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Introduction
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Childhood and Athletic Beginnings
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2006 terni, convegno regionale, l'ablazione della fibrillazione atriale. il registro osservazionale terni
1. Stefano Nardi, MD, PhD
AZIENDA OSPEDALIERA SANTA MARIA TERNIAZIENDA OSPEDALIERA SANTA MARIA TERNI
DIPARTIMENTO CARDIOTORACOVASCOLAREDIPARTIMENTO CARDIOTORACOVASCOLARE
STRUTTURA COMPLESSA DI CARDIOLOGIASTRUTTURA COMPLESSA DI CARDIOLOGIA
UNITA’ OPERATIVA DI ARITMOLOGIA CARDIACAUNITA’ OPERATIVA DI ARITMOLOGIA CARDIACA
LABORATORIO DI ELETTROFISIOLOGIA ED ELETTROSTIMOLAZIONELABORATORIO DI ELETTROFISIOLOGIA ED ELETTROSTIMOLAZIONE
L’ablazione transcatetere della Fibrillazione Atriale.L’ablazione transcatetere della Fibrillazione Atriale.
Il registro osservazionaleIl registro osservazionale T.E.R.N.I.T.E.R.N.I.
((TTernierni EEvaluation of Pulmonavaluation of PulmonaRRy Vein Isolatioy Vein IsolatioNN with EnSwith EnSIItete
System)System)
15. What is success?
• Complete freedom of AF, off drug RX?
• No symptoms, but drug Rx required?
• Dramatic decrease in symptoms, but AADs
still required?
• QoL
• How do we detect asymptomatic episodes?
• Anticoagulation ………………...?
QUESTIONSQUESTIONS
18. Ernst, JACC ‘03Ernst, JACC ‘03
Complete LesionsComplete Lesions
A – 5%A – 5%
B – 21%B – 21%
C –C –
50%50%
D - 58-65%D - 58-65%
OutcomeOutcome
• Complete lesion 74%Complete lesion 74%
arrhythmia free w/o AADsarrhythmia free w/o AADs
• Incomplete lesion – almostIncomplete lesion – almost
all recurrent arrhythmiaall recurrent arrhythmia
Limitation of CLAALimitation of CLAA
• SEVERAL GAPS can be
found within the ablation
lines (2-4mm) exploring the
“encircling line”.
19.
20. • Studi recenti hanno dimostrato che FASCI di
MUSCOLATURA PARIETALE presenti nella
TONACA MEDIA delle VP possono
rappresentare una sorgente dominante d’innesco
(TRIGGER) della FA nell’uomo
• Evidenza indiretta a favore della presenza di
SORGENTI MULTIPLE nelle diverse VP e nel
contesto della vena singola
80. Circumferential
lesion pathway
Type A AF (PV
Tachycardia)
AF waves
Lesion Validation (Preablation)Lesion Validation (Preablation)
Incomplete
lesion
Type A AF (PV
Tachycardia)
Lesion Validation (Lesion Validation (AblationAblation))
Complete lesion
Lesion Validation (Lesion Validation (AblationAblation))
Atrial activity
reduction
Type A AF (PV
Tachycardia)
Abolition
Lesion ValidationLesion Validation Type A AF/PV Tachycardia AbolitionType A AF/PV Tachycardia Abolition
≤ 0.1mV
≤0.05mV
Validazione delle lesioniValidazione delle lesioni (abbattimento dei(abbattimento dei
potenziali)potenziali)
96. REGISTRO
OSSERVAZIONALE
T.E.R.N.I.
AZIENDA OSPEDALIERA SANTA MARIA TERNIAZIENDA OSPEDALIERA SANTA MARIA TERNI
DIPARTIMENTO CARDIOTORACOVASCOLAREDIPARTIMENTO CARDIOTORACOVASCOLARE
STRUTTURA COMPLESSA DI CARDIOLOGIASTRUTTURA COMPLESSA DI CARDIOLOGIA
UNITA’ OPERATIVA DI ARITMOLOGIA CARDIACAUNITA’ OPERATIVA DI ARITMOLOGIA CARDIACA
LABORATORIO DI ELETTROFISIOLOGIA ED ELETTROSTIMOLAZIONELABORATORIO DI ELETTROFISIOLOGIA ED ELETTROSTIMOLAZIONE
97. Procedure (min): 148±26 144±24 151± 29
Fluoroscopy (min): 59±17 58±16 66±19
Mapping (min): 35±8 33±9 38±4
Nr. Pulses of RF: 72±16
70±17 75±19
RESULTSRESULTS Global Pz.in SR Pz. in AF
TERNI RegistryTERNI Registry
629 VP treated (145 pts)
Acute Complete BlockAcute Complete Block
558 VP (89%)558 VP (89%)
Incomplete BlockIncomplete Block
71 VP (11%)71 VP (11%)
98. • 422 pts with symptomatic PaAF and PeAF referred to us
between July ‘04 and September ’06. CA performed in 145/422
pts (34%).
TERNI registryTERNI registry
• At least one MONTHLY episode
of Persistent symptomatic AF
• At least ONE WEEKLY episode
of PaAF or PeAF
• At least Two or More AADs
unable to control symptoms
• Age >75 yrs
• Contraindications to ACT
• Congestive HF
• NYHA class III or IV
• LVEF ≤35%
• LA diameter ≥55mm
• CARDIAC THROMBUS
• Life expectancy <1 yr
• CCH surgery <3 mo or
PROSTHETIC valves
Inclusion criteriaInclusion criteria Exclusion criteriaExclusion criteria
99. AFib PAROX. PERSIST. TOTAL
Patients 91 54 145
Age 62±13 67±8 64±15
Sex (M/F) 61/26 37/21 98/47
Duration 36±12
N.episodes/mo 4±6
LVEF (%) 55±6 51±9 53±9,7
LA diameter 44±8 47±8 46±8
CAD 15 21 36
TERNI registryTERNI registry
100. • NO major complication
(including death, stroke or
other thromboembolic events)
observed.
• MILD pericardial effusion
observed in 4 pts.
• ANGIOGRAFIC analysis
of all PVs performed post-
procedure in all pts (no PV
stenosis).
Clinical OUTCOME
TERNI RegistryTERNI Registry
101. • TELEMETRY MONITORING
from 24 to 36 hr.
• Eparin Na+ iv for 24 to 36 h.
• ACT started 24 h post RFCA
• ECHO pre-discharge.
• Discharged with ACT
(maintained for ≥ 6 mo)
• Discharged with AADs
(maintained for ≥ 6 mo)
(35% with propafenone and 65%
with flecainide)
Post-ablation MANAGEMENT
TERNI RegistryTERNI Registry
102. • After a mean FU Overall FREEDOM FROM AF (both PaAF
and PeAF) was 60% (69% and 48%), w/o AADs and 72%
(80% and 55%) with previous ineffective AADs.
Clinical OUTCOME
• The Kaplan-Meier statistical analysis probability of
freedom from arrhythmia was maximal at 12 months
TERNI RegistryTERNI Registry
• Among UNIVARIATE predictors, the variables of age,
sex, duration and frequency of AF, LVEF, LA size and
structural heart disease, this approach revealed that an
increased LA SIZE >50mm is an indipendet predictor
of AF recurrence
104. • NO major complication
(including death, stroke or
other thromboembolic events)
observed.
• MILD pericardial effusion
observed in 4 pts.
• ANGIOGRAFIC analysis
of all PVs performed post-
procedure in all pts (no PV
stenosis).
Clinical OUTCOME
TERNI RegistryTERNI Registry
105. • TELEMETRY MONITORING
from 24 to 36 hr.
• Eparin Na+ iv for 24 to 36 h.
• ACT started 24 h post RFCA
• ECHO pre-discharge.
• Discharged with ACT
(maintained for ≥ 6 mo)
• Discharged with AADs
(maintained for ≥ 6 mo)
(35% with propafenone and 65%
with flecainide)
Post-ablation MANAGEMENT
TERNI RegistryTERNI Registry
106. • After a mean FU Overall FREEDOM FROM AF (both PaAF
and PeAF) was 60% (69% and 48%), w/o AADs and 72%
(80% and 55%) with previous ineffective AADs.
Clinical OUTCOME
• The Kaplan-Meier statistical analysis probability of
freedom from arrhythmia was maximal at 12 months
TERNI RegistryTERNI Registry
• Among UNIVARIATE predictors, the variables of age,
sex, duration and frequency of AF, LVEF, LA size and
structural heart disease, this approach revealed that an
increased LA SIZE >50mm is an indipendet predictor
of AF recurrence
107. 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
power deliverypower delivery
Atrial Fibrillation approachAtrial Fibrillation approach
108. • 422 pts with symptomatic PaAF and PeAF referred to us
between July ‘04 and September ’06. CA performed in 145/422
pts (34%).
TERNI registryTERNI registry
• At least one MONTHLY episode
of Persistent symptomatic AF
• At least ONE WEEKLY episode
of PaAF or PeAF
• At least Two or More AADs
unable to control symptoms
• Age >75 yrs
• Contraindications to ACT
• Congestive HF
• NYHA class III or IV
• LVEF ≤35%
• LA diameter ≥55mm
• CARDIAC THROMBUS
• Life expectancy <1 yr
• CCH surgery <3 mo or
PROSTHETIC valves
Inclusion criteriaInclusion criteria Exclusion criteriaExclusion criteria
109. AFib PAROX. PERSIST. TOTAL
Patients 91 54 145
Age 62±13 67±8 64±15
Sex (M/F) 61/26 37/21 98/47
Duration 36±12
N.episodes/mo 4±6
LVEF (%) 55±6 51±9 53±9,7
LA diameter 44±8 47±8 46±8
CAD 15 21 36
TERNI registryTERNI registry
110. evolution of 3D mapping system
Atrial Fibrillation approachAtrial Fibrillation approach
111. Procedure (min): 148±26 144±24 151± 29
Fluoroscopy (min): 59±17 58±16 66±19
Mapping (min): 35±8 33±9 38±4
Nr. Pulses of RF: 72±16
70±17 75±19
RESULTSRESULTS Global Pz.in SR Pz. in AF
TERNI RegistryTERNI Registry
629 VP treated (145 pts)
Acute Complete BlockAcute Complete Block
558 VP (89%)558 VP (89%)
Incomplete BlockIncomplete Block
71 VP (11%)71 VP (11%)
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.
(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 7) This last one approach has the ambitious convincement that the electrical isolation of PVs from the LA have been showed to be reliable for eliminating AF in an high percentage of selected patients. At this purpose, even if SOCA has been guided by EP mapping, novel strategies have emerged over the last decade, mostly based on anatomic considerations that support the adjunctive role of a 3D mapping.
(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.
Any type of catheter (electrode based)
Up to 12 catheters, 64 electrodes
(SLIDE 12) 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 12) 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 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 25 ) Because atrio-esophageal fistula is very rare but its occurrence is dramatic and devastating, we utilized lower RF energy applications when ablating particularly on the LA posterior wall, and to make the pulses on the posterior wall near to the roof of the LA, where the LA is not in direct contact with the esophagus. Anatomical-guided electrophysiological ablation procedures have been shown to be effective for curing AF.
(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 18)
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 23) Therefore, a clinical need exists for a “good mapping systems” that allow the possibility to provide us the best anatomic information’s of a specific cardiac chamber. In this view, today is possible to obtain a detailed 3D anatomy of cardiovascular structures with a previous acquisition of a CT heart images and then synchronized (splitting the monitor) or merge these highly resolution information in a dedicated workstation with the conventional 3D mapping systems. One attractive aspect of this information is that effectively, the integration of a previous registered CT images to guide CA represents a significant advantage respect to a less-detailed and surrogate geometry created by previously available 3D mapping systems, especially for maximize the efficacy and minimize the risks of the procedures (such as PV stenosis).
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.
Any type of catheter (electrode based)
Up to 12 catheters, 64 electrodes
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.
Distal PV branches can serve as useful spatial landmarks, and can be readily delineated by the placement of 3D spherical markers during catheter pullback.
Internal and external view
Sequential mapping is very fast and easy.
During the study, we recorded several segments of catheter navigation to discrete locations. You can see here a data segment where a catheter is navigated from the right superior to the right inferior pulmonary veins.
Detailed geometry creation allows for reconstruction of PV morphology 1-2 cm beyond the ostia. The geometry results can be verified 1) by CT comparison, 2) by electrogram, and 3) by impedance.
The catheter locations were registered to the CT model. In this example, six discrete points were used for registration. All points were obtained on the posterior side of the model.
As the example plays, notice the catheter motion from the previous slide RSPV to RIPV, now correlated to the CT model. Also, notice the catheter motion as it breaks the anterior surface of the model during the cardiac cycle. The cause of this is that NavX is a real-time navigation system that displays cardiac motion on the catheters. This artifact could be minimized by using a more aggressive navigation filter.
The model allows multiple viewing options, allowing us to see the relative position of all catheters within the heart and the related cardiac structures.
By rotating to a lateral view and clipping the model, we can obtain an interior view of the chamber. Here again is the example of navigating to the posterior wall.
And another view of our navigation from superior to inferior
During the study, we recorded several segments of catheter navigation to discrete locations. You can see here a data segment where a catheter is navigated from the right superior to the right inferior pulmonary veins.
Detailed geometry creation allows for reconstruction of PV morphology 1-2 cm beyond the ostia. The geometry results can be verified 1) by CT comparison, 2) by electrogram, and 3) by impedance.
The catheter locations were registered to the CT model. In this example, six discrete points were used for registration. All points were obtained on the posterior side of the model.
As the example plays, notice the catheter motion from the previous slide RSPV to RIPV, now correlated to the CT model. Also, notice the catheter motion as it breaks the anterior surface of the model during the cardiac cycle. The cause of this is that NavX is a real-time navigation system that displays cardiac motion on the catheters. This artifact could be minimized by using a more aggressive navigation filter.
The model allows multiple viewing options, allowing us to see the relative position of all catheters within the heart and the related cardiac structures.
By rotating to a lateral view and clipping the model, we can obtain an interior view of the chamber. Here again is the example of navigating to the posterior wall.
And another view of our navigation from superior to inferior
(SLIDE 33)
(SLIDE 32)
(SLIDE 34)
(SLIDE 34)
(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 32)
(SLIDE 21) We know that Virtual geometry and 3D mapping systems evolving over the time and one adjunctive methodological aspect of these newer EnSite applications, in contrast with previous and more rudimental algorithms, is that the introduction of a more reliable algorithms have dramatically improved the definition of the virtual reality of the cardiac chambers, with a greater power resolution of the number of points acquired, and then with a better and more accurate definition of the anatomy, particularly around the LA-PV junctions and especially when variations in PV anatomy are present and that may contribute to create more complex the problem. In our experiences, using the NavX system with catheter guidance we were always able to allowed the precise positioning of each of them and, even more important, repositioning in case of change of position (shodow line).