Outcomes of Aortic Dissection Repair
- Conditions
- Type A Aortic DissectionAscending Aortic DissectionAortic DiseasesAortic ArchAortic Valve InsufficiencyAortic Root DissectionAortic Root DilatationType B Aortic Dissection
- Interventions
- Procedure: Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR)Procedure: Extensive Root and Ascending Aorta Replacement with Total Arch ReplacementProcedure: Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP)Procedure: Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch Repair
- Registration Number
- NCT05927090
- Lead Sponsor
- Centre Cardiologique du Nord
- Brief 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.
- Detailed Description
For patients requiring surgical repair for a TAAD, there is still some disagreement regarding which factors should be considered during the preoperative evaluation, the best decision-making process to undertake that best assesses procedural risk, and how operative mortality can be predicted. Furthermore, the impact of different surgical strategies on outcomes remains unclear.This prospective study was designed to evaluate the impact of the center volume-outcome relationship and that on mortality which remain poorly understood. A better understanding of the determinants of outcome in patients undergoing surgery could support decision making, aid in the design of service delivery, and improve outcomes for surviving patients who are referred to specialized centers for treatment of aortic disease.Furthermore, the study aims to evaluate whether precise risk stratification can provide better patient counseling and be used for unit-surgeon benchmarking. Ultimately in the present study, we aimed to investigate outcome predictors in patients undergoing surgery for TAAD, including clinical and perioperative variables as well as to evaluate follow up beyond 15 years.TBAD occurring beyond the left subclavian artery (LSA) is classified in chronological order based on the timing of clinical presentation: acute (14 days or less), subacute (more than 14 days and less than or equal to 3 months), and chronic (more than 3 months).TBADs are also divided into complicated or non-complicated based on their initial clinical manifestation. Acute complicated TBAD is characterised by tearing of the aorta, pain, rapid expansion, hypertension, or blockages in the vasculature.Malperfusion syndrome is the most common complication, occurring in nearly 30% of cases. More than 30% of patients with mesenteric compromise following aortic dissection die .
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1200
- 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.
- 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 Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR) Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR) Patient who will require the extensive procedure including ascending aorta replacement associated to root replacement with or without sparing of the aortic valve Root and Ascending Aorta Replacement with Total Arch Replacement Extensive Root and Ascending Aorta Replacement with Total Arch Replacement Patient who will require the extensive procedure including root and ascending aorta replacement associated to TARP Ascending Aorta Replacement with Total Arch Replacement (TARP) Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP) Patient who will require the extensive procedure including ascending aorta replacement associated to TARP Ascending Aorta Replacement (AAR) with or without Hemiarch Repair Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch Repair Patients who will require a conservative prosthetic replacement of the ascending aorta with or without hemiarch.Patients who required a concomitant aortic valve replacement with conventional xenograft or mechanical prosthesis
- Primary Outcome Measures
Name Time Method Rate of mesenteric ischemia 30-day Rate of abdominal pain with or without nausea and vomiting and rectal bleeding or bloody diarrhea
Operative Mortality (OM) 30-day Patients who died within 30 days
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.
- Secondary Outcome Measures
Name Time Method Rate of acute kidney injury 30-day 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.
Rate of spinal Cord Injury (SCI) 30-day Number of participants with SCI intended as rate of paraplegia and/or paraparesis
Rate of Transient Neurologic Deficit (TND) 30-day Number of participants who will complicate postoperatively with episode of TND which will include complication rate such as confusion, delirium, agitation
Rate of perioperative bleeding 30-day Number of participants who will receive postoperative 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
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.
Rate of composite of Major Adverse Pulmonary Events (MAPE) 30-day Number of participants with MAPE which will include the composite rate of intubation \>48 hours, pneumonia, reintubation, tracheostomy according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
Rate of reintervention 18-years The number of participants who will require reoperation for the aortic valve, proximal aorta, or distal aorta.
Rate of late survival 18-years Data on patient's survival status will be collected
Trial Locations
- Locations (1)
Francesco Nappi
🇫🇷Saint-Denis, France