European Registry of Type A Aortic Dissection

Study Overview
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Brief Summary
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Acute Stanford type A aortic dissection (TAAD) is a life-threatening condition. Surgery is usually performed as a salvage procedure and is associated with significant postoperative early mortality and morbidity. Understanding the patient's conditions and treatment strategies which are associated with these adverse events is essential for an appropriate management of acute TAAD.

Detailed Description
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Twenty centers from eight European centers of cardiac surgery have collaborated to create a multicentre observational registry (ERTAAD), which will enroll consecutive patients who underwent surgery for acute TAAD from January 2005 to March 2021. The investigators will compare patient's comorbidities, condition at referral, surgical strategies and perioperative treatments in patients with and without early and late adverse events. The primary clinical outcome will be in-hospital mortality, late mortality and reoperations on the aorta. Secondary outcomes will be stroke, acute kidney injury, surgical site infection, reoperation for bleeding, transfusion of blood products and length of stay in the intensive care unit.

Official Title
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European Registry of Type A Aortic Dissection

Conditions
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Type A Aortic Dissection

Intervention / Treatment
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* Procedure: Surgery on the ascending aorta with or without repair of the aortic root and/or aortic arch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type A aortic dissection or intramural hematoma involving the aortic root/ascending aorta; Patients aged > 18 years: Symptoms started within 7 days from surgery; Primary surgical repair of acute type A aortic dissection; Any other major cardiac surgical procedure concomitant with surgery for type A aortic dissection. Exclusion Criteria: Patients aged < 18 years; Onset of symptoms > 7 days from surgery; Prior procedure for type A aortic dissection; Retrograde type A aortic dissection (with primary tear located in the descending aorta); Concomitant endocarditis; Type A aortic dissection secondary to blunt or penetrating chest trauma.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute type A aortic dissection<br>Patients who underwent surgery for acute type A aortic dissection | Procedure: Surgery on the ascending aorta with or without repair of the aortic root and/or aortic arch<br>* Surgical repair of the ascending aorta with or without surgical repair of the aortic root and/or aortic arch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate | All-cause mortality | During the index hospital stay until last follow-up control | 
| Cumulative incidence of reoperation on the aorta | Any surgical and endovascular procedure on any segment of the aorta for aortic dissection or its related complication | During the index hospital stay until last follow-up control | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of stroke | change in the level of consciousness, hemiplegia, hemiparesis, numbness, or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia, amaurosis fugax, or other neurological signs or symptoms consistent with stroke duration of a focal or global neurological deficit ≥ 24 h; OR <24 h if available neuroimaging documents a new brain hemorrhage or infarct; OR the neurological deficit results in death. | From date of procedure until the date of hospital discharge, assessed up to 3 months | 
| Incidence of acute kidney injury | It will be defined according to postoperative change in serum creatinine levels and its severity will be stratified according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria | From date of procedure until the date of hospital discharge, assessed up to 3 months | 
| Incidence of surgical site infection | Proven infection involving deep sternal wound tissues and/or mediastinum. | From date of procedure until the date of hospital discharge, assessed up to 3 months | 
| Incidence of reoperation for bleeding | Chest reopening for excessive bleeding. | From date of procedure until the date of hospital discharge, assessed up to 3 months | 
| Incidence and amount of blood transfusion | Transfusions of red blood cells | From date of procedure until the date of hospital discharge, assessed up to 3 months | 
| Length of stay in the intensive care unit | Duration of stay in the intensive care unit | From date of procedure until the date of hospital discharge, assessed up to 3 months | 
| Incidence of global brain ischemia | Diffuse hypoxic damage as diagnosed at brain imaging and electroencephalography. | From date of procedure until the date of hospital discharge, assessed up to 3 months | 
| Incidence of paraplegia/paraparesis | Bilateral weakness and/or multimodality sensory disturbance below the level of the ischemic spinal lesion. | From date of procedure until the date of hospital discharge, assessed up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic dissection