Outcomes of Type A Aortic Dissection Repair

Aortic Valve Insufficiency Clinical Trial

— STAAD  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05927090
• Other study ID #: CN-202201173-3
• Status: Enrolling by invitation
• Start date: January 1, 2005
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: Centre Cardiologique du Nord
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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%)

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Arch
• Aortic Diseases
• Aortic Dissection
• Aortic Root Dilatation
• Aortic Root Dissection
• Aortic Valve Insufficiency
• Ascending Aortic Dissection
• Type A Aortic Dissection

Intervention

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.
• 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

Locations

Country	Name	City	State
France	Francesco Nappi	Saint-Denis

Sponsors (4)

Lead Sponsor	Collaborator
Centre Cardiologique du Nord	Henri Mondor University Hospital, Pitié-Salpêtrière Hospital, Universita degli Studi di Genova

Country where clinical trial is conducted

France, 

References & Publications (9)

Benedetto U, Dimagli A, Kaura A, Sinha S, Mariscalco G, Krasopoulos G, Moorjani N, Field M, Uday T, Kendal S, Cooper G, Uppal R, Bilal H, Mascaro J, Goodwin A, Angelini G, Tsang G, Akowuah E. Determinants of outcomes following surgery for type A acute aor — View Citation

Biancari F, Juvonen T, Fiore A, Perrotti A, Herve A, Touma J, Pettinari M, Peterss S, Buech J, Dell'Aquila AM, Wisniewski K, Rukosujew A, Demal T, Conradi L, Pol M, Kacer P, Onorati F, Rossetti C, Vendramin I, Piani D, Rinaldi M, Ferrante L, Quintana E, P — View Citation

Braverman AC. Acute aortic dissection: clinician update. Circulation. 2010 Jul 13;122(2):184-8. doi: 10.1161/CIRCULATIONAHA.110.958975. No abstract available. — View Citation

Czerny M, Schoenhoff F, Etz C, Englberger L, Khaladj N, Zierer A, Weigang E, Hoffmann I, Blettner M, Carrel TP. The Impact of Pre-Operative Malperfusion on Outcome in Acute Type A Aortic Dissection: Results From the GERAADA Registry. J Am Coll Cardiol. 20 — View Citation

Geirsson A, Shioda K, Olsson C, Ahlsson A, Gunn J, Hansson EC, Hjortdal V, Jeppsson A, Mennander A, Wickbom A, Zindovic I, Gudbjartsson T. Differential outcomes of open and clamp-on distal anastomosis techniques in acute type A aortic dissection. J Thorac — View Citation

Harris KM, Nienaber CA, Peterson MD, Woznicki EM, Braverman AC, Trimarchi S, Myrmel T, Pyeritz R, Hutchison S, Strauss C, Ehrlich MP, Gleason TG, Korach A, Montgomery DG, Isselbacher EM, Eagle KA. Early Mortality in Type A Acute Aortic Dissection: Insight — View Citation

Howard DP, Banerjee A, Fairhead JF, Perkins J, Silver LE, Rothwell PM; Oxford Vascular Study. Population-based study of incidence and outcome of acute aortic dissection and premorbid risk factor control: 10-year results from the Oxford Vascular Study. Cir — View Citation

Mahase E. Half of patients with acute aortic dissection in England die before reaching a specialist centre. BMJ. 2020 Jan 23;368:m304. doi: 10.1136/bmj.m304. No abstract available. — View Citation

O'Hara D, McLarty A, Sun E, Itagaki S, Tannous H, Chu D, Egorova N, Chikwe J. Type-A Aortic Dissection and Cerebral Perfusion: The Society of Thoracic Surgeons Database Analysis. Ann Thorac Surg. 2020 Nov;110(5):1461-1467. doi: 10.1016/j.athoracsur.2020.0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of urgent procedure	Number of participants who will require scheduled procedure within 24 hours of admission.	30-day
Other	Rate of emergency grade 1	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.	30-day
Other	Rate of emergency grade 2	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.	30-day
Other	Rate of salvage grade 1	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.	30-day
Other	Rate of salvage grade 2	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.	30-day
Primary	Operative Mortality (OM)	Patients who died within 30 days	30-day
Primary	Rate of mesenteric ischemia	Rate of abdominal pain with or without nausea and vomiting and rectal bleeding or bloody diarrhea	30-day
Primary	Rate of permanent Neurologic Deficit (PND)	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.	30-day
Primary	Rate of composite of Major Adverse Events (MAE)	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)	30-day
Primary	Rate of perioperative Myocardial Infarction (MI)	Number of participants with MI based on fourth universal definition.	30-day
Primary	Rate of acute heart failure (AHF)	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.	30-day and in-hospital mortality
Secondary	Rate of Transient Neurologic Deficit (TND)	Number of participants who will complicate postoperatively with episode of TND which will include complication rate such as confusion, delirium, agitation	30-day
Secondary	Rate of spinal Cord Injury (SCI)	Number of participants with SCI intended as rate of paraplegia and/or paraparesis	30-day
Secondary	Rate of acute kidney injury	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.	30-day
Secondary	Rate of perioperative bleeding	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	30-day
Secondary	Reoperation for bleeding	Number of participants who will receive postoperative chest reopening for excessive bleeding.	30-day
Secondary	Rate of mechanical circulatory support	Number of participants who will receive the use of intra-aortic balloon pump and/or venoarterial extracorporeal membrane oxygenation for postoperative acute heart failure.	30-day
Secondary	Rate of composite of Major Adverse Pulmonary Events (MAPE)	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)	30-day
Secondary	Rate of reintervention	The number of participants who will require reoperation for the aortic valve, proximal aorta, or distal aorta.	18-years
Secondary	Rate of late survival	Data on patient's survival status will be collected	18-years