Optimal Strategy for Repair of Type A Acute Aortic Dissection
- Conditions
- Aortic Dissection
- Interventions
- Procedure: Conservative TAAAD-RProcedure: Extensive TAAAD-R
- Registration Number
- NCT05912608
- Lead Sponsor
- Centre Cardiologique du Nord
- 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.
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 900
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conservative Type A Acute Aortic Dissection Repair (TAAAD-R) Conservative 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. Conservative Type A Acute Aortic Dissection Repair (TAAAD-R) Extensive 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. Extensive Type A Acute Aortic Dissection Repair (TAAAD-R) Extensive 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) Extensive Type A Acute Aortic Dissection Repair (TAAAD-R) Conservative 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)
- Primary Outcome Measures
Name Time Method 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.
Operative Mortality (OM) 30-day Patients who died within 30 days
- Secondary Outcome Measures
Name Time Method Late survival 10 years The secondary endpoint of the study is the evaluation of late survival
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 reintervention 10 years The number of participants who will require reoperation for the aortic valve, proximal aorta, or distal aorta.
Rate of perioperative Myocardial Infarction (MI) 30-day Number of participants with MI based on fourth universal definition.
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)
Trial Locations
- Locations (1)
Francesco Nappi
🇫🇷Saint-Denis, France