Repair Versus Non-repair of the Aortic Arch in Type A Aortic Dissection

NCT05912634 | Enrolling By Invitation

• 2 other identifiers: CN-202201173-2CN-23-27
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

Acute Stanford type A aortic dissection (TAAD) is a life-threatening clinical status requiring surgery that is usually performed as a salvage procedure.We planned a multicenter study to evaluate the balance between the patient's condition and those therapeutic strategies that may limit the risk of late adverse events in patients who will be underwent surgery for appropriate management of TAAD

Conditions

Aortic Dissection; Aortic Arch; Aortic Dissection Rupture; Aortic Dilatation

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Operative Mortality (OM)

  Patients who died within 30 days

  30-day

• Rate of acute heart failure

  Number of participants with postoperative heart failure 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

• Stroke

  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

• Rate of global brain ischemia

  Rate of diffuse hypoxic damage as diagnosed at brain imaging and electroencephalography.

  30-days

• Rate of mesenteric ischemia

  Rate of abdominal pain with or without nausea and vomiting and rectal bleeding or bloody diarrhea

  30-days

• 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-days

Secondary Outcomes (5)

• Rate of paraplegia/paraparesis

  30-day

• Rate of perioperative bleeding

  30-day

• Rate of reoperation for bleeding

  30-day

• Rate of mechanical circulatory support

  30-day

• Late outcomes

  18 years

Other Outcomes (5)

• Rate of urgent procedure

  30-days

• Rate of emergency grade 1

  30-days

• Rate of emergency grade 2

  30-days

Study Arms (2)

Conservative Type A Aortic Dissection Repair (TAAD-R)

The Conservative procedure will include patients receiving ascending aortic root sparing replacement with or without the implantation of the aortic hemiarch

Procedure: Conservative TAAD-R

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

The extensive procedure will include patients receiving ascending aorta replacement associated to TARP

Procedure: Extensive TAAD- R

Interventions

Conservative TAAD-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 Aortic Dissection Repair (TAAD-R)

Extensive TAAD- 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 arch)

Also known as: Aortic root procedures.TARP procedures. Frozen Elephant Trunk (FET) procedure

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The retrospective multicenter study including patients who underwent surgery for acute TAAAD at 5 centers of cardiac surgery located in 2 European countries and Japan (2 France, 2 Italy and 1 Hokkaido ). Data will be prospectively collected fron patients (conservative vs estensive TAAD- R) treated during the study period and the aim will be to gather further data for future clinical research on this topic. Preoperative and postoperative variables will be included during in-hospital stay and follow-up data instead they will be included on subsequent encounters for all other patients who will be hospitalized. Data on consecutive patients with acute TAAD will be collected with pre-specified baseline, operative and outcome variables.

You may qualify if:

• 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.

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

Study Sites (1)

Francesco Nappi

Saint-Denis, 93200, France

Location

Related Publications (5)

• 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

• 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

• 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

• 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

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 22, 2023
• Study Start: January 1, 2014
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)