| | Virtual reality simulation objectively differentiates level of carotid stent experience in experienced interventionalistsPresented at the Twenty-Fourth Meeting of the Vascular Society of Great Britain and Ireland, Edinburgh, UK, Nov 24, 2006. Received 27 April 2007; accepted 11 June 2007. ObjectivesTechnical 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. MethodsForty-five interventionalists (cardiologists, radiologists, vascular surgeons) who had performed at least 100 endovascular therapeutic cases, with varying experience in CAS were recruited: groups A, n = 12 (0 CAS procedures), B, n = 12 (1to 20 CAS), C, n = 10 (21 to 50 CAS) and D, n = 11 (>50 CAS). All subjects performed a standard CAS procedure with a type I arch and were assessed by quantitative (procedure time, amount of contrast given, number of cineloops recorded, fluoroscopic time) and qualitative (clinical parameters and errors) metrics of the simulator. Participants also rated the realism and training potential of the simulator on a scale from 1 (poor) to 5 (excellent). ResultsThere were significant differences across the four groups A to D for procedure time (medians 20.5 vs 24 vs 19 vs 16 minutes, P = .002) and fluoroscopic time (12.5 vs 13 vs 10 vs 7 minutes, P < .001), respectively. Total numbers of errors recorded by the VR simulator did not achieve statistical significance (P = .209) across the four groups. All subjects rated the simulator highly (median 4) in terms of realism and training potential. ConclusionsTotal time and fluoroscopic time both recorded by a realistic VR simulator differentiate between levels of CAS experience in experienced interventionalists. Error scoring is currently not a valid mode of assessment and needs refinement. The last decade has witnessed an exponential growth in the field of endovascular arterial interventions, though only in the last few years has there been widespread interest in carotid artery stent (CAS). Interventional cardiologists, neurologists, radiologists, and vascular surgeons recognize the significance of this changing technology and have initiated prospective randomized studies with rigorous oversight to help guide the issues surrounding CAS.1 CAS has a definite learning curve as evidenced by the reduced number of procedure-related complications, fluoroscopic time, and contrast volume that occur in clinical practice as a result of increase in physician experience.2, 3 This procedure is almost unique since the risks to the patient as a result of the physicians’ learning curve are unacceptably high as demonstrated in the Endarterectomy vs Angioplasty in Patients with Symptomatic Severe Carotid Stenosis trial (EVA-3S).4 Traditional methods designed to ensure initial competence have focused on meeting a minimum number of procedures performed and on the duration of training, inappropriately correlating experience with expertise.5 Recent publications of the rates of medical errors6 and adverse events within healthcare have drawn the spotlight toward the method of credentialing physicians to perform the procedures independently. What is needed, given the complexities and risks of CAS and the competing and conflicting interests of the physicians across several subspecialties, is a standardized and objective manner to assess procedural performance. The Food and Drug Administration (FDA) reported in April 2004 that simulation might be beneficial as part of a training package prior to granting privileges for a physician to perform a CAS procedure on a real patient.7 Virtual reality (VR) simulation has proven in other fields such as aviation and in other surgical specialities to be able to objectively assess technical performance without risk to patient safety8, 9 and subsequently to define benchmark levels of skills.10 Simulation offers the possibility to train in an educationally-orientated environment with less time and cost pressures of learning new skills than in the clinical area.11 Importantly, VR may potentially allow access to a wide variety of clinical scenarios such as rare but important adverse clinical events, enables immediate feedback and permits repetition of the procedures until proficiency levels are reached prior to performing the procedure in real life.12 As demonstrated in the laparoscopic field, a stepwise, structured and proficiency-based training curriculum can be defined, and can be useful as a mode of credentialing prior to operating on real patients.13 However, this has yet to be scientifically proven for interventional vascular procedural simulations. Prior to assessment and training of subjects the validity of the simulator needs to be demonstrated. Face validity is the extent to which the model resembles real life situations and content validity is the extent to which the domain that is being measured is measured by the assessment tool, for example, while trying to assess technical endovascular skills, we may actually be testing anatomical knowledge. Construct validity is a test to which a test measures the trait that it purports to measure namely whether the carotid module of the simulator can distinguish between various levels of CAS experience.8 This study aims to determine the face and construct validity of the carotid VR module on a commercially available simulator (VIST, Vascular Interventional Surgical Trainer, Mentice, Gothenburg, Sweden). Methods  Subjects Forty five interventionalists (nine cardiologists, 13 radiologists, 23 vascular surgeons) experienced in endovascular procedures (>100 therapeutic cases) were recruited to the study at international meetings and at the simulation laboratory of Imperial College, London. After treating the same simulated carotid artery lesion, all subjects completed a questionnaire to determine their endovascular and CAS experience. They were arbitrarily divided into four groups, based upon their experience in CAS procedures. As agreed in the literature, physicians who had performed more than 50 CAS procedures were regarded as highly experienced:5 12 participants had never performed a CAS procedure (group A: 0 CAS), 12 interventionalists had some experience in CAS (group B: 1 to 20 CAS), 10 had performed a moderate number of CAS procedures (group C: 21 to 50 CAS) and 11 had extensive experience in the field of CAS (group D: >50 CAS). The participants rated the realism and training potential (face validity) of the simulator on a Likert scale from 1 (poor) through to 5 (excellent) (Fig 1). Ethics approval was not necessary for this study but all participants gave informed consent. Simulation device The virtual reality simulator (VIST) is a device consisting of a personal computer-based software interface (Procedicus, Mentice AB, Gothenburg, Sweden), two flat-panel monitors coupled to a mechanical interface device (haptics unit) that allows the user to insert and manipulate wires, catheters, balloons, stents, and an embolic protection device. The interface device is designed to be the virtual patient with a simulated groin. The subject begins the procedure by selecting the specific tool(s) to be used during the simulation, inserts this into the user interface, and a fluoroscopic image (activated with a foot pedal) is subsequently displayed together with the virtual tool, which has been selected. Separate controllers for simulated stent deployment, balloon inflation, and contrast material injection are provided. User interface functions include table movement, fluoroscopic C-arm positioning, cine-loop recording, and road mapping. Task performed At the commencement of the study, didactic teaching regarding the VIST simulator was performed. All subjects were familiarized to the VR simulator by treating a simple simulated ipsilateral common iliac artery lesion. Next, the available endovascular materials and the patient’s journal showing the carotid lesion were explained. A right internal carotid artery angioplasty and stent procedure was chosen with an easily accessible arch (type I arch) and a stenosis limited to the proximal internal carotid artery. This study aimed to test the endovascular skills rather than procedural knowledge, so for less experienced subjects in CAS, a protocol was available explaining the different steps of a CAS procedure. During the same simulated iliac and CAS procedure, passive assistance was provided by an interventional team: assistant, radiographer, circulating nurse. Appropriate endovascular tools were selected when asked for, orientation of the C-arm was changed if necessary, and an assistant was ready to help out when requested, for example to select the correct size of embolic protection device (EPD). A ruler is available but can not be moved, and, therefore, only provides a crude assessment of diameter of an artery. Performance evaluation The VR simulator assesses performance by recording metrics objectively and instantly. At the end of each task, a performance report is available, which can be used for further analysis. During each simulated carotid procedure, quantitative and qualitative metrics are recorded. An overview is given in Table I. The quantitative metrics recorded for this study were procedure time (PT), contrast volume, number of performed angiograms, and fluoroscopic time (FT). The qualitative metrics registered by the VR simulator were either clinical parameters or errors: catheter errors and procedure-specific errors. This study aimed to investigate the construct validity of the carotid module based on these assessment parameters recorded by the VIST simulator. | | |  | Quantitative metrics | Qualitative metrics | |
|---|
| Errors | Clinical parameters | |
|---|
| Total time (minutes) | Catheter vessel errors-pressing diagnostic catheter against the wall -pressing guiding catheter against the wall | Used tools during procedure-diagnostic catheter -guiding catheter or sheath -EPD size/angle tip -predilation balloon size/length -stent size/length -postdilation balloon size/length | | | Total amount of contrast fluid used (cc) | Catheter movement errors-moving diagnostic catheter without support of a guide wire -moving guiding catheter without support of a guide wire | Placement accuracy-predilation balloon -stent -postdilation balloon | | | Number of cineloops | Moving near lesion-moving guide wire near lesion -moving diagnostic catheter near lesion -moving guiding catheter near lesion | % Lesion covered with | | | Total fluoroscope time (minutes) | Moving EPD-during deployment -after deployment | Balloon-vessel ratio | | | | Deployment of stent-moving stent during deployment -in guiding catheter or sheath | Max pressure reached during deployment | | | | Balloon inflated in guiding catheter or sheath | Residual stenosis after-predilation -stent -postdilation | | | | |
Statistical analysis Data were analyzed with the Statistical Package for the Social Sciences version 12.0 (SPSS, Chicago, Ill) using nonparametric tests. Comparisons of performance for continuous variables across the four groups were undertaken using the Kruskall Wallis test. Comparisons of performance between two groups for continuous variables were undertaken using the Mann-Whitney U test, for categorical variables the Fisher exact test was used. A level of P < .05 was considered to be statistically significant. Results Demographic details and experience level of the participants are summarized in Table II. Sixty four percent had performed >500 endovascular procedures as a primary operator. The higher experienced in CAS, the more likely the subject was to be advanced in endovascular therapeutic procedures (P < .001, Fisher exact). With regards to assessment parameters derived from the simulator, data was not available from two participants (1 in group B and 1 in group C) due to technical difficulties. Only two highly experienced subjects in CAS (group D) were familiar with this VR simulator. Comparisons between the four groups in the remaining 43 subjects revealed significant differences across groups A, n = 12 (0 CAS procedures), B, n = 11 (1 to 20), C, n = 9 (21 to 0) and D, n = 11 (>50) for procedure time (median 20.5 vs 24 vs 19 vs 16 min P = .002), fluoroscopy time (median 12.5 vs 13 vs 10 vs 7 min P < .001) and number of performed angiograms (arch and selective angiogram) (median 3.5 vs 5 vs 6 vs 3 P =.038) to complete the procedure (Fig 2, Fig 3, Fig 4). Post-hoc analysis, as shown in Table III revealed that the simulator was only able to differentiate group D from all other groups for the three valid quantitative assessment parameters but these metrics were not statistically different between groups A-B, A-C, and B-D. | | | | Number of CAS | Number of endovascular procedures | Number of subjects | |
|---|
| 0 | >100 | 9 | | | >500 | 3 | | | 1-20 | >100 | 6 | | | >500 | 6 | | | 21-50 | >100 | 1 | | | >500 | 9 | | | >50 | >500 | 11 | | | Total number of participants | 45 | | | | |
| | | | P value Mann-Whitney U | Procedure time | Number of angiograms | Fluoroscopic time | Total errors recorded by VIST | |
|---|
| Group A | | | | | | |  0 CAS | .007 | .695 | .003 | .116 | | | Group B | | | | | | | 1-20 CAS | <.001 | .028 | <.001 | .699 | | | Group C | | | | | | | 21-50 CAS | .012 | .012 | .003 | .131 | | | | |
The total number of errors (recorded by the VIST simulator) committed did not reach statistical significance (29 vs 21 vs 27 vs 20, P = .209) (Fig 5), not even when comparing the groups in pairs. Clinically relevant parameters such as sizing of the stent (P = .072) or balloon (P = .811), accuracy of stent (P = .745), and balloon (P = .863) placement and residual stenosis (P = .756) were not statistically significantly different (Fig 6). Subjects who had completed >500 endovascular procedures performed the virtual CAS procedure quicker (18 minutes vs. 22.5 minutes, P = .007) and used less often fluoroscopy (9 minutes vs 13 minutes, P = .024) than those who had performed 100 to 500 endovascular procedures as the primary operator (Fig 7, Fig 8). The participants rated the realism and training potential of the carotid module of the simulator on a Likert scale from 1 (poor) to 5 (excellent). All groups, independently of their CAS experience, including the highly experienced group agreed that this simulator is a realistic model (median 4) with good force feedback (median 4). They agreed that all interventionalists should train on the model prior to performing real procedures on patients (median 4) and 67% of the subjects in group D thought that a minimum of 20 cases should be practiced on the simulator. However, it was noted that vascular surgeons and interventional cardiologists rated the realism and the value of the simulator slightly higher (median score = 4) than the interventional radiologists (median score = 3 till 3.5) when comparing the subjects according with their specialty (vascular surgeon n = 20, cardiologist n = 9 and radiologist n = 12). Discussion This study has proven the construct validity of a realistic high-fidelity VR simulator, namely VIST, is able to objectively differentiate level of CAS experience across four groups of experienced interventionalists based on the quantitative assessment parameters recorded by the VR simulator (procedure time, fluoroscopic time, and number of recorded angiograms). FT in this study during a simulated CAS procedure does not only differentiate but also discriminates the highly from the less experienced physicians since the confidence intervals do not overlap between group D and the less experienced groups. Apart from a handful of commentaries, review articles, or editorials,14 only three papers have sought to assess the construct validity of the carotid module of a VR simulator. These three papers have also shown that the quantitative metrics can differentiate amongst level of endovascular experience.15, 16, 17 But these studies included not only experienced interventionalists, but even novices such as medical students who did not have any basic endovascular skills. Our study on the contrary tried to respect the guidelines of several international societies who stated that CAS procedures should only be performed by interventionalists who have acquired at least basic generic endovascular skills.18, 19 Only subjects who had performed over 100 therapeutic endovascular procedures in other vascular beds as the primary operator, were allowed to participate in this study. The number 100 was chosen arbitrarily in this study since there is no clear-cut definition in the literature of an endovascular experienced interventionalist. One of the limitations of stating target numbers of baseline endovascular experience is that the number of endovascular procedures that a physician has carried out does not automatically guarantee that the physician is an endovascular expert.20 Subjects with a huge endovascular experience (>500 endovascular procedures) perform the procedure quicker and use less radiation compared with the other group (100 to 500 endovascular procedures). These results are to be expected since the more experienced CAS physicians also had performed more endovascular procedures compared with the less experienced groups Table II. Post-hoc analysis of the results demonstrate that the simulator is only able to differentiate the highly experienced group (group D) from the other groups based on these quantitative metrics (except number of angiograms performed comparing group A and D). This might be explained by arbitrarily breaking endovascularly experienced physicians into four groups with minor differences in CAS experience. Nevertheless, since there was still a significant difference between group C and D (only one subject in group C belonged to 100 to 500 group) for the three valid assessment parameters, we can conclude that the VIST simulator can differentiate the highly experienced physicians in CAS from the less experienced groups, and that the difference in performance is not solely influenced by prior endovascular experience (Table III). Additionally, the more experienced the group in CAS was, the greater the consistency of performance in the group. The variability within the inexperienced group (group A) for the three quantitative parameters shows that some tried to perform the CAS procedure as quickly as possible without realizing the dangers of the procedure while others tried to commit as few mistakes as possible but needed more time, fluoroscopic time, and performed more angiograms in order to complete the procedure. This phenomenon probably explains why the quantitative metrics all rose when moving from group A to group B. This observation accounts for the fact that some researchers in the field state that performing a procedure faster and with less fluoroscopy time might only provide a crude assessment of the virtual technical performance.21 To overcome this criticism, the current generation of simulators not only uses quantitative metrics to assess technical performance but also include clinically more relevant parameters and error scoring. To our knowledge, this study is the first to investigate the construct validity of the qualitative metrics of the VIST simulator during a virtual CAS procedure. The clinical parameters such as positioning or sizing of the stent or balloon, do not reach statistical significance in this study. This may have been as a result of assistance given to less experienced subjects in endovascular material selection. But this assistance was necessary because of the lack of an accurate measuring tool available on the VIST simulator. Accuracy of stent placement and residual stenosis are unable to distinguish most likely because all participants were endovascularly experienced. Error definition and recognition is crucial to the safe completion of any interventional procedure and especially in carotid stent procedures since they are fraught with the potential for catastrophic complications such as stroke, or even death. However, in this study error scoring by the VIST simulator is currently not able to differentiate level of CAS experience. Why do none of the error-based assessment parameters validate? There are a number of possible explanations. First, error scores may not have reached statistical significance in this study because of the heterogeneity of the groups. Physicians from different specialties participated in the study that resembles the real life situation. Second, subjects are split arbitrarily into four groups according to the number of performed CAS procedures but that number only resembles the experience of the subject, not necessarily the expertise. In addition, the chosen clinical scenario used in this study may have been too easy: a type I arch configuration with a straight common carotid artery and a lesion located in the proximal right internal carotid artery. A further explanation is that all four groups are endovascularly experienced, 64% of the participants in this study have performed over 500 therapeutic endovascular procedures. Subsequently, the simulator needs to differentiate predominantly between level of technical skill in CAS and not between level of generic endovascular skills. Unfortunately, the used VR simulator registers predominantly guide wire and catheter movement errors and only two procedure-specific errors (movement of EPD during and after deployment). Three other commercially available VR simulators have integrated similar metrics to the VIST simulator (although the definition of the assessment parameters might vary) during a virtual CAS procedure, but also other metrics such as case selection errors and management of complications. Unfortunately to our knowledge, no studies have been published that have tried to assess the construct validity of the carotid module of these VR simulators.22 Follow-up studies will focus on task analysis similar to what has been done in the laparoscopic field.23 The aim for a multidisciplinary team highly experienced in CAS is to define during which task or step of the CAS procedure most mistakes are made and to define and weight the different errors. Currently, each error is regarded as equally important as the other. For example a residual stenosis of less than 30% may be regarded as no mistake whereas the lack of physiological monitoring of the patient during the procedure can be regarded as a life-threatening situation. The failure of the recorded errors to distinguish between the different level of experience may also be explained by the difficulty in “error” definition. There is indeed no standard definition of a medical error, although a working definition is given by Reason “an error is defined as a generic term to encompass all those occasions in which a planned sequence of mental or physical activities fails to achieve its intended outcome”.24 It is relatively simple for a computer to measure quantitative parameters but to define and record an activity that has failed to achieve its intended outcome is difficult even for the human brain to quantify.13 The outcome of both our task analysis and weighting of the errors should enhance the metrics currently available on the VR simulator and improve the assessment of the performance of a subject. In the future error scoring might become a valid parameter in assessing technical skill during a virtual CAS procedure. However sensitive a VR simulator is to differentiate level of CAS experience, it needs to be regarded by the subject as a real case. The simulator is rated slightly less realistic and valuable by the interventional radiologists compared with the vascular surgeons and the interventional cardiologists. However, the different groups according to their CAS experience in this study including the highly experienced physicians (group D) certainly agree that the simulated CAS procedure is a realistic interpretation of the actual procedure, provides good force feedback and that all interventionalists should train on this model prior to performing CAS on a real patient. Indeed the eventual aim is to use VR simulation technologies to shorten the learning curve of CAS allowing proficiency to be achieved before practicing on real patients, in a similar manner to aviation industry training. However, all aspects of training take time and resources, including simulation. The amount of time and resources available for training is limited. Consequently, time and resources spent on simulator training will detract from time spent on other training activities. The overall approach to training endovascular skills should be graded and provided within a structured curriculum, rather than over an unpredictable and often short training period.25 As mentioned by Satava, training on a simulator is not about the simulator, it is about the curriculum that includes errors identification in addition to skills acquisition.26 The curriculum needs to consist of teaching the cognitive component followed by a test before allowing a subject to begin using the simulator for psychomotor skills training. Subjects who train on a simulator benefit from a flexible training curriculum that is made to their pace, learning comprehension, and schedule. They have the opportunity to practice interventional skills and procedures, to make mistakes, and learn from the errors prior to performing real cases. This proficiency based curriculum may enable inexperienced practitioners to train to expert benchmark levels and might be used as a mode of credentialing. It is hoped that this new paradigm of training in an educationally orientated laboratory environment will lead to the safer delivery of interventional procedures to patients. Author contributions Conception and design: IV, RA Analysis and interpretation: IV, RA, FV, NC Data collection: IV, AC, RB, FV Writing the article: IV Critical revision of the article: IV, RA, AC, RB, FV, NC Final approval of the article: IV, RA, AC, RB, FV, NC Statistical analysis: IV, RA, NC Obtained funding: NC Overall responsibility: IV, NC References 1. 1Coward LJ, Featherstone RL, Brown MM. Safety and efficacy of endovascular treatment of carotid artery stenosis compared with carotid endarterectomy: a Cochrane systematic review of the randomized evidence. Stroke. 2005;36:905–911.
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a Department of Biosurgery and Surgical Technology, Imperial College London, United Kingdom b Regional Vascular Unit, St. Mary’s Hospital, London, United Kingdom c Department of Thoracic and Vascular Surgery, Ghent University Hospital, Ghent, Belgium.  Reprint requests: Mrs. Isabelle Van Herzeel, Clinical Research Fellow, Department of Biosurgery and Surgical Technology, Imperial College London, 10th Floor, QEQM building, St. Mary’s Hospital, Praed Street, London, W2 1NY UK.
Competition of interest: This research project has been supported in part by a grant from Boston Scientific Corporation, Natick, Massachusetts and Mentice, Gothenburg, Sweden. PII: S0741-5214(07)01026-9 doi:10.1016/j.jvs.2007.06.028 © 2007 The Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved. | |
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