Optimal Strategy for Repair of Type A Acute Aortic Dissection

Aortic Dissection Clinical Trial

— TARAD  

Official title:

Searching Optimal Tailored Strategy for Repair of Acute Type A Acute Aortic Dissection

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05912608
• Other study ID #: CN-202201173-1
• Secondary ID: CN-23-26
• Status: Enrolling by invitation
• Start date: October 30, 2023
• Est. completion date: December 31, 2024

Study information

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

Clinical Trial Summary

Acute type A aortic dissection (TAAD) persists as a clinicopathologic entity with high lethality in the current era. Several procedures are presently used to repair the TAAAD. The objective of this study is to analyze two groups of individuals using a conservative approach through root-sparing and hemiarch techniques in patients who are hospitalized in higher-risk clinical conditions or more aggressive procedures such as root replacement and total arch replacement in low-risk patients.

Description:

The target population enrolled in the registry includes patients with TAAAD.The high volume of patients that will be enrolled in this registry will receive proximal and distal aortic repair in elective, urgent or emergency clinical condition. Efforts of investigators will be concentrated in TAAAD repair using a conservative approach of root preservation and hemiarch reconstruction in the majority of patients who will be referred in critical clinical condition. High-risk patients with older age or more comorbidities had more conservative repairs to limit surgical insult to these complicated patients. Total arch reconstruction and root replacement will be optional procedures for specific subgroups of patients who may benefit from a more complex index finger operation without incurring additional immediate risk.

Investigators hope to demonstrate a reduction in operative mortality and an improvement in early and late outcomes. The experience of investigators will be summarized in an algorithm for TAAAD repair with an analysis of early morbidity and mortality, as well as late survival and no reoperation.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 800
• Est. completion date: December 31, 2024
• Est. primary completion date: March 30, 2024
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• TAAD or intramural hematoma involving the ascending aorta

• Patients aged > 18 years

• 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 Dissection

Intervention

Procedure:
• Conservative TAAAD-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.
• Extensive TAAAD-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 hemiarch) or reimplantation of the innominate trunk only (partial hemiarch).

Locations

Country	Name	City	State
France	Francesco Nappi	Saint-Denis

Sponsors (6)

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

Country where clinical trial is conducted

France, 

References & Publications (6)

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

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

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
Primary	Operative Mortality (OM)	Patients who died within 30 days	30-day
Primary	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
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
Secondary	Rate of perioperative Myocardial Infarction (MI)	Number of participants with MI based on fourth universal definition.	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 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
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.	10 years
Secondary	Late survival	The secondary endpoint of the study is the evaluation of late survival	10 years