Conflitto d’interesse:Contratto con Biosense Webster per

lo sviluppo di nuove tecnologie

Ospedale “F. Miulli”

Acquaviva delle Fonti - Bari

Massimo Grimaldi

Cardiologia Universitaria

Foggia

Spunti di innovazione tecnologica nell’ablazione della fibrillazione atriale

100 pazienti con FA ( 51 parossistica) sottoposti ad ablazione ostiale o circonferenziale

84% recidive

97 % recidiva di conduzione di 1.8 +1 (circonferenziale) vs 1.9 +0.8 (ostiale) delle vene

Am Heart J, 2004

Perché l’ablazione di fibrillazione atriale è difficile

Corretto riconoscimento delle strutture anatomiche

Corretta interpretazione dei potenziali elettrici

Posizionamento dell’elettrodo ablatore

Stabilizzazione dell’elettrodo ablatore

Applicazione della RF con la giusta forza sul tessuto e per il giusto tempo

Crio Pallone

Nuova tecnologia

Arctic Front 174,0 113,8 45,3

Arctic Front Advance (US) 146,4 93,8 36,1

Arctic Front Advance (EU) 129,0 85,0 24,0

Dati Medtronic al 20 Nov 2012; AFB: N = 7787; AFA US: N = 865; AFA EU: N = 390

Tempi procedurali e di fluoroscopia

Assenza di recidive a 12 mesi

Andrade, Heart Rhythm 2011

Assenza di recidive a 12 mesi: 72,8 %Assenza di differenze statisticamente significative con RF

Europace, Feb 2013

COMPLICANZE

Laser Ballon lesione video-guidata

ENDOSCOPIC VIEW

Aiming ArcPV

§ VGLB– 2nd Generationl Compliant, adjustable diameterl 2Fr endoscopel 300 adjustable aiming arcl Diode laser (980nm) for ablation

VGLB – 2nd Generation

Studio in vivo

RSPV

LSPV

Ablation Lesions

Chronic Histology (10 PVs/120 sections)

• Circumferentiality 100%

• Transmurality = 99.0±5.5%

• 96.7% of sections were transmuralDukkipati SR, d’Avila A, Reddy VY et al.

Circ Arrhythm Electrophysiol. 2010,3:266-73

Heart Rhythm 2012; 9: 919–925

N = 56

# PV Isolated (%) 202/206 (98.1%)# Attempts to isolate/PV, mean 1.3

Fluoroscopy Time, mean±sd, min (limits) 23±15 (7 – 85)

# Ablation Lesions per Patient, mean±sd 143±33

Ablation Time, mean±sd, min (limits) 113±38 (46 – 221)

Procedure Time, mean±sd, min (limits) 198±43 (120 – 285)

# Catheters per Patient 1.05

Catetere ablatore circolare con tecnologia “over the wire”

10 elettrodi eroganti radiofrequenza unipolare e bipolareGeneratore di radiofrequenza dedicato

1 Bittner, A.,Randomized study comparing duty-cycled bipolar and unipolar radiofrequency with point by point ablation in PVs isolation, HR

2011.

2. Choo WK, Experience of AF Ablation in a New Cardiac Centre using 3D Mapping and Multielectrode Duty-Cycled RFCA.ArchCardiovascDis 2011

3. Bulava A, Catheter Ablation for PAF: A Randomized Comparison between Multielectrode Catheter and Point-by-Point Ablation. PACE 2010

4. Rypko J. PV isolation to treat PAF: conventional versus multi-electrode RFCA, J Int C Elect 2012

Efficacia in studi randomizzati

Radiofrequency Catheter Ablation of Atrial Fibrillation: A Cause of Silent Thromboembolism?

Gaita, Circulation 2010

Gaita, JCE 2011

0

40

30

20

10

RF open irrigated

PVAC Crio-ballon

p=0,001

38,9

%

Asy

mp

tom

atic

cer

eb

ral l

esio

ns

8,3 5,6

p=0,001

Rilievo di lesioni cerebrali silenti in 33 di 86 pazienti (38%)Numero medio di lesioni per paziente: 3,6

Esame neurologico normale in tutti i pazienti

Heart Rhythm, 2011

Ablatore circolare a radiofrequenza unipolare e bipolare irrigata

Unipolar vs bipolar RF lesions

Uni 25W 25W

Bi 15W 15W

#67604 R4

Distal Distal

- Depth at Distal Electrode: 5.2 mm- Depth at Proximal Electrode: 5.3 mm- Lesion Length (Long Axis Diameter): 14.0 mm- Lesion Width (Short Axis Diameter): 7.9 mm

Unipolar and Bipolar Ablation

Long Axis TransactionShort Axis Transactionat Max Depth PortionSurface

Visualizzazione del catetere mediante sistema di mappaggio

Radiofrequenza unipolare Radiofrequenza bipolare

Posterior box isolation

Posterior wall dissociated beat

REVOLUTION Investigators

BELGIUMMattias Duytschaever, MD. Brugge

CZECHJosef Kautzner, MD. Prague

DENMARKPeter Steen Hansen, MD. Värde

FRANCE

Christian De Chillou, MD. Nancy

Pierre Jaïs, MD. Pessac

GERMANY

Gerhard Hindricks, MD. Leipzig

ITALY

Claudio Tondo, MD. Milan

Massimo Grimaldi, MD. Bari

Results – Acute Effectiveness

Site # of PV targets (%)

Site 01 24/32 (75%)

Site 02 59/59 (100%)

Site 03 12/12 (100%)

Site 04 35/51 (68.6%)

Site 05 102/111 (92%)

Site 06 3/4 (75%)

Site 07 39/78 (50%)

Site 08 107/107 (100%)

All Sites 381/454 (84%)

Results shown for effectiveness cohort; generator version 2.0

Targets successfully isolated without the use of focal touch-up

Results – Acute EffectivenessAcute Pulmonary Vein Isolation documented by confirmed entrance block

N=111

ACUTE SUCCESS 110/110* (100%)

First Ablation 110/110 (100%)

Second Ablation 16/16 (100%)

Third Ablation 2/2 (100%)

Results shown for effectiveness cohort; generator version 2.0

*Missing data for 1 patient

Confirmation of first ablation PVI with:Circular nMARQ 57.7% LASSO 36.0%Other 6.3% (crescent, combination of circular and

crescent, thermocool)

Results – Primary Endpoint -Safety

Cardiac Tamponade 2/161 (1.2%)

Diaphragmatic paralysis 1/161 (0.6%)

TIA 1/161 (0.6%)

Hospitalization 5/161 (3.1%)

Injection site hematoma 1/161 (0.6%)

Headache 1/161 (0.6%)

Inguinal hematoma 1/161 (0.6%)

Atrial flutter 1/161 (0.6%)

Artery-venous fistula 1/161 (0.6%)

Pericardial Effusion 1/161 (0.6%)

Early Onset Primary AEs 10/161 (6.2%)

Barium

RIPV

Unipolar RF: 18 WBipolar RF: 15 W

Stop RF

Time (seconds)

Temp. (°C)

Posterior wall

Unipolar RF: 18 WBipolar RF: 15 W

Temp. (°C)

Objective:

Evaluation for evidence of intracerebral microemboli and associated neurological deficits following RF ablation

Methods:

nMARQTM (test-group) vs. NAVISTAR® THERMOCOOL®

(control group)

Pre-ablation neurological examination and MRI

<48 hour pre-ablation

Post-ablation neurological examination and MRI

during day 1-2 post-ablation

REVOLUTION – Subpopulation Neurological Assessment (SNA)

Results Hospital F. Miulli:

REVOLUTION – Subpopulation Neurological Assessment (SNA)

nMARQTM (*) THERMOCOOL® New neurological findings post-ablation

0/12 (0%) 0/11 (0%) None

SNA population 100% lesion-free. No subjects observed with intracerebral microembolic lesions post-ablation

No new neurological deficits observed post-ablation

(*) Subjects on WarfarinTarget INR ≥ 2.0Target ACT≥325s

Acute safety and efficacy of a novel multipolar irrigated radiofrequency ablation catheter for pulmonary vein isolation

Lesioni silenti nel 33% dei pzDiametro medio 2,3 mm (1-9 mm)

Deneke, JCE 2013

Esophago-pericardial fistula complicating atrial fibrillation ablation using a novel irrigated radiofrequency multipolar ablation catheter

Deneke, JCE 2013

CONCLUSIONI

Nella terapia ablativa della fibrillazione atriale le nuove tecnologie devono garantire la sicurezza prima dell’efficacia

Malgrado le nuove tecnologie, l’efficacia e la sicurezza sono ancora operatore dipendenti:

L’operatore accorto impara dai propri erroriL’operatore stolto non impara dai propri erroriL’operatore saggio impara dagli errori degli altri

Nell’ablazione della fibrillazione atriale la prima prevenzione dell’errore nasce dal corretto inquadramento del paziente e dalla corretta indicazione ad eseguire l’ablazione, che non sempre è la scelta migliore