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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
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Page 1: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

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

Page 2: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

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

Page 3: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

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.

Page 4: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

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!!

Page 5: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,
Page 6: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

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

Page 7: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

Enhanced Cooling

Page 8: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

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

Page 9: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

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

Page 10: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

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

Page 11: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

Tondo C et al Heart Rhythm, 2017 in press

Page 12: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

Tondo C et al Heart Rhythm, 2017 in press

Page 13: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

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

Page 14: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

RF BALLOON PLATFORM

Personal data

Page 15: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

RF BALLOON PLATFORM

Pre-PVI Post-PVI

Page 16: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

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%)

Page 17: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,
Page 18: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

(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.

Page 19: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,
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Page 21: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,
Page 22: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

How to approach Persistent Atrial Fibrillation

Personal Data

Page 23: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

Goal(s) OF THE SURGICAL LESION

Page 24: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

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

Page 25: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

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

Epicardial ablation

Endocardial ablation

Page 26: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

Follow up

under review

Page 27: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,

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

Page 28: Start with PVI”ecc-conference.com/1/mam2017/mam2017-d1-s3-1-Tondo-Start...Claudio Tondo 1; Saverio Iacopino2, Paolo Pieragnoli3, Giulio Molon4, Roberto Verlato5, Antonio Curnis6,
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