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Energie alternative per l’ablazione della
Fibrillazione Atriale
Dott. L. Ottaviano
U.O Cardiologia I - Aritmologia
IC Città di Pavia
Pavia
AF
Ablation
Haissaguerre M, et al. N Engl J Med 1998; 339:659-666.
Pappone C et al. Circulation 2000
(
HRS/EHRA/ECAS Expert Consensus Statement on Catheter
ablation of AF
Ablation strategies that target the PVs are
the cornerstore for AF ablation procedure
Ablation of CTI is reccomended only in pts
with history of typical atrial flutter or inducible
CTI dependent atrial flutter
In patients with long standing persistent
AF, operators should consider more
extensive ablation based on linear lesion or
complex fractionated electrograms
Calkins et al “2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation”, Europace 2012
Tip & Tricks
• Pulmonary vein ectopic activity is a main trigger
for paroxysmal atrial fibrillation .
• Traditionally, PV isolation is achieved by a 'point-
by-point' ablation technique.
• It makes difficult to create continuous ablation
lines.
• Therefore gaps can develop facilitating
arrhythmia recurrences.
AF
«One Shot»
Company Prodotto
Bard Inc. HD Mesh Ablator CatheterTM
CardioFocus Inc CardioFocus Endoscopic Ablation SystemTM
Biosense Webster Inc. nMarqTM
Medtronic Inc PVACTM & PVAC GOLDTM
Medtronic Inc. Arctic FrontTM & Arctic Front AdvanceTM
Energie alternative
CRYO vs RF
Potential advantages of cryo vs RF
• Ability to create transient block prior to creation of complete irreversible block.
• Greater catheter stability (cryoadhesion)
• Less discomfort on energy delivery
• Higher safety margin with equivalent efficacy
• Less trauma to vascular structure (CS)
• Ability to create deep focal lesions, as well as long, continuous transmural lesion
CRYO vs RF
Disadvantages of cryo vs RF
• Longer procedure time and possibly
fluoroscopy exposure.
• Cryocatheter are limited to single shot
ablation whereas RF catheters can use
both “point to point” and the “drug and
burn” ablation method.
Cryo Ablazione • Il Criopallone Arctic Front Advance utilizza la Cryo Energia per
deconnettere elettricamente le Vene Polmonari
• Il refrigerante (N2O liquido) raggiunge la punta del catetere,
attraverso un tubicino di iniezione.
• All’interno del Cryo Pallone il refrigerante evapora, sottraendo
calore all’ambiente circostante e, quindi, al tessuto.
• Il vapore ritorna alla Cryo Console attraverso un canale
costantemente sotto vuoto.
• L’estensione della superficie di raffreddamento dell’Arctic Front Advance permette di
ottenere una lesione uniforme a livello dell’antro della vena polmonare,
indipendentemente dal posizionamento del pallone.
• Questa caratteristica, permette, inoltre, di trattare un’ampia varietà di anatomie con
sicurezza, semplicità ed efficacia in tempi procedurali ridotti e prevedibili.
Ablate with Arctic Front – 6 Steps
1. Wiring
4. Ablation
6. Deflating
(Retracting when
necessary)
2. Inflation
5. Thawing
3. Positioning
Contrast injection
Author Study Size Freedom from AF
Follow-Up method
Complications
Andrade 2011 Meta-analysis
1221 73% 12 months 6.4 PNP 0.37% lasted > 1 year 0.1 PV stenosis requiring intervention 0.57% thromboembolic events
Packer STOP AF 2010
245 69.9% 12 months 24h Holter at 3, 6, 12 months
3.1 PV stenosis 11.2 PNP 3.1% cryoablation procedure events
Kojodjojo 2010
90 77% 13 months 24h Holter at 1,3,6,12 months
1.6% transient PNP 0.8% pericardial effusion
Chun 2009
27 70% 12 months 11.1 PNP
Klein 2008
21 86% 6 months 14.3%PNP
Neumann 2008
293 74% 12 months 24h Holter
2.8% PNP 5.7% pericardial effusion 0.7% hematopneumothorax
Arctic Front Cryoballoon (1st Generation ) PVI in paroxysmal AF patients
Arctic Front Long Term Results
Neumann T. et al “Cryoballoon ablation of paroxysmal atrial fibrillation: 5-year outcome after single procedure and predictors of success”, Europace doi:10.1093/europace/eut021
Bertaglia E, et al. Europace.2010;12:181-187
Fiala M, et al. J Interv Card Electrophysiol.2088;22:13-21
Giata F, et al. Circ Arrhythm Electrophysiol.2008;1:269-275
Ouyang F, et al. Circulation.2010;122:2368-2377
Weerasooriya R, et al. Catheter Ablation for Atrial Fibrillation: Are Results Maintained at 5 Years of Follow-up? J Am Coll Cardiol.2011;57:160–6
Cryo vs RF 1 year FU
J Cardiovasc Electrophysiol, Vol. 25, pp. 8-10, January 2014.
Arctic Front Advance: The Cold Standard
Calkins et al “2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation”, Europace 2012
…point-by-point RF
energy and Cryoballoon
ablation are the two
standard ablation
systems used for
catheter ablation of AF
today ….
First experience
with Freezor chateter in
Europe
2001 2005 2008 2010 2011 2012 2013 2014
CE Mark first generation
CryoBalloon Arctic Front
After STOP AF results
FDA approval
Achieve Mapping Catheter deployed through the Arctic
Front guide wire lumen
Second generation CryoBalloon
Arctic Front Advance
Second generation steereable sheat
FlexCath Advance
New Indication for the
treatment of all forms of AF with the Arctic Front
Advance
Medtronic Acquires CryoCath
New Advancement in Pulmonary Vein Isolation
STOP AF Trial
ARCTIC FRONT®
Arctic Front Advance: Caratteristiche
Nella prima generazione di
Criopallone, la zona più fredda è
situata a livello dell’equatore.
È molto importante posizionare il
Criopallone in modo coassiale alla
vena,
L’Arctic Front Advance, grazie
alla tecnologia EvenCoolTM,
permette di raffreddare una
superfice più estesa e più
omogenea.
Questo implica una minore
dipendenza dal posizionamento
del pallone rispetto alla vena e
dalle dimensioni.
ARCTIC FRONT ADVANCE®
18
Arctic Front Advance Cryoballoon: 12 months Efficacy
83%
80%
83.6%
Free from AF at 1 year
Fürnkranz et al. “Improved procedural efficacy of pulmonary vein isolation using the novel second-generation cryoballoon”. doi: 10.1111/jce.12082.
Arctic Front AdvanceTM Clinical Experience
129
98
20 13
Arctic Front Advance is Effective for Pulmonary Vein Isolation in PAF Patients
87%83% 84% 84%
64%69%
77%
66%
0%
20%
40%
60%
80%
100%
Kuniss, et al.7 months FU
Casado-Arroyo, et al.8 months FU (CBA)12 months FU (CB)
Moltrasio, et al.12 months FU
Di Giovanni G, et al.12 months FU
Arctic Front Advance (CBA) Arctic Front (CB)
% Free from AF after a Single Procedure
N = 45 N = 45 n=41 n=80 n=32 n=34
P = 0.026 logrank = 0.1 P = 0.17
n=28 n=28
P < 0.05
Contact force vs Cryoballoon
Free from AFat 1 year FU: CF: 88%, CB: 85%
• 150 Pts (75 CF, 75 CB)
• RF Strategy:
FAM with Lasso
Large encircling
Lasso pre and post
Force >10gr
• Cryo Strategy:
Occlusion with contrast or pressure
2 appl at 240 sec
Achieve or Lasso
Europace Sept 2014
Key Messages
•FA Parossistica •Singola puntura transettale
•No sistemi 3D
•No sistemi di imaging
•PVI: 100%
•Single shot: 84%
•Applicazioni per vena: 1.2-2.3
•Tempo procedura: 93-98 min
•Tempo di scopia: 12-13 min
•TTE was observed in 47-70% of PVI
•TTEffect: 70 sec
•Tempo di erogazione: 240 sec (180)
•Follow-up a 1 anno : 80-83% (AFA)
•Follow-up a 3 anni: 61% free from AF
•Follow-up 5 anni: 53% free from AF
At 1 year follow-up, freedom from ATas
after a single procedure was 60%
Heart Rhythm 2014 Oct 1
• La tecnologia One-shot contribuisce ad estendere la
terapia ablativa ad un numero sempre maggiore di
pazienti
• I dati di successo in acuto ed al FU ed il profilo di
sicurezza non inferiore a quello dell’approccio classico
con catetere puntiforme a radiofrequenza, rendono la
Crioablazione, una valida ed efficace alternativa nel
trattamento della Fibrillazione Atriale
• Come per tutte le tecnologie, il corretto utilizzo e la Best
Practice garantiscono il miglior outcome
• La crioablazione è attualmente l’unica tecnologia one
shot che garantisce riproducibilità e standardizzazione
con una breve curva di apprendimento.
Conclusioni