Infrarenal Aortic Aneurysm
Conditions
Keywords
suitable for endovascular exclusion
Brief summary
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.
Interventions
None listed
Sponsors
University Hospital, Ghent
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical operative metrics | during EVAR procedure | * C-arm positioning for proximal and distal landing zone * Fluoroscopy time * Number of angiograms * Amount of contrast |
| Errors occurring during EVAR procedure (Imperial College Error Capture record) | during EVAR procedure | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any deviation from initial treatment plan | immediately after EVAR procedure | — |
| 30 day mortality and morbidity | within the first 30 days after surgery | — |
| Subjective sense of realism of patient-specific rehearsal reported by team members | immediately after EVAR procedure | Subjective sense of realism of patient-specific rehearsal reported by team members (Measurement: questionnaire) |
| Initial clinical success | within the first 30 days after surgery | 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 |
| Technical and clinical success rate | immediately after EVAR procedure | * 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 |
| Team satisfaction | immediately after EVAR procedure | Team satisfaction Measurement: questionnaire |
Countries
Belgium, Switzerland
Outcome results
None listed