A PROpensity Score Matching Analysis on ENDovascular vs Open Thoraco-Abdominal Aortic Aneurysm Repair . A Single-center, Retrospective-prospective, Observational Study/ EUnetHTA Core Model
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Thoracoabdominal Aortic Aneurysms
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 650
- Locations
- 1
- Primary Endpoint
- free survival
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of the registry is to compare the surgical and endovascular approaches to the treatment of thoracoabdominal aortic aneurysms.
Detailed Description
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.
Investigators
Bertoglio Luca
Prof
IRCCS San Raffaele
Eligibility Criteria
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
Outcomes
Primary Outcomes
free survival
Time Frame: 1 year
1 year aortic-related and all cause mortality
aortic-related reintervention
Time Frame: 1 year
1 year clinical success