Outcomes of Aortic Dissection Repair

NCT ID: NCT05927090

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-01-01
• Study Completion Date: 2025-12-31

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.

Detailed 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.TBAD occurring beyond the left subclavian artery (LSA) is classified in chronological order based on the timing of clinical presentation: acute (14 days or less), subacute (more than 14 days and less than or equal to 3 months), and chronic (more than 3 months).TBADs are also divided into complicated or non-complicated based on their initial clinical manifestation. Acute complicated TBAD is characterised by tearing of the aorta, pain, rapid expansion, hypertension, or blockages in the vasculature.Malperfusion syndrome is the most common complication, occurring in nearly 30% of cases. More than 30% of patients with mesenteric compromise following aortic dissection die .

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

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

Intervention Type: 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.

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

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

Intervention Type: 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

Ascending Aorta Replacement with Total Arch Replacement (TARP)

Patient who will require the extensive procedure including ascending aorta replacement associated to TARP

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

Intervention Type: 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)

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

Extensive Root and Ascending Aorta Replacement with Total Arch Replacement

Intervention Type: 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

Thoracic Endovascular Aortic Repair

Patient who will require the procedure including thoracic endovascular aorta repair

Thoracic Endovascular Aortic Repair

Intervention Type: 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.

Open Thoracic Aortic Repair

Patient who will require the procedure including open thoracic aorta repair

Open Thoracic Aortic Descendig Repair

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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)

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Thoracic Endovascular Aortic Repair

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.

Intervention Type: PROCEDURE

Open Thoracic Aortic Descendig Repair

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.

Intervention Type: PROCEDURE

Other Intervention Names

Ascending Aorta Replacement with Aortic Valve Replacement (AVR); ARR with or without aortic valve sparing; AAR with TARP or Frozen Elephant Trunk (FET); Full anterior thoracic aorta replacement with partial hemiarch repair or TARP or FET; TEVAR; TOAR

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henri Mondor University Hospital

OTHER

Sponsor Role: collaborator

Universita degli Studi di Genova

OTHER

Sponsor Role: collaborator

Pitié-Salpêtrière Hospital

OTHER

Sponsor Role: collaborator

Ospedale San Camillo, Rome, Italy

UNKNOWN

Sponsor Role: collaborator

Campus Bio-Medico University

OTHER

Sponsor Role: collaborator

Centre Cardiologique du Nord

OTHER

Sponsor Role: lead

Responsible Party

Francesco Nappi

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Nappi, MD

Role: STUDY_CHAIR

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

Locations

Francesco Nappi

Saint-Denis, , France

Countries

France

References

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Reference Type: RESULT

PMID: 31974270 (View on PubMed)

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Reference Type: RESULT

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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.

Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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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.

Reference Type: RESULT

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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.

Reference Type: RESULT

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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.

Reference Type: RESULT

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Other Identifiers

CN-202201173-3

Identifier Type: REGISTRY

Identifier Source: secondary_id

CN-202201173-3

Identifier Type: -

Identifier Source: org_study_id