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Clinical Research & Publications

Research with a new level of insight

For over two decades, virtual medical simulators and physiological flow systems have been featured in a variety of publications as a key tool for medical device and procedural research and curriculum development to facilitate medical professionals.

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Neurovascular
Virtual SIM platforms
Metric-Based Simulation Training to Proficiency for Endovascular Thrombectomy in Ischemic Stroke

Ischemic stroke is one of the leading causes of death and long-term disability in the West. Mechanical revascularization techniques are considered the standard of care for large vessel occlusive stroke. Traditional apprenticeship models involve doctors training their skills on patients. Simulation platforms have long been recognized as an alternative to this. There has however been very little robust assessment of the training outcomes achieved on some of these platforms.

Virtual SIM platforms
Peripheral Vascular
Neurovascular
Cardiovascular
Focus on Radiation Protection Improves Both Correct Behavior and Procedural Performance During Simulation-Based Training - A Randomized Comparison

To explore whether simulation-based endovascular training with focus on radiation safety could improve correct behavior without jeopardizing the learning of procedural skills.

Neurovascular
Importance and potential of simulation training in interventional radiology

Simulation training is a common method in many medical disciplines and is used to teach content knowledge, manual skills, and team skills without potential patient danger.

Neurovascular
Differences in beginner and expert neurointerventionalists” heart rate variability during simulated neuroangiographies

Likewise work experience, heart rate variability (HRV) has repeatedly been correlated with improved performance under real life and simulator conditions. Using HRV as a correlate of workload, it is meaningful to assess the impact of work experience. To understand the impact of work experience on HRV metrics, we examined differences in HRV among experts and beginners during simulated endovascular neuroradiological procedures.

ANKYRAS
Neurovascular
Modification of Woven Endo-Bridge After Intracranial Aneurysm Treatment: A Methodology for Three-Dimensional Analysis of Shape and Relative Position Changes

Purpose: During follow-up of patients treated with WEB devices, shape changes have been observed. The quantitative three-dimensional measurement of the WEB shape modification (WSM) would offer useful information to be studied in association with the anatomical results and try to better understand mechanisms implicated in this modification phenomenon.

Neurovascular
Virtual SIM platforms
Transradial Angiography Skill Acquisition Using an Endovascular Simulation Program

This study assessed the effectiveness of simulation-based training for neuroendovascular interventions using primary and secondary catheters via a transradial approach (TRA). Five neurosurgical residents participated, using the Mentice Visit G5 simulator. Results showed significant improvements in task completion time and knowledge of catheter techniques. The training was rated highly useful by the participants, demonstrating that simulator-based training is effective in enhancing residents' skills in neuroendovascular procedures using TRA.

Physiological SIM platform
Neurovascular
Physician training protocol within the WEB Intrasaccular Therapy (WEB-IT) Study

The WEB Intra-saccular Therapy (WEB-IT) trial is an investigational device exemption study to demonstrate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms. The neurovascular replicator (Vascular Simulations, Stony Brook, New York, USA) creates a physical environment that replicates patient-specific neurovascular anatomy and hemodynamic physiology, and allows devices to be implanted under fluoroscopic guidance.

Virtual SIM platforms
Neurovascular
Metric-Based Virtual Reality Simulation A Paradigm Shift in Training for Mechanical Thrombectomy in Acute Stroke

Virtual SIM platforms
Neurovascular
Simulation Training in Neuroangiography-Validation and Effectiveness.

Simulators are increasingly used in the training of endovascular procedures; however, for the use of the Mentice vascular interventional system trainer (VIST) simulator in neuroradiology, the validity of the method has not yet been proven. The study was carried out to test the construct validity of such a simulator by demonstrating differences between beginner and expert neurointerventionalists and to evaluate whether a training effect can be demonstrated in repeated cases for different levels of experience.

ANKYRAS
Neurovascular
Porosity distribution upon the surface of a deployed flow diverter: an experimental and simulation study

Flow diverters are widely extended in clinical practice for intracraneal aneurysms treatment. They are formed by a dense mesh of braided wires that partially occludes the aneurysm neck and restores the blood flow into the parent vessel. The occlusion degree is highly dependant on the distribution of the wires under the aneurysm, which is affected by the vessel geometry. Nowadays, there are no clinical indicators of the covering ratio once the flow diverter is deployed.

Virtual SIM platforms
Neurovascular
Prospective, randomised and blinded comparison of proficiency-based progression full-physics virtual reality simulator training versus invasive vascular experience for learning carotid artery angiography by very experienced operators

We assessed the transfer of training (ToT) of virtual reality simulation training compared to invasive vascular experience training for carotid artery angiography (CA) for highly experienced interventionists but new to carotid procedures.

Neurovascular
Virtual SIM platforms
Radial Access Simulation Using Mentice

ANKYRAS
Neurovascular
Assessing flow diverter porosity: a comparative analysis of quantification techniques based on imaging and simulation

Flow diverter porosity directly influences the blood flow reduction at the aneurysm neck level and the anatomical result of the treatment. In this research, we present and compare three methodologies to determine the local porosity of deployed flow diverters.

Physiological SIM platform
Neurovascular
E-090 Feasibility of a Vascular Replicator for Endovascular Procedure Rehearsal

Multiple studies have shown the benefit of simulator use for medical trainees. In the endovascular realm, this has been demonstrated in the cardiac, vascular and neurovascular literature with both computer simulation models and physical models of the vasculature. In this study, the authors investigate the feasibility of a customized 3D model, not for training purposes, but for rehearsal prior to an actual endovascular treatment procedure.

Virtual SIM platforms
Neurovascular
Simulation in Angiography - Experiences from 5 Years Teaching, Training, and Research

The example of university radiology/neuroradiology illustrates how high-tech angiography simulators can be used meaningfully in teaching, clinical training and research.

ANKYRAS
Neurovascular
Computation of the Change in Length of a Braided Device when Deployed in Realistic Vessel Models”

An important issue in the deployment of braided stents, such as flow diverters, is the change in length, also known as foreshortening, underwent by the device when is released from the catheter into a blood vessel. The position of the distal end is controlled by the interventionist, but knowing a priori the position of the proximal end of the device is not trivial.

Physiological SIM platform
Neurovascular
4D Interventional Device Reconstruction from Biplane Fluoroscopy

Biplane angiography systems provide time resolved 2D fluoroscopic images from two different angles, which can be used for the positioning of interventional devices such as guidewires and catheters. The purpose of this work is to provide a novel algorithm framework, which allows the 3D reconstruction of these curvilinear devices from the 2D projection images for each time frame. This would allow creating virtual projection images from arbitrary view angles without changing the position of the gantries, as well as virtual endoscopic 3D renderings.

ANKYRAS
Neurovascular
Simulation of intra-saccular devices for pre-operative device size selection: Method and validation for sizing and porosity simulation

Intra-saccular devices (ID) are novel braided devices used for complex intracranial aneurysms treatment. Treatment success is associated with correct device size selection. A technique that predicts the ID size within the aneurysm before intervention will provide a powerful computational tool to aid the interventionist during device selection.

Physiological SIM platform
Neurovascular
Three-dimensional printing and neuroendovascular simulation for the treatment of a pediatric intracranial aneurysm: case report

The use of simulators has been described in a variety of fields as a training tool to gain technical skills through repeating and rehearsing procedures in a safe environment. In cerebrovascular surgery, simulation of skull base approaches has been used for decades. The use of simulation in neurointervention to acquire and enhance skills before treating a patient is a newer concept, but its utilization has been limited due to the lack of good models and deficient haptics. The advent of 3D printing technology and the development of new training models has changed this landscape.

ANKYRAS
Neurovascular
Cerebral Aneurysm Occlusion at 12-Month Follow-Up After Flow-Diverter Treatment: Statistical Modeling for V&V With Real-World Data

Flow-Diverter (FD) porosity has been pointed as a critical factor in the occlusion of cerebral aneurysms after treatment. Objective: Verification and Validation of computational models in terms of predictive capacity, relating FD porosity and occlusion after cerebral aneurysms treatment.

Physiological SIM platform
Neurovascular
Quantitative Evaluation of Performance in Interventional Neuroradiology: An Integrated Curriculum Featuring Theoretical and Practical Challenges

We sought to develop a standardized curriculum capable of assessing key competencies in Interventional Neuroradiology by the use of models and simulators in an objective, quantitative, and efficient way. In this evaluation we analyzed the associations between the practical experience, theoretical knowledge, and the skills lab performance of interventionalists.

ANKYRAS
Neurovascular
Intra-saccular device modeling for treatment planning of intracranial aneurysms: from morphology to hemodynamics

Intra-saccular devices (ID), developed for the treatment of bifurcation aneurysms, offer new alternatives for treating complex terminal and bifurcation aneurysms. In this work, a complete workflow going from medical images to post-treatment CFD analysis is described and used in the assessment of a concrete clinical problem.

Physiological SIM platform
Neurovascular
Preliminary in vitro angiographic comparison of the flow diversion behavior of Evolve and Pipeline devices

Flow diverters are increasingly used to treat a broad category of cerebral aneurysms. We conducted an in vitro study to angiographically compare the flow diversion effect of Surpass Evolve from Stryker Neurovascular with the Pipeline Shield Embolization Device from Medtronic Neurovascular.

Virtual SIM platforms
Neurovascular
Differences in beginner and expert neurointerventionalists" heart rate variability during simulated neuroangiographies

Likewise work experience, heart rate variability (HRV) has repeatedly been correlated with improved performance under real life and simulator conditions. Using HRV as a correlate of workload, it is meaningful to assess the impact of work experience. To understand the impact of work experience on HRV metrics, we examined differences in HRV among experts and beginners during simulated endovascular neuroradiological procedures.

ANKYRAS
Neurovascular
Software-based simulation for preprocedural assessment of braided stent sizing: a validation study

Validate the use of a software-based simulation for pre-assessment of braided self-expanding stents in the treatment of wide-necked intracranial aneurysms

Physiological SIM platform
Neurovascular
Physical Simulators and Replicators in Endovascular Neurosurgery Training - Short Guide - Comprehensive Healthcare Simulation: Neurosurgery 

The increased adoption of endovascular neurosurgery procedures to treat cerebrovascular pathologies has led to the commercialization of a wide array of medical devices which, in turn, necessitates a more sophisticated training environment for physicians and fellows than the traditional “see one, do one, teach one” concept. Improvements in simulation technology and a changing healthcare culture are facilitating a wider assimilation of benchtop simulation models in lieu of cadaver or animal models in physician training as well as treatment planning. Medical device manufacturers as well as regulators are also increasingly utilizing such simulators for device development and assessment of efficacy.

Virtual SIM platforms
Neurovascular
Learning curves and reliability measures for virtual reality simulation in the performance assessment of carotid angiography

Improvement in performance as measured by metric-based procedural errors must be demonstrated if virtual reality (VR) simulation is to be used as a valid means of proficiency assessment and improvement in procedural-based medical skills.

ANKYRAS
Neurovascular
Early Results in Flow Diverter Sizing by Computational Simulation: Quantification of Size Change and Simulation Error Assessment

Sizing of flow diverters (FDs) stent in the treatment of intracranial aneurysms is a challenging task due to the change of stent length after implantation

Virtual SIM platforms
Neurovascular
Metric based virtual simulation training for endovascular thrombectomy improves interventional neuroradiologists' simulator performance

Metric based virtual reality simulation training may enhance the capability of interventional neuroradiologists (INR) to perform endovascular thrombectomy. As pilot for a national simulation study we examined the feasibility and utility of simulated endovascular thrombectomy procedures on a virtual reality (VR) simulator.

Virtual SIM platforms
Neurovascular
Virtual reality simulation objectively differentiates level of carotid stent experience in experienced interventionalists

Technical proficiency in carotid artery stent (CAS) procedures is paramount to ensure patient safety. If virtual reality (VR) simulation is to be used as a valid means for credentialing physicians for CAS procedures, the assessment parameters must be able to evaluate the performance during CAS and to differentiate level of CAS experience. The aim of this study was to validate assessment parameters of a commercially available VR simulator (VIST, Vascular Interventional Surgical Trainer, Mentice, Gothenburg, Sweden) during a CAS procedure in experienced interventionalists.

ANKYRAS
Neurovascular
Deployment of flow diverter devices: prediction of foreshortening and validation of the simulation in 18 clinical cases

Flow diverter (FD) devices show severe shortening during deployment in dependency of the vessel geometry. Valid information regarding the geometry of the targeted vessel is therefore mandatory for correct device selection, and to avoid complications. But the geometry of diseased tortuous intracranial vessels cannot be measured accurately with standard methods. The goal of this study is to prove the accuracy of a novel virtual stenting method in prediction of the behavior of a FD in an individual vessel geometry.

ANKYRAS
Neurovascular
ID-Fit: Intra-Saccular Device Adjustment for Personalized Cerebral Aneurysm Treatment

Intrasaccular devices, like Woven EndoBridge (WEB), are novel braided devices employed for the treatment of aneurysms with a complex shape and location, mostly terminal aneurysms. Such aneurysms are often challenging or impossible to treat with other endovascular techniques such as coils, stents, flow diverter stents.

ANKYRAS
Neurovascular
A robustness test of the braided device foreshortening algorithm

Different computational methods have been recently proposed to simulate the virtual deployment of a braided stent inside a patient vasculature. Those methods are primarily based on the segmentation of the region of interest to obtain the local vessel morphology descriptors. The goal of this work is to evaluate the influence of the segmentation quality on the method named "Braided Device Foreshortening" (BDF).

Virtual SIM platforms
Neurovascular
Cardiovascular
Peripheral Vascular
Increasing face validity of a vascular interventional training system

Many aspects of medical training take place on real patients in a live environment thus incurring risk. Apart from the obvious risks to patients there is the issue of X-ray exposure to both staff and trainees. Image quality used during interventional procedures is low to ensure minimum X-ray radiation dose. A virtual interventional system may be used to simulate the interventional cardiology training environment therefore reducing overall risk.

ANKYRAS
Neurovascular
Porosity distribution upon the surface of a deployed flow diverter: an experimental and simulation study

Flow diverters are widely extended in clinical practice for intracraneal aneurysms treatment. They are formed by a dense mesh of braided wires that partially occludes the aneurysm neck and restores the blood flow into the parent vessel. The occlusion degree is highly dependant on the distribution of the wires under the aneurysm, which is affected by the vessel geometry. Nowadays, there are no clinical indicators of the covering ratio once the flow diverter is deployed. We propose a novel method for the simulation of the flow diverter local porosity before its deployment into the parent vessel. We validate the method on curved silicon models, obtaining a correlation of 0.9 between the simulated values and the measured porosity on the deployed flow diverter.

Virtual SIM platforms
Neurovascular
Simulation Training in Neuroangiography—Validation and Effectiveness

Simulators are increasingly used in the training of endovascular procedures; however, for the use of the Mentice vascular interventional system trainer (VIST) simulator in neuroradiology, the validity of the method has not yet been proven. The study was carried out to test the construct validity of such a simulator by demonstrating differences between beginner and expert neurointerventionalists and to evaluate whether a training effect can be demonstrated in repeated cases for different levels of experience.