Optimal Strategy for Repair of Type A Acute Aortic Dissection

NCT05912608 | Enrolling By Invitation

• 1 other identifier: CN-202201173-1
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Dissection

Keywords

Type A Acute Aortic Dissection (TAAAD); Root-Sparing Replacement; Hemiarch Procedures; Ascending Aorta Replacement; Total Arch Replacement (TARP); Frozen Elephant Trunk (FET)

Outcome Measures

Primary Outcomes (3)

• Operative Mortality (OM)

  Patients who died within 30 days

  30-day

• 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

• 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 Outcomes (6)

• Rate of perioperative Myocardial Infarction (MI)

  30-day

• Rate of spinal Cord Injury (SCI)

  30-day

• Rate of composite of Major Adverse Events (MAE)

  30-day

• Rate of composite of Major Adverse Pulmonary Events (MAPE)

  30-day

• Rate of reintervention

  10 years

Study Arms (2)

Conservative Type A Acute Aortic Dissection Repair (TAAAD-R)

ACTIVE COMPARATOR

All conservative TAAAD-R will be performed through a median sternotomy. The conservative TAAAD-R will include patients receiving valve-sparing root procedures and recipients of ascending aortic root sparing replacement if the intima separation extended into the sinuses resulting in commissural collapse.When necessary, the hemiarch technique will be used with a limited extension of the conservative procedure by resection of all the aortic tissue up to the left common carotid artery and which will be dictated according to the presentation of the lesion.

Procedure: Conservative TAAAD-R; Procedure: Extensive TAAAD-R

Extensive Type A Acute Aortic Dissection Repair (TAAAD-R)

OTHER

All extensive TAAAD-R will be performed through a median sternotomy.The extensive TAAAD-R will include patients receiving replacement of the aortic root and total arch replacement procedures (TARP)

Procedure: Conservative TAAAD-R; Procedure: Extensive TAAAD-R

Interventions

Conservative TAAAD-R PROCEDURE

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.

Also known as: Ascending aortic root sparing replacement with or without hemiarch repair

Conservative Type A Acute Aortic Dissection Repair (TAAAD-R); Extensive Type A Acute Aortic Dissection Repair (TAAAD-R)

Extensive TAAAD-R PROCEDURE

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).

Also known as: Aortic root procedures.TARP procedures

Conservative Type A Acute Aortic Dissection Repair (TAAAD-R); Extensive Type A Acute Aortic Dissection Repair (TAAAD-R)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Cardiologique du Nord: lead
• Henri Mondor University Hospital: collaborator
• Universita degli Studi di Genova: collaborator
• Pitié-Salpêtrière Hospital: collaborator
• Ospedale San Camillo, Rome, Italy: collaborator

Study Sites (1)

Francesco Nappi

Saint-Denis, 93200, France

Location

Related Publications (6)

• 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, Pruna-Guillen R, Rodriguez Lega J, Pinto AG, Acharya M, El-Dean Z, Field M, Harky A, Nappi F, Gerelli S, Di Perna D, Gatti G, Mazzaro E, Rosato S, Raivio P, Jormalainen M, Mariscalco G. Current Outcome after Surgery for Type A Aortic Dissection. Ann Surg. 2023 Oct 1;278(4):e885-e892. doi: 10.1097/SLA.0000000000005840. Epub 2023 Mar 13.

  PMID: 36912033 RESULT

• 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 aortic dissection: the UK National Adult Cardiac Surgical Audit. Eur Heart J. 2021 Dec 28;43(1):44-52. doi: 10.1093/eurheartj/ehab586.

  PMID: 34468733 RESULT

• 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 Cardiovasc Surg. 2019 May;157(5):1750-1758. doi: 10.1016/j.jtcvs.2018.09.020. Epub 2018 Sep 29.

  PMID: 30401530 RESULT

• 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: Insights From the International Registry of Acute Aortic Dissection. JAMA Cardiol. 2022 Oct 1;7(10):1009-1015. doi: 10.1001/jamacardio.2022.2718.

  PMID: 36001309 RESULT

• 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. 2015 Jun 23;65(24):2628-2635. doi: 10.1016/j.jacc.2015.04.030.

  PMID: 26088302 RESULT

• 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.2020.04.144. Epub 2020 Jun 26.

  PMID: 32599034 RESULT

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Officials

• Francesco Nappi

  Cardiac Surgery Centre Cardiologique du Nord de Saint-Denis, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 28, 2023
• First Posted: June 22, 2023
• Study Start: January 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)