The purpose of the study is to describe Sodium Fluoride uptake (using Positron Emission Tomography-Computed Tomography - PET-CT) following Endovascular Aneurysm Repair (EVAR) and to determine whether Sodium Fluoride PET-CT can predict the development of endoleaks.
Abdominal aortic aneurysms are a leading cause of death in the United Kingdom. Surveillance programmes and pre-emptive surgical repair are lifesaving. Traditional open surgical repair is associated with major perioperative morbidity and mortality and there has been a move towards minimally invasive Endovascular Aneurysm Repair (EVAR), which reduces these early risks. However, the cost effectiveness and long-term clinical effectiveness of EVAR is undermined by concerns of durability due to the development of endoleaks and late aneurysm rupture secondary to progression of native aortic aneurysm disease and stent graft failure. It has previously been demonstrated that 18F-Sodium Fluoride Positron Emission Tomography can predict progression of aneurysm disease and is associated with greater rates of abdominal aortic aneurysm expansion and the future risk of rupture or surgical repair. The investigators here wish to examine whether 18F-Sodium Fluoride on Positron Emission Tomography uptake (i) is increased in patients with endoleaks or related complications, (ii) can prospectively predict the likelihood of developing endoleaks in patients undergoing EVAR, and (ii) is a feasible approach to select patients for EVAR with a reduced future risk of stent graft failure and re-intervention. The investigators believe that there is a compelling scientific rationale for this approach with major translational potential to better select subgroups of patients for EVAR and ultimately improve their outcome.
Study Type
OBSERVATIONAL
Enrollment
102
PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan
CT scan to assess aortic morphology and contextualise PET scan
CT scan to assess aortic morphology and the stent graft
Ninewells Hospital
Dundee, United Kingdom
University Hospital Hairmyres
East Kilbride, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
Microcalcification activity in stented and aneurysmal aorta
Will be measured as 18F Sodium Fluoride binding in the aorta. Uptake will be quantified in Standardised Uptake Values and as a tissue to background ratios.
Time frame: 12 months
Pattern of microcalcification activity in the stented aorta
Microcalcification activity
Time frame: 12 months
Intensity of microcalcification activity in the stented aorta
Microcalcification activity
Time frame: 12 months
Endoleaks
Computed tomography and ultrasound endpoints
Time frame: 12 months
Stent graft migration
Computed tomography and ultrasound endpoints
Time frame: 12 months
Aneurysm sac diameter
Computed tomography and ultrasound endpoints
Time frame: 12 months
Neck diameter and neck angulation
Computed tomography and ultrasound endpoints
Time frame: 12 months
Geometry: tortuosity, curvature, torsion
Computed tomography and ultrasound endpoints
Time frame: 12 months
Aneurysm-related mortality
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This will consist of a telephone consultation with the study participant and review of electronic clinical records
Clinical endpoints
Time frame: 24 months
Re-intervention
Clinical endpoints
Time frame: 24 months
All-cause mortality
Clinical endpoints
Time frame: 24 months