2009 roma, corso ablation frontiers nell'ablazione della fibrillazione atriale

1. Ablation
Frontiers
System

2. Technology Review:
• Electrode design driven by
the catheter shaft diameter
• Single ablation electrode
(point-to-point)
• Requires 35 – 100 Watts
• ~ 75% of surface area in
blood pool
Highly inefficient power
delivery to tissue
(i.e., 75% of power lost to
blood pool)
• Unipolar Only
• 2-D catheter requiring 3-D
Imaging
• Lack of control over lesion
creation and catheter
placement
Current Catheter Technology – Highly
Inefficient
Clinically Review:
• Risk of perforation
• Risk of steam pops from a
boiling process with gas
expansion as tissue temp
increases
• Needs saline cooling / flush
• Esophageal damage
• Large Δt between tissue &
electrode
• Ablates single point at a time
• Requires precise catheter
positioning
(high level of skill)
• Long procedure times
• Requires complex mapping
Flow

3. Ablation Frontiers
Solution
• Multi-electrode device that tailors the
treatment to the patient
– Catheters design to conform to the anatomy
– Mapping / Pacing and Ablations from all electrodes
– Much easier procedure than current approaches
• Highly skilled operators NOT required
– Reduce procedure times to less than 3.0 hours for Permanent
– Reduce procedure times to less than 1.5 hours for PAF
– Tailored lesions (i.e., depths, lengths, configurations)
– Cover large area with a single catheter placement
• Fewer SAE / Complications
• Do not require complex/3D imaging systems

4. Ablation Frontiers
Catheter Solution
Improve AF Ablation Efficacy and Reduce Procedure Time
How accomplished:
1. Created anatomically designed catheters
(catheters conform to the anatomy)
2. Large footprint and multiple electrodes for mapping & ablations
(facilitate mapping/ablation over a large with a single catheter
placement)
3. Very stable catheter placements
(catheters do not bounce due to beating atrium)
4. Enables easy assess to PV’s and quick electrical isolation
(guidewire assist to engage PV’s and 2-4 minutes of ablations)
5. Easy access to septum and other area’s in atrium
6. Gold standard RF energy delivered in a new/novel way for controlled
lesions

5. Ablation Frontiers RF
Generator Solution
• RF Generator Features:
– Automated temperature control / power limited
– RF energy (bipolar / unipolar)
• Maximize operator control of lesion size,
shape, depth
• Maximize power delivered efficiency to each
catheter electrode or electrode pair
– Remote control capability
– Interfaces with existing electrogram recording
systems e.g. EP Lab and Prucka System

6. ™
Multi-Channel RF
Generator
• User-friendly interface
(remote control access capable)
• Individual channel / electrode temperature
and power control/delivery
- Power mode identification
- Catheter
- Ablation timeRF Generator is CE Mark Approval

7. =
16
Conventional
Generators
Ablation Frontiers Multi-
Channel RF Generator

8. Ablation Frontiers Multi-
Channel RF Generator
PVAC_RUN1.m4v

9. Ablation Frontiers Ablation
Catheters
• Steerable and torque-able for maneuvering in the left atrium
• Multiple mapping and ablation channels per catheter
• Operator control of each channel to tailor lesions to patient
anatomy and desired lesion set
• Capable of creating large lesions in a single ablation
• 3-D design eliminates the need for costly 3-D mapping
All three catheters are CE Mark Approval

10. Pulmonary Vein Ablation Catheter
Ablation Frontiers Ablation
Catheters

11. Multi-Array Septal
Catheter
Ablation Frontiers Ablation
Catheters

12. Multi-Array Ablation Catheter
Ablation Frontiers Ablation
Catheters

13. How Does It Work Clinically?
• Anatomically Designed Catheters
• Selectable Energy Delivery
• Tailored Lesion Depth & Length

14. Mapping & Lesion
Creation Example
• Low Power RF Energy Delivery
– Efficient
• Each Electrode Pair
– Mapping
– Bipolar
– Unipolar
– Combo RF
– Duty-Cycled
– Efficient electrode design
• Depth and Filling in Center
Dependant on Energy Mode

15. Mapping & Lesion Creation
Example
• Low Power RF Energy
Delivery
– Efficient
• Each Electrode Pair
– Mapping
– Bipolar
– Unipolar
– Combo RF
– Duty-Cycled
– Efficient electrode
design
• Depth and Filling in Center
Dependant on Energy Mode

16. Radiofrequency Energy Modes
5 Different and
Selectable Energy
Modes:
Bipolar Unipolar
1:1 2:1 4:1
Ablation Electrode
Tissue
Return Electrode

17. RF Energy Modes
• Ablation and Return
Electrodes Same Potential
and Phase Angle
• Current Flows from
Ablation Electrode to
Return Electrode
• 100% Power is Unipolar

18. Bipolar Only RF Delivery Mode
• Ablation and Return
Electrodes Different
Potential and Phase Angle
• Return Electrode Off
• Current Flows Between
Ablation Electrode on
Catheter Only
• 100% Power is Bipolar

19. 1:1 (Bipolar:Unipolar) RF
Delivery Mode
• Power Ratio of
Bipolar:Unipolar = 1 to
1
• Current Flows Between
Ablation Electrodes
and to Return
Electrode
• 50% of Power is
Bipolar
• 50% of Power is
Unipolar

20. 2:1 (Bipolar:Unipolar) RF
Delivery Mode
• Power Ratio of
Bipolar:Unipolar = 2 to 1
• Current Flows Between
Ablation Electrodes and
to Return Electrode
• 66.7% of Power is
Bipolar
• 33.3% of Power is
Unipolar

21. 4:1 (Bipolar:Unipolar) RF
Delivery Mode
• Power Ratio of
Bipolar:Unipolar = 4 to
1
• Current Flows Between
Ablation Electrodes
and to Return
Electrode
• 80% of Power is
Bipolar
• 20% of Power is
Unipolar

22. Radiofrequency Energy
Modes
5 Different and
Selectable Energy
Modes
– Bipolar
• Unipolar
• 1:1
• 2:1
• 4:1
Ablation Electrode
Tissue
Return Electrode

23. Catheter Comparison
4mm Tip Catheter PVAC MAAC MASC
Electrode
Shape
Electrode
Surface
Area
33.7 mm2
13.64 mm2
9.09 mm2
Power
Input
35 W Max 10W Max 10W
Current
Density
0.016
A/mm2
0.015 A/mm2
0.018 A/mm2

24. In-vitro Lesion
Characterization: MAAC
• In-vitro Lesion
Characterization of AFI
Cardiac Ablation System (n=16)
• Lesion Depth Decrease from
Unipolar  Bipolar
60°C – 60s – 1:1 60°C – 60s – 4:1

25. In-vivo Lesion Depth
(Gross Pathology & Histological
Data)60°C – 60s – 1:1 60°C – 60s – 4:1
MAAC Lesion Depth
0
1
2
3
4
5
6
7
8
Depth(mm)
Gross 5.9 4.9 4 3.3 3.2
Histological 6.8 5.1 4.3 3.6 3.5
Unipolar 1:1 2:1 4:1 Bipolar

26. In-vivo Lesion Depth:
PVAC60°C – 60s – 1:1 60°C – 60s – 4:1
PVAC Lesion Depth
0
1
2
3
4
5
6
7
8
Depth(mm)
Gross 5.4 5.5 3.8 4.3 4.1
Histological 6.0 5.5 4.6 4.5 4.3
Unipolar 1:1 2:1 4:1 Bipolar

27. Lesion Depth
0
1
2
3
4
5
6
7
8
Depth(mm)
Gross 5.9 4.9 4 3.3 3.2
Histological 6.8 5.1 4.3 3.6 3.5
Unipolar 1:1 2:1 4:1 Bipolar
Typically used around
thicker and more robust
Atrial anatomies
i.e. Septal wall
Typically used around
thinner and more sensitive
Atrial anatomies
i.e. PV’s, Posterior wall

28. in-vivo Tissue Temperature
60°C – 60s – 1:1 60°C – 60s – 4:1
Thermocouples placed at 2mm in depth under electrodes and between electrodes

29. Tailoring Lesions
• RF Energy Selection
↑ Unipolar – more depth
↑ Bipolar – more fill between electrodes
• Increase Ablation Temperature
↑ Lesion Depth
• Increase Ablation Duration
↑ Lesion Depth

30. Lesion Comparison
4mm Tip Catheter PVAC
Top View
Cross
Section
Length
of Lesion
Ø: 7-10 mm;
Depth: 7-8 mm
Length: 70 - 80 mm Width: 2-3 mm
Depth: 2-8 mm (depending on energy mode)

31. In-vitro Lesion Characterization: PVAC
Creates contiguous lesions
Cross Section
Top

32. Multi-electrode Catheter Ablation

33. Atrial Fibrillation ablationAtrial Fibrillation ablation
Vagal GangliaVagal Ganglia

35. • Electrode design driven by the catheter
shaft diameter
• Single ablation electrode (point-to-point)
• Requires 35 – 40 Watts
• ~ 75% of surface area in blood pool
(i.e., 75% of power lost to blood pool)
• Unipolar RF energy only
• 2-D Cath requiring generally 3-D Imaging
• Lack of CTR over lesion creation and Cath
placement
Standard Catheter Technology
technology Review
Flow

36. Standard Catheter Technology
Clinically Review
• Risk of steam pops from a boiling
process with gas expansion as tissue
temp increases
• Needs saline cooling / flush
• “Point by point” RFCA strategies
• Requires precise catheter positioning
(high level of skill) Flow

37. Multi-electrode Catheter Ablation
- Steerable Catheters able to map, pace and
ablate from all electrodes
- Tailored lesions (i.e., depths, lengths,
configurations) according to unipolar and or
bipolar setting configuration

38. • Single ablation electrode
(point-to-point)
• Requires high energy
• ~ 75% of of power is lost to blood pool
• Unipolar RF energy only
• Lack of CTR over lesion creation
Standard Catheter Technology
technology Review
Flow
• Risk of steam pops from a boiling
process with gas expansion as tissue
temp increases
• Needs saline cooling / flush

39. • Ablation and Return Electrodes
Same Potential and Phase Angle
• Current Flows from Ablation
Electrode to Return Electrode
• 100% Power is Unipolar
Unipolar Only
RF energy modes
Ablation Electrode
Tissue
Return Electrode

40. Bipolar Only
RF Delivery Mode
• Ablation and Return Electrodes
Different Pot. and Phase Angle
• Return Electrode Off
• Current Flows Between
Ablation Electrode on Cath only
• 100% Power is Bipolar
Ablation Electrode
Tissue
Return Electrode

41. 50% of Power is Bipolar
50% of Power is Unipolar
66.7% of Power is Bipolar
33.3% of Power is Unipolar
80% of Power is Bipolar
20% of Power is Unipolar
Different RF Delivery Mode
Creates contiguous lesions
Cross Section

42. Catheter Comparison
4mm Tip Catheter PVAC
Electrode Shape
Electrode
Surface Area
33.7 mm2
13.64 mm2
Power Input 35 W Max 10W
Current Density 0.016 A/mm2
0.015 A/mm2

43. Multi-electrode Catheter Ablation
RF energy modes
Current Flows from Abl
Electrode to Return Electrode
• 100% Power is Unipolar
Current Flows between
Abl Electrode on Cath only
• 100% Power is Bipolar

44. Multi-electrode Catheter Ablation
- Anatomically designed lesions
- Large footprint for map/abl with a
single Cath placement
- Energy delivered in a new/novel
way for CTR lesions size
• Low Power RF Energy Delivery
• Different and Selectable RF
energy modes

45. Atrial Fibrillation ablationAtrial Fibrillation ablation
Anatomical considerationsAnatomical considerations