Optimal Strategy for Repair of Type A Acute Aortic Dissection (TARAD)

Centre Cardiologique du Nord

Status: Invitation-only

Conditions: Aortic Dissection

Treatments: Procedure: Extensive TAAAD-R; Procedure: Conservative TAAAD-R

Study type: Interventional

Funder types: Other

Identifiers

NCT05912608

CN-202201173-1

Details and patient eligibility

About

Acute type A aortic dissection (TAAD) persists as a clinicopathologic entity with high lethality in the current era. Several procedures are presently used to repair the TAAAD. The objective of this study is to analyze two groups of individuals using a conservative approach through root-sparing and hemiarch techniques in patients who are hospitalized in higher-risk clinical conditions or more aggressive procedures such as root replacement and total arch replacement in low-risk patients.

Full description

The target population enrolled in the registry includes patients with TAAAD.The high volume of patients that will be enrolled in this registry will receive proximal and distal aortic repair in elective, urgent or emergency clinical condition. Efforts of investigators will be concentrated in TAAAD repair using a conservative approach of root preservation and hemiarch reconstruction in the majority of patients who will be referred in critical clinical condition. High-risk patients with older age or more comorbidities had more conservative repairs to limit surgical insult to these complicated patients. Total arch reconstruction and root replacement will be optional procedures for specific subgroups of patients who may benefit from a more complex index finger operation without incurring additional immediate risk.

Investigators hope to demonstrate a reduction in operative mortality and an improvement in early and late outcomes. The experience of investigators will be summarized in an algorithm for TAAAD repair with an analysis of early morbidity and mortality, as well as late survival and no reoperation.

Enrollment: 900 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• TAAD or intramural hematoma involving the ascending aorta
• Patients aged > 18 years
• Symptoms started within 7 days from surgery
• Primary surgical repair of acute TAAD
• Any other major cardiac surgical procedure concomitant with surgery for TAAD.

Exclusion criteria

• Patients aged < 18 years
• Onset of symptoms > 7 days from surgery
• Prior procedure for TAAD
• Concomitant endocarditis;
• TAAD secondary to blunt or penetrating chest trauma.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 2 patient groups

Conservative Type A Acute Aortic Dissection Repair (TAAAD-R)

Active Comparator group

Description:

All conservative TAAAD-R will be performed through a median sternotomy. The conservative TAAAD-R will include patients receiving valve-sparing root procedures and recipients of ascending aortic root sparing replacement if the intima separation extended into the sinuses resulting in commissural collapse.When necessary, the hemiarch technique will be used with a limited extension of the conservative procedure by resection of all the aortic tissue up to the left common carotid artery and which will be dictated according to the presentation of the lesion.

Treatment:

Procedure: Conservative TAAAD-R

Procedure: Extensive TAAAD-R

Extensive Type A Acute Aortic Dissection Repair (TAAAD-R)

Other group

Description:

All extensive TAAAD-R will be performed through a median sternotomy.The extensive TAAAD-R will include patients receiving replacement of the aortic root and total arch replacement procedures (TARP)

Treatment:

Procedure: Conservative TAAAD-R

Procedure: Extensive TAAAD-R