2009 ferrara, congresso regionale, i tools da raggiungere nell'ablazione della fibrillazione atriale
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Transcript of 2009 ferrara, congresso regionale, i tools da raggiungere nell'ablazione della fibrillazione atriale
Stefano Nardi, MD, PhD
Tools to successfully Tools to successfully achieve PV isolation: achieve PV isolation:
efficacy and safety data efficacy and safety data
“ “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
Atrial Fibrillation MechanismsAtrial Fibrillation Mechanisms
• PVs as TRIGGER and PERPETUATORS
• SUBSTRATE with CRITICAL MASS
• GANGLIONIC PLEXI affecting vagal innervation
• ROTOR sites critical to the maintenance of reentry
How does it work?
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 - Tagging of ablation sitessites
- Determine Determine catheter contactcatheter contact
- Improved Improved efficiency of efficiency of energy deliveryenergy delivery
How we can approach AF ablation ?
What is really useful?3D mapping system in AFib 3D mapping system in AFib
Cutaneous patches and conventional catheter
for tracking (NavX)
Superimposed EM field With a dedicated mapping
catheter (CARTO)
Anatomical Approach Anatomical Approach CLAACLAA
• 251 Patients• 54±12 min of RF
End Point: (75%)• PVP < 0.1 mV• Delay > 30 ms
Success off AADs:• 148/179 PaAF (83%)• 40/72 PeAF (55%)Pappone, Circulation ‘01Pappone, Circulation ‘01
AuthorsAuthors Success w/o AADsSuccess w/o AADs
PAPPONEPAPPONE 83% FAP/75%FAC83% FAP/75%FACJACC 2003JACC 2003
STABILESTABILE 38% FAP/FAC38% FAP/FACCirculation Circulation 20032003
HOCINIHOCINI 60% FAP*60% FAP*AbstractAbstract
ORALORAL 88% FAP (+ line)*88% FAP (+ line)*Circulation 2003Circulation 2003
Anatomical Approach Anatomical Approach CLAACLAA
Authors Success Rate (%)Success Rate (%)
HaissaguerreHaissaguerre Circulation 2000Circulation 2000 73%73%PAFPAF
Chen SAChen SA Circulation 2001Circulation 2001 81%81% PAFPAF
ErnstErnst PACE 2003PACE 2003 69%69% PAFPAF
ArentzArentz Circulation 2003Circulation 2003 62%62% PAFPAF
CappatoCappato Circulation 2003Circulation 2003 8888%% PAFPAF
MarroucheMarrouche JACC 2002JACC 2002 90%90% PAF PAF
OralOral Circulation 2002Circulation 2002 85% 85% PAF PAF 22%22% CAFCAF
Pulmonary Vein isolationAtrial Fibrillation ablationAtrial Fibrillation ablation
Left Atrial/PVs junctionLeft Atrial/PVs junction• Functionally is a “BROAD
BAND” • Wide, complex & articulate anatomy, (irregular disposition of myocardial sleeves (Ho, JCVE. ‘99; Heart ‘01; Saito, JCVE. ’00) • 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 Complete LesionsLesionsA – 5% A – 5% B – 21% B – 21% C – 50% D C – 50% D - 58-65%- 58-65%
Anatomical Approach (CLAA)Anatomical Approach (CLAA)
LIPV
CS pacing
Mitral
Anatomical CLAA: Incomplete PVI in ~ 60%Anatomical CLAA: Incomplete PVI in ~ 60%
70 ms70 ms
IIIIIIIIIIIIV1V1
PV1-2PV1-2
PV10-1PV10-1
CSDCSD
CSPCSP
Limitations of CLAA
• What substrate is “real target” for AF ablation ?
• Almost 60% of pts no PVI • Extensive LA damage• LA flutters more common (20%)
V1V1
RF probeRF probe(ostial)(ostial)
LIPV 1-2LIPV 1-2
2-32-3
3-43-4
4-54-5
5-65-6
6-76-7
7-87-8
8-98-9
9-109-10
10-110-1
LA appLA app
Discrete Residual PV bundle - Producing Discrete Residual PV bundle - Producing ArrhythmiaArrhythmia
• Inadequate Mapping of complex anatomical substrates
Limitation of standard Limitation of standard SOCASOCA
• PVs potential running along the LA posterior wall could be missed with
a standard EP approach
• A complex design for transition between anatomical structures
• SUCCESS RATE related to the ability to apply RF at predefined target sites, and the identification of
all PVs bundles could be challenging
Limitation of standard Limitation of standard SOCASOCA
IIIIII
PV 1-2
PV 10-1
V1
CSP
• FLUOROSCOPY has a poor soft-tissue resolution, with high exposure to ionizing radiation.
• Conduction recovery after a previously successful PVI
could be due to a ”SUB-OPTIMAL” identification of all PVs pot.
• A multi-step approach provides a significant clinical benefit and suggest that PVs are an important “End Point”
Atrial Fibrillation ablationAtrial Fibrillation ablationvirtual geometry reconstructionvirtual geometry reconstruction
•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 Technologytechnology Review
Flow•Risk of steam pops from a boiling process with gas expansion as tissue temp increases
•Needs saline cooling / flush
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
Multi-electrode Catheter Ablation RF
energy modesCurrent Flows from Abl
Electrode to Return Electrode
• 100% Power is Unipolar
Current Flows between Abl Electrode on Cath only
• 100% Power is Bipolar
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
• 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 Center
s
No. of Pts
Success without AADs Success with AADs
Overall Success
No Pts
Total Rate Median
74.9[64.9-82.6]
64.8[52.4-72.0]
63.1[53.3-71.4]
No Pts
Rate Median
9.1[0.2-14.7]
10.0[0.8-15.2]
7.9[0.9-15.9]
NoPts
Rate Median
Paroxysmal
85 9,590 6,580
1,290
7,870 84.0[79.7-88.6]
Persistent 73 4,712 2,800
595 3,395 74.8[66.1-80.04
Permanent
40 1,853 1,108
162 1,270 71.0[67.4-72.3]
AF Survey II
Cappato R, Boston 2008
Relationship between success rate and type of Ablation Catheter
Relationship between success rate and type of Ablation Catheter
Type of Catheter
No Center
No Pts
Success without AADs Success with AADs Overall Success
Total No of Pts
Total Rate Median
68.3
[48.4-80.8]
67.9
[44.7-73.6]
68.1
[46.2-73.6]
Total No of Pts
Rate Median
11.5
[8.6-26.7]
9.0
[0.0-14.8]
10.0
[0.0-20.0]
Total No of Pts
Rate Median
4-mm 23 2,892 1,803 609 2,412 79.8[55.0-87.2]
Irrigated/ Cooled
39 6,674 3,891 721 4,612 76.9[56.4-88.5]
TOTAL 62 9,5665,694 1,330 7,024 78.1
[66.8-86.7]
AF Survey II
Cappato R, Boston 2008
Type of Strateg
y
No Center
No Pts
Success without AADs
Success with AADs
Overall Success
Total No of Pts
Total Rate Median
78.0[67.9-78.8]
69.8 [56.8-73.4]
71.1[58.3-78.0]
Total No of Pts
Rate Median
6.7[0.0-13.3]
10.4[5.1-13.0]
10.0[0.0-13.0]
Total No of Pts
Rate Median
Lasso 21 3,722 2,616 499 3,115 84.7[78.8-89.5]
Carto 33 7,059 4,369 795 5,164 80.2[66.8-83.8]
TOTAL 54 10,781
6,985 1,294 8,279 81.0[73.3-84.0]
AF Survey II
Cappato R, Boston 2008
Relationship between success rate and type of Ablation Catheter
Major ComplicationsType of Complication No of Pts Rate,%
Death 25 0.15
Tamponade 213 1.31
Pneumothorax 15 0.09
Haemothorax 4 0.02
Sepsis, abscesses or endocarditis 2 0.01
Permanent diaphragmatic paralysis 28 0.17
Total femoral pseudoaneurysm 152 0.93
Total artero-venous fistulae 88 0.54
Valve damage/requiring surgery 11/7 0.07
Atrium-esophageal fistulae 3 0.02
Stroke 37 0.23
Transient ischaemic attack 115 0.71
Pulmonary veins stenoses requiring intervention 48 0.29
Total 741 4.54
AF Survey II
Cappato R, Boston 2008
• 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 technological improvements needs technological improvements • An individually tailored approach is An individually tailored approach is neededneeded
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) Maintaining sinus rhythm (cure of AF) must 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 Non-inducibility may be a useful procedural procedural endpoint to rationalize endpoint to rationalize strategiesstrategies
Catheter Comparison
4mm 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
Atrial Fibrillation ablationAtrial Fibrillation ablationvirtual geometry reconstructionvirtual geometry reconstruction
Technique no. of centers no. of patients %
RAC 8 75 0.1CA-TF 10 222 1.7OED 34 3,889 27.4Cartow/o PV isolation 15 1,460 10.3w/ PV isolation 37 5,394 37.9
3D non-contact 11 663 4.7Basket 10 150 1.1CFAEs 16 349 2.4Other 5 968 6.9Combination 19 1,048 7.4
Total 165 14,218 100.0
Cappato R, Boston 2008
AF Survey IIefficacy and safety data
Previous Survey
Current Survey
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 76.9
Overall complication rate (%) 5.9 4.5
Iatrogenic 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 energy modes
• 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
•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 Technologytechnology Review
Flow
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