Repair Versus Non-repair of the Aortic Arch in Type A Aortic Dissection (AoArch)

Centre Cardiologique du Nord

Status: Invitation-only

Conditions: Aortic Dissection Rupture; Aortic Dissection; Aortic Arch; Aortic Dilatation

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

Study type: Observational

Funder types: Other

Identifiers

NCT05912634

CN-202201173-2

CN-23-27 (Other Identifier)

Details and patient eligibility

About

Acute Stanford type A aortic dissection (TAAD) is a life-threatening clinical status requiring surgery that is usually performed as a salvage procedure.We planned a multicenter study to evaluate the balance between the patient's condition and those therapeutic strategies that may limit the risk of late adverse events in patients who will be underwent surgery for appropriate management of TAAD

Full description

Substantial evidence has suggested a decrease of early mortality during the last years, however recently the Nordic Consortium for Acute Type A Aortic Dissection registry recorded 18% of 30-day mortality after surgery for ATAAD. Similarly, the prospective German Registry for Acute Aortic Dissection Type A confirmed this data reporting a 30-day mortality of 16.9%. Again, results from recent analysis of the Society of Thoracic Surgeon database that report 7353 procedures from 2014 and 2017 for acute TAAD revealed a 30-day mortality of 17%. Understanding the balance between the patient's conditions which may not allow extensive procedure and those treatment strategies which may limit the risk of late adverse events in patients who remain alive long after the surgery is essential for an appropriate management of ATAAD. The best treatment option in patients with ATAAD is dictated by the balance between patient conditions that may not allow for extensive procedures and those more conservative treatment strategies that limit the risk of late adverse events in patients who remain alive long after surgery. surgery. However, previous evidence from large series of patients do not provide information on the long-term durability of these procedures.

Here investigators planned a multicenter study to evaluate the contemporary early outcomes and duration of different surgical strategies for 15-year acute ATAAD in a large study population.

Enrollment: 900 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients aged > 18 years
• TAAD or intramural hematoma involving the ascending aorta
• 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

900 participants in 2 patient groups

Conservative Type A Aortic Dissection Repair (TAAD-R)

Description:

The Conservative procedure will include patients receiving ascending aortic root sparing replacement with or without the implantation of the aortic hemiarch

Treatment:

Procedure: Conservative TAAD-R

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

Description:

The extensive procedure will include patients receiving ascending aorta replacement associated to TARP

Treatment:

Procedure: Extensive TAAD- R