Surgical Management of the Aortic Root and Long-term Outcomes For Acute Type A Aortic Dissection

NCT ID: NCT05346497

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-01-01
• Study Completion Date: 2021-11-01

Brief Summary

The investigators focus on the patients who underwent aortic root surgery for acute type A aortic dissection between 2005.01-2021.11. The patients are divided into 3 groups according to the different aortic root surgical methods(Bentall，David and root reconstruction). Clinical data including age, gender, comorbidities, surgical informations and perioperative informations will be collected. All patients will receive follow-ups in hospital or by telephone.

All the informations will be analyzed by SPSS to show the difference of both perioperative and long-term results among different surgical strategies.

Detailed Description

Acute type A aortic dissection (ATAAD) is a rare but life threatening situation requiring immediate intervention. Regarding emergency operation for ATAAD, an important principle is to reconstruct the afflicted aorta to prevent fatal rupture.

For aortic root dissection, the Bentall procedure has been the standard operation and has been proven simple and effective. However, the requirement for lifelong anticoagulation therapy is associated with increased risk of thromboembolic and bleeding complications. Valve sparing aortic root reimplantation (David reimplantation), which has been proven effective in root aneurysm with satisfactory safety and long-term outcomes, is an appealing alternative to preserve native aortic valve, especially for younger patients with intact valve function. Aortic root reconstruction without valve surgery is also a well-used strategy for aortic root dissection, but the long-term outcome is still controversial.

The investigators focus on the patients who underwent aortic root surgery for acute type A aortic dissection between 2005.01-2021.11. The patients are divided into 3 groups according to the different aortic root surgical methods(Bentall，David and root reconstruction). Clinical data including age, gender, comorbidities, surgical informations and perioperative informations will be collected. All patients will receive follow-ups in hospital or by telephone.

All the informations will be analyzed by SPSS to show the difference of both perioperative and long-term results among different surgical strategies.

Conditions

Type A Aortic Dissection

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Bentall

Patients who underwent Bentall procedure for ATAAD

Bentall

Intervention Type: PROCEDURE

Bentall procedure: include replacement of both aortic valve and root

David

Patients who underwent David procedure for ATAAD

David

Intervention Type: PROCEDURE

David procedure: include replacement of aortic root and aortic valvuloplasty

ARR

Patients who underwent aortic root reconstruction procedure except Bentall and David procedure for ATAAD

ARR

Intervention Type: PROCEDURE

Aortic root reconstruction: reconstruction instead of replacement of aortic root, without surgery of the valve. include sandwich procedure, adventitia invertion procedure, etc.

Interventions

Bentall

Bentall procedure: include replacement of both aortic valve and root

Intervention Type: PROCEDURE

David

David procedure: include replacement of aortic root and aortic valvuloplasty

Intervention Type: PROCEDURE

ARR

Aortic root reconstruction: reconstruction instead of replacement of aortic root, without surgery of the valve. include sandwich procedure, adventitia invertion procedure, etc.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients who were followed up at our hospital for aortic lesions or who underwent aortic root surgery (including the Bentall procedure, the David procedure, and other aortic root angioplasty or replacement procedures)
• Patients older than 18 years of age, no specific gender requirement
• Patients who are compliant and able to complete follow-up
• Patients who understand the purpose of the study, voluntarily participate, and have signed the Biospecimen and Health-Related Information Donation Form by themselves or their legal representative.
• Patients who understand the purpose of the study, voluntarily participate and have signed the informed consent form for donation of biological samples and health-related information by themselves or their legal representative

Exclusion Criteria

• Patients who are unable or unwilling to participate in the study and sign the informed consent form
• Patients with poor compliance and unable to complete follow-up
• Patients with severe organ insufficiency

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

B2021-776R

Identifier Type: -

Identifier Source: org_study_id