None listed
Conditions
Brief summary
Endovascular aortic aneurysm repair (EVAR) is being performed at an increasing rate in both the elective and emergency settings. The lower immediate morbidity and mortality rates of EVAR have been influential in the rapid adoption of this technique. However, the need for ongoing monitoring and higher rates of subsequent re-intervention that are required remain a concern for Vascular surgeons. The ability to be able to identify and predict the patient group most likely to require such re-interventions would be highly beneficial to rationalising treatment for patients. Intra-operative pressure measurements of the aneurysm sac is one method that may be able to guide therapy and this study is an extension of the currently mixed evidence surrounding this area. The primary aim will be to assess if intra-sac pressure measurements (and changes in these measurements) can predict the development of intra-operative or persistent endoleaks or continued aneurysm sac enlargement. The intra-sac pressure measurements will be measured in terms of reduction in systolic and diastolic pressures as well as pulse pressure and as a ratio to the systemic circulation pressure. The progress of the aneurysm sac post-operatively will be monitored through the usual follow-up procedure of ultrasounds at regular intervals. If any persistent endoleaks are detected or there is continued sac enlargement then Computed Tomography (CT) with contrast injection or conventional angiography will be performed to further delineate the pathology.
Interventions
Intra-sac pressure monitoring will be performed during endovascular aortic aneurysm repair (EVAR). The procedure will be performed by an experience Vascular surgeon. The pressure will be measured using a pressure transducing catheter that will be introduced at the start of the case through a separate femoral micro-puncture. The pressure will be measure at pre-defined intervals; before deployment of the stent graft, after deployment of the stent graft, after balloon moulding of the stent graft an
Intra-sac pressure monitoring will be performed during endovascular aortic aneurysm repair (EVAR). The procedure will be performed by an experience Vascular surgeon. The pressure will be measured using a pressure transducing catheter that will be introduced at the start of the case through a separate femoral micro-puncture. The pressure will be measure at pre-defined intervals; before deployment of the stent graft, after deployment of the stent graft, after balloon moulding of the stent graft and after administration of protamine if it is given at the end of the case. The results will be correlated with any ability to predict continued endoleak or endotension at the completion of the procedure and upon follow up for 24 months.
Sponsors
Dr Arvind Deshpande
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients over the age of 18 years of age who are undergoing elective or semi-urgent booked endovascular aortic aneurysm repair at the John Hunter Hospital.
Exclusion criteria
Patients from the above group will be excluded if they: • are under 18 years of age, or • refuse or are unable to give written informed consent to participate in the study, or • are unable to understand verbal and written consent documentation due to English not being the primary language, or • have severe renal impairment, or • severe allergy to iodine contrast which contraindicated endovascular repair, or • require a thoraco-abdominal aneurysm repair, or • pregnant or lactating females
Outcome results
None listed