Stefano Nardi, MD, PhD Tools to successfully Tools to successfully achieve PV isolation achieve PV isolation “ “ SANTA MARIA” GENERAL HOSPITAL - TERNI SANTA MARIA” GENERAL HOSPITAL - TERNI THORACIC SURGERY AND THORACIC SURGERY AND CARDIOVASCULAR DEPARTMENT ARRHYTHMIA ELECTROPHYSIOLOGIC CARDIOVASCULAR DEPARTMENT ARRHYTHMIA ELECTROPHYSIOLOGIC CENTER AND CARDIAC PACING UNIT CENTER AND CARDIAC PACING UNIT
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2009 lisbona, congresso europeo, ablazione della fibrillazione atriale
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Stefano Nardi, MD, PhD
Tools to successfully Tools to successfully achieve PV isolation achieve PV isolation
“ “SANTA MARIA” GENERAL HOSPITAL - TERNISANTA MARIA” GENERAL HOSPITAL - TERNI THORACIC SURGERY AND THORACIC SURGERY AND
CARDIOVASCULAR DEPARTMENT ARRHYTHMIA ELECTROPHYSIOLOGIC CARDIOVASCULAR DEPARTMENT ARRHYTHMIA ELECTROPHYSIOLOGIC CENTER AND CARDIAC PACING UNIT CENTER AND CARDIAC PACING UNIT
Who benefits from AF ablation ?
Atrial FibrillationAtrial FibrillationMechanisms and ConsiderationsMechanisms and Considerations
• ROTOR sites critical to the maintenance of reentry
How does it work?
RF
Pulmonary vein anatomy
TRIGGERTRIGGER
Haissaguerre, NEJM ’98
It’s really important to use the appropriate technique for
AF ablation
Different TechnologiesDifferent TechnologiesMappingMapping• Point by pointPoint by point
• LassoLasso• SpiralSpiral• BasketBasket
TrackingTracking• XrayXray
• CARTOCARTO• LocaLisaLocaLisa• NavXNavX• RPMRPM
• ICEICE
AblationAblation• ConventionalConventional
• 8 mm tip8 mm tip• Irrigated tipIrrigated tip• InvestigationalInvestigational(balloon, cryo...)(balloon, cryo...)- Framework for ablationFramework for ablation
- Mapping guidanceMapping guidance
- Anatomic localizationAnatomic localization
- Tagging of ablation sites- Tagging of ablation sites- Determine Determine catheter contactcatheter contact
- Improved Improved efficiency of efficiency of energy deliveryenergy delivery
How we can approach AF ablation ?
Different Approaches
What is really useful?3D mapping system in AFib 3D mapping system in AFib
Cutaneous patches and conventional catheter for tracking (NavX)
• Arrhythmogenic nature due to (Embrional Nature) or micro-reentry (anisotropic carachteristic of junction) (Hocini M, Card. Res ’02, Arora, Circulation 03)
Ernst, JACC ‘03Ernst, JACC ‘03
Complete LesionsComplete LesionsA – 5% A – 5% B – 21% B – 21% C – 50% D - C – 50% D - 58-65%58-65%
– Cover large area with a single catheter placement
• Fewer SAE / Complications
• Do not require complex/3D imaging systems
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
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
™ 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
=16
ConventionalGenerators
Ablation Frontiers Multi-Channel RF Generator
Ablation Frontiers Multi-Channel RF Generator
PVAC_RUN1.m4v
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
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
• 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
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
50% of Power is Bipolar50% of Power is Unipolar
66.7% of Power is Bipolar33.3% of Power is Unipolar
80% of Power is Bipolar20% of Power is Unipolar
Different RF Delivery Mode
Creates contiguous lesions
Cross Section
Catheter Comparison4mm Tip Catheter PVAC
Electrode Shape
Electrode Surface Area
33.7 mm2 13.64 mm2
Power Input 35 W Max 10WCurrent Density 0.016 A/mm2 0.015 A/mm2
PV Isolation using the Cryo-Balloon
HD Mesh Ablator
HD Mesh Ablator
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
• The purpose of AF Survey I was to assess on a large scale level methods, safety and efficacy of curative CA of AF (1995-2002)
• The rationale for AF Survey II is to evaluate the impact of newer techniques applied to broadened indications, according to the increased investigator’s experience
• Parameters were compared and selected for a post-hoc analysis and results reflect exclusively the experience of singles centres
AF Survey II
AF Survey II
Previous Survey
Current Survey
Period investigated 1995-2002 2003-2006
Nr of centers 90 85
No. of pts 8,745 16,309
No. of pts per center 97 192
No. procedures 12,830 20,825
No. procedures per pts 1.5 1.3
Male, % 63.8 60.8
Lower and upper age limit for entry
18-82 15-90
% of centers performing ablation of- Paroxysmal AF 100 100
- Persistent AF 53.4 85.9
- Permanent AF 20 47.1
Cappato R, Boston 2008
efficacy and safety data
Type of AF No. of Centers
No. of Pts
Success without AADs Success with AADs Overall SuccessNo Pts
• Results reflect the experience of centers electing to respond
• Intermediate-term follow up data• Post-ablation asymptomatic AF not investigated• CA of AF evolving over the time and these data
may not reflect the efficacy and safety rates of 2009
considerationsAF Survey II
• PVI is efficacy in 52-84% of PAF non-PVI is efficacy in 52-84% of PAF non-inducible and results in clinical successinducible and results in clinical success
• Substrate modification is likely to be Substrate modification is likely to be required in 30% of PAF and most CAF, but required in 30% of PAF and most CAF, but needs needs technological improvements technological improvements • An individually tailored approach is neededAn individually tailored approach is needed
What is the future for What is the future for satisfactory treatment of AF ?satisfactory treatment of AF ?
What is success?
• Complete freedom of AF, off drug RX?• No symptoms, but drug Rx required?• Dramatic decrease in symptoms, but
drugs still required?• QoL• How do we detect asymptomatic
episodes?• Anticoagulation ………………...?
What is the future for What is the future for satisfactory treatment of AF ?satisfactory treatment of AF ?
• Maintaining sinus rhythm (cure of AF) must Maintaining sinus rhythm (cure of AF) must remain our goalremain our goal• Indications for AF ablation will expand ? Indications for AF ablation will expand ? Role in complicated AFRole in complicated AF• Non-inducibility may be a useful procedural Non-inducibility may be a useful procedural endpoint to rationalize strategiesendpoint to rationalize strategies
Proportion (%) of centers using as exclusion- Left atrial size upper limit 46.3 68.2- Lower cut-off limit of LVEF 64.3 22.4Success rate (%, median)- Free of AADs 52.0 64.3- With AADs 23.5 12.5- Overall 75.5 76.9Overall complication rate (%) 5.9 4.5Iatrogenic flutter 3.9 8.3
Entry Criteria, Outcome and Complications
Abstract Ref Pts Efficacy SafetyACUTE RESULTS OF PVI IN PTS WITH PaAF USING A SINGLE MESH CATHETERSteinwender C, Hönig S, Leisch F, Hofmann R.
JCVE ‘09
26 PaAF Acute: PVI in 99/102 (97%) PVs
Follow-Up: 6-month FU in 13 pts:8/13 (61%) of success2/13 (15%) improved3/13 (23%) failure
Pericardial effusion (pericardocentesis) in 1 ptNo other complication during the procedure or the subsequent hospital stay were observed. RF ABLATION OF
PaAF BY MESH CATHETERPratola C, Notarstefano P, Artale P.
JICE ‘09
15 PaAF Acute: PVI in 40 pts (100%)
Follow-Up: NA
No complications occurred during and after or procedures.
Clinical experience with a single Cath. for Map/Abl of PV ostium De Filippo P
JCVE ‘08
17 pts PaAF (10pts) PeAF (7 pts)
Acute: 100% (17/17) for LUPV, LIPV and RUPV 47% (8/17) for RIPV.Follow-up: 11±4 mo, 64% of pts in SR (8/10 PaAF and 3/7 for PeAF)
No complications occurred
either acutely or at follow-
Up
HD Mesh Ablator
ResultsResults
PV Isolation using the Cryo-Balloon
• Successfull electrical isolation of 97% PVs in a single procedure (28 mm Balloon)
• Follow Up of 89 ± 66 days – 15 pts. free of AF (75%)– 5 pts. reduced AF burden but still AF
• No complications, besides of 1 PN palsy
Asklepios Klink St. Georg, Hamburg
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