giora weisz, md · • dopamine (drip) • levophed • act (beginning, max/min sustained during...

Cardiovascular Research FoundationCardiovascular Research FoundationColumbia University Medical CenterColumbia University Medical Center

Interventional Cardiovascular Simulation Interventional Cardiovascular Simulation for for

Training, Certification, and Credentialing Training, Certification, and Credentialing

Giora Weisz, MDGiora Weisz, MD

Cardiovascular Research FoundationCardiovascular Research FoundationColumbia University Medical CenterColumbia University Medical Center

Center for Interventional Vascular TherapyCenter for Interventional Vascular TherapyNYNY--Presbyterian Hospital, Columbia UniversityPresbyterian Hospital, Columbia University

The Write Brothers The Write Brothers -- 19031903

Where is the third brother?Where is the third brother?

Virtual Reality Medical SimulatorsVirtual Reality Medical Simulators

•• 11stst generationgeneration –– laparoscopic and laparoscopic and endoscopic trainingendoscopic training

•• Technology dramatically improved Technology dramatically improved

•• 22ndnd generationgeneration –– endovascular training endovascular training

•• 33rdrd generationgeneration –– procedure specific simulatorprocedure specific simulator

•• Simulation trainingSimulation training

•• PatientPatient--based simulationbased simulation

•• Credentialing and certificationCredentialing and certification

•• Development of new devicesDevelopment of new devices

This is not a computer gameThis is not a computer game……

Interventional Cardiovascular SimulationInterventional Cardiovascular Simulation

Simulation is Still YoungSimulation is Still Young

Interventional vascular simulationInterventional vascular simulation

1.1. High techHigh tech2.2. High fidelityHigh fidelity3.3. Complex hardware Complex hardware 4.4. Progressive high power softwareProgressive high power software5.5. Visual virtual realityVisual virtual reality6.6. HapticsHaptics7.7. Performance evaluation (metrics)Performance evaluation (metrics)

The technology

Advantages of IVSAdvantages of IVS

1.1. Learning anatomy and anatomyLearning anatomy and anatomy--imaging imaging interactionsinteractions

2.2. Gaining good working habitsGaining good working habits3.3. Examining variety of devicesExamining variety of devices4.4. Use of new or nonUse of new or non--conventional devicesconventional devices5.5. Interactive decision makingInteractive decision making6.6. Analyzing complex situationsAnalyzing complex situations7.7. StresslessStressless management of urgent situationsmanagement of urgent situations8.8. Crime and punishment interactionCrime and punishment interaction9.9. RiskRisk--free environmentfree environment

The essentials

The World of SimulatorsThe World of Simulators

TRI SimulatorTRI Simulator

The first training simulator dedicated for TRA Portable design..The first training simulator dedicated for TRA Portable design..

Puncture DevicePuncture DeviceTRI Simulator FeaturesTRI Simulator Features

Pulsatile Pulsatile air air compressedcompressed flowflow

TRI Simulator FeaturesTRI Simulator Features

Different radial anatomies to learn typical difficulties with TRA

Assessment & feedbackAssessment & feedback

Paradigm shiftParadigm shift

See oneSee one

Do oneDo one

Teach oneTeach one

Metric Metric based based

simulation simulation trainingtraining

SuperalistSuperalist

Modern Training Modern Training

•• SeeSee

•• HearHear

•• FeelFeel

•• PracticePractice

Potential Benefit of SimulationPotential Benefit of SimulationAs evaluated by 379 interventional cardiologistsAs evaluated by 379 interventional cardiologists

(4, 5)(4, 5)4.464.46For fellows in interventional cardiologyFor fellows in interventional cardiology

(4, 5)(4, 5)4.354.35For fellows in cardiologyFor fellows in cardiology

(3, 5)(3, 5)3.823.82For patientsFor patients

(4, 5)(4, 5)4.444.44For training of new device/procedureFor training of new device/procedure

(3, 5)(3, 5)3.833.83For experienced operatorsFor experienced operators

RangeRangeGradingGrading

scale of 1-5 (5=best, 1=worst)

Simulation as a Medical Training ApproachSimulation as a Medical Training Approach

Ann Surg 2002; 236: 458Ann Surg 2002; 236: 458--6363

Anthony G Gallagher PhDAnthony G Gallagher PhD1, 21, 2, Neal Seymour MD, Neal Seymour MD22, , SanzianaSanzianaRomanRoman

MDMD22, Mike O, Mike O’’Brien MD PHDBrien MD PHD22, Dana K Andersen MD, Dana K Andersen MD22, Richard M , Richard M SatavaSatava MDMD22

QueenQueen’’s University s University EndoscopicEndoscopic Research Laboratory, BelfastResearch Laboratory, Belfast11

Dept. of Surgery, Yale UniversityDept. of Surgery, Yale University22

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10

Num

. of E

rrors

per

pro

cedu

re

Standard trained VR trained

40

0

5

10

15

20

25

30

35

Pro

cedu

re T

ime

(min

utes

)Standard trained VR trained

6 times fewer errors

30% shorter procedure

Benefit of training on a simulator before performing a first intervention on a real patient:

Gallagher et al. Ann Surg 2002; 236: 458-63

Learning Curve of Carotid SimulationLearning Curve of Carotid Simulation

Patel et al. JACC 2006 Patel et al. JACC 2006

Training the use of new devicesTraining the use of new devices

FilterWireFilterWire TrainingTraining

112 (24.3%)112 (24.3%)Previous Previous FilterWireFilterWire experienceexperience

105 (22.8%)105 (22.8%)Previous simulation experiencePrevious simulation experience

3535Annual SVG (mean)Annual SVG (mean)

203203Annual physician PCI volume (mean)Annual physician PCI volume (mean)

5959Number of sitesNumber of sites

461461Number of physiciansNumber of physicians

NNDemographicsDemographics

FilterWireFilterWire TrainingTraining

3.123.12±±0.370.37P<0.0001P<0.0001

Pre vs. postPre vs. post

5.65.6±±1.131.13Post simulation training (mean)Post simulation training (mean)

2.502.50±±16.916.9Prior to simulation training (mean)Prior to simulation training (mean)

N=461N=461

Basic skill level: pre vs. post simulation Basic skill level: pre vs. post simulation

Scoring: 1Scoring: 1--7 scale7 scale11--not at all proficient, 7=highly proficientnot at all proficient, 7=highly proficient

CASESCASES--PMSPMS

Level 1:Level 1: Experienced in CAS & with Cordis devices – exemptfrom training

Level 2:Level 2: Some experience in CAS / no experience with Cordis devices - intermediate training program

Level 3:Level 3: Limited or no experience in CAS – full trainingprogram including simulation

DidacticDidacticDidactic ObservationObservationObservation SimulationSimulationSimulation Staff In-Service

Staff Staff InIn--ServiceService

Proctor NetworkProctor Proctor

NetworkNetwork

InternetDelivery

InternetInternetDeliveryDelivery

Conducted at CASExperienced Centers

Conducted at CASConducted at CASExperienced Centers Experienced Centers

Qualified / ExperiencedProctors & Nurses

Qualified / ExperiencedQualified / ExperiencedProctors & NursesProctors & Nurses

OutcomesOutcomesOutcomesStaff Training

Staff Staff TrainingTraining

1.0

3.5

4.8

0.9

4.55.7

3.64.5

0.81.4 0.90.4

0

5

10

15

Death MI Stroke MAE

Level 1 (n=918 patients)Level 2 (n=352 patients)Level 3 (n=223 patients)

Physician Training LevelPhysician Training Level

CASESCASES--PMS: Events at 30 Days PMS: Events at 30 Days

3.5

1.1

4.5

2.03.6

0.4

2.71.9 1.7

0

5

10

15

All Stroke Major Ipsilateral Minor Ipsilateral

Level 1 (n=918 patients)Level 2 (n=352 patients)Level 3 (n=223 patients)

(%) (%)

Safety & efficacy outcomes of physicians who underwent training Safety & efficacy outcomes of physicians who underwent training in the CASES Training Program were similar to those of in the CASES Training Program were similar to those of physicians experienced in carotid stentingphysicians experienced in carotid stenting

Credentialing & Certification 2006Credentialing & Certification 2006in Endovascular Interventionin Endovascular Intervention

•• Fellowship TrackFellowship TrackWritten exam: multiple choice questionWritten exam: multiple choice question

•• Practice trackPractice trackSelf report of experience (# of cases)Self report of experience (# of cases)Recommendation lettersRecommendation lettersPersonal relationsPersonal relations

Lacks assessment of interventional skills Lacks assessment of interventional skills and management of complicationand management of complication

No objectivityNo objectivity

AAssessment of Operator Performance by the ssessment of Operator Performance by the SSimbionix Carotid imbionix Carotid SSttEEntingnting SSimulator imulator SStudy tudy

((ASSESSASSESS))

•• PrimaryPrimaryTo validate the simulatorTo validate the simulator--based metrics based metrics of the Simbionix of the Simbionix AngioAngio--Mentor Mentor simulator as a tool to discriminate simulator as a tool to discriminate between different levels of operatorsbetween different levels of operators..

•• SecondarySecondaryTo identify parameters that enhance To identify parameters that enhance the discrimination between the different the discrimination between the different levels of operatorslevels of operators

ObjectivesObjectives

ASSESSASSESS

•• SimbinixSimbinix AngioAngio--Mentor simulationMentor simulation•• Comprehensive scoring system, supported by Comprehensive scoring system, supported by

panel of expertspanel of experts•• RunRun--in, introductory casein, introductory case•• 3 carotid stenosis cases with increasing 3 carotid stenosis cases with increasing

difficulty:difficulty:Aortic archAortic archRCC vs. LCC accessRCC vs. LCC accessHemodynamicHemodynamic interactivityinteractivity

MethodsMethods

Parameters tracked Parameters tracked –– Medical ManagementMedical Management

Drugs administered, (name, Drugs administered, (name, dose, time, method of dose, time, method of administration, vital signs administration, vital signs at time of administration)at time of administration)

•• AtropineAtropine•• HeparinHeparin•• FluidsFluids•• MetroprololMetroprolol•• Nitro (IA and IV)Nitro (IA and IV)•• NicardipineNicardipine•• PhenylephrinePhenylephrine•• Dopamine (drip)Dopamine (drip)•• LevophedLevophed

•• ACT (beginning, max/min ACT (beginning, max/min sustained during case,at sustained during case,at time of devices time of devices deployment, end of case)deployment, end of case)

•• SBP/HR (beginning, close SBP/HR (beginning, close of case, highest and of case, highest and lowest sustained during lowest sustained during case and any time that case and any time that SBP/HR was above or SBP/HR was above or below threshold levels for below threshold levels for greater than 60 seconds)greater than 60 seconds)

•• Was the patient Was the patient symptomatic during the symptomatic during the procedure?procedure?

Parameters tracked Parameters tracked –– technical performancetechnical performance

Devices used (type, size), wires, Devices used (type, size), wires, catheters, sheaths, filters, catheters, sheaths, filters, stents, balloons)stents, balloons)

Lesion (length, width, location, Lesion (length, width, location, degree of stenosis)degree of stenosis)

Alignment/size relationship of Alignment/size relationship of interventional devices to interventional devices to lesion and vessel diameter.lesion and vessel diameter.

Time (total procedure time, time Time (total procedure time, time to place sheath proximal to to place sheath proximal to bifurcation, bifurcation, fluorofluoro time, time time, time to deploy each device)to deploy each device)

Crossing lesion with .035 wire, Crossing lesion with .035 wire, catheter, sheath, and if done catheter, sheath, and if done prior to filter placement.prior to filter placement.

Advancing catheter or sheath in Advancing catheter or sheath in CCA without leading wire. CCA without leading wire. Excludes leading hook of Excludes leading hook of VitekVitek, Simmons, etc (mm), Simmons, etc (mm)

Filter movement during Filter movement during procedure (mm)procedure (mm)

Contrast usedContrast usedOverall number of devices usedOverall number of devices usedMatch of device size to native Match of device size to native

lumen diameter where lumen diameter where deployed. deployed.

Coverage of lesion by Coverage of lesion by interventional devices.interventional devices.

Overlap of multiple stents, if Overlap of multiple stents, if appropriate.appropriate.

OperatorsOperators

•• Interventional CardiologistsInterventional CardiologistsNovice:Novice: Experienced Experienced interventionalistinterventionalist, no/minimal , no/minimal experience in carotid stentingexperience in carotid stentingIntermediate:Intermediate: Little experience in carotid stentingLittle experience in carotid stentingExpert:Expert: Wide experience in carotid stenting (national Wide experience in carotid stenting (national leaders)leaders)

•• Integrated experience scoring (of relative importance)Integrated experience scoring (of relative importance)By panel of national leadersBy panel of national leadersAll had very close opinions (minimal SD)All had very close opinions (minimal SD)Mean annual number of:

• Years in interventional practice 5% (0-20)• Annual number of diagnostic coronary procedures 5% (0-10)• Annual number of interventional coronary procedures 10% (5-15)• Annual number of diagnostic peripheral procedures 10% (5-15)• Annual number of interventional peripheral procedures 15% (10-18)• Annual number of diagnostic carotid procedures 20% (10-25)• Annual number of interventional carotid procedures 25% (20-30)• Visual/observation assessment of performance on the simulator 10% (8-20)

Mean Score per Case/Operator LevelMean Score per Case/Operator Level

Operator LevelOperator Level

8080

ExpertExpert IntermediateIntermediate NoviceNovice

Case 1Case 1

7070

6060

5050

4040

3030

2020

1010

00

AverageAverageCase 2Case 2 CombinedCombined

x

x

x

x

The lower the score, the better the performanceThe lower the score, the better the performance

Primary endPrimary end--pointpoint

Case 3Case 3

Operator Performance ValidationOperator Performance Validation

Score

N

Novices Experts

Intermediate

Ready for proctored cases

Operator Performance ValidationOperator Performance Validation

Score

N

Novices Experts

Intermediate

Approved independent operator

Use of an endovascular simulator may be Use of an endovascular simulator may be useful in the evaluation of:useful in the evaluation of:

•• Correct interpretation of the anatomy, Correct interpretation of the anatomy, selecting the best views selecting the best views

•• Cognitive understanding of the Cognitive understanding of the procedureprocedure

•• HemodynamicHemodynamic managementmanagement•• Adjunctive pharmacotherapyAdjunctive pharmacotherapy•• CatheterCatheter--based skillbased skill

Credentialing & Certification 200XCredentialing & Certification 200Xin Endovascular Interventionin Endovascular Intervention

Automated and ObjectiveAutomated and Objective

Medical SimulationMedical Simulation






PatientPatient--Specific SimulationSpecific Simulation

PatientPatient--Specific SimulationSpecific Simulation

•• Complex anatomies Complex anatomies •• PrePre--selection of the appropriate devicesselection of the appropriate devices•• Eliminates the need for multiple Eliminates the need for multiple

exchangesexchanges•• Save contrast mediaSave contrast media

•• Higher successHigher success•• Less complicationsLess complications

Train today on the patient of tomorrowTrain today on the patient of tomorrow


•• Training of fellowsTraining of fellows•• Training of new devicesTraining of new devices•• Training of new proceduresTraining of new procedures•• Practice the procedure of tomorrowPractice the procedure of tomorrow•• Evaluation of operator proficiencyEvaluation of operator proficiency•• Development of new devicesDevelopment of new devices


It is good for:It is good for:

giora weisz, md · • dopamine (drip) • levophed • act (beginning, max/min sustained during...

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