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

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

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.

Study Overview

• Status: Completed
• Conditions: Infrarenal Aortic Aneurysm

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Belgium
  • Duffel, Belgium, 2570
    • Sint - Maarten Hospital, Campus Rooienberg
  • Ghent, Belgium, 9000
    • Ghent University Hospital
• Switzerland
  • Zurich, Switzerland, 8091
    • Zurich University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with an infrarenal aortic aneurysm suitable for endovascular exclusion. The suitability for endovascular repair is based upon the physician's decision.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
PROcedure rehearsal; PROcedure rehearsal performed before real EVAR procedure No intervention
No PROcedure rehearsal; no PROcedure rehearsal performed before real EVAR procedure No intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Liesbeth Desender, University Hospital, Ghent

Publications and helpful links

General Publications

• Desender L, Van Herzeele I, Lachat M, Duchateau J, Bicknell C, Teijink J, Heyligers J, Vermassen F; PAVLOV Study Group. A Multicentre Trial of Patient specific Rehearsal Prior to EVAR: Impact on Procedural Planning and Team Performance. Eur J Vasc Endovasc Surg. 2017 Mar;53(3):354-361. doi: 10.1016/j.ejvs.2016.12.018. Epub 2017 Jan 20.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2012
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: June 28, 2012
• First Submitted That Met QC Criteria: July 2, 2012
• First Posted (Estimate): July 3, 2012

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: suitable for endovascular exclusion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm
• Other Study ID Numbers: EC/2012/412