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