F-BEVAR vs Open Surgery for Complex Abdominal Aortic Aneurysm

Completed

• Conditions: Aneurysm Aortic; Vascular Diseases
• Interventions: Procedure: Fenestrated and branched endovascular aortic repair (F-BEVAR); Procedure: Open repair

• Registration Number: NCT05247944
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2018-01-31
• Study Completion: 2022-01
• Study First Submitted: 2022-01-31
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-09
• Last Update Submitted: 2022-02-09
• Study First Posted: 2022-02-21
• Last Update Posted: 2022-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
F-BEVAR	Fenestrated and branched endovascular aortic repair (F-BEVAR)	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).
OPEN SURGERY REPAIR	Open repair	Patients with complex abdominal aortic aneurysm who underwent open surgery repair the Unit of Vascular Surgery of Policlinic Gemelli (FPUG; Rome, Italy).

Primary Outcome Measures

Name	Time	Method
Overall mortality	Through study completion, an average of 5 year	All cause death
Aortic-related mortality	Through study completion, an average of 5 year	Any death related to the initial procedure.
Chronic renal decline during follow-up	Through study completion, an average of 5 year	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.

Secondary Outcome Measures

Name	Time	Method
Aortic-related reintervention	Through study completion, an average of 5 year	All secondary interventions related to the initial procedure or to the endograft and its target vessels during follow-up
Clinical failure	Through study completion, an average of 5 year	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.
Target vessel occlusion	Through study completion, an average of 5 year	Complete obstruction of the artery with no evidence of flow identified on any follow-up CT scan or duplex ultrasound.
Proximal aorta degeneration Proximal aorta degeneration	Through study completion, an average of 5 year	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