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 )

NCT05751200 | Completed

• 1 other identifier: XJTU1AF2023LSK-150
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

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.

Conditions

Type A Aortic Dissection

Keywords

Type A Aortic Dissection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The postoperative bleeding necessitating re-operation

  About 2 weeks after the surgery.

• Change in the incidence of anastomotic pseudoaneurysm

  About 2 weeks after surgery, 3-month and 6-month follow-up.

• Change in the incidence of residual aortic root dissection

  About 2 weeks after surgery, 3-month and 6-month follow-up.

• Change in the incidence of severe aortic regurgitation

  About 2 weeks after surgery, 3-month and 6-month follow-up.

Study Arms (2)

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.

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.

Interventions

No Intervention. OTHER

No Intervention.

CARS group; XJ-procedure group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Related Publications (1)

• Li J, Zhao C, Li B, Yan P, Zhang Y, Li Y, Wang Q, He X, Zheng X, Yan Y. Aortic Root Reinforcement Combined with Vascular Grafts Eversion and Built-in Procedure (XJ-Procedure) for Acute Type A Aortic Dissection Surgery. Adv Ther. 2023 Dec;40(12):5354-5365. doi: 10.1007/s12325-023-02655-2. Epub 2023 Oct 4.

  PMID: 37789228 DERIVED

Study Officials

• Yang Yan

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: March 2, 2023
• Study Start: March 1, 2023
• Primary Completion: March 2, 2023
• Study Completion: March 2, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)