Outcomes of Aortic Dissection Repair

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

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)

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

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Operative Mortality (OM) — 30-day
  Patients who died within 30 days
• Rate of mesenteric ischemia — 30-day
  Rate of abdominal pain with or without nausea and vomiting and rectal bleeding or bloody diarrhea
• 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.
• 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 perioperative Myocardial Infarction (MI) — 30-day
  Number of participants with MI based on fourth universal definition.
• Rate of acute heart failure (AHF) — 30-day and in-hospital mortality
  Number of participants with postoperative AHF 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.

Trial sites (1)

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