AAA Rupture Risk Assessment in COVID-19 Pandemic

Study Overview
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Brief Summary
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The acute phase of the COVID-19 pandemic requires a redefinition of healthcare system to increase the number of available intensive care units for COVID-19 patients. This leads to the postponing of elective surgeries including the treatment of abdominal aortic aneurysm (AAA). The probabilistic rupture risk index (PRRI) recently showed its advantage over the diameter criterion in AAA rupture risk assessment. Its major improvement is in increased specificity and yet has the same sensitivity as the maximal diameter criterion. The objective of this study was to test the clinical applicability of the PRRI diagnostic method in a quasi-prospective observational patient cohort study.

Official Title
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Biomechanical Rupture Risk Assessment in Management of Patients With Abdominal Aortic Aneurysm in COVID-19 Pandemic

Conditions
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Abdominal Aortic Aneurysm, COVID-19

Intervention / Treatment
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* Diagnostic Test: Biomechanical rupture risk assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of asymptomatic abdominal aortic aneurysm (AAA) regular CT angiography scans available Exclusion Criteria: rupture of AAA
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BRRA group<br>Rupture risk of asymptomatic AAAs in this group was estimated using Biomechanical rupture rist assessment (BRRA). BRRA considers an AAA as a pressure vessel and estimates its risk of rupture by comparing its wall stress to wall strength | Diagnostic Test: Biomechanical rupture risk assessment<br>* 3D computational model is created from CT angiographic images available during standard AAA diagnostic process. Vascular wall stress is assessed based on the 3D model using Finite element method to identify highly stressed parts of AAA and results are compared to populational wall strength information (gathered from previous large histological study), thus rupture risk (stress/strength ratio) of each particular AAA is estimated. Other relevant factors such as gender, blood pressure, presence of intraluminal thrombus etc. are used during the calculation as well.<br>* Other names: Vascular wall stress assessment using finite element method;|
| Maximal diameter group<br>Rupture risk of asymptomatic AAAs in this group was estimated by a classical approach based on a maximal diameter. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test the clinical applicability of the BRRA method | Identify the number of number of false positive and false negative cases assessed by BRRA method according to clinical data and compare these data to control group where the decision making process was based only on maximal diameter of AAA | 21 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of time required for AAA assessment | To investigate the feasibility of cooperation between the biomechanical and medical teams in a modified AAA management workflow leading to reduced time required for an AAA assessment | 21 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal aortic Aneurysm, Biomechanics, Rupture risk, Predictability, COVID-19