A PROpensity Score Matching Analysis on ENDovascular vs Open Thoraco-Abdominal Aortic Aneurysm Repair (PRO-ENDO TAAA Study)

Study Overview
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Brief Summary
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The purpose of the registry is to compare the surgical and endovascular approaches to the treatment of thoracoabdominal aortic aneurysms.

Detailed Description
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The purpose of the study is to compare the surgical and endovascular approaches to the treatment of thoracoabdominal aortic aneurysms. In particular, the study aims at comparing the short- and mid-term mortality, morbidity and reintervention rate after open surgery or endovascular repair of thoracoabdominal aortic aneurysms in comparable cohorts of patients according to preoperative characteristics and evaluating the cost-effectiveness of both techniques, according to the EUnetHTA core model. The study results will contribute to the creation of a HTA Report regarding endovascular technology to treat thoracoabdominal aortic aneurysms which will be evaluated by the appropriate Health Authorities.

Official Title
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A PROpensity Score Matching Analysis on ENDovascular vs Open Thoraco-Abdominal Aortic Aneurysm Repair . A Single-center, Retrospective-prospective, Observational Study/ EUnetHTA Core Model

Conditions
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Thoracoabdominal Aortic Aneurysms

Intervention / Treatment
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* Procedure: Surgical repair
* Procedure: Endovascular repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients affected by a thoracoabdominal aortic aneurysm who received an open surgical repair (aneurysmectomy and aortic reconstruction with a surgical graft) or endovascular repair (with off-the-shelf or custom-made Fenestrated/Branched-Endovascular Aortic Repair - F/BEVAR) between January 2013 and June 2021 at San Raffaele Hospital (Vascular Surgery Unit) Adult patients ≥18 years The patient is able to understand and sign the informed consent approved by the Ethics Committee of the San Raffaele Hospital Exclusion Criteria: Patients treated with a hybrid approach (open surgical retrograde revascularization of renovisceral arteries followed by aneurysm exclusion with endograft) Patients treated with other endovascular techniques besides fenestrated or branched technology (e.g., physician-modified endografts, parallel grafts). Patients with a juxtarenal or pararenal aortic aneurysm Patients treated with F/BEVAR for a visceral artery patch aneurysm after open thoracoabdominal repair

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open surgical repair<br>Aneurysmectomy and aortic reconstruction with a surgical graft | Procedure: Surgical repair<br>* Patients affected by a thoracoabdominal aortic aneurysm who received an open surgical repair (aneurysmectomy and aortic reconstruction with a surgical graft<br>|
| Endovascular repair<br>Off-the-shelf or custom-made Fenestrated/Branched-Endovascular Aortic Repair - F/BEVAR | Procedure: Endovascular repair<br>* Patients affected by a thoracoabdominal aortic aneurysm who received endovascular repair (with off-the-shelf or custom-made Fenestrated/Branched-Endovascular Aortic Repair - F/BEVAR)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| free survival | 1 year aortic-related and all cause mortality | 1 year | 
| aortic-related reintervention | 1 year clinical success | 1 year |