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PROcedure Rehearsal Studio Validation
& Publication
Patient-specific simulation for endovascular procedures: qualitative evaluation of the development process.
Willaert WI, Aggarwal R, Nestel DF, Gaines PA, Vermassen FE, Darzi AW, Cheshire NJ; European Virtual Reality Endovascular Research Team, EVEResT.
Department of Biosurgery and Surgical Technology, St. Mary's Hospital, Imperial College, London, UK.
Int J Med Robot. 2010 Jun; 6(2):202-10.
Background : Recent advancements in simulation permit patient-specific rehearsal of carotid artery stenting procedures. This study evaluates the feasibility of transferring patient-specific CT data into the simulator, creating a 3D reconstruction and performing a rehearsal. The face validity of the model was assessed.
Methods/Results : By thematic analysis of qualitative data, an algorithm was generated, focusing on simulation set-up, time of data transfer, software/compatibility issues and problem-solving strategies. The face validity of the simulated case was evaluated by 15 expert interventionalists: realism (median 4/5), training potential (median 4/5) and pre-procedure rehearsal potential for challenging CAS cases (median 4/5) were rated highly.
Conclusions : Setting up a procedure rehearsal is feasible and reproducible for different patients in different hospital settings without major software compatibility issues. The time to create a 3D reconstruction of patient-specific CT data is a major factor in the total time necessary to set up a rehearsal. The face validity is highly rated by experts. (c) 2010 John Wiley & Sons, Ltd.
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The following abstract was presented and won the 1st prize at the 36th Annual VEITH Symposium November 18 - 22, 2009; New York, USA
VIRTUAL REALITY PROCEDURE REHEARSAL CAN ENHANCE THE CHOICE OF ENDOVASCULAR TOOLS FOR CAROTID ARTERY STENTING PROCEDURES
Willaert Willem MD 1, Aggarwal Raj MD PhD 1, Van Herzeele Isabelle MD 2, O’Donoghue Kevin BSc 1, Kabbar Marwan 2, Gaines Peter FRCP FRCR 3, Vermassen Frank MD PhD 2, Darzi Ara KBE MD FRCS 1, Cheshire Nick MD, FRCS 1
1Department of Biosurgery and Surgical Technology, Imperial College London, St. Mary's Hospital, London, United Kingdom, 2Department of Thoracic and Vascular Surgery, Ghent University Hospital, Ghent, Belgium, 3Sheffield Vascular Institute, Northern General Hospital, Sheffield, United Kingdom
Introduction: Patient-specific simulated rehearsal of the carotid artery stenting procedure (CAS) allows incorporation of patient-specific CT data into the simulation software. This enables the interventionalist to evaluate the effect of different endovascular material and fluoroscopy angles prior to performing the real procedure. Procedure rehearsal is a technological advance with potential benefits to patients undergoing complex endovascular procedures.
Aim: This study aimed to evaluate whether patient-specific, procedure rehearsal of a CAS procedure has an influence on tool selection and the use of fluoroscopy. Secondary aims were to evaluate the face validity of this technology and to evaluate if the potential benefit is influenced by the level of CAS experience.
Methods: Endovascular physicians with a varying degree of CAS experience were recruited and divided into three groups: inexperienced (5-20 CAS), moderately (21-50 CAS) and highly experienced in CAS (>50 CAS procedures). A 3D model was created of an actual patient with the PROcedure TM rehearsal studio software. Following case note and CT angiographic review of a real patient case, all participants rehearsed this patient-specific CAS procedure on the AngioMentor TM Express simulator. Preoperative and postoperative questionnaires registered tool and fluoroscopy preferences in a stepwise fashion for this specific CAS procedure. A questionnaire rated face validity, training potential and pre-procedure potential on a Likert scale from 1 (poor) to 5 (excellent). Results: Thirty three endovascular physicians with varying degrees of CAS experience participated: inexperienced (n=11), moderately (n=7) and highly experienced (n=15). For all participants 98 of a possible 363 changes (27%) were observed from pre- to post-case questionnaires. This was most notable for optimal fluoroscopy C-arm position 17/33 (52%), chosen guide wire to introduce the sheath in the common carotid artery 15/33 (46%), choice of selective catheter 13/33 (39%) or guiding catheter (or sheath) 12/33 (36%) and balloon dilatation strategy 10/33 (30%). Although modifications in tool preferences were more apparent in the inexperienced group, these alterations were not significantly influenced by level of CAS experience (p>0.05) Face validity of the model, training potential and pre-procedure potential were rated high by the interventionalists and all measured a median of 4.
Conclusion: Patient-specific simulated rehearsal of a complex endovascular procedure strongly influences tool selection and fluoroscopy. This influence seems irrespective of the prior experience level with CAS. This technology requires further investigation with respect to a potential reduction in the use of endovascular material and X-ray exposition and with respect to improved outcomes in the clinical setting.
Real case virtual reality training prior to carotid artery stenting.
Roguin A, Beyar R.
Department of Cardiology, Rambam Medical Center, B. Rappaport-Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.
Catheter Cardiovasc Interv. 2009 Jul 15.
Background: The majority of procedural training especially in interventional cardiology, still occurs on patients with direct mentoring by experienced physicians during an actual clinical procedure. In recent years there is an increase use of simulators especially for carotid artery stenting. However, most simulators use "generic" predefined cases.
Methods and Result: We report here a simulation done on data of a real patient prior to intervention. The patient's specific carotid anatomy was modeled using CTA on an endovascular simulator. Pre-procedure patient-specific case rehearsal accurately predicted procedure experience.
Conclusions: A case rehearsal prior to an intervention may be useful in the planning and execution of carotid artery stenting. The use of patient specific simulation helps with planning of procedure and device selection, and may lead to use of less contrast and radiation, and shorter procedure duration. These may benefit the patient with increased success and lower complication rates.
Simulation case rehearsals for carotid artery stenting.
Hislop SJ, Hedrick JH, Singh MJ, Rhodes JM, Gillespie DL, Johansson M, Illig KA.
Division of Vascular Surgery Department of Surgery, University of Rochester Medical Center, Rochester, NY, USA.
Eur J Vasc Endovasc Surg. 2009 Dec;38(6):750-4. Epub 2009 Oct 3.
A case series of 5 patients is presented assessing the utility of simulation case rehearsals of individual patients for carotid artery stenting on an endovascular simulator. Simulated and operative device dimensions were similar. Results of subjective surveys indicated that face and content validity were excellent. The simulations predicted difficulty with vessel cannulation, however had difficulty predicting post-stent changes in bifurcation angulation. Our experience suggests that it may be feasible to use patient-specific CTA-derived data in the creation of a realistic case rehearsal simulation. The overall utility of this concept, including cost-benefit analysis, has yet to be determined.
The following abstract was presented at the Annual Meeting of the Society for Vascular Surgery (SVS) June 11-14, 2009 Denver, USA
Patient Specific Endovascular Simulation Influences the Material Selection of All Interventionalists Performing a Carotid Artery Stent Procedure
Willem Willaert1, Rajesh Aggarwal1, Isabelle Van Herzeele2, Kevin O’Donoghue1, Marwan Kabbar2, Peter Gaines3, Frank Vermassen2, Ara Darzi1, Nick Cheshire1.
1Department of Biosurgery and Surgical Technology, Imperial College London, London, United Kingdom; 2Department of Thoracic and Vascular Surgery, Ghent University Hospital, Ghent, Belgium; 3Sheffield Vascular Institute, Northern General Hospital, Sheffield, United Kingdom
Objective: Virtual reality endovascular simulation permits the integration of patient-specific data into the software and allows rehearsal of carotid artery stent (CAS) procedures before the ‘real’ intervention. The aim of this study is to evaluate the effect of this technology on physicians’ attitudes towards the selection of endovascular materials necessary for a CAS procedure.
Methods: Twenty eight interventionalists were recruited and divided into three groups: highly experienced (_50 CAS procedures) n_11, moderately experienced (21- 50 CAS) n_6 and inexperienced in CAS (5- 20 CAS) n_11. After review of the CT scan of a type II arch with a tortuous common carotid artery (CCA), all subjects performed the same virtual CAS procedure. Before and after the intervention the choice of endovascular tools and fluoroscopy angles were documented with a questionnaire. Quantitative metrics (procedure time, fluoroscopy time, number of cineloops and amount of contrast given) were recorded by the simulator. Participants also rated the realism and training potential of patient specific simulation on a Likert scale from 1 (poor) to 5 (excellent).
Results: For the 28 participants a total of 252 potential changes were identified. In general 76 changes were observed (33%). Change was most notable in the type of guide wire chosen to exchange a sheath 15/28 (54%), optimal C-arm position 13/28 (46%), choice of selective catheter
12/28 (43%), selection of a sheath or guiding catheter 10/28 (36%) and balloon dilatation strategy 10/28 (36%). The type of embolic protection device 3/28 (11%), position of exchange for a guiding catheter or sheath 3/28 (11%) and the sort of guide wire to cannulate the CCA 1/28 (4%), were altered less frequently. Statistical analysis showed that the degree of change was not influenced by the level of operator experience (P_0.05). The quantitative metrics did not differ significantly between the groups (P_0.05). Participants rated the simulator high for realism (median 4) and for the potential to be used as a pre-procedural training tool (median 4).
Conclusions: Patient specific simulation remarkably influences the endovascular tool selection and C-arm positions in CAS procedures, irrespective of the level of endovascular CAS experience.
The following abstract was presented at the Annual Meeting of the EuroPCR May 19,-22, 2009 Denver, USA
Understanding patient-specific virtual reality endovascular simulation
Willem Willaert MD, Rajesh Aggarwal PhD, MRCS, Isabelle Van Herzeele MD, Kevin O’Donoghue Bsc, Marwan Kabbar, Peter Gaines FRCP,FRCR, Frank Vermassen MD, PhD, Ara Darzi KBE, MD, FRCS and Nick Cheshire MD, FRCS.
1Department of Biosurgery and Surgical Technology, Imperial College London, London, United Kingdom. 2Department of Thoracic and Vascular Surgery, Ghent University Hospital, Ghent, Belgium. 3Sheffield Vascular Institute, Northern General Hospital, Sheffield, United Kingdom.
Aims Recent advancements in endovascular simulation permits patient-specific rehearsal of carotid artery stenting procedures. This study aimed to evaluate the feasibility of transferring patient-specific CT data into the simulator software and creating a 3D reconstruction and to evaluate the feasibility of performing a subsequent rehearsal on the simulator. The face validity of the model was also assessed.
Methods/Results By thematic analysis of qualitative data (coded transcripts and field notes of 30 simulated cases), an algorithm was generated describing the process of Procedure Rehearsal. The analysis focused on simulation set up, ease and time of data transfer, software/compatibility issues and problem-solving strategies. The face validity of the simulated case was evaluated by 15 expert interventionalists using a questionnaire with a Likert scale from 1 (poor) to 5 (excellent). Realism (median 4), training potential (median 4) and pre-procedure rehearsal potential (median 3) were rated high.
Conclusion Setting up a Procedure Rehearsal is feasible and reproducible for different patients in different hospital settings without major software compatibility issues. The time to create a 3D reconstruction of patient specific CT data is a major factor in the total time necessary to set up a rehearsal. The face validity is highly rated by experts.
The following abstract was presented at the Annual Meeting of the SITE, May 7- 9 2009 in Barcelona.
PATIENT SPECIFIC REHEARSAL ON A VIRTUAL REALITY SIMULATOR INFLUENCES THE BEHAVIOR OF INTERVENTIONALISTS DURING A CAROTID ARTERY STENTING PROCEDURE.
Willem Willaert MD, Rajesh Aggarwal PhD, MRCS, Isabelle Van Herzeele MD, Peter Gaines FRCP,FRCR, Frank Vermassen MD, PhD and Nick Cheshire MD, FRCS.
1Department of Biosurgery and Surgical Technology, Imperial College London, London, United Kingdom. 2Department of Thoracic and Vascular Surgery, Ghent University Hospital, Ghent, Belgium. 3Sheffield Vascular Institute, Northern General Hospital, Sheffield, United Kingdom.
Introduction: Patient-specific simulated rehearsal of complex endovascular interventions allows incorporation of patient-specific CT data into the simulation software, enabling the interventionalist to evaluate the use of the C-arm, different endovascular tools and the optimal access strategy prior to performing the real procedure. It is a technological advance with potential benefits to patients undergoing carotid artery stenting (CAS) procedures.
Objectives: This study aimed to evaluate whether patient-specific rehearsal of a CAS procedure has an influence on tool selection and the use of fluoroscopy. Secondary aims were to evaluate the face validity of this technology and if the potential benefit of patient-specific rehearsal is influenced by the level of CAS experience.
Materials: Endovascular physicians with a varying degree of CAS experience were recruited and divided into three groups: inexperienced (5-20 CAS), moderately (21-50 CAS) and highly experienced in CAS (>50 CAS procedures). A 3D model was created of an actual patient with the PROcedureTM rehearsal studio software. Subsequently all participants rehearsed this patient-specific CAS procedure on the AngioMentorTM Express simulator. Preoperative and postoperative questionnaires registered tool and fluoroscopy preferences in a stepwise fashion for this specific CAS procedure. A questionnaire rated face validity, training potential and pre-procedure potential on a Likert scale from 1 (poor) to 5 (excellent).
Metholodogy: Following case note and CT angiographic review of a real patient case, subjects performed a familiarization virtual iliac procedure. Thereafter they proceeded to the CAS procedure. Endovascular tool requirements, fluoroscopic angles and the face validity were recorded.
Results: Thirty three endovascular physicians with varying degrees of CAS experience participated: inexperienced (n=11), moderately (n=7) and highly experienced (n=15). For all participants 98 of a possible 363 changes (27%) were observed from pre- to post-case questionnaires. This was most notable for optimal fluoroscopy C-arm position 17/33 (52%), chosen guide wire to introduce the sheath in the common carotid artery 15/33 (46%), choice of selective catheter 13/33 (39%) or guiding catheter (or sheath) 12/33 (36%) and balloon dilatation strategy 10/33 (30%). Although modifications in tool preferences were more apparent in the inexperienced group, these alterations were not significantly influenced by level of CAS experience (p>0.05) Face validity of the model, training potential and pre-procedure potential were rated high by the interventionalists and all measured a median of 4.
Conclusion: Patient-specific simulated rehearsal of a complex endovascular procedure strongly influences tool selection and fluoroscopy. This influence seems irrespective of the prior experience level with CAS. This technology requires further investigation with respect to a potential reduction in the use of endovascular material and X-ray exposition and with respect to improved outcomes in the clinical setting.
Patient Specific Simulation Enabling Hands-On Rehearsal of Carotid Stenting
Giora Weisz, Center for Interventional Vascular Therapy, Columbia University Medical Center, New York, NY, USA
EuroIntervention Journal, 2009 March, Volume 4, Number 5 page 684
Introduction: Endovascular procedures like carotid stenting can pose challenges even to experienced interventionists. Tortuous anatomy, complex lesion morphology, and difficult device access can increase procedure time, fluoroscopy exposure, contrast use, and complications.
The New Technology: Simbionix PROcedure Rehearsal Studio™ simulates the interventional environment and allows rehearsal of a complete endovascular procedure on a virtual model of the patient’s specific anatomy. Loading the patient’s CT scan directly into the system generates a digital 3D model of the patient’s clinically relevant anatomy. It generates a simulated interventional suit environment that provides the impression of a real procedure on a real patient. This includes display of the c-arm, visual presentation of fluoroscopic images, reliable tactile feedback of the movement and function of intravascular devices, and interactive hemodynamic effects.
Preliminary Testing: Initial experience with the system demonstrated ease of use, and accurate vascular simulation. Rehearsal of complex cases of carotid stenting gave the operators the opportunity to practice the specific anatomy of the patient and to select the appropriate devices for the specific anatomy of the patient, in advance of the actual intervention. The actual interventional procedures were eventually easier and faster.
Conclusion: Using patient specific simulation with the Simbionix PROcedure Rehearsal Studio™ helps with planning of procedure and device selection, leading to use of less contrast and radiation, and shorter procedure duration. These benefit the patient with increased success and lower complication rates. Virtual rehearsal, derived from patient-specific simulation may increase the demand for the placement of simulators in larger number of institutions.
The following abstract was presented at the New England Society for Vascular Surgery on Oct 5, 2008
Patient Specific Case Rehearsals Using an Endovascular Simulator
Prior to Carotid Artery Stenting
Sean J Hislop, MD, Joseph H Hedrick, MD, Michael J Singh, MD, Jeffrey M Rhodes, MD, Joseph P Hart, MD, Marcia Johansson, ACNP,
and Karl A Illig, MD
Division of Vascular Surgery, at the Strong Heart and Vascular Center, University of Rochester Medical Center, NY, 14642
Objectives: To determine whether a patient’s specific carotid anatomy can be modeled using CTA on an endovascular simulator and whether preoperative patient-specific case rehearsal accurately predicts operative experience.
Methods: Patients underwent CTA of the arch and carotid circulation. Simbionix Corporation (Lod, Israel) used deidentified CTAs to create simulation files. The surgeon performed the simulated case within 24 hours of the actual procedure. Likert surveys (strongly agree - strongly disagree) were completed assessing face validity, or the degree to which the simulation mimicked real life.
Results: Five patient-specific simulations were performed. The surgeons “strongly agreed” (median score 5/5) that the simulation improved the operative flow, increased patient safety and efficiency of instrument use, assisted in selection of EPD, stent, diagnostic catheter and balloon, decreased overall operative and fluoroscopy time and the amount of contrast used, and that the operative and simulator outcomes were similar. They “agreed” (median score 4/5) that the simulation assisted with vessel access and with wire selection. Face validity was excellent: surgeons “strongly agreed” that the simulator was easy to use, realistically replicated reality, produced realistic imaging and tactile feedback (haptics), realistically replicated patient arch, carotid and lesion anatomy and that it accurately predicted stent dimensions. All simulated EPD, stent, and balloon dimensions matched those used in the operating room. Subjective observations suggested that the simulation predicted difficulty with vessel cannulation but did not accurately model post-stent deployment changes in bifurcation angulation.
Conclusions: These data indicate that patient-specific CTA-derived data can be converted to an endovascular simulator with high face validity. We suggest that case rehearsal prior to an operation may be useful in the planning and execution of carotid artery intervention.
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