Comparison of Outcomes of Complex Abdominal Aortic Aneurysm Treatment

Summary

Background: Open repair remains the gold standard for fit patients with complex AAA. In the past decade, an evolution of devices, design, components, and delivery systems expanded the application of EVAR in these challenging anatomies. Fenestrated stent-grafts are now commercially available for the repair of complex AAA in the United States and Europe. Initial reports have demonstrated a high technical success rate, low renal dysfunction rate, and low morbidity and mortality, with promising short- and long-term results. Other reports have shown excessive morbidity and mortality with fenestrated EVAR (FEVAR). Studies comparing endovascular and open repair are sparse, especially when it concerns long-term outcomes. There are till nowadays only two propensity score-matched studies, one showing worse short-term and another long-term clinical outcome for fenestrated-branched EVAR (F/BEVAR) over open surgical repair (OSR).

Aim: The aim of this study will be to compare F/BEVAR versus open AAA repair on short- and long-term clinical outcomes for the treatment of juxta- and pararenal AAA.

Methodology: This is a prospective cohort study from the four high-volume AAA repair centers: Belgrade/Serbia, Bologna/Italy, Milan/Italy, Dijklander/Netherland, Amsterdam/Netherland, and Helsinki/Finland. Data will be collected on demographics, baseline comorbidities, AAA parameters (diameter and localization), laboratory values, intra-, and postoperative data. Follow-up examinations (clinical visits and color duplex ultrasonography, CT scans) will be performed 1, 6, and 12 months after the intervention, and annually thereafter. Propensity score analysis will be performed by matching open repair patients to endovascularly treated controlling for demographics and baseline comorbidities.

Endpoints: Primary endpoints are all-cause mortality and the freedom from aortic-related reintervention. The secondary endpoint is the 30-day complication rate, especially acute kidney injury according to the RIFLE criteria.

Conditions

• Juxtarenal Aortic Aneurysm
• Pararenal Aneurysm

Interventions

PROCEDURE

Open surgery and complex EVAR due to AAA

There will be two cohorts: 1. Patient undergoing open surgery 2. Patients undergoing complex endovascular repair (fenestrated, chimney, etc.)

Sponsors & Collaborators

• Università Vita-Salute San Raffaele

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• Dijklander Ziekenhuis

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• IRCCS Azienda Ospedaliero-Universitaria di Bologna

  collaborator OTHER

• Clinical Centre of Serbia

  lead OTHER

Principal Investigators

• Petar Zlatanovic, MD · University Clinical Centre of Serbia

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-01

Primary Completion

2022-01-01

Completion

2022-01-01

Countries

• Serbia

Study Locations