EXPERIENCE WITH STEREOTAXIS ROBOTIC IN THE EP … · EXPERIENCE WITH STEREOTAXIS ROBOTIC IN THE EP LABORATORY EMAD F AZIZ, DO, MB CHB, FACC Director, Advanced Cardiac Admission Program

EXPERIENCE WITH STEREOTAXIS ROBOTIC IN THE EP LABORATORY

EMAD F AZIZ, DO, MB CHB, FACC Director, Advanced Cardiac Admission Program (ACAP)

Interventional Cardiac Electrophysiology

St. Luke’s and Roosevelt Hospitals

University Hospitals; Columbia University

Al Sabah Arrhythmia Institute, New York

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AL SABAH ARRHYTHMIA INSTITUTE 2

State of the Art Lab Made Possible by a generous 22 Million Dollar Endowment from Sheik Jaber Al-Ahmad Al-Jaber Al-Sabah

Amir of Kuwait

The Institute 3

Stereotaxis Suite

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The Institute 4

Biplane Suite

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The ACAP Research Group 5

Disclosures:

• Honoraria:

Medtronic

• Research

Support:

Medtronic,

Biotronick, St.

Jude, Sorin

THE ACAP PROGRAM

www.NYCardiologyPathways.Org

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“Advanced Cardiac Admission Program” (ACAP)

In 2004 a new program “Advanced Cardiac Admission

Program” (ACAP) was developed and implemented at

St. Luke’s-Roosevelt Hospital Center, New York, NY.

ACAP consisted of tools and strategies for

implementing ACC/AHA guidelines.

Uptodate the ACAP program include 9 state of the

ART Pathways in management.

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Key features of the program

Building partnerships with ED physicians,

Flexibility to allow local adaptation,

Involvement of caregivers across the continuum of

care (i.e., not just cardiologists),

Involvement of patients in their care,

Use of champions/opinion leaders,

Use of collected data to change behavior and measure

effectiveness of the approach.

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Treatment Pathways of the ACAP

program

Chest Pain Pathway (PAIN Pathway). 2004, 2008

Heart failure (ADHF). 2005

Atrial Fibrillation & Flutter (RACE Pathway) 2006

Syncope (SELF Pathway) 2007

Intensive Hyperglycemia Control. 2007

Hypertension 2008

Sudden cardiac death Prevention (ESCAPE) 2009

Hypothermia Protocol (MOCHA) 2010

Pericardial Effusion Diagnosis Protocol (CHASER) 2011

NYCardiologyPathways.Org

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How ACAP was Implemented?

2013 2013

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How ACAP was Implemented?

2013

ATRIAL FIBRILLATION

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Haissaguerre M, et al. N Engl J Med. 1998;339(10):659-666. Calkins H, et al.

Heart Rhythm. 2007;4(6):816-861.

Triggers of AF: Focal Firing and Interplay

with Reentrant Rotors

SVC

IVC

PVs

6 11

17 31

Septum

Fossa Ovalis

CS

RA LA

Extension of

muscular

fibers into PV

Ganglia noted

in yellow

Large and

small

reentrant

wavelets that

play a role in

initiating and

sustaining AF

Common

locations of

PV (purple)

and common

sites of origin

of non-PV

triggers (black)

Composite

of anatomic

and

arrhythmic

mechanisms

of AF

LSPV

LIPV

RSPV

IVC

RIPV

SVC

LSPV

LIPV

RSPV

IVC

RIPV

SVC

LSPV

LIPV

RSPV

IVC

SVC

RIPV

LSPV

LIPV

RSPV

IVC

RIPV

SVC

Calkins H, et al. Heart Rhythm. 2007;4(6):816-861.

Anatomy of PVs

Triggering of AF from PV Focus

A. Segmental or

Circumferential

ablation around left

and right PV antra

B. and C. Additional

linear lesion sets

for the roof,

mitral isthmus,

carinae, SVC,

and cavotricuspid

isthmus

D. Targeting fractionated

electrograms and/or

ganglionic plexi

Calkins H, et al. Heart Rhythm. 2007;4(6):816-861.

Common Lesions Performed in

AF Ablation

A. B.

LSPV

LIPV

RSPV

IVC

RIPV

LSPV

LIPV

RSPV

IVC

RIPV

LSPV

LIPV

RSPV

IVC

RIPV

SVC

C. D.

LSPV

LIPV

RSPV

IVC

RIPV

SVC

SVC SVC

Integration of CT and CART-3

Images

Epoch Stereotaxis System

The fully remote, networked and modular EP solution only offered by Stereotaxis.

Epoch pushes the envelope of patient care, delivering a more powerful solution with the precision of robotics and versatility of an EPs manual techniques.

“The Epoch solution is a major step toward making robotics standard of care and is a big step toward the goal exceeding the

human hand.”

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Robotic Navigation Generations

• Electromagnetic configuration has limitations and compromises when accessing patients.

• Significant site requirements.

• High operating expenses.

• Limited viability for new Hybrid lab configurations and requirements.

1st Generation

Electromagnetic

• First in the world magnetic navigation system to enable early research and development globally.

• Early adoption from top Cardiac Hospitals in the world.

2nd Generation

Niobe I

• Early adopters enabled and pushed boundaries of clinical discovery.

• Established excellent safety profile for magnetic/robotics.

• Deep industry experience, > 100 clinical papers

• 150+ Installations globally

3rd Generation

Niobe II

4th Generation Robotic Navigation

Epoch technology delivers…

Faster navigation: 0.125 second

response time is up to 7X faster

than before.

Intuitive and Responsive real-time

control helps create the impression

of feeling like manual control.

New automations to master difficult

techniques or improve precision

with the click of a mouse.

Smaller pods, nearly 15% smaller

by volume.

…without compromising safety.

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Summary of MAIN features

• CARTO integration

• Continuous Motion

• Improved Contact Meter

• Bull's-eye with Retraction

• Access Protection

• Septal Flip Mode

• Automap

• Vectorless Navigation

EPOCH™ – Integration with CARTO3®

PRO-693 Rev B effective 5/3/2012

Saving navigation targets −Save Catheter Positions in Navigant. −Can be used as navigation targets.

Customized color maps: −Display Color Maps in Navigant. −Overlay Color Map with Fluoro. −All catheters are displayed

Electrode Targeting −Select an electrogram in CARTO3. −Navigant will drive RMT catheter to

location with excellent accuracy.

The NAVISTAR RMT Ablation Catheter

designed to be used solely

with the CARTO RMT System

and the Niobe® Magnetic

Navigation System.

This catheter combines the

accurate 3-D maps, ablation

targeting and temperature

control of NAVISTAR

technology with the magnetic

catheter steering capability

of Niobe® technology.

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Continuous Motion

4th generation navigation provides

real-time responsive navigation for

quicker FAM creation and rapid

automated mapping.

Benefits:

Faster navigation response time:

Niobe ES responds quickly to

physician input and is designed to

decrease procedure times.

Dynamic control: continually move

and change direction.

Improved automations: designed

to take advantage of increased

speed to provide improved

productivity and efficiency.

“Epoch replicates the speed, feel and movement of manual procedures.

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Continuous Motion with Vector Lock

Responsive magnetic technique Fast and smooth catheter advancement

Improved Contact Tracing

The contact tracing is a real-time indicator that displays when the catheter is in contact with cardiac tissue.

Benefits:

Displays real time information

The calculation is based on the difference between the magnetic direction and catheter direction with the force to shape the catheter factored out of the measurement.

Access Protection

In a transseptal procedure, the Access Protection tool allows the physician to mark the septum on fluoro; for the remainder of the procedure, the system is designed to prevent accidental retraction through this location.

Benefits:

Avoid significant procedure delays

Potential for increased patient safety

Efficient navigation

Septal Flip mode

To facilitate navigation to the

septum from within the left

atrium, the Septal Flip Mode

is an automated routine that

rotates the catheter to face

right lateral from within the

left atrium.

Benefits:

A most difficult maneuver

made more simple,

replicating and

automating a technique

from the most experienced

navigators.

Epoch Bull's-eye Automation

Continuous rotational mapping for any tubular structure. With Epoch technology, fully computer and robotic driven mapping that’s easy and fast.

Benefits

Efficiency and speed

One click maneuver with the mouse.

Vectorless Navigation with Click-and-Go

Double-clicking on the surface of the CARTO model, allows the robot and computer to quickly navigate automatically for both ablation and line validation.

Turn-off the Vectors for an intuitive feel and fast procedure.

Benefits

Next position is obtained quickly and even faster than NaviLine.

Continuous guidance creates straight and contiguous ablation lines.

Navigation is reliable with constant updating of maps.

“My vision was to click on the map and the catheter goes on the click that I define. Today this is a reality and is the best way to allow everyone to use robotic

navigation successfully. The learning curve is dramatically reduced. “

Prof. Pappone, Villa Maria Cecilia Hospital, Cotignola Italy

The Odyssey System

Manage patient care, Improve hospital efficiency and quality

A fully enabled Odyssey lab standardizes procedure room processes and supports Quality improvement programs.

Sharing information between labs, offices and facilities has never been easier, bringing efficiency and productivity to your procedure room operations.

Odyssey™ Enterprise Cinema A data management platform which enables live and recorded playback of high definition lab information anywhere your hospital network can be accessed.

Reduced X-ray exposure where needed most

Children are 10 times more

sensitive to induction of cancer by

radiation than adults

Pediatr Radiol 2002;32:700 –706.

Data have strongly suggested that

using the magnetic navigation for

treating young children is

advantageous, because it

significantly reduced the

procedure and fluoroscopy

times without compromising

efficacy.

Schwagten, PACE 2009

Radiation exposure concerns heighten

“Our findings clearly emphasize for the first time that exposure to a level of radiation which is considered safe

by regulatory standards for interventional cardiologists can induce a profound biochemical and cellular

adaptation.” And, “It remains unclear whether these changes are adaptive,

beneficial … or the harbinger of clinically relevant adverse

changes….”

European Heart Journal. doi:10.1093/eurheartj/ehr263

“…facilities will need to take steps to

eliminate avoidable radiation doses,

and raise awareness among staff

about radiation issues…. “

“There will be a new focus on safe

technology and a culture of safety,…”

The Joint Commission

Sentinel Event Alert

Issue 47, August 24, 2011

60% reduction in fluoroscopy time Arya, et al. Europace 2010

Stereotaxis, continues to lead in radiation

reduction for patients and clinicians

Cardiologists who perform

heart operations using x-ray

guided catheters are exposed

to ionizing radiation at levels

two to three times higher per

year than those experienced

by radiologists.

Clinical trial results

demonstrate how a physician

can expect up to 90% less

radiation with Stereotaxis over

career.

minutes Patient Exposure

European Heart Journal. doi:10.1093/eurheartj/ehr263

Significant reduction in complications Bauernfeind, et al. Europace 2011

Improved outcomes for patients

Study found that magnetic navigation provided nearly

10X safety advantage for

major complications.

Patient consumerism trends should continue to accelerate, favoring robotic technologies with proven value propositions.

Significant incidence of perforation or tamponade in conventional population.

3.2%

0.34%

0.0%

0.5%

1.0%

1.5%

2.0%

2.5%

3.0%

3.5%

Major complications

Conventional

Stereotaxis

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Comparative Patient Outcomes STOP-VT Study Results

Multi-center, global,

prospective study

Presented at world’s largest

cardiology meeting (ESC)

53 patients with scar-related

VT

Mapping and ablation

completed with magnetic

irrigated catheter

94.3%

74%

16.8 mins

0.0%

81%

49%45 min

7.3%

0

20

40

60

80

100

Pe

rce

nt/

Min

ute

s

STOP-VT

Manual Study*

*Manual study data: Stevenson, et al. Circulation 2008;118:2773-2782

PRO-693 Rev B effective 5/3/2012

TITLE

St Luke’s Early Experience

St. Luke’s Initial Experience with Stereotaxis Breakdown of first 27 Procedures

Cases Breakdown

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165

72

145

107 95

85

34

199

128

62

20 32

90

78

0

50

100

150

200

250

1st Case 2nd Case 3rd Case 4th Case 5th Case 6th Case

Procedure Breakdown: STXS case time (mins.)

PVI's

VT/PVC

AVNRT

A-Tachs

PVI procedure

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51

The Odyssey Screen System 51

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All in One Screen 52

53

Exit Block 53

54

Left Pulmonary Veins

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Left Pulmonary Veins

56

57

58

Right Pulmonary Veins

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Right Pulmonary Veins

Stereotaxis Average case time per

Procedure type

Mapping

Duration

(mins)

Ablation

Duration

(mins)

Total Case

Time not

including

access (mins)

Stereotaxis

(STXS) Time

Total X-

Ray time

(mins)

STXS X-

Ray time

(mins)

AF 18.5 122 140.5

122

*mapping is

done w/ Lasso

49.13 7.5

PVC/VT 56 59 115 115 24.4 7.3

SVT/AT/

AP 27.6 28 55.6 55.6 20.25 3.85

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Afib Initial Procedures (Zero Complications)

61

165

72

145

107

95

95

26 31 26

8

5 10

13.6

1.6 9.4

3.3

7.9 12.1

46 45 42

54.8 61.1

45.9

0

20

40

60

80

100

120

140

160

180

1st AF 2nd AF 3rd AF 4th AF 5th AF 6th AF

Ablation Time (mins)

Mapping Time w/ Lasso (mins)

STXS Fluoro time (mins)

Non STXS Fluoro Time (mins)

Comparison: Stereotaxis PVI vs. Manual PVI Take a look at last STXS PVI and last Manual PVI

0

20

40

60

80

100

120

140

Mapping Time Ablation Time Total Fluoro Time

Total Time since 2nd TS

15

85

49.6

121

10

95

39.9

140 Time in minutes

Manual PVI

Robotic PVI

PVI (WACA)

PVI (WACA) Afib Initial Procedures (Zero Complications)

35 3120

218

146

86

5 2.4 6.3

83.2

41.2 40.9

0

50

100

150

200

250

1st AF (WACA) 2nd AF (WACA) 3rd AF (WACA)

Mapping time (mins)

Ablation time (mins)

STXS Fluoro time (mins)

Non STXS fluoro time (mins)

PVC/VT

66

105

69

15

94

59

4 12.6 5.35.1

20.5 25.7

00

20

40

60

80

100

120

1: RVOT PVC 2: Left Sided VT 3. Septal PVC

STXS Ablation Time (mins)

STXS Mapping Time (mins)

STXS Fluoro time (mins)

Non STXS Fluoro Time (mins)

Complications

PVC/VT

PVC/VT Initial Procedures (Zero Complications)

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VT/PVC procedure notes

1st PVC was bracketed to the RVOT.

fastest case and least amount of flouro time used in all procedures

2nd PVC contained three clinical morphologies localized to the Left Ventricle

1st Morphology: 62 minutes for mapping and ablation

2nd Morphology: 78 minutes for mapping and ablation

3rd Morphology: 61 minutes for mapping and ablation

3rd PVC contained extensive (194 CARTO points) mapping in the Right and Left Ventricle (retrograde approach)

RV Mapping and ablating 68 minutes

LV mapping and ablating duration: 130 minutes

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Left Sided A-Tach 69

0

48

53

11

15

13

62

42

2521

11

57.6 4.75.9 2 1.5 1.4

11.6 16.7

6

16.5

2225.8

0

10

20

30

40

50

60

70

AVNRT A Tach -RSPV

A Tach AVNRT AVNRT WPW

Ablation Time (mins)

Mapping Time (mins)

STXS Fluoro time (mins)

Non STXS Fluoro time (mins)

SVT Procedures

AVT/Atach/AP Initial Procedures (Zero Complications)

My Colleague – RA Flutter

71

42 43

33

107 7

5755 54

52.5

48

31

0.5

4.6

0.8 0.5 0 0.9

17.3

7.3 7.8

128.4

16.4

0

10

20

30

40

50

60

1st AFL 2nd AFL 3rd AFL 4th AFL 5th AFL 6th AFL

Mapping time (mins)

Ablation time (mins)

STXS Fluoro time (mins)

Non STXS fluoro time (mins)

My Colleague Atrial Flutter Initial Procedures (Zero Complications)

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Challenging Case 73

51 F presented with Afib with unknown duration to the ED with RVR in the 180’s BB and CCB failed to slow the patient HR.

Attempted electrical CV failed even with the aid of AAD (Ibutilide)

Started on Dofetilide (after one dose developed Tdp requiring CPR, DC shock and intubation.

Recovered and started on amiodarne, BB, CCB however had a very long post conversion pause 15 seconds PEA, CPR and intubation again, after recovery back to Afib with RVR

PVI Case Study

PVI Case Study (Continued)

PVI Case Study (Continued)

PVI Case Study (Continued)

PVI Case Study (Continued)

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Remote Magnetic Navigation System 79

Shorter procedures and faster recovery time,

enabling patients to return to normal activity within

a few days.

Less patient exposure to X-ray radiation and

contrast dyes.

Less physician exposure and reduce burden of

wearing the lead

Significantly reduced risk of serious complications

from perforation of blood vessels or heart tissue.

What is missing…

Tactile Feedback

BEFORE. . . .Robotic

Electrophysiologist Profile

AFTER….Robotic

THANK YOU

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