA) from January 2020 to December 2021 in the First Affiliated Hospital of Xi'an Jiaotong University Mild to moderate aortic root involvement Aortic arch involvement undergoing Sun's procedure Exclusion Criteria: Patients with severe aortic root involvement (root diameter >45 mm, root tear, severe disruption of aortic root, concomitant valve disease) The Bentall, Wheat or David procedure performed Recurrent ATAAD Preoperative severe brain complications (cerebral infarction, cerebral hemorrhage, coma, etc.) Mal-perfusion of abdominal organs or lower extremities >12 h Incomplete clinical data.
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CARS group<br>In the CARS group, 3-0 polypropylene was used to suture the proximal end of aortic with the vascular grafts continuously, followed by one interrupted suture loop of 3-0 polypropylene for reinforcement. | Other: No Intervention.<br>* No Intervention.<br>|
| XJ-procedure group<br>In the XJ-procedure group, a 1.5-2cm wide bovine pericardial patch and graft ring were placed inside and outside the aortic root and against the aortic wall, respectively, and continuously sutured near the commissure using 5-0 polypropylene. Then an eversion about 15mm of vascular graft was intermittently sutured to full layers of aortic vascular with 2-0 pad polyester sutures. Finally, the eversion and aortic wall were continuously sutured together in one more turn. | Other: No Intervention.<br>* No Intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality | Patients died within 30 days after the surgery. Data were obtained from the medical records. | Within 30 days after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The postoperative bleeding necessitating re-operation | Postoperative bleeding necessitated reoperation during hospitalization. Data were obtained from the surgical records and medical records. | About 2 weeks after the surgery. | 
| Change in the incidence of anastomotic pseudoaneurysm | The occurrence of anastomotic pseudoaneurysm was examined by postoperative computed tomography angiography examination. | About 2 weeks after surgery, 3-month and 6-month follow-up. | 
| Change in the incidence of residual aortic root dissection | The occurrence of residual aortic dissection was examined by postoperative computed tomography angiography examination. | About 2 weeks after surgery, 3-month and 6-month follow-up. | 
| Change in the incidence of severe aortic regurgitation | The occurrence of aortic valve regurgitation greater than grade2+, which was decided by cardiac ultrasonography. | About 2 weeks after surgery, 3-month and 6-month follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type A Aortic Dissection