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

• Conditions: Aortic Dissection Rupture; Aortic Dilatation; Aortic Dissection; Aortic Arch
• Interventions: Procedure: Conservative TAAD-R; Procedure: Extensive TAAD- R

• Registration Number: NCT05912634
• Lead Sponsor: Centre Cardiologique du Nord

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

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 Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-06-20
• Study First Posted: 2023-06-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-03
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 900

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conservative Type A Aortic Dissection Repair (TAAD-R)	Conservative TAAD-R	The Conservative procedure will include patients receiving ascending aortic root sparing replacement with or without the implantation of the aortic hemiarch
Extensive Type A Acute Aortic Dissection Repair (TAAD-R)	Extensive TAAD- R	The extensive procedure will include patients receiving ascending aorta replacement associated to TARP

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
Rate of paraplegia/paraparesis	30-day	Rate of bilateral weakness and/or multimodality sensory disturb- ance below the level of the ischemic spinal lesion.
Late outcomes	18 years	Data on patient's survival status will be collected
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.

Trial Locations

Locations (1)

Francesco Nappi; 🇫🇷 Saint-Denis, France