experience with stereotaxis robotic in the ep … · experience with stereotaxis robotic in the ep...
TRANSCRIPT
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
49
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
52
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)
73
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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