Optimizing CO2 Injection Technique for Renal Artery Detection in Endovascular Abdominal Aortic Aneurysm Repair
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Aortic neck detection
Study Overview
Brief Summary
Automated carbon dioxide (CO2) angiography is considered a safe diagnostic alternative to standard iodinated contrast medium (ICM) for endovascular aortic repair (EVAR) of abdominal aortic aneurysm (AAA), especially in patients with preoperative renal function impairment.
Recent literature experiences describe the use of automated CO2 angiography in EVAR.
One of the main issues of CO2 angiography is the inability to detect the origin of the lowest renal artery (proximal neck visualization) that was estimated up to 38%.
In these experiences, the CO2 automated angiography is usually performed by a 5F pigtail catheter placed at renal arteries level.
The aim of the study is to evaluate the efficacy of a new automated CO2 injection technique by a 5F introducer (single hole catheter) positioned at the distal level of the proximal neck in detecting both renal arteries in the first diagnostic and completion angiographies.
Detailed Description
Endovascular aneurysm repair is currently a wide spread therapeutic option due to a lower 30-day morbidity/mortality compared with open repair (OR), especially in patients with high surgical risk. The routinary EVAR technique requires the use of iodinated contrast medium (ICM) which can cause contrast induced-acute kidney injure (CI-AKI). The incidence of CI-AKI after EVAR is estimated between 2% and 16% although renal insult can also be caused by microembolization, unplanned renal (or polar) artery coverage, renal artery lesion (as dissection) or post-operative inflammatory reaction.
In the past few years, several studies pointed out the importance of reducing the amount of iodinated contrast medium injected and proposed carbon dioxide (CO2) as an alternative to partially or completely replace ICM, especially in patients with preoperative chronic renal impairment.
According with the literature, manual or automatic CO2 injection provides a good quality imaging of both proximal and distal sealing zone in standard EVAR procedures and, combined with fusion imaging, allows to perform juxta and pararenal abdominal aortic aneurysm repair with fenestrated endograft reducing the total amount of ICM required to the procedure.
The most relevant limit to the use of CO2 is the inability to identify the proximal landing zone and the lowest renal artery that occurs in a significant number of cases (38.7%).
This limit could be related to the physical property of CO2 because, differently from ICM, it is a gas that does not completely fill the aortic lumen but it floats in the anterior portion of the aneurysmatic sac and does not allow the detection of renal arteries with a posterior origin.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with asymptomatic infrarenal abdominal aortic aneurysm admitted to the S. Orsola - Malpighi Hospital for a planned EVAR procedure. All patients underwent a preoperative computed tomography angiography (CTA) with a <2mm slices.
Exclusion Criteria
- •Patients with contraindication for CO2 (cardiac septal defects, pulmonary arteriovenous malformations, pulmonary hypertension, severe emphysema)
- •Patients requiring advanced aortic repair (FEVAR, BEVAR)
- •Urgent cases
Outcomes
Primary Outcomes
Aortic neck detection
Time Frame: At the moment of CO2 injection during the procedure
Define the efficacy of the alternative CO2 injection technique in the detection of renal arteries in those cases when the usual technique doesn't succeed.
Procedure success
Time Frame: At the moment of CO2 injection during the procedure
Define the efficacy of the alternative CO2 injection technique in the detection of renal arteries, hypogastric arteries and endoleaks at the final angiography in those cases when the usual technique doesn't succeed.
Secondary Outcomes
- Mortality(within 30 days from the procedure)
- Adverse events(within 30 days from the procedure)
- Rate of early reintervention(within 30 days from the procedure)
- CO2 complications(within 30 days from the procedure)
Investigators
Enrico Gallitto
Principal Investigator
University of Bologna