ANGIO Mentor Clinical Validations

Training with simulation versus operative room attendance.

Desender LM, Van Herzeele I, Aggarwal R, Vermassen FE, Cheshire NJ.

Department of Thoracic and Vascular Surgery, University Hospital Ghent, Ghent, Belgium.

J Cardiovasc Surg (Torino). 2011 Feb;52(1):17-37.

Reduced training times, increasing complexity of endovascular and open vascular interventions and concerns for patient’s safety have necessitated a modernization in surgical training. A more strategic approach is required to facilitate the acquisition of surgical skills outside the operating room and to minimize the risks to patients as surgeons develop their technical expertise. Virtual reality simulation has been proposed as a means to train and objectively assess technical endovascular performance without risks to patient safety. This article reviews the evidence and the limitations for this adjunctive tool, the implementation in current training programs and future applications to maintain the highest standards of care for treatment of vascular disease.

Simulation in Neurosurgical Residency Training: A New Paradigm

Alejandro M. Spiotta, MD Richard P. Schlenk, MD

The Cleveland Clinic Foundation, Cleveland, Ohio, USA

The Congress of Neurological Surgeons(CNS) Quarterly 2010 page 18-20

In the era of duty hour restrictions and increasing medico-legal pressures, surgical simulation offers a viable alternative to bridge the gap in experience and knowledge of residents. The value of simulation for the re-creation of invasive procedures has a rich history in cadaveric dissection and animal experimentation. While these exposures provide a valuable experience and do not require sophisticated technological support, cadavers and laboratory animals are a scarce and expensive resource. Three years ago, we established a ‘fundamental skills laboratory’ funded by educational grant support. The course was run by our faculty and senior level residents and provided an educational experience to the junior level residents. The course involved intensive hands-on exercises designed to familiarize the trainees with fundamental bedside procedures and operative skills such as external ventricular drain and intracranial pressure bolt placement, suturing, drilling and turning a craniotomy flap. This course was extremely successful and was the forerunner to the SNS Boot Camp that will be offered for its second consecutive year in July 2011 for all incoming post-graduate graduate year 1 (PGY1) neurosurgery residents.

Virtual Reality Simulation in the Endovascular Field

Aggarwal Rajesh , Herzeele Isabelle Van

European Virtual Reality Endovascular Research Team (EVEREST)

US Cardiology, 2008;5(1):41-5

The last decade has witnessed exponential growth in the field of endovascular interventions, although only in the last few years has there been a widespread interest in the carotid artery stent (CAS). Endovascular physicians with different medical backgrounds such as interventional cardiologists, radiologists, and vascular surgeons all recognize the importance of this changing technology.1This procedure is almost unique, as the risks to the patient (stroke and death) as a result of the physician’s learning curve are unacceptably high. This has been summarized by editorials written after the publication of the Carotid and Vertebral Artery Angioplasty Study (CAVATAS)2–4 and the Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis trial (EVA-3S).5–7 Recent publications of the rates of medical errors and adverse events within healthcare8 have drawn the spotlight toward methods of establishing credentials for physicians preparing to perform complex procedures. In order to improve patient safety, operators must have the appropriate cognitive and technical skills and experience of CAS. Furthermore, physicians should have previously achieved a high level of proficiency in other catheter-based interventions and completed dedicated training in CAS.9

The Utility of Endovascular Simulation to Improve Technical Performance and Stimulate Continued Interest of Preclinical Medical Students in Vascular Surgery

Jason T. Lee , Mary Qiu , Mediget Teshome, Shyam S. Raghavan, Maureen M. Tedesco, and Ronald L. Dalman

Division of Vascular Surgery, Stanford University School of Medicine, Stanford, California

Journal of Surgical Education Volume 66, Issue 6, November-December 2009, Pages 367-373 Available online 30 January 2010.

Presented at the Association for Program Directors in Surgery/Association for Program Directors in Vascular Surgery Meeting, April 30, 2009, Salt Lake City, UT.

Objective: New training paradigms in vascular surgery allow for early specialization out of medical school. Surgical simulation has emerged as an educational tool for trainees to practice procedures in a controlled environment allowing interested medical students to perform procedures without compromising patient safety. The purpose of this study is to assess the ability of a simulation-based curriculum to improve the technical performance and interest level of medical students in vascular surgery.

Design: Prospective observational cohort study of medical student performance.

Setting: Academic medical center.

Participants: Forty-one medical students (23 first year, 15 second year, 3 other) enrolled in a vascular surgery elective course. Students completed a survey of their interests and performed a renal stent procedure on an endovascular simulator (pretest). The curriculum consisted of didactic teaching and weekly mentored simulator sessions and concluded with a final renal stent procedure on the simulator (posttest). Objective procedural measures were determined during the pre- and posttest by the simulator, and subjective performance was graded by expert observers utilizing a structured global assessment scale. After the course, the students were surveyed as to their opinions about vascular surgery as a career option. Finally, 1 year after the course, all students were again surveyed to determine continued interest in vascular surgery.

Results: The objective and subjective criteria measured on the simulator and structured global assessment scale significantly improved from pre- to posttest in terms of performer technical skill, patient safety measures, and structured global assessments. Before beginning the course, 8.5% of the students expressed high interest in vascular surgery, and after completing the course 70% were seriously considering vascular surgery as a career option (p = 0.0001). More than 95% of the students responded that endovascular simulation increased their knowledge and interest in vascular surgery. In the 1-year follow-up survey (n = 23 medical students), 35% had already entered their clinical years. Seventy percent of the students were still considering vascular surgery, while several other career options were still popular including the surgical subspecialties (70%), interventional cardiology (57%), and interventional radiology (48%). Most respondents indicated the major reasons for continued interest in vascular surgery were the ability to practice endovascular procedures on the simulator (100%) and mentorship from vascular surgery faculty (78%).

Conclusions: The use of high fidelity endovascular simulation within an introductory vascular surgery course improves medical student performance with respect to technical skill, patient safety parameters, and global performance assessment. Mentored exposure to endovascular procedures on the simulator positively impacts long term medical student attitudes towards vascular surgery. Simulator-based courses may have the potential to be an important component in the assessment and recruitment of medical students for future surgical training programs.

Experienced Endovascular Interventionalists Objectively Improve their Skills by Attending Carotid Artery Stent Training Courses

Van Herzeele I, Aggarwal R, Neequaye S, Hamady M, Cleveland T, Darzi A, Cheshire N, Gaines P.

Department of Biosurgery and Surgical Technology, Imperial College London, UK; Regional Vascular Unit, St. Mary’s Hospital, London, UK.

Eur J Vasc Endovasc Surg. 2008 May;35(5):541-50. Epub 2008 Feb 8.

Objectives: Carotid artery stenting (CAS) is an advanced endovascular intervention with a steep learning curve. Virtual reality (VR) simulation has been proposed as a means to train and objectively assess technical performance. AIM: To objectively assess psychomotor skills acquisition of experienced interventionalists attending a two-day CAS course, using a VR simulator.

Methods: Both cognitive and technical skills of 11 interventionalists were trained in a two-day course using didactic sessions, case reviews, supervised VR simulation and live-cases. Pre- and post-course skills were assessed through performance on the same CAS procedure using metrics derived from the simulator.

Results: Significant differences were noted between pre- and post-course performance for procedure (36 vs. 20min., p=0.005), X-ray (20 vs. 11min., p=0.016) and delivery-retrieval time of the embolic protection device (12 vs. 9min., p=0.007). Advancement of the guiding catheter without a leading wire occurred to a greater extent pre- versus post-course (199 vs. 152mm., p=0.050) as did spasm of the internal carotid artery (4 vs. 2, p=0.049).

Conclusions: This study has objectively proven a benefit for experienced interventionalists to attend CAS courses for skills acquisition measured by a VR simulator. These data can be used to offer participants an insight into their skills and objectively audit course efficacy.

The following abstract was presented in the prize session of the European Society for Vascular Surgery (ESVS) Annual Meeting September 20 – 23, 2007 in Madrid, Spain

Experienced Endovascular Interventionalists Objectively Improve their Skills by Attending Carotid Artery Stent Training Courses

S. Neequaye, I. Van Herzeele, R. Aggarwal, M. Hamady, A. Darzi, T. Cleveland, P. Gaines, N. Cheshire

Department of Biosurgery and Surgical Technology, Imperial College London, U.K.

Objective: Carotid artery stenting is an advanced endovascular intervention with a steep learning curve. Its success is tempered by the need to ensure that all interventionalists possess technical proficiency prior to performing cases on patients. Virtual reality simulation has been proposed as a means to train and objectively assess technical performance without risks to patient safety. The aim of this study was, using a commercially available simulator, to objectively assess psychomotor skills acquisition of experienced interventionalists attending a two-day carotid artery stent course.

Methods: Eleven experienced endovascular physicians from several medical disciplines with minimal experience in carotid artery stenting participated in this study. During two identical two-day courses, cognitive and technical skills were trained using didactic sessions, case reviews, supervised VR simulation and live-cases. Pre- and post-course skills were assessed through performance on the same carotid artery stent procedure using the quantitative and qualitative assessment parameters derived from the simulator. The Wilcoxon signed ranks test was used to compare performance across the two groups.

Results: Significant differences were noted between pre- and post-course performance for total procedure time (medians 36 vs. 20 minutes, p=0.005), fluoroscopic time (20 vs. 11 minutes, p= 0.016) and delivery-retrieval time of the embolic protection device (12 vs. 9 minutes, p= 0.007). Advancement of the guiding catheter or guiding sheath without a leading wire occurred to a greater extent pre-course versus post-course (199 vs. 152 millimetres, p= 0.050) as did spasm of the internal carotid artery (4 vs. 2, p= 0.049).

Conclusions: This study has objectively proven a benefit for experienced interventionalists to attend carotid artery stenting courses for skills acquisition measured by a virtual reality simulator. In addition to providing participants with an insight into their skills, these data can be used to objectively audit course efficacy.

Analysis of Simulated Angiographic Procedures. Part 2: Extracting Efficiency Data from Audio and Video Recordings

Duncan JR, Kline B, Glaiberman CB.

Mallinckrodt Institute of Radiology, Washington University School of Medicine, 510 S. Kingshighway Blvd., St. Louis, MO 63110, USA.
J Vasc Interv Radiol. 2007 Apr;18(4):535-44

Purpose: To create and test methods of extracting efficiency data from recordings of simulated renal stent procedures.

Materials and Methods: Task analysis was performed and used to design a standardized testing protocol. Five experienced angiographers then performed 16 renal stent simulations using the Simbionix AngioMentor angiographic simulator. Audio and video recordings of these simulations were captured from multiple vantage points. The recordings were synchronized and compiled. A series of efficiency metrics (procedure time, contrast volume, and tool use) were then extracted from the recordings. The intraobserver and interobserver variability of these individual metrics was also assessed. The metrics were converted to costs and aggregated to determine the fixed and variable costs of a procedure segment or the entire procedure.

Results: Task analysis and pilot testing led to a standardized testing protocol suitable for performance assessment. Task analysis also identified seven checkpoints that divided the renal stent simulations into six segments. Efficiency metrics for these different segments were extracted from the recordings and showed excellent intra- and interobserver correlations. Analysis of the individual and aggregated efficiency metrics demonstrated large differences between segments as well as between different angiographers. These differences persisted when efficiency was expressed as either total or variable costs.

Conclusions: Task analysis facilitated both protocol development and data analysis. Efficiency metrics were readily extracted from recordings of simulated procedures. Aggregating the metrics and dividing the procedure into segments revealed potential insights that could be easily overlooked because the simulator currently does not attempt to aggregate the metrics and only provides data derived from the entire procedure. The data indicate that analysis of simulated angiographic procedures will be a powerful method of assessing performance in interventional radiology.

The Use of Interventional Cardiovascular Simulation to Evaluate Operator Performance: The Carotid Assessment of Operator Performance by the Simbionix Carotid StEnting Simulator Study (ASSESS)

Giora Weisz, Jacque Devaud, Stephen Ramee, Mark Reisman, William Gray

Cardiovascular Research Foundation, and Center for Interventional Vascular Simulation, New-York Presbyterian Hospital, Columbia University, New York, NY

Journal of the Society for Simulation in Healthcare 2007, Volume2, Issue 1

Background: The percutaneous endovascular carotid stenting procedure has only recently been approved by the FDA, and interventional operators from multiple disciplines (Cardiology, Radiology, Vascular Surgery) are getting training in this field. The professional societies of these disciplines are looking for novel ways to assess the competency of an operator, before they grant authorization to perform this complex procedure.
Simulators have been suggested as tools to evaluate operators in specific procedures and operative techniques. The virtual reality machines can be used to capture numerous factors that translate into the success and safety of the procedure. These include selection of devices, accuracy of manual performance, reaction to interactive problems, use of adjuvant pharmacotherapy, management of hemodynamic changes, and prevention and resolution of complications. All of these can be automatically evaluated and scored by a complex software designed virtual reality simulator. The simulators that are used in Interventional Cardiology and endovascular therapy have not been validated yet as such assessment tool.

Objective: The main objective of the ASSESS study is to validate the simulator-based metrics as a tool to discriminate between different levels of operators.

Methods: We used the Angio-Mentor carotid Stenting simulator system (Simbionix). The simulators had been loaded with predefined cases demonstrating increasing complexity for stenting intervention.
Total of 34 operators (10 experts, 12 intermediate level, and 12 novice; based on prior reported experience) were asked each to do three cases of carotid stenting on the simulator. All the operators had the same cases that were selected to demonstrate increased complexity to judge anatomy, correct performance of the technical steps, use of wires, catheters, embolic protection device, balloons, and stents, adjuvant pharmacotherapy, and management of interactive hemodynamic response. During the procedure, multiple features of all of the above elements were automatically captured by the simulator. Each step and parameter captured had a pre-defined score. Scoring was based on penalty points for mal-performance, as pre-defined by a panel of independent experts in carotid stenting, prior to conducting the study.

Results: The study has been completed, and all the data that were captured is being analyzed. Full results will be available at the time of the presentation

Conclusions: Being able to demonstrate the ability of a hi-tech, virtual reality simulator to differentiate between different levels of interventional operators, may enlighten the simulator as a potential objective “examination tool”, to evaluate the performance and competence of an interventional operator. These will justify the use of Interventional Cardiovascular Simulation for certification and credentialing