Outcomes of Aortic Dissection Repair (STAAD)

Centre Cardiologique du Nord

Status: Invitation-only

Conditions: Aortic Root Dilatation; Type A Aortic Dissection; Type B Aortic Dissection; Ascending Aortic Dissection; Aortic Valve Insufficiency; Aortic Arch; Aortic Diseases; Aortic Root Dissection

Treatments: Procedure: Open Thoracic Aortic Descendig Repair; Procedure: Thoracic Endovascular Aortic Repair; Procedure: Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP); Procedure: Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch Repair; Procedure: Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR); Procedure: Extensive Root and Ascending Aorta Replacement with Total Arch Replacement

Study type: Observational

Funder types: Other

Identifiers

NCT05927090

CN-202201173-3

Details and patient eligibility

About

Type A aortic dissection (TAAD) is a potentially life-threatening pathology associated with significant risk of mortality and morbidity. In acute forms of type A aortic dissection (TAAD) mortality is 50% by 24 h and 50% of patients die before reaching a specialist center. Rapid diagnosis and subsequent prompt surgical repair remain the primary goal for these patients.

In the last decade it has been observed that improvements in diagnostic techniques, initial management and increased clinical awareness have contributed to a substantial increase in the number of patients benefiting from a prompt diagnosis and undergoing surgery.However, survival after surgical repair has not yet reached optimal follow-ups and is burdened by high in-hospital mortality(16-18%)The main approach to acute type B non-complicated aortic dissection (TBAD) has always been to use medicines to control the patient's heart rate and blood pressure. However, recent findings suggest that a large number of patients treated for acute complicated (TBAAD) and non-complicated TBAD experience aortic complications, such as aneurysmal degeneration, at a later stage.

Full description

For patients requiring surgical repair for a TAAD, there is still some disagreement regarding which factors should be considered during the preoperative evaluation, the best decision-making process to undertake that best assesses procedural risk, and how operative mortality can be predicted. Furthermore, the impact of different surgical strategies on outcomes remains unclear.This prospective study was designed to evaluate the impact of the center volume-outcome relationship and that on mortality which remain poorly understood. A better understanding of the determinants of outcome in patients undergoing surgery could support decision making, aid in the design of service delivery, and improve outcomes for surviving patients who are referred to specialized centers for treatment of aortic disease.Furthermore, the study aims to evaluate whether precise risk stratification can provide better patient counseling and be used for unit-surgeon benchmarking. Ultimately in the present study, we aimed to investigate outcome predictors in patients undergoing surgery for TAAD, including clinical and perioperative variables as well as to evaluate follow up beyond 15 years.TBAD occurring beyond the left subclavian artery (LSA) is classified in chronological order based on the timing of clinical presentation: acute (14 days or less), subacute (more than 14 days and less than or equal to 3 months), and chronic (more than 3 months).TBADs are also divided into complicated or non-complicated based on their initial clinical manifestation. Acute complicated TBAD is characterised by tearing of the aorta, pain, rapid expansion, hypertension, or blockages in the vasculature.Malperfusion syndrome is the most common complication, occurring in nearly 30% of cases. More than 30% of patients with mesenteric compromise following aortic dissection die .

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

1,200 participants in 6 patient groups

Ascending Aorta Replacement (AAR) with or without Hemiarch Repair

Description:

Patients who will require a conservative prosthetic replacement of the ascending aorta with or without hemiarch.Patients who required a concomitant aortic valve replacement with conventional xenograft or mechanical prosthesis

Treatment:

Procedure: Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch Repair

Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR)

Description:

Patient who will require the extensive procedure including ascending aorta replacement associated to root replacement with or without sparing of the aortic valve

Treatment:

Procedure: Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR)

Ascending Aorta Replacement with Total Arch Replacement (TARP)

Description:

Patient who will require the extensive procedure including ascending aorta replacement associated to TARP

Treatment:

Procedure: Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP)

Root and Ascending Aorta Replacement with Total Arch Replacement

Description:

Patient who will require the extensive procedure including root and ascending aorta replacement associated to TARP

Treatment:

Procedure: Extensive Root and Ascending Aorta Replacement with Total Arch Replacement

Thoracic Endovascular Aortic Repair

Description:

Patient who will require the procedure including thoracic endovascular aorta repair

Treatment:

Procedure: Thoracic Endovascular Aortic Repair

Open Thoracic Aortic Repair

Description:

Patient who will require the procedure including open thoracic aorta repair

Treatment:

Procedure: Open Thoracic Aortic Descendig Repair