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 )

Completed

• Conditions: Type A Aortic Dissection
• Interventions: Other: No Intervention.

• Registration Number: NCT05751200
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-02-14
• Study Start: 2023-03-01
• Study First Submitted QC: 2023-03-01
• Primary Completion: 2023-03-02
• Study Completion: 2023-03-02
• Study First Posted: 2023-03-02
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CARS group	No Intervention.	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.
XJ-procedure group	No Intervention.	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.

Primary Outcome Measures

Name	Time	Method
30-day mortality	Within 30 days after the surgery	Patients died within 30 days after the surgery. Data were obtained from the medical records.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China