Hybrid Strategies Context: Ablation in Persistent AF

“ Start with PVI”

Claudio Tondo, MD, PhD, FESC, FHRS

Heart Rhythm Centre

Department of Cardiovascular Sciences and Community Health

Monzino Cardiac Center, IRCCS, University of Milan, Milan, Italy

and

Texas Cardiac Arrhythmia Institute- Austin, Tx, USA

Potential conflicts of interest

Speaker’s name: Claudio Tondo, MD, PhD

▪ I have the following potential conflicts of interest to report:

1. Proctor fees for Medtronic, Abbotts, Biosense&Webster

2. Member of Advisory Boards of Medtronic, Boston Scientific

Daniel Scherr et al. Circ Arrhythm Electrophysiol. 2015;8:18-24

Single procedure success rate off AADs. Multiple procedure success rate off and on AADs of

PeAF ablation.

Copyright © American Heart Association, Inc. All rights reserved.

STAR AF 2 Trial

589 patients randomized 1:4:4 to the three

strategies: PVI, PVI+CFE, PVI+Lines

PVI 97%

BLOCKED LINES 74%

PVI group!!

Technology Advancement for

Atrial Fibrillation Ablation

AGENDA

- Balloon-based Technology :

1. Cryo energy

2. Laser energy

3. RF balloon

- Contact Force Technology:

1. Smart-touch Catheter

2. Tacticath Catheter

Enhanced Cooling

0,2

0,3

0,4

0,5

0,6

0,7

0,8

28 mm 23 mm

Arctic Front Uniformity Score + STDev

Arctic Front AdvanceUniformity Score + STDev

0,2

0,3

0,4

0,5

0,6

0,7

0,8

28 mm 23 mm

.33

.47

.60

.68

N = 30 N = 30 N = 30 N = 30

~47% increase in uniformity for the 23 mm ~83% increase in uniformity for the 28 mm

Refrigerant distribution comes from 4 jets

Improved surface temperature gradient

8

Arctic Front Advance-EvenCool TechnologyTM

PV Lesion Durability with RF and Cryoballoon Studies evaluating PV reconduction using repeat electrophysiology and

mapping after the index procedure

30%

23%

8%

35%

63% 67%

78%

0%

20%

40%

60%

80%

100%

GAP-AF Willems Jiang EFFICAS I EFFICAS II* Ahmed SUPIR

% of Patients without Gaps During Remapping Procedure

5

RF: Contact Sensing RF Arctic Front™

Cryoballoon

1 2 3 4

Arctic Front Advance™

Cryoballoon

6 7

* Calculated rate from manuscript data reporting 9/24 patients with gaps.

**Time between index procedure and re-mapping procedure. All patients were evaluated regardless of clinical symptoms

20 1Late Breaking Clinical Trials session I at the EHRA EUROPACE 2013 meeting in Athens, Greece 2 Williems, et al. J Cardiovasc Electrophysiol. 2010; 21(10):1079-84; 3 Jiang, et al. Heart

Rhythm. 2014;11(6):969-76; 4 Neuzil et al. Circ Arrhythm Electrophysiol. (2):327-33; 5 Kautzner, J. et al. Europace. 2015; 2015 Aug;17(8):1229-35; 6 Ahmed, et al. J Cardiovasc

Electrophysiol. 2010;21(7):731-7; 7 Reddy VY, et al. J Cardiovasc Electrophysiol. 2015 May;26(5):493-500

Patients (n) n=117 n=40 n=75 n=75 n=24 n=12 n=21

Follow-up** 3 Months 3 Months 12 Months 3 Months 3 Months 3 Months 3 Months

Pulmonary Vein Isolation Cryoablation for Persistent and Long-Standing

Persistent Atrial Fibrillation Patients. Clinical Outcomes from Real Word

Multicentric Observational Project

Short title: Cryoablation in Persistent and Long-Standing Persistent AF

Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5,

Antonio Curnis6, Maurizio Landolina7, Giuseppe Allocca8, Giuseppe Arena9, Gaetano

Fassini1, Luigi Sciarra10, Mario Luzi11, Massimiliano Manfrin12, Luigi Padeletti13; on

behalf of ClinicalService 1STOP project investigators.

Heart Rhythm, 2017 in press

Tondo C et al Heart Rhythm, 2017 in press

Tondo C et al Heart Rhythm, 2017 in press

Compatible with both 3D mapping system and fluoroscopy

10 irrigated electrodes to deliver RF energy from selected electrode(s), allowing segmental isolation

Spherical, compliant balloonto conform to the anatomy of Pulmonary Vein

Over-the-wire design foreasy maneuverability

FIM study (no results)- Investigators- 40 patients- MRI/ENDOSCOPY/3M CT SCAN

FIM case video- CARTO- FLURO- ICE

RF BALLOON PLATFORM

Personal data

RF BALLOON PLATFORM

Pre-PVI Post-PVI

The main ablation technique in patients undergoing first-time ablation for

persistent, but not long-standing AF was stand-alone PVI in the majority of the

centres (67%)

(A) Very Long-Term from atrial fibrillation in the CONFIRM trial for FIRM-guided ablation (blue) and conventional ablation (red; P=0.003) after 1.2±0.4 procedures;

(B) Very Long Term Single-Procedure freedom from the AF for FIRM-guided ablation (blue) and conventional ablation (red) in the CONFIRM trial. Data shows all cases (solid lines, P=0.002) and those undergoing their first ablation (dashed lines, P=0.002). AF,

atrial fibrillation; FIRM, Focal Impulse and Rotor Modulation.

How to approach Persistent Atrial Fibrillation

Personal Data

Goal(s) OF THE SURGICAL LESION

Tondo, C, Polvani GL, et al. Hybrid approach for AF; under review

Hybrid Treatment (RF surgical epicardial ablation+transcatheter endocardial ablation)

Epicardial ablation

Endocardial ablation

Follow up

under review

Final Remarks

For the time being, persistent AF is regarded as the most controversial form of the

arrhythmia to be treated

The shorter is the duration of AF, the higher is the chance to parallel paroxysmal AF in

terms of clinical outcome

PVI ablation remains the first step to be accomplished and it can be deemed the initial

approach for early persistent AF

For long-persistent AF or redo cases, searching for more functional approach (rotor-like

mapping; AQ mapping,..) can be considered. Endocardial left posterior wall isolation

might have a rationale for electrophysiologists, but hybrid approach (torascopic surgical

approach + concomitant EP) remains a valuable option for higher success rate