TARAD: Optimal Strategy for Repair of Type A Acute Aortic Dissection
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Conservative Type A Acute Aortic Dissection Repair (TAAAD-R) 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. |
Procedure: Conservative TAAAD-R
Cardiac arrest will be ensured using antegrade potassium-rich cardioplegia solution delivered directly into the coronary ostium or after coronary sinus cannula insertion, in patients with aortic regurgitation aorta will be resected down to the sinotubular junction and the thrombus located in the false lumen of the aortic root will be removed so that the aortic lesion could be visualized. The commissures will be resuspended using 4-0 or 5-0 sutures reinforced with a Teflon pledget over each 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 revealing normal-sized aortic roots associated with poor-quality valve leaflets, concomitant aortic valve replacement with conventional xenograft or mechanical prosthesis will be preferred.
Other Names:
Procedure: Extensive TAAAD-R
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 undergoing replacement of the aortic root using a biologic or mechanical composite valve graft or valve-sparing root reimplantation procedure.Total arch replacement procedures (TARP) will fulfilled 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 hemiarch) or reimplantation of the innominate trunk only (partial hemiarch).
Other Names:
|
| Extensive Type A Acute Aortic Dissection Repair (TAAAD-R) 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) |
Procedure: Conservative TAAAD-R
Cardiac arrest will be ensured using antegrade potassium-rich cardioplegia solution delivered directly into the coronary ostium or after coronary sinus cannula insertion, in patients with aortic regurgitation aorta will be resected down to the sinotubular junction and the thrombus located in the false lumen of the aortic root will be removed so that the aortic lesion could be visualized. The commissures will be resuspended using 4-0 or 5-0 sutures reinforced with a Teflon pledget over each 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 revealing normal-sized aortic roots associated with poor-quality valve leaflets, concomitant aortic valve replacement with conventional xenograft or mechanical prosthesis will be preferred.
Other Names:
Procedure: Extensive TAAAD-R
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 undergoing replacement of the aortic root using a biologic or mechanical composite valve graft or valve-sparing root reimplantation procedure.Total arch replacement procedures (TARP) will fulfilled 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 hemiarch) or reimplantation of the innominate trunk only (partial hemiarch).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Operative Mortality (OM) [30-day]
Patients who died within 30 days
- Rate of Transient Neurologic Deficit (TND) [30-day]
Number of participants who will complicate postoperatively with episode of TND which will include complication rate such as confusion, delirium, agitation
- Rate of permanent Neurologic Deficit (PND) [30-day]
Number of participants with acute episode of a focal or global neurological deficit. Rates of alteration of degree of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopsia, amaurosis fugax. To consider rate of other neurologic signs or symptoms consistent with stroke duration of focal or global neurologic deficit greater than 24 hours.
Secondary Outcome Measures
- Rate of perioperative Myocardial Infarction (MI) [30-day]
Number of participants with MI based on fourth universal definition.
- Rate of spinal Cord Injury (SCI) [30-day]
Number of participants with SCI intended as rate of paraplegia and/or paraparesis
- Rate of composite of Major Adverse Events (MAE) [30-day]
Number of participants with MAE which will include the composite rate of myocardial infarction, cerebrovascular accident, need for dialysis, or need for tracheostomy according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
- Rate of composite of Major Adverse Pulmonary Events (MAPE) [30-day]
Number of participants with MAPE which will include the composite rate of intubation >48 hours, pneumonia, reintubation, tracheostomy according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
- Rate of reintervention [10 years]
The number of participants who will require reoperation for the aortic valve, proximal aorta, or distal aorta.
- Late survival [10 years]
The secondary endpoint of the study is the evaluation of late survival
Eligibility Criteria
Criteria
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
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Any other major cardiac surgical procedure concomitant with surgery for TAAD.
Exclusion Criteria:
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Patients aged < 18 years
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Onset of symptoms > 7 days from surgery
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Prior procedure for TAAD
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Concomitant endocarditis;
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TAAD secondary to blunt or penetrating chest trauma.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Centre Cardiologique du Nord
- Henri Mondor University Hospital
- Universita degli Studi di Genova
- Campus Bio-Medico University
- Hokkaido University
Investigators
- Principal Investigator: Francesco Nappi, Cardiac Surgery Centre Cardiologique du Nord de Saint-Denis, Paris, France
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CN-202201173-1
- CN-23-26