1. Constellation™
Taiki Esheim
Product Manager, EP

2. Agenda
Constellation™ Mapping Catheter Clinical Use
Constellation Connectology
Constellation Clinical Examples
Atrial Fibrillation and Rotor Mapping

3. Constellation™ Mapping Catheter Clinical Use

4. Constellation™ Indications For Use
“Indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording, only. The Constellation Mapping Catheter is designed to obtain electrograms in the atrial region of the heart”
Constellation DFU, Boston Scientific Image Library. 4

5. Constellation™ Clinical Application
Simultaneous recording of an entire chamber provides ‘single beat mapping
Provides a stable electrode grid
Can pace from any electrode in the chamber
Navigation of roving catheter relative to the basket
Ablation with the basket in place
Boston Scientific Image Library 5

6. Constellation™ Product Specifications
Pebax is a trademark of Arkema Corporation.
Shaft Tubing
Double-wire braided Pebax® (Blazer™ Temperature Ablation Catheter Shaft Technology)
Spline Material
Nitinol, Titanium, Chromium
Spline Tubing
Polyurethane
Electrodes
Platinum/Iridium, 2F × 1.5 mm
# of Splines
8 (labeled clockwise A–G)
# of Electrodes/Spline 8
Active Electrodes
32 (31mm only) or 64
Marker Electrodes
Adjacent or A/B
Useable Length
120cm

7. Chamber Sizing for Constellation™
Importance of Correct Chamber Sizing
Correct chamber sizing critical for reliable electrograms
Constellation must touch chamber walls
Too small, Constellation floats in chamber
Too large, Constellation folds on itself and causes noise artifact
Boston Scientific Image Library. 7

8. Chamber Sizing for Constellation™
How to Size Constellation
Obtain data to determine chamber size
Trans Thoracic Echo – TTE
Trans Esophageal Echo – TEE
Intracardiac Echo – ICE
Fluoroscopy
Physician’s best guess
Signs of Good Sizing
Splines move with cardiac chamber
Constellation takes the shape of the cardiac chamber on fluoro
Good intracardiac electrogram signals
Low pacing thresholds
ICE shows endocardial contact
40mm
38mm
Boston Scientific Image Library. 8

9. Constellation™ Electrode Spacing
Basket Sizes Available
31, 38, 48, 60, and 75
Uniform Inter-Electrode Spacing
Basket Sizing
Spacing
31mm
2mm
38mm
3mm
48mm
4mm
60mm
5mm
75mm
7mm 9

10. Constellation™ Deployment
55°, 60 cm Sheath (M ) – recommended for right-sided placements
90°, 79.4 cm Sheath (M ) – recommended for left-side placements
55°, 79.4 cm Sheath (M ) – recommended for left-sided placements
120°L, 79.4 cm Sheath (M ) - recommended for left-side placements
Some physicians use a steerable sheath
SJM 8.5F Agilis™ (or BSC alternative!!!!)
Constellation must be advanced through a long sheath
Boston Scientific Image Library. Agilis is a trademark of St. Jude Medical, Daig Division Inc.
*Heartspan is a trademark of Merit Medical, Inc.

11. Constellation™ Deployment and Removal
Caution with the sheath and catheter is paramount!
Place the Constellation catheter within the lumen of the sheath
Advance the sheath to the targeted anatomical location
Never advance Constellation out of the sheath into the anatomy
Hold the Constellation catheter in a fixed position and withdraw the sheath for safe deployment
If after inserting the catheter, the EP encounters resistance when advancing the catheter, pull the short introducer sheath on the catheter back by 2-3 mm’s (still inserted through the hemostasis valve) and re-advance the catheter. Make sure to then slide the short introducer sheath down the proximal catheter shaft.
Boston Scientific Image Library.
Constellation Mapping Catheter DFU 11

12. Constellation™ and Heparin
To minimize Constellation deployment risks, thorough preparation is required
Flush Bowl in the Sterile Table
Wiping down exterior surfaces removes potential debris
Flushing Luminal objects removes air from the lumen
Wipe shaft of Constellation with Heparinized saline from flush bowl
Submerge Constellation under the Heparinized Saline and close short blue sheath over the splines
Flush sideport with Heparinized saline
Through Long Sheath Sideport
Prevents clot formation within the long sheath
Continuously flush sideport of sheath with Heparinized saline using an ‘art line’ set up
Systemic
Prevents clot formation on the complex nature of the Constellation
Advise the administration of systemic Heparin according to routine lab procedure to keep ACT at least 300 sec.
Constellation Mapping Catheter DFU

13. Constellation™ Connectology

14. Constellation™ Connectology
Required Data to Determine Constellation Connectology
Intended use for Constellation
Type of recording system (NavX, Bard)
Number of recording channels available
What other catheters will be used (Dx and Rx)
When in Doubt, Pin it Out… 14

15. Constellation™ Connectology – Method 1
Note:
*Note: 4901AS0 and 4901BS0 have an extra shrouded pin (labeled “distal tip”) on each cable. Do not connect that pin for Constellation™.
M004901AS0 M
Constellation Catheter M
M004901BS0

16. Constellation™ – What to Order
M – Qty 2
M004901AS0 – Qty 1
M004901BS0 – Qty 1
Constellation Catheter
PV isolation = 31 mm
RA, LA = 48, 60 mm
RVOT = 38, 48 mm
LV =60, 75 mm

17. Constellation™ Spline Identification
64 Electrodes
8 Splines A–H
Each Spline has 8 electrodes 1–8
Electrode 1 is distal tip of catheter
Electrode 1
Electrode 8
Boston Scientific Image Library.

18. Constellation™ Spline Identification
How does a physician know which electrode is where?
Large basket - markers on the splines
Constellation 38mm to 60mm have adjacent marker scheme
Each spline has one larger electrode with exception of Spline H
Spline A has larger electrode on 8, Spline B has a larger electrode on 7, etc.
31mm Constellation is too small to see adjacent markers
31mm Constellation uses A/B marker system
A/B markers are only on A and B splines
A marker has 1 larger non-active marker
B marker has 2 larger non-active markers
Boston Scientific Image Library.

19. Constellation™ Spline Identification
Large Basket Splines Small Basket Splines
B Marker
A Marker
Boston Scientific Image Library.

20. Constellation™ Spline Identification
Fluoro Identification
You can see markers on fluoro
If it is difficult to see the spline, the physician may slightly rotate the fluoro image
Difficult to determine 3-D orientation
What’s in front?
When Constellation is viewed in upright position:
When A is right of B: A is in foreground
When A is left of B: A is in background B
B Marker A
A Marker
Boston Scientific Image Library.

21. Constellation™ Catheter with NavX™ System
Points acquired at a faster rate
Smooth, more complete looking anatomy
Complete voltage acquisition more readily obtained
More electrodes available (32) for identifying and marking activation sites
Only 4 electrodes on each spline or 4 complete splines can be viewed with the legacy EnSite NavX System
Most useful to display mid electrodes (3,4,5, and 6) on each spline
More electrode visualization available with Velocity™ and Velocity 3 Systems
NAVX and Velocity are trademarks of St. Jude Medical.

22. Contraindications for Use
In or through a chamber with any permanent leads present
In patients who cannot be anticoagulated or infused with heparinized saline or have heparin-induced thrombocytopenia.
For use from the femoral approach in patients who have a vena cava embolic protection filter device or known femoral thrombus.
In patients with recurrent/active sepsis or with hypercoaguable state
In patients with echocardiographically-confirmed visual presence of thrombus
For transseptal approach in patients with atrial thrombus or myxoma, or inter-atrial baffle or patch.
Constellation Mapping Catheter DFU 22

23. Constellation™ Clinical Examples
Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.

24. EGMs – Atrial Tachycardia (Focal)
Lateral
TV-IVC Isthmus
Septal *
Lateral
Earliest activation
(focus) near
electrodes B3 and C3 *
Valve
Activation spreads
from focus, across
septum, and toward
valve
TV-IVC Isthmus
Septal
Lateral
Over valve
Valve
TV-IVC Isthmus
Septal
Lateral
Valve
V4:
Boston Scientific Image Library.
TV-IVC Isthmus
Septal

25. PV Foci Location 3-D Single Beat Map of Pulmonary Veins Constellation
Electrograms
Vein A
A12
Distal Vein
Vein A
A34
Mid-Vein A
Vein
A56
Ostium A
A78
Atrium
Boston Scientific Image Library.

26. Constellation™ Positioning in PV
Constellation shape offers stability and good PV positioning
3-D shape eliminates catheter repositioning and distortion
Left Superior Pulmonary Vein
Boston Scientific Image Library.

27. Left Inferior PV – Pre and Post Ablation
Boston Scientific Image Library.

28. Atrial Fibrillation and Rotor Mapping

29. AF Ablation Summary
Targeted ablation methods in patients with persistent atrial fibrillation have had limited success based on point by point mapping using 3D navigation systems.
The rotor mapping concept has been recently introduced by Topera Medical led by Sanjiv Narayan based on application of basic research techniques for visualization of cardiac activity.
Excitement has mounted around this old, but newly revised concept and iteration; data is still limited and restricted to a small number of sites.

30. AF Ablation Strategies
Pathophysiology of AF
Triggers
(Initiation) +
Substrate
(Maintenance)
AF Ablation Strategies
PV Isolation
Autonomic
Electrophys.
Mapping GP
CFAE
Linear Lesions
Sequential approach
Rotor?
Circumferential PV Ablation
PV Antrum Isolation
Do these results suggest a re-think of the fundamentals of AF ablation guidance? Is there a unifying fundamental basis that can be leveraged to guide ablation and ensure success? Is the mother rotor hypothesis the fundamental basis for persistent AF?
Conclusion: No clear winner, all ablation strategies have similar outcomes, not exceeding 50-60% AF-free success rates. Successful single center investigational approaches seldom imply similar outcomes in general practice.

31. State of the Art: 3D Electroanatomical Mapping
J&J CARTO™ & STJ NAVX™
Merge navigation data with MRI or CT Images
Anatomically guided ablation
Limited utility of point-by-point mapping techniques to identify sources in substrate
Dominant Frequency/CFAE algorithms not specific enough to improve procedure time or outcomes
Anatomically based strategies are effective for PVI but single point mapping strategies have not been successful in identifying AF “drivers” in the substrate
CARTO is a trademark of Cordis Corporation.
NAVX is a trademark of St. Jude Medical.

32. AF Ablation Success Rates Persistent AF
Significant opportunity to improve on single procedure success rates of 50% in Persistent AF → requires improved substrate modification approach
Procedural Success
PVI: Pulmonary Vein Isolation
PVAI: Pulmonary Vein Antrum Isolation
LIN: Linear Isolation
CFAE: Complex Fractionated Atrial Electrograms
Stepwise: PVI + CFAE + Linear Isolation
Source (adapted): Brooks et al. Outcomes in Long Standing Persistent Atrial Fibrillation Ablation Procedures. Heart Rhythm 2010

33. Limitations of Point-by-Point Approach
3D Navigation technologies have enabled precise positioning of the ablation catheter; however, anatomically-based segmentation of the atria has been elusive due to challenges in creation of linear lesions via point-by-point approach.
Current electrophysiology mapping procedures have not improved outcomes because they only provide a very limited view of the chaotic electrical activity in the atria → difficult to find “drivers” or sites critical to maintaining the fibrillation
Ultimately, multi-procedure success may be related to sequential reduction of viable tissue or the so-called “Atrial debulking” phenomenon
Identification of “drivers” may require deployment of an array of electrodes to decipher regional and global activity

34. Background – Rotor Mapping Concept
In spite of significant advances in mapping and navigation technology, atrial substrate mapping methods using sequential acquisition of single point electrical information have not translated into improved outcomes in ablation procedures due to instability of the underlying electrical activity.
Common ablation practice include various combinations of lesion sets: WACA + CFAE + LA Roof + Mitral Isthmus
Simultaneous acquisition of atrial electrical activity using a multipolar contact mapping system may be beneficial if, in fact, there are regions of stable electrical activity and the electrode density is sufficient to identify patterns of activation.
Recent publications* by Sanjiv Narayan (UCSD, Topera Medical) have demonstrated that regions of stable activity may be identified and targeted to terminate or slow the atrial rhythm with a significant improvement in maintenance of sinus rhythm by visualization and targeting focal or rotor activity using multipolar electrical activity data from Constellation™ catheter.
* Krummen, David, et. Al “ Ablating Persistent AF Successfully”,Current Cardiology Reports, 25July 2012, 14: ; Narayan, SM, et. Al., “Treatment of Atrial Fibrillation by the Ablation of Localized Sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) Trial”, J Am Coll Cardiol Aug 14;60(7): Epub 2012 Jul 18.

35. Rotor Mapping Methods
Use Navigation technology (NAVX™/CARTO™) to create anatomical model (optional)
Deploy BSC Constellation (64 pole) to RA/LA
Record 10 seconds of activity (EGMs)
Convert EGMs to activation times and assign APD mode (reduce noise from far-field signals)
Extract phase information and interpolate the data to create visual maps
Visualize activity with color coded map and identify core region to target with lesion
Create lesion with roving ablation catheter and observe for slowing or termination of rhythm (remap if needed)
Reference: Umapathy et al. Phase Mapping of Cardiac Fibrillation. Circ Arrhythm Electrophysiol February 2010
CARTO is a trademark of Cordis Corporation. NAVX is a trademark of St. Jude Medical.
Boston Scientific Image Library

36. 64 electrode Constellation™ Mapping
Rotor Mapping Concept
64 electrode Constellation™ Mapping
Catheter
Determine activation times from electrograms
Use model to assign tissue dynamics
Transform and visualize data in 2D

37. CONFIRM Trial Data presented by Sanjiv Narayan, MD, PhD
Single center experience driven by Topera founder
Methods
N = 103 pts enrolled, 95 pts with sustained AF (67% Persistent)
Patients randomized to WACA or WACA + FIRM
Patients mapped in RA and LA using Constellation™ catheter
Results:
AF Termination or Significant Slowing: WACA+FIRM (88%) vs WACA (14%)
AF Free Survival (2 yrs) : WACA+FIRM (84%) vs WACA (50%)
Reference success rates for Persistent or Permanent AF range from 20-60%1
Conclusions
Impressive long-term follow-up backed by implanted loop recorders
Limited details on lesion locations and sizes
Small number of discrete lesions
Most “sources” located in LA
Indicated that some lesions may be on the order of 2cmx2cm
WACA – Wide Area Circumferential Ablation (Pulmonary Vein Isolation)
FIRM – Focal Impulse and Rotor Modulation
Narayan, SM, et. Al., “Treatment of Atrial Fibrillation by the Ablation of Localized Sources: CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) Trial”, J Am Coll Cardiol Aug 14;60(7): Epub 2012 Jul 18.
1 Brooks et al. Outcomes of long standing atrial fibrillation ablation: A systematic review. Heart Rhythm, Vol 7, No. 6, June 2010

38. Rotor Mapping For BSC
Multi-electrode endocardial contact mapping using the Constellation™ catheter for identification of arrhythmic sources in persistent atrial fibrillation
Constellation now has RA/LA indication for use in EU, Canada, and Japan.
Integration of phase/vector mapping software application into Rhythmia 3D mapping & navigation platform
Evaluating high density sequential mapping using small basket Rhythmia™ catheter

39. Competitive Landscape
STJ
Non contact mapping: volume electrograms and computation of tissue electrograms.
For complex rhythms, the “inverse problem” is highly ill-posed (non-unique solution). Therefore, rotor mapping is not a simple or straightforward enhancement.
Reflexion™ HD catheter
Dual spiral catheter, high resolution within field of view (more contact electrodes in small area) . Possible to identify rotor on placement on or near rotor core. Sequential “area mapping” may be possible to reveal rotor cores.
MDT
Unknown
Biosense Webster
Electro-anatomical maps created by sequential “point mapping” – shown to be unreliable in uncovering sources underlying complex rhythms (CAFÉ, DF, etc.)
*Source: Product functionality – St. Jude & Biosense Webster Website; Assessment: BSC personnel
Reflexion is a trademark of St. Jude Medical.