Patient-specific Virtual Reality Rehearsal Prior to EVAR: Influence on Technical and Non-technical Operative Performance

Study Overview
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Brief Summary
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Ongoing technological advances, especially in the field of image processing, have refined medical simulations to offer life-like replications of medical and surgical procedures in a variety of specialties. Patient-specific image data are incorporated into these simulations, and transformed into a 3D model. This enables the practitioner and his/her team to perform and practice 'real' cases on a virtual patient prior to performing the real procedure on the actual patient. This new technology has been referred to as 'patient-specific' rehearsal, also 'mission' or 'procedure' rehearsal. Research has already proven that simulated patient-specific rehearsal of a carotid artery stenting procedure may enhance surgical and team performance. The PROcedure rehearsal software can now also be used to practice patient-specific endovascular repair of infrarenal aortic aneurysms (EVAR). The ability to rehearse a challenging and complex procedure like EVAR may not only influence device selection based on preoperative planning, but also improve the technical performance of the surgeon/radiologist and the awareness and communication within the entire endovascular team. However, further research is needed to evaluate if this new technology may enhance clinical safety and efficiency, i.e. if patients actually benefit from physicians and team members conducting patient-specific rehearsals of EVAR interventions.

Official Title
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Patient-specific Virtual Reality Rehearsal Prior to EVAR: Influence on Technical and Non-technical Operative Performance. A Randomized Controlled Trial.

Conditions
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Infrarenal Aortic Aneurysm

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -infrarenal aortic aneurysm suitable for endovascular exclusion Exclusion Criteria: Adult patients who do not have capacity to consent. Previous stent-graft implanted in the abdominal aorta

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PROcedure rehearsal<br>PROcedure rehearsal performed before real EVAR procedure No intervention | |
| No PROcedure rehearsal<br>no PROcedure rehearsal performed before real EVAR procedure No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical operative metrics | C-arm positioning for proximal and distal landing zone Fluoroscopy time Number of angiograms Amount of contrast | during EVAR procedure | 
| Errors occurring during EVAR procedure (Imperial College Error Capture record) |  | during EVAR procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective sense of realism of patient-specific rehearsal reported by team members | Subjective sense of realism of patient-specific rehearsal reported by team members (Measurement: questionnaire) | immediately after EVAR procedure | 
| Team satisfaction | Team satisfaction Measurement: questionnaire | immediately after EVAR procedure | 
| Any deviation from initial treatment plan |  | immediately after EVAR procedure | 
| 30 day mortality and morbidity |  | within the first 30 days after surgery | 
| Technical and clinical success rate | Successful access to the arterial system using a remote site Successful deployment of the endoluminal graft with secure proximal and distal fixation Absence of either type I or III endoleak Patent endoluminal graft without significant twist, kinks, or obstruction | immediately after EVAR procedure | 
| Initial clinical success | o Successful deployment of the endovascular device at the intended location, without: Death as a result of aneurysm-related treatment Type I or III endoleak Graft infection or thrombosis Aneurysm expansion (diameter > 5mm) Aneurysm rupture Conversion to open repair Graft dilatation (≥ 20% by diameter) Graft migration Failure of device integrity | within the first 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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suitable for endovascular exclusion