STAAD: Outcomes of Type A Aortic Dissection Repair

Sponsor

Centre Cardiologique du Nord (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05927090

Collaborator

Henri Mondor University Hospital (Other), Universita degli Studi di Genova (Other)

1,000

Enrollment

Location

227.9

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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%)

Condition or Disease	Intervention/Treatment	Phase
Type A Aortic Dissection Ascending Aortic Dissection Aortic Diseases Aortic Arch Aortic Valve Insufficiency Aortic Root Dissection Aortic Root Dilatation	Procedure: Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch Repair Procedure: Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR) Procedure: Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP) Procedure: Extensive Root and Ascending Aorta Replacement with Total Arch Replacement

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Surgical Strategy for Repair of Type A Aortic Dissection: A Multicenter Registry

Actual Study Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Dec 30, 2021

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Ascending Aorta Replacement (AAR) 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	Procedure: 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. Other Names: Ascending Aorta Replacement with Aortic Valve Replacement (AVR)
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	Procedure: 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 Other Names: ARR with or without aortic valve sparing
Ascending Aorta Replacement with Total Arch Replacement (TARP) Patient who will require the extensive procedure including ascending aorta replacement associated to TARP	Procedure: 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) Other Names: AAR with TARP or Frozen Elephant Trunk (FET)
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	Procedure: 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 Other Names: Full anterior thoracic aorta replacement with partial hemiarch repair or TARP or FET

Outcome Measures

Primary Outcome Measures

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.

Secondary Outcome Measures

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 spinal Cord Injury (SCI) [30-day]
Number of participants with SCI intended as rate of paraplegia and/or paraparesis
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 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

Other Outcome Measures

Rate of urgent procedure [30-day]
Number of participants who will require scheduled procedure within 24 hours of admission.
Rate of emergency grade 1 [30-day]
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-day]
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-day]
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-day]
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.