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.

Front Neurol . 2022 Sep 27;13:742263
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.

J Neurointerv Surg . 2018 May;10(5):500-504
Virtual SIM platforms
Neurovascular
Metric-Based Virtual Reality Simulation A Paradigm Shift in Training for Mechanical Thrombectomy in Acute Stroke

AHA, Stroke. 2018;49:e239–e242
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.

Clin Neuroradiol . 2021 Jun;31(2):465-473
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.

Proceedings of the SPIE, Volume 10160, id. 101601C 10 pp. (2017).
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.

BMJ Simul Technol Enhanc Learn . 2016 Feb 8;2(1):1-5
October 11, 2022
Neurovascular
Virtual SIM platforms
Radial Access Simulation Using Mentice

World Neurosurg . 2022 Feb;158:314-315.
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.

Journal of NeuroInterventional Surgery 2016;8:A89-A90.
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.

Rofo . 2019 Jun;191(6):547-552.
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.

Int J Comput Assist Radiol Surg . 2015 Oct;10(10):1659-65
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.

Med Phys . 2016 Mar;43(3):1324-34.
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.

Comput Biol Med . 2022 Aug;147:105744.
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.

J Neurosurg Pediatr . 2018 Dec 1;22(6):672-677
Virtual SIM platforms
Peripheral Vascular
Operators believe patient-specific rehearsal improve individual and team performance

Rehearsing endovascular aortic aneurysm repair on patient-specific data is recent within virtual reality simulation and opens up new possibilities for operators to prepare for complex procedures. This study evaluated the feasibility of patient-specific rehearsal (PsR) and assessed operators' appraisal of the VIST-LAB simulator from Mentice.

Minim Invasive Ther Allied Technol . 2022 Jan;31(1):149-158.
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.

Front Med Technol . 2021 Sep 17;3:705003
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.

PLoS One . 2016 Feb 5;11(2):e0148694
Virtual SIM platforms
Peripheral Vascular
Endovascular repair of ruptured abdominal aortic aneurysm: technical and team training in an immersive virtual reality environment

This study evaluates a fully immersive simulated angiosuite for training and assessment of technical endovascular and human factor skills during a crisis scenario.

Cardiovasc Intervent Radiol . 2014 Aug;37(4):920-7
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.

Int J Comput Assist Radiol Surg . 2021 Oct;16(10):1663-1673
Peripheral Vascular
Virtual SIM platforms
Endovascular simulation training: a tool to increase enthusiasm for interventional radiology among medical students

Interventional radiology (IR) is a growing field but is underrepresented in most medical school curricula. We tested whether endovascular simulator training improves medical students' attitudes towards IR.

Eur Radiol . 2020 Aug;30(8):4656-4663
Physiological SIM platform
Realistic Vascular Replicator for TAVR Procedures

Transcatheter aortic valve replacement (TAVR) is an over-the-wire procedure for treatment of severe aortic stenosis (AS). TAVR valves are conventionally tested using simplified left heart simulators (LHS). While those provide baseline performance reliably, their aortic root geometries are far from the anatomical in situ configuration, often overestimating the valves’ performance. We report on a novel benchtop patient-specific arterial replicator designed for testing TAVR and training interventional cardiologists in the procedure. The Replicator is an accurate model of the human upper body vasculature for training physicians in percutaneous interventions.

Cardiovasc Eng Tech 9, 339–350 (2018).
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.

J Neurointerv Surg . 2020 Jun;12(6):616-620
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.

Interv Neuroradiol . 2022 Sep 19;15910199221128439
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

JNS, Volume 131: Issue 5, 1423–1429, 09 Nov 2018
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.

Comprehensive Healthcare Simulation (CHS)
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.

J Am Coll Cardiol . 2006 May 2;47(9):1796-802
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

Oper Neurosurg (Hagerstown) . 2018 Nov 1;15(5):557-566.
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.

Interv Neuroradiol . 2022 Jul 13;15910199221113902
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.

J Vasc Surg . 2007 Nov;46(5):855-63
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.

Neuroradiology . 2019 Nov;61(11):1319-1326.
Virtual SIM platforms
Peripheral Vascular
Simulation-based endovascular skills assessment: the future of credentialing?

Simulator-based endovascular skills training measurably improves performance in catheter-based image-guided interventions. The purpose of this study was to determine whether structured global performance assessment during endovascular simulation correlated well with trainee-reported procedural skill and prior experience level.

J Vasc Surg . 2008 May;47(5):1008-1
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.

Springer International Publishing, Medical Image Computing and Computer Assisted Intervention – MICCAI 2020
Virtual SIM platforms
Cardiovascular
Use of Simulator-Based Teaching to Improve Medical Students' Knowledge and Competencies: Randomized Controlled Trial

Simulator-based teaching for coronary angiography (CA) is an attractive educational tool for medical students to improve their knowledge and skills. Its pedagogical impact has not been fully evaluated yet.

J Med Internet Res . 2018 Sep 24;20(9):e261.
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).

Proc. SPIE 10572, 13th International Conference on Medical Information Processing and Analysis, 105721H (17 November 2017);
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.

Stud Health Technol Inform . 2004;98:410-5
Virtual SIM platforms
Peripheral Vascular
Simulation in training: one-year experience using an efficiency index to assess interventional radiology fellow training status

To compare objective fellow and expert efficiency indices for an interventional radiology renal artery stenosis skill set with the use of a high-fidelity simulator.

J Vasc Interv Radiol . 2008 Sep;19(9)
Virtual SIM platforms
Peripheral Vascular
Cognitive training improves clinically relevant outcomes during simulated endovascular procedures

Virtual reality (VR) simulation has been suggested to objectively assess endovascular skills. The aim of this study was to determine the impact of cognitive training on technical performance of inexperienced subjects on a commercially available VR simulator (VIST, Vascular Intervention Simulation Trainer, Mentice, Gothenburg, Sweden).

J Vasc Surg . 2008 Nov;48(5)
Virtual SIM platforms
Cardiovascular
Simulator training reduces radiation exposure and improves trainees' performance in placing electrophysiologic catheters during patient-based procedures

Currently, training in interventional electrophysiology is based on conventional methodologies, and a paucity of data on the usefulness of simulation in this field is available.

Heart Rhythm . 2012 Aug;9(8):1280-5
Virtual SIM platforms
Peripheral Vascular
Virtual interventional radiology: evaluation of performances as a function of experience

To determine the value of an angioplasty simulation to differentiate the users based on their level of experience. To determine the perceived usefulness of an angioplasty simulation program.

J Radiol . 2009 Jan;90(1 Pt 1):37-41
Virtual SIM platforms
Peripheral Vascular
Simulation-Based Virtual-Reality Patient-Specific Rehearsal Prior to Endovascular Procedures: A Systematic Review

Patient-specific rehearsal (PsR) is a new concept whereby a procedure can be rehearsed virtually using the exact patient’s anatomical data prior to performing the real procedure. The aim of this study was to ascertain if endovascular virtual-reality PsR simulation enhanced performance in real life. This was done by performing a systematic review following the preferred reporting items for systematic reviews and meta-analysis (PRISMA) guidelines.

Procedures: A Systematic Review. Diagnostics. 2020; 10(7):500.
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.

Clin Neuroradiol 31, 465–473 (2021)

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