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 )

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

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.

Study Overview

• Status: Completed
• Conditions: Type A Aortic Dissection
• Intervention / Treatment: Other: No Intervention.

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 Type: Observational
• Enrollment (Actual): 183

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study enrolled patients who were diagnosed with ATAAD by computed tomography angiography (CTA) from January 2020 to December 2021 in the First Affiliated Hospital of Xi'an Jiaotong University. Inclusion criteria included mild to moderate aortic root involvement, combined with aortic arch involvement undergoing Sun's procedure. The exclusion criteria included 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 and incomplete clinical data.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CARS group; 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.; No Intervention.
XJ-procedure group; 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.; No Intervention.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Principal Investigator: Yang Yan, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): March 2, 2023
• Study Completion (Actual): March 2, 2023

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Type A Aortic Dissection
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Dissection
• Other Study ID Numbers: XJTU1AF2023LSK-150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No