F-BEVAR vs Open Surgery for Complex Abdominal Aortic Aneurysm

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to investigate outcomes of a propensity matched series of patients treated with F-BEVAR and open surgery repair for complex abdominal aortic aneurysm in two aortic high-volume centres.

Detailed Description
-----------------
This retrospective study analyzes the long-term outcomes of a propensity-matched cohort of patients with complex abdominal aortic aneurysm prospectively collected between January 2010 and June 2016 from the Aortic Center of Lille (Lille, France) and the Unit of Vascular Surgery of Policlinic Gemelli (Rome, Italy). Patients were observed with regular postoperative appointments. The long-term imaging follow-up consisted in a yearly computed tomography angiography in the F-BEVAR group; and yearly abdominal ultrasound examination and 5-year computed tomography angiography were performed in the open surgery repair group. In case of abnormal renal function (eGFR<60 mL/min/1.73 m2), the patient underwent computed tomography without contrast associated to a contrast-enhanced ultrasound examination in both groups. Laboratory data with evaluation of renal function by estimated glomerular filtration rate (eGFR), were completed at three, six, and 12 months, and yearly thereafter. Survival assessment was completed after general partitioner's, patients' or patient siblings' contact by phone.

Official Title
-----------------
Propensity Matched Comparison of Fenestrated Endovascular Aneurysm Repair and Open Surgical Repair for Complex Abdominal Aortic Aneurysms.

Conditions
-----------------
Aneurysm Aortic, Vascular Diseases

Intervention / Treatment
-----------------
* Procedure: Fenestrated and branched endovascular aortic repair (F-BEVAR)
* Procedure: Open repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: juxtarenal abdominal aortic aneurysms pararenal abdominal aortic aneurysms suprarenal abdominal aortic aneurysms type IV thoracoabdominal aneurysms Exclusion Criteria: extent I to III thoracoabdominal aneurysms ruptured o symptomatic aneurysms dissections or connective tissue disorder aneurysms.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| F-BEVAR<br>Patients with complex abdominal aortic aneurysm who underwent fenestrated and branched endovascular aortic repair (F-BEVAR) at the Aortic Center of Lille (ACL; Lille, France). | Procedure: Fenestrated and branched endovascular aortic repair (F-BEVAR)<br>* Fenestrated and branched endovascular aortic repair (F-BEVAR)<br>|
| OPEN SURGERY REPAIR<br>Patients with complex abdominal aortic aneurysm who underwent open surgery repair the Unit of Vascular Surgery of Policlinic Gemelli (FPUG; Rome, Italy). | Procedure: Open repair<br>* Open surgery for complex abdominal aortic aneurysm<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall mortality | All cause death | Through study completion, an average of 5 year | 
| Aortic-related mortality | Any death related to the initial procedure. | Through study completion, an average of 5 year | 
| Chronic renal decline during follow-up | Chronic renal decline was defined in patients with normal (stage 1-2) preoperative renal function as a reduction in the eGFR to <60 mL/min/1.73 m2 during follow-up. In patients with abnormal function (stages 3 and 4) preoperatively, it was defined as an eGFR reduction of >20% or de novo dependence on permanent renal replacement therapy. | Through study completion, an average of 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic-related reintervention | All secondary interventions related to the initial procedure or to the endograft and its target vessels during follow-up | Through study completion, an average of 5 year | 
| Target vessel occlusion | Complete obstruction of the artery with no evidence of flow identified on any follow-up CT scan or duplex ultrasound. | Through study completion, an average of 5 year | 
| Clinical failure | Death from complications of the initial operation or a secondary intervention, aortic aneurysm rupture, aortic conversion to open surgical repair, persistent type I or III endoleak, sac expansion >5 mm, device migration >10mm, infection or thrombosis in the F-BEVAR group and death, graft infection or thrombosis or para-anastomotic aneurysm in the open group. | Through study completion, an average of 5 year | 
| Proximal aorta degeneration Proximal aorta degeneration | Diameter increase >5 mm within 5 cm above the ostium of the more proximal target vessel for the endovascular group and 5 cm above the proximal anastomosis for the open group | Through study completion, an average of 5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
F-BEVAR, Open surgery, complex abdominal aortic aneurysm