Outcomes of Aortic Dissection Repair
NCT05927090 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 1200
Last updated 2026-05-19
Summary
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.
Conditions
- Type A Aortic Dissection
- Ascending Aortic Dissection
- Aortic Diseases
- Aortic Arch
- Aortic Valve Insufficiency
- Aortic Root Dissection
- Aortic Root Dilatation
- Type B Aortic Dissection
Interventions
- PROCEDURE
-
Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch Repair
Cardiac arrest will be performed by administering a potassium-rich antegrade cardioplegia solution delivered directly into the coronary ostium or in the case of aortic regurgitation after insertion of the coronary sinus cannula.The aorta will be resected up to the sinotubular junction and the thrombus located in the false lumen of the aortic root will be removed so that the aortic lesion can be visualized. The commissures will be resuspended using 4-0 or 5-0 sutures reinforced with a Teflon pledget above every commissure. A 4-0 or 5-0 polypropylene suture will be chosen to seal the proximal anastomosis and this suture line will also be used to secure the intima to the adventitia. In patients demonstrating normal-sized aortic roots associated with poor-quality valve leaflets, concomitant aortic valve replacement with conventional xenograft or mechanical prosthesis will be preferable.
- PROCEDURE
-
Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR)
Patients who experienced dilatation of the sinuses of Valsalva \> 4.5 cm in diameter on computed tomography imaging, those with connective tissue disease, or those in whom intimal tears extended into the sinuses, will receive replacement of the aortic root using a biologic or mechanical composite valve graft or valve-sparing root reimplantation procedure associated to AAR
- PROCEDURE
-
Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP)
Total arch replacement procedures (TARP) will performed with the use of deep hypothermic circulatory arrest and with either antegrade or retrograde cerebral perfusion, maintaining systemic cooling between 19°C to 25°C and depending on the surgeon's practice.TARPs will be carried out using 1- and 4-branch grafts and involved the resection of all the aortic tissue up to the left common carotid artery (total arch)
- PROCEDURE
-
Extensive Root and Ascending Aorta Replacement with Total Arch Replacement
This extensive procedure will include complete replacement of the anterior thoracic aorta extending to part or all of the aortic arch. It will be performed with the previously reported techniques
- PROCEDURE
-
Thoracic Endovascular Aortic Repair
TEVAR patients have a higher incidence of complications and reintervention than open repair patients. TEVAR complications may include endoleak, retrograde type A aortic dissection, stent-graft migration, fracture or collapse, and increased size.
- PROCEDURE
-
Open Thoracic Aortic Descendig Repair
Surveillance imaging can detect complications of open repair, such as graft infection and anastomotic pseudoaneurysm. After open repair or TEVAR, patients may develop progressive aneurysmal dilatation of adjacent or remote aortic segments.
Sponsors & Collaborators
-
Henri Mondor University Hospital
collaborator OTHER -
Universita degli Studi di Genova
collaborator OTHER -
Pitié-Salpêtrière Hospital
collaborator OTHER -
Ospedale San Camillo, Rome, Italy
collaborator UNKNOWN -
Campus Bio-Medico University
collaborator OTHER -
Centre Cardiologique du Nord
lead OTHER
Principal Investigators
-
Francesco Nappi, MD · Cardiac Surgery Centre Cardiologique du Nord de Saint-Denis, Paris, France
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-01-01
- Primary Completion
- 2021-12-30
- Completion
- 2026-12-31
Countries
- France
Study Locations
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