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

Type A Aortic Dissection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05346497
• Other study ID #: B2021-776R
• Status: Completed
• Start date: January 1, 2005
• Est. completion date: November 1, 2021

Study information

• Verified date: April 2022
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Type A Aortic Dissection

Intervention

Procedure:
• Bentall
Bentall procedure: include replacement of both aortic valve and root
• David
David procedure: include replacement of aortic root and aortic valvuloplasty
• ARR
Aortic root reconstruction: reconstruction instead of replacement of aortic root, without surgery of the valve. include sandwich procedure, adventitia invertion procedure, etc.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death for any reason	Death for any reason	From date of surgery until the date of death for any reason, up to 20 years
Secondary	Redo aortic surgery	Patients underwent aortic surgery again for any reason	From date of surgery until the date of redo aortic surgery for any reason, up to 20 years