Repair Versus Non-repair of the Aortic Arch in Type A Aortic Dissection (TAAD)

Study Overview
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Brief Summary
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Acute Stanford type A aortic dissection (TAAD) is a life-threatening clinical status requiring surgery that is usually performed as a salvage procedure.We planned a multicenter study to evaluate the balance between the patient's condition and those therapeutic strategies that may limit the risk of late adverse events in patients who will be underwent surgery for appropriate management of TAAD

Detailed Description
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Substantial evidence has suggested a decrease of early mortality during the last years, however recently the Nordic Consortium for Acute Type A Aortic Dissection registry recorded 18% of 30-day mortality after surgery for ATAAD. Similarly, the prospective German Registry for Acute Aortic Dissection Type A confirmed this data reporting a 30-day mortality of 16.9%. Again, results from recent analysis of the Society of Thoracic Surgeon database that report 7353 procedures from 2014 and 2017 for acute TAAD revealed a 30-day mortality of 17%. Understanding the balance between the patient's conditions which may not allow extensive procedure and those treatment strategies which may limit the risk of late adverse events in patients who remain alive long after the surgery is essential for an appropriate management of ATAAD. The best treatment option in patients with ATAAD is dictated by the balance between patient conditions that may not allow for extensive procedures and those more conservative treatment strategies that limit the risk of late adverse events in patients who remain alive long after surgery. surgery. However, previous evidence from large series of patients do not provide information on the long-term durability of these procedures. Here investigators planned a multicenter study to evaluate the contemporary early outcomes and duration of different surgical strategies for 15-year acute ATAAD in a large study population.

Official Title
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Early Complication and Outcomes in Surgical vs no Surgical Involvement of Aortic Arch in Type A Aortic Dissection

Conditions
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Aortic Dissection, Aortic Arch, Aortic Dissection Rupture, Aortic Dilatation

Intervention / Treatment
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* Procedure: Conservative TAAD-R
* Procedure: Extensive TAAD- R


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Conservative Type A Aortic Dissection Repair (TAAD-R)<br>The Conservative procedure will include patients receiving ascending aortic root sparing replacement with or without the implantation of the aortic hemiarch | Procedure: Conservative TAAD-R<br>* 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.<br>* Other names: Ascending Aortic Root Sparing Replacement with or without Hemiarch Repair;|
| Extensive Type A Acute Aortic Dissection Repair (TAAD-R)<br>The extensive procedure will include patients receiving ascending aorta replacement associated to TARP | Procedure: Extensive TAAD- R<br>* 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 arch)<br>* Other names: Aortic root procedures.TARP procedures. Frozen Elephant Trunk (FET) procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Mortality (OM) | Patients who died within 30 days | 30-day | 
| Rate of acute heart failure | Number of participants with postoperative heart failure who will require prolonged use of concentration of inotropes for a period greater than 24 h and/or the insertion of any mechanical circulatory support device. | 30-day | 
| Stroke | 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. | 30-day | 
| Rate of global brain ischemia | Rate of diffuse hypoxic damage as diagnosed at brain imaging and electroencephalography. | 30-days | 
| Rate of mesenteric ischemia | Rate of abdominal pain with or without nausea and vomiting and rectal bleeding or bloody diarrhea | 30-days | 
| Rate of acute kidney injury | Number of participants with postoperative change in serum creatinine concentration. Severity will be stratified on the basis of number of participants with the KDIGO (Kney Disease Improving Global Outcomes) criteria. | 30-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of paraplegia/paraparesis | Rate of bilateral weakness and/or multimodality sensory disturb- ance below the level of the ischemic spinal lesion. | 30-day | 
| Rate of perioperative bleeding | Number of participants will receive postoprative transfused red blood cell units. The E-CABG ( coronary artery by pass grafting) classification of bleeding rate has been proposed as a simple classification of perioperative bleeding | 30-day | 
| Rate of reoperation for bleeding | Number of participants who will receive postoperative chest reopening for excessive bleeding. | 30-day | 
| Rate of mechanical circulatory support | Number of participants who will receive the use of intra-aortic balloon pump and/or venoarterial extracorporeal membrane oxygenation for postoperative acute heart failure. | 30-day | 
| Late outcomes | Data on patient's survival status will be collected | 18 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type A Aortic Dissection (TAAAD), Root-Sparing Replacement, Ascending Aorta Replacement, Partial Arch Repair, Total Arch Replacement (TARP), Frozen Elephant Trunk (FET), Hemiarch Procedures