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

Sponsor

Centre Cardiologique du Nord (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05912634

Collaborator

Henri Mondor University Hospital (Other), Hokkaido University (Other), Universita degli Studi di Genova (Other), Campus Bio-Medico University (Other)

800

Enrollment

Location

Anticipated Duration (Months)

33.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Dissection Aortic Arch Aortic Dissection Rupture Aortic Dilatation	Procedure: Conservative TAAD-R Procedure: Extensive TAAD- R

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

800 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 30, 2022

Actual Primary Completion Date :

Jan 30, 2023

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Conservative Type A Aortic Dissection Repair (TAAD-R) 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 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: Ascending Aortic Root Sparing Replacement with or without Hemiarch Repair
Extensive Type A Acute Aortic Dissection Repair (TAAD-R) The extensive procedure will include patients receiving ascending aorta replacement associated to TARP	Procedure: Extensive TAAD- 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 arch) Other Names: Aortic root procedures.TARP procedures. Frozen Elephant Trunk (FET) procedure

Arm

Intervention/Treatment

Conservative Type A Aortic Dissection Repair (TAAD-R)

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

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:

Ascending Aortic Root Sparing Replacement with or without Hemiarch Repair

Extensive Type A Acute Aortic Dissection Repair (TAAD-R)

The extensive procedure will include patients receiving ascending aorta replacement associated to TARP

Procedure: Extensive TAAD- 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 arch)

Other Names:

Aortic root procedures.TARP procedures. Frozen Elephant Trunk (FET) procedure

Outcome Measures

Primary Outcome Measures

Operative Mortality (OM) [30-day]
Patients who died within 30 days
Rate of acute heart failure [30-day]
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.
Stroke [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 global brain ischemia [30-days]
Rate of diffuse hypoxic damage as diagnosed at brain imaging and electroencephalography.
Rate of mesenteric ischemia [30-days]
Rate of abdominal pain with or without nausea and vomiting and rectal bleeding or bloody diarrhea
Rate of acute kidney injury [30-days]
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.

Secondary Outcome Measures

Rate of paraplegia/paraparesis [30-day]
Rate of bilateral weakness and/or multimodality sensory disturb- ance below the level of the ischemic spinal lesion.
Rate of perioperative bleeding [30-day]
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
Rate of reoperation for bleeding [30-day]
Number of participants who will receive postoperative chest reopening for excessive bleeding.
Rate of mechanical circulatory support [30-day]
Number of participants who will receive the use of intra-aortic balloon pump and/or venoarterial extracorporeal membrane oxygenation for postoperative acute heart failure.
Late outcomes [18 years]
Data on patient's survival status will be collected

Other Outcome Measures

Rate of urgent procedure [30-days]
Number of participants who will require scheduled procedure within 24 hours of admission.
Rate of emergency grade 1 [30-days]
Number of participants will require procedure within 24 hours of hospital admission and who are symptomatic or minimally symptomatic with stable hemodynamic conditions and no signs of malperfusion.
Rate of emergency grade 2 [30-days]
Number of participants who will require procedure within the first 6 hours of hospital admission due to hemodynamic instability despite use of concentration inotropes and/or malperfusion.
Rate of salvage grade 1 [30-days]
Number of participants who will require immediate surgical procedure. Rate of cardio pulmonary resuscitation with external chest compressions and/or open cardiac massage between induction of anesthesia and initiation of cardiopulmonary bypass.
Rate of salvage grade 2 [30-days]
Number of participants who will require immediate surgical procedure. Rate of cardiopulmonary resuscitation with external chest compressions en route to the operating theatre or prior to induction of anesthesia.