Outcomes of Aortic Dissection Repair

NCT05927090 | Enrolling By Invitation

• 1 other identifier: CN-202201173-3
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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%)The main approach to acute type B non-complicated aortic dissection (TBAD) has always been to use medicines to control the patient's heart rate and blood pressure. However, recent findings suggest that a large number of patients treated for acute complicated (TBAAD) and non-complicated TBAD experience aortic complications, such as aneurysmal degeneration, at a later stage.

Conditions

Type A Aortic Dissection; Ascending Aortic Dissection; Aortic Diseases; Aortic Arch; Aortic Valve Insufficiency; Aortic Root Dissection; Aortic Root Dilatation; Type B Aortic Dissection

Keywords

DeBakey type I Dissection; DeBakey type II Dissection; Type A Acute Aortic Dissection (TAAAD); Root-Sparing Replacement; Ascending Aorta Replacement; Partial Arch Repair; Hemiarch Procedures; Total Arch Replacement (TARP); Frozen Elephant Trunk (FET) Hemiarch Procedures; Type B Acute Aortic Dissection (TBAAD); Type B non acuteAortic Dissection (TBAD)

Outcome Measures

Primary Outcomes (6)

• Operative Mortality (OM)

  Patients who died within 30 days

  30-day

• Rate of mesenteric ischemia

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

  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

• 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

• Rate of perioperative Myocardial Infarction (MI)

  Number of participants with MI based on fourth universal definition.

  30-day

• 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 Outcomes (9)

• Rate of Transient Neurologic Deficit (TND)

  30-day

• Rate of spinal Cord Injury (SCI)

  30-day

• Rate of acute kidney injury

  30-day

• Rate of perioperative bleeding

  30-day

• Reoperation for bleeding

  30-day

Other Outcomes (5)

• Rate of urgent procedure

  30-day

• Rate of emergency grade 1

  30-day

• Rate of emergency grade 2

  30-day

Study Arms (6)

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

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)

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)

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

Thoracic Endovascular Aortic Repair

Patient who will require the procedure including thoracic endovascular aorta repair

Procedure: Thoracic Endovascular Aortic Repair

Open Thoracic Aortic Repair

Patient who will require the procedure including open thoracic aorta repair

Procedure: Open Thoracic Aortic Descendig Repair

Interventions

Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch Repair PROCEDURE

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.

Also known as: Ascending Aorta Replacement with Aortic Valve Replacement (AVR)

Ascending Aorta Replacement (AAR) with or without Hemiarch Repair

Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR) 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 receive replacement of the aortic root using a biologic or mechanical composite valve graft or valve-sparing root reimplantation procedure associated to AAR

Also known as: ARR with or without aortic valve sparing

Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR)

Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP) PROCEDURE

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)

Also known as: AAR with TARP or Frozen Elephant Trunk (FET)

Ascending Aorta Replacement with Total Arch Replacement (TARP)

Extensive Root and Ascending Aorta Replacement with Total Arch Replacement PROCEDURE

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

Also known as: Full anterior thoracic aorta replacement with partial hemiarch repair or TARP or FET

Root and Ascending Aorta Replacement with Total Arch Replacement

Thoracic Endovascular Aortic Repair PROCEDURE

TEVAR patients have a higher incidence of complications and reintervention than open repair patients. TEVAR complications may include endoleak, retrograde type A aortic dissection, stent-graft migration, fracture or collapse, and increased size.

Also known as: TEVAR

Thoracic Endovascular Aortic Repair

Open Thoracic Aortic Descendig Repair PROCEDURE

Surveillance imaging can detect complications of open repair, such as graft infection and anastomotic pseudoaneurysm. After open repair or TEVAR, patients may develop progressive aneurysmal dilatation of adjacent or remote aortic segments.

Also known as: TOAR

Open Thoracic Aortic Repair

Eligibility Criteria

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

Study Population

The STAAD study is a prospective multicenter registry including patients who will underwent surgery for acute TAAD at 6 centers of cardiac surgery located in 2 European countries and Japan (3 France, 2 Italy and 1 Hokkaido ). Data will be prospectively collected from patients (conservative vs estensive Type A aortic dissection repair) who will be treated during the study period. In addition, 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.

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
• Ospedale San Camillo, Rome, Italy: collaborator
• Campus Bio-Medico University: collaborator

Study Sites (1)

Francesco Nappi

Saint-Denis, 93200, France

Location

Related Publications (9)

• 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.

  PMID: 31974270 RESULT

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

  PMID: 20625143 RESULT

• 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. Circulation. 2013 May 21;127(20):2031-7. doi: 10.1161/CIRCULATIONAHA.112.000483. Epub 2013 Apr 18.

  PMID: 23599348 RESULT

• 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

Dissection, Ascending Aorta; Aortic Diseases; Aortic Valve Insufficiency

Interventions

TARP; Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Dissection, Thoracic Aorta; Aortic Dissection; Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Francesco Nappi, MD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 3, 2023
• First Posted: July 3, 2023
• Study Start: January 1, 2005
• Primary Completion: December 30, 2021
• Study Completion: December 31, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

FR (1)