Interest of a Post-operative Ultrasound With Systematic Use of Ultrasonic Contrast in the Follow-up of Aortic Endoprosthesis: Prospective Study at the University Hospital of Nice

Study Overview
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Brief Summary
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This is a prospective study conducted on a population with an aortic endoprosthesis in the context of an abdominal aortic aneurysm. The study's objective is to standardize the ultrasound methodology in the monitoring of aortic endoprosthesis in immediate post-operative care by comparing the results with CT-scan (gold standard). To improve ultrasound methodology, the investigators propose to use the VESMA protocol for ultrasound diameter measurement at four incidences. In addition, the use of ultrasonic contrast agents increases the accuracy of vascular structures, the quality of the ultrasound blood flow image and the duration of signal enhancement. This makes it possible to visualize small gauge vessels and those with slow flows. In this way, the investigators could improve the ultrasound technique for measuring aneurysm bag diameters and endoleak detection. Moreover, the toxicity of iodinated contrast agents is the third cause of acute renal failure in hospitalized patients and is all the more frequent when the investigators increase injections. Improving the quality of ultrasound investigations for the monitoring of aortic endoprosthesis would therefore allow us to reduce the number of CT-scan performed in this population and thus reduce irradiation and the injection of nephrotoxic products. Thereby, the investigators would like to integrate the technique into the systematic follow-up of patients who have benefited from the placement of an aortic endoprosthesis by replacing the CT-scan.

Official Title
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Interest of a Post-operative Ultrasound With Systematic Use of Ultrasonic Contrast in the Follow-up of Aortic Endoprosthesis: Prospective Study at the University Hospital of Nice

Conditions
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Aneurysm, Abdominal Aortic

Intervention / Treatment
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* Other: écho-doppler with ultrasonar Sonovue® injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years of age. Abdominal aortic aneurysm treated with aortic stent. Signature of informed consent. Person affiliated or beneficiary of a social security scheme Exclusion Criteria: Hypersensitivity to sulphur hexafluoride or to these excipients (Macrogol 4000, Distearoylphosphatidylcholine, Dipalmitoylphosphatidylglycerol sodé, Palmitic acid). Right-left shunt patient Patient with severe pulmonary hypertension (pulmonary blood pressure > 90 mm Hg), Patient with uncontrolled systemic hypertension Adult patients with respiratory distress syndrome. Dobutamine patient in patients with a pathology suggesting cardiac instability Hypercoagulation, recent thromboembolic accident Fenestrated aortic stent Pregnant or nursing woman. Severe heart failure. Person deprived of liberty by judicial or administrative decision. Person subject to legal protection.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: écho-doppler with ultrasonar Sonovue® injection<br> | Other: écho-doppler with ultrasonar Sonovue® injection<br>* During this unique visit they will benefit from 2 imaging exams performed by two different operators: Echo-doppler without standard method contrast injection (common practice) An echo-doppler with Sonovue® ultrasound injection Ultra_evar method (2.5 ml bolus 2-3 seconds) During this examination, the endoprosthesis and the aneurysm sac will be scanned according to the 4 incidences described above in order to objective whether or not there is a endoleak. The patient then performs the control CT-scan prior to discharge from hospital. The results of the medical imaging exams will be communicated to them before the hospital discharge, once the CT-scan has been performed. A cross-review of the studies will be performed later.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of anterior-posterior diameters according to 4 aortic endoprosthesis incidences after PCUS injection in immediate post-operative |  | 1 day | 
| detection of endoleaks after PCUS injection in immediate post-operative |  | 1 day | 
| measurement of anterior-posterior diameters of endoleaks after PCUS injection in immediate post-operative |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of endoleaks after PCUS injection in immediate post-operative |  | 1 day | 
| Description of exit doors of heart after PCUS injection in immediate post-operative |  | 1 day | 
| Description of their flows after PCUS injection in immediate post-operative |  | 1 day | 
| Description of maximum circulatory speeds after PCUS injection in immediate post-operative |  | 1 day |