Efficacy and safety data of tools to successfully achieve PV isolation for AF ablation
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2009 ferrara, congresso regionale, i tools da raggiungere nell'ablazione della fibrillazione atriale
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Efficacy and safety data of tools to successfully achieve PV isolation for AF ablation
- 1. Stefano Nardi, MD, PhD Tools to successfullyTools to successfully achieve PV isolation:achieve PV isolation: efficacy and safety dataefficacy and safety data ““SANTA MARIA” GENERAL HOSPITAL - TERNISANTA MARIA” GENERAL HOSPITAL - TERNI THORACIC SURGERY ANDTHORACIC SURGERY AND CARDIOVASCULAR DEPARTMENT ARRHYTHMIA ELECTROPHYSIOLOGCARDIOVASCULAR DEPARTMENT ARRHYTHMIA ELECTROPHYSIOLOG CENTER AND CARDIAC PACING UNITCENTER AND CARDIAC PACING UNIT
- 2. Who benefits from AF ablation ?
- 3. Atrial FibrillationAtrial Fibrillation Mechanisms and ConsiderationsMechanisms and Considerations
- 4. 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?
- 6. It’s really important to use the appropriate technique for AF ablation
- 7. Different TechnologiesDifferent Technologies MappingMapping • 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 - DetermineDetermine catheter contactcatheter contact - ImprovedImproved efficiency ofefficiency of energy deliveryenergy delivery How we can approach AF ablation ?
- 9. What is really useful? 3D mapping system in AFib3D mapping system in AFib Cutaneous patches and conventional catheter for tracking (NavX) Superimposed EM field With a dedicated mapping catheter (CARTO)
- 10. Point-by-Point Medium-Low Virtual Geometry reconstructionVirtual Geometry reconstruction
- 11. Virtual Geometry reconstructionVirtual Geometry reconstruction
- 12. Anatomical ApproachAnatomical 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
- 13. AuthorsAuthors Success w/o AADsSuccess w/o AADs PAPPONEPAPPONE 83% FAP/75%FAC83% FAP/75%FACJACC 2003JACC 2003 STABILESTABILE 38% FAP/FAC38% FAP/FACCirculation 2003Circulation 2003 HOCINIHOCINI 60% FAP*60% FAP*AbstractAbstract ORALORAL 88% FAP (+ line)*88% FAP (+ line)*Circulation 2003Circulation 2003 Anatomical ApproachAnatomical Approach CLAACLAA
- 14. Pulmonary Vein isolation Atrial Fibrillation ablationAtrial Fibrillation ablation
- 15. 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% PAFPAF OralOral Circulation 2002Circulation 2002 85%85% PAFPAF 22%22% CAFCAF Pulmonary Vein isolation Atrial Fibrillation ablationAtrial Fibrillation ablation
- 16. Pulmonary vein anatomy the first challenge Left common trunk 3 right lower veins Normal
- 17. 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)
- 18. Ernst, JACC ‘03Ernst, JACC ‘03 Complete LesionsComplete Lesions A – 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
- 19. Anatomical CLAA: Incomplete PVI in ~ 60%Anatomical CLAA: Incomplete PVI in ~ 60% 70 ms70 ms II IIII IIIIII V1V1 PV1-2PV1-2 PV10-1PV10-1 CSDCSD CSPCSP
- 20. 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 ArrhythmiaDiscrete Residual PV bundle - Producing Arrhythmia
- 21. • Inadequate Mapping of complex anatomical substrates Limitation of standard SOCALimitation of standard SOCA • 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
- 22. Limitation of standard SOCALimitation of standard SOCA I II III 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”
- 23. Which is the impact of the new technologies ?
- 24. Atrial Fibrillation ablationAtrial Fibrillation ablation virtual geometry reconstructionvirtual geometry reconstruction
- 25. Atrial Fibrillation ablationAtrial Fibrillation ablation 3D Mapping System3D Mapping System
- 26. Atrial Fibrillation ablationAtrial Fibrillation ablation PVs analysisPVs analysis
- 27. • 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
- 28. PV Isolation using the Cryo-Balloon
- 29. HD Mesh Ablator
- 30. HD Mesh Ablator
- 31. 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
- 32. 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
- 33. 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
- 35. Atrial Fibrillation ablationAtrial Fibrillation ablation Vagal GangliaVagal Ganglia
- 36. • 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
- 37. 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
- 38. Type of AF No. of Centers 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] No Pts 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
- 39. Relationship between success rate and type of Ablation Catheter Type of Catheter No Cent er 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 9,566 5,694 1,330 7,024 78.1 [66.8-86.7] AF Survey II Cappato R, Boston 2008
- 40. Type of Strategy 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
- 41. Major Complications Type 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
- 42. • 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 considerations AF Survey II
- 43. • 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 beSubstrate modification is likely to be required in 30% of PAF and most CAF, butrequired in 30% of PAF and most CAF, but needsneeds technological improvementstechnological improvements • An individually tailored approach is neededAn individually tailored approach is needed What is the future forWhat is the future for satisfactory treatment of AF ?satisfactory treatment of AF ?
- 44. 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 ………………...?
- 46. What is the future forWhat is the future for satisfactory treatment of AF ?satisfactory treatment of AF ? • Maintaining sinus rhythm (cure of AF) mustMaintaining 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 proceduralNon-inducibility may be a useful procedural endpoint to rationalize strategiesendpoint to rationalize strategies
- 47. 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
- 49. Atrial Fibrillation ablationAtrial Fibrillation ablation virtual geometry reconstructionvirtual geometry reconstruction
- 50. Be carefull don’t miss the right way
- 51. Technique no. of centers no. of patients % RAC 8 75 0.1 CA-TF 10 222 1.7 OED 34 3,889 27.4 Carto w/o PV isolation 15 1,460 10.3 w/ PV isolation 37 5,394 37.9 3D non-contact 11 663 4.7 Basket 10 150 1.1 CFAEs 16 349 2.4 Other 5 968 6.9 Combination 19 1,048 7.4 Total 165 14,218 100.0 Cappato R, Boston 2008 AF Survey II efficacy and safety data
- 52. 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 22.4 Success 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
- 53. Abstract Ref Pts Efficacy Safety ACUTE RESULTS OF PVI IN PTS WITH PaAF USING A SINGLE MESH CATHETER Steinwender 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 success 2/13 (15%) improved 3/13 (23%) failure Pericardial effusion (pericardocentesis) in 1 pt No other complication during the procedure or the subsequent hospital stay were observed.RF ABLATION OF PaAF BY MESH CATHETER Pratola 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 No complications occurred either acutely or at follow- Up HD Mesh Ablator
- 54. 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
- 55. 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
- 56. • 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
- 57. 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
- 58. • 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
- 59. 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
- 60. Atrial Fibrillation ablationAtrial Fibrillation ablation Anatomical considerationsAnatomical considerations
Editor's Notes
- (SLIDE 2) It’s always more clearly evident that different mechanism (such as trigger, substrates, rotor and or ganglionomic plexia or vagal ganglia) can exist and coexist in the same subject that can trigger or perpetuate AF. In this view, substantial progress has been made in the elucidation of the electro-physiologic (EP) mechanisms responsible of initiation and maintenance of this arrhythmia. However the specific role of some of them actually it’s not always clearly elucidated so that the true mechanism underlying the therapeutic success of different catheter-based approaches has not still clearly demonstrated yet.
- (SLIDE 3) However, at this purpose it’s clearly evident that pulmonary veins (PVs) can play a dominant role for initiation and maintenance AF, especially in Paroxismal AF or in mild or moderate LA enlargement, since Dr. Haissaguerre and colleagues firstly discovered that ectopic beats or rapidly firing foci, predominantly located in the muscle sleeves within pulmonary veins (PVs) or around the left atrium (LA) – PV junction, can start AF. PVs can play a dominant role as source of trigger and in the maintenance of AF and, defined the pivotal role played by PVs and considering the dominant role played by the excitable tissues located around the PVs ostia, the next step was limited the EP interactions between these areas and the remaining LA tissue.
- (SLIDE 5) At this purpose nowadays, novel and different technologies for mapping, tracking and ablation are available for approaching AF and in this view the technologic progress continuous to evolving over the time.
- (SLIDE 6) Currently, there are two mains and very different ablation strategies, all of them with the aiming primary purpose to eliminate the arrhythmogenic activity around the PVs ostia. (1) The first, named cirumferential left atrial ablation (CLAA) with the primary objective to create of an “encircling” line around at the LA antrum with or without the addition of further LA linear lesions, according with the outcome of the initial procedure and with the underlying atrial substrate. (2) Another and always more prevalent strategy that have emerged, aiming at segmental ostial catheter ablation (SOCA), with primary “end-point” of eliminate the focal triggers of AF, with disconnect all PVs from the adjacent LA tissue using a circular mapping steerable catheter placed under fluoroscopic guidance at the putative LA-PV antrum.
- (SLIDE 15) The mapping process of cardiac chambers is possible using both cutaneous patches and conventional catheter for tracking (such as NavX technologies) or a superimposed electromagnetic field using dedicate mapping catheter (such as CARTO system with Navistar). The resultant virtual geometry of the LA anatomy reconstructed with both the system, is then created building a “point-by-point” geometry by dragging the catheter at the endocardium surface, especially around the putative “region of interest”. In addition, some of them (such as NavX) technologies allows us also the possibility of a multi-electrodes simultaneously acquisition, such as with a conventional circular mapping catheter, and tracking the location of each catheters placed within a cardiac chamber.
- AVI movie Here’s a quick illustration to show you how the chamber maps are built. At the start of an EnSite procedure, the catheter is inserted in the chamber and validated by the system. (click on map image) As a catheter is moved within the chamber, the system records three-dimensional points. The operator can also give certain points special emphasis (indicated by white squares)—these are called locked points, to help define key areas of the anatomy, such as the isthmus or crista. As seen in the published literature, chamber maps or geometries can be built in as little as five minutes. Thereafter, there is no need for fluoroscopy, since the system provides superior orientation to fluoroscopy through the 3D model and superior catheter orientation through the 3D catheter display. When the geometry is finished, event data can then be recorded.
- (SLIDE 16) One of the first application of virutal geometry with the integrated use of 3D mapping system was applied by Dr. Pappone and collagues, in another strategies anatomically-based, named cirumferential left atrial ablation (CLAA) that has the primary objective to create an “encircling” line around at the LA antrum with or without the addition of further LA linear lesions, according with the underlying atrial substrate and with the outcome of the initial procedure.
- (SLIDE 8) However, PVs anatomy and LA/PVs junction can be very changeable in morphology and anatomic variation, as you can see in this pictures (such as left or right common trunk, or numeber or anatomic variation in PVs numbers). At this purpose even if SOCA has clearly demonstrated to be very effective in AFib treatment, performing this procedure using the fluoroscopy technique alone could be technically challenging especially if LA three-dimensional (3D) geometry is particularly complex or atypical. A this purpose, the positioning of a circular mapping catheter or a repositioning after displacement could be imprecise under only fluoroscopic view and renders the creation of several lesions sometimes extremely difficult.
- (SLIDE 18)
- (SLIDE 17) One of the methodological aspect and probably strong limitation of a pure EA approach, is that performing large “encircling” line around the PVs ostia could not to be the treatment of choice for disconnecting the PVs. In this fashion, anatomo-patologic studies reveals a non-uniform distribution of the myocardial sleeves that extent from LA into PVs so that their disposition could not be circumferencial rather segmental. In this fashion to disconnect PVs from adiacent LA tissue and blocked the conduction, could not be necessary performed an encircling line around the PVs ostia as reported with CLAA.
- (SLIDE 20)
- (SLIDE 9) The main drawback of EP criteria is that the reconstruction and the identification of a complete target zone could be extremely difficult to achieve, and this is true for the high variablility from one patient to the other.
- (SLIDE 9) The main drawback of EP criteria is that the reconstruction and the identification of a complete target zone could be extremely difficult to achieve, and this is true for the high variablility from one patient to the other.