Clinical trial NCT05751200: 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 )
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type A Aortic Dissection
Keywords: Type A Aortic Dissection
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 183
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 30-day mortality
timeFrame: Within 30 days after the surgery
Secondary outcomes:
measure: The postoperative bleeding necessitating re-operation
timeFrame: About 2 weeks after the surgery.
measure: Change in the incidence of anastomotic pseudoaneurysm
timeFrame: About 2 weeks after surgery, 3-month and 6-month follow-up.
measure: Change in the incidence of residual aortic root dissection
timeFrame: About 2 weeks after surgery, 3-month and 6-month follow-up.
measure: Change in the incidence of severe aortic regurgitation
timeFrame: About 2 weeks after surgery, 3-month and 6-month follow-up.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yang Yan
role: PRINCIPAL_INVESTIGATOR
References: