Atrial Fibrillation: Catheter Ablation with New Technologies, Improving Quality of Life and Outcomes in Various Disease States

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1 Atrial Fibrillation: Catheter Ablation with New Technologies, Improving Quality of Life and Outcomes in Various Disease States Srinivas R. Dukkipati, MD Co-Director, Cardiac Arrhythmia Service The Mount Sinai Hospital

2 Disclosures Research Grant Biosense Webster, Inc.

3 Paroxsymal AF: Catheter Ablation LEFT ATRIUM

4 Long-term Outcome after PVI: Late Recurrence Single Procedure Success Singe Procedure Success Multiple Procedure Success Multiple Procedure Success Ouyang F et al. Circulation 122:2368, 2010 Weerasooriya R et al. JACC 57:160, 2011

5 Long-term Outcome after PVI: Late Recurrence No AADs Parox AF On AADs Persist AF Bertaglia E et al. Europace: 12:181, 2010

6 Why does AF ablation fail? PV Reconnections Non-PV Triggers

7 Force Sensing Catheters TACTICATH THERMOCOOL SMARTTOUCH

8 Force Sensing Catheters TACTICATH Reddy VY et al. Circulation 2015;132: THERMOCOOL SMARTTOUCH Natale A et al. JACC 2014;64:647-56

9 Force Sensing Catheters

10 Balloon Catheter Ablation CRYOBALLOON LASER BALLOON Noncompliant (23 & 28 mm) Over-the-wire Balloon within a balloon Refrigerant N 2 O Compliant, adjustable size Flexible tip Endoscopic visualization Laser diode (980 nm) Adjustable aiming/ablative arc

11 Balloon Catheter Ablation CRYOBALLOON LASER BALLOON Reddy VY et al JCE patients with paroxysmal AF Cryoballoon ablation (28 mm, 2 nd gen) Remapping at 3 months Outcomes: 100 % PVs acutely isolated 91% of PVs persistently isolated at 3 months Freedom from AF: 89% Dukkipati SR et al Heart Rhythm patients with paroxysmal AF Laser balloon ablation Remapping at 3 months Outcomes: 98% PVs acutely isolated 86% of PVs persistently isolated at 3 months Freedom from AF: 71.2%

Visually-Guided Laser Balloon Prospective, Multicenter, Randomized Controlled

Control (Thermocool, N=175) Aiming/Ablation Arc 1.0 0.

9802 Probability of Primary Efficacy 0.6 0.4 LIPV 0.2 0.

12 Visually-Guided Laser Balloon Prospective, Multicenter, Randomized Controlled Trial Laser Ablation (N=178) vs. Control (Thermocool, N=175) Aiming/Ablation Arc Primary Efficacy Endpoint + Censored Logrank p= Probability of Primary Efficacy LIPV P S I A Time to failure (days) Study Arm Control Arm VGLB Primary Efficacy Endpoint: VGLB 61.1% vs. Control 61.7% Dukkipati SR et al. JACC 2015;66: (p=0.002 for non-inferiority)

the coronary sinus, the crista terminalis, the left atrial

13 Causes of AF Recurrence Post-PVI Non-Pulmonary Vein Triggers: - superior vena cava, the ligament of Marshall, the coronary sinus, the crista terminalis, the left atrial posterior wall, and left atrial appendage (27% in redo procedures).

LAA Isolation in Long-Standing Persistent AF: BELIEF Trial SUCCESS SUCCESS AFTER AFTER MULTIPLE SINGLE PROCEDURES 76% 56% 56% 28% Log-rank p=0.001 0.

14 LAA Isolation in Long-Standing Persistent AF: BELIEF Trial SUCCESS SUCCESS AFTER AFTER MULTIPLE SINGLE PROCEDURES 76% 56% 56% 28% Log-rank p= Overall, LAA isolation in addition to standard ablation, was associated with 55% reduction in overall recurrence: (HR 0.45 [ ], p=0.004) Di Biase L et al. ESC Hot Line Sessions 2015

LAA Isolation in Long-Standing Persistent AF: BELIEF Trial TEE @ 6 MONTHS Strokes:

15 LAA Isolation in Long-Standing Persistent AF: BELIEF Trial 6 MONTHS Strokes: LAA Isolation 0 (0%), Standard: 4 (4.5%) Di Biase L et al. ESC Hot Line Sessions 2015

16 Percutaneous LAA Ligation: LARIAT Bartus K et al. JACC 2013;62: Lee RJ et al. Circ Cardiovascular Interv 2010;3:

LAA Ligation for the Treatment of AF: LARIAT JACC CEP 2015;1:153-160 Prospective, Multicenter, Observational AF ablation +

17 LAA Ligation for the Treatment of AF: LARIAT JACC CEP 2015;1: Prospective, Multicenter, Observational AF ablation + LARIAT (N=69) AF ablation (N=69) Freedom from AF (1 year, off AAD, single procedure): LARIAT + Ablation 65% Ablation only 39% (p=0.002)

18 Why does AF ablation fail? FIRM Focal Impulse & Rotor Modulation Narayan SM et al. JACC 2012;60: Panoramic Mapping of AF AF Drivers Haissaguerre M et al. Circulation 2014;130:530-38

19 Roy D et al. NEJM 2008;358: Rate vs. Rhythm Control: AF & Heart Failure (LVEF 35%) Multicenter, RCT 1376 patients (AF & LVEF 35%) Rhythm (N=682) vs. rate control (N=694) Primary Outcome: CV Death (rhythm vs. rate control) HR 1.06 (95% CI , p=0.59) Secondary outcomes were similar (rhythm vs. rate control): All cause death: 32% vs. 33% Stroke: 3% vs. 4% Worsening HF: 28% vs. 31% Composite: 43% vs. 46% Primary Outcome (CV Death)

20 AF Ablation vs. Rate Control in Heart Failure: Meta-Analysis of RCTs Study N Mean Age (Years) Mean LVEF (%) Persistent AF (%) FU (months) Khan et al. NEJM 2008 Jones et al. JACC 2013 MacDonald et al. Heart 2011 Hunter et al. Circ EP ± ± ± ± ± ± ± ± Al Halabi S et al. JACC CEP 2015;1:200-9

21 AF Ablation vs. Rate Control in Heart Failure: Meta-Analysis of RCTs LVEF MLWHF 6MWD Al Halabi S et al. JACC CEP 2015;1:200-9 O 2 Consumption

22 AF Ablation vs. Rate Control in Heart Failure: Meta-Analysis of RCTs Major Adverse Events All Adverse Events HF Re-admissions Al Halabi S et al. JACC CEP 2015;1:200-9

AATAC-AF: Ablation vs Amiodarone in CHF-AF Patients Multicenter, Open-Label RCT Ablation vs Amiodarone LVEF 40%, NYHA II-III, Persistent AF All patients had ICD or CRTD Randomized 203 patients

23 AATAC-AF: Ablation vs Amiodarone in CHF-AF Patients Multicenter, Open-Label RCT Ablation vs Amiodarone LVEF 40%, NYHA II-III, Persistent AF All patients had ICD or CRTD Randomized 203 patients Catheter ablation (Group I, n=102) Amiodarone (Group 2, n=101) Primary Endpoint: Freedom from AF, AFL, or AT of >30sec off AAD Secondary Endpoints: LVEF, 6MWD, QOL-MLHFQ, CV Hospitalization, All-Cause Mortality In ablation group, a 2 nd ablation was permitted within 3-months L.Di Biase, P.Mohanty, S.Mohanty, et al. ACC-2015, LBCT Presentation

24 AATAC-AF: Primary Endpoint Freedom from AF/AT (>30 Sec Duration) Catheter Ablation, n=102 70% P < Amiodarone, n=101 34% Amiodarone Discontinuation at 2 years: 10% L.Di Biase, P.Mohanty, S.Mohanty, et al. ACC-2015, LBCT Presentation

25 AATAC-AF: Secondary Endpoints According to AT/AF Recurrence Status At baseline, the LVEF, 6MWD, and MLHFQ scores were not different between the two groups. At end of follow-up, compared outcomes of AT/AF recurrence free patients (n=105) with those experiencing AT/AF (n=98). AT/AF-Free (n=105) AT/AF (n=98) p value LVEF 9.6 ± 7.4% 4.2 ± 6.2% < MWD 27 ± 38 8 ± 42 < MLHFQ 14 ± ± 15 < L.Di Biase, P.Mohanty, S.Mohanty, et al. ACC-2015, LBCT Presentation

26 AATAC-AF: Secondary Endpoints Hospitalizations & Mortality Group 1 Ablation Group 2 Amio p value CV Hospitalization 32 (31%) 58 (57%) < All-Cause Mortality 8 (8%) 18 (18%) L.Di Biase, P.Mohanty, S.Mohanty, et al. ACC-2015, LBCT Presentation

27 Hypertrophic Cardiomyopathy: Results of AF Ablation Single center, retrospective HCM [N=40, age 54.3±7.3 years, 70% male, 67.5% persistent AF; mean LV thickness 17.5±2.8 mm; LVOT obstruction 37.5% (mean gradient 37±12.5 mmhg)] Comparison group (N=64, age 56.2±5.8 years, 70% male, 70.3% persistent AF) PV reconnections at redo procedures: HCM 61.5%; Comparison 91.6% (p=0.0004) LVOT was independently associated with arrhythmia recurrence: HR 4.3, 95% CI , p= % of those with AF recurrence had LVOT obstruction vs. 0% in those without recurrence Contreras-Valdes FM et al. J Am Coll Cardiol 2015;65:1485-7

28 Hypertrophic Cardiomyopathy: Meta-Analysis of AF Ablation Zhao DS et al. Europace 2015;doi: /europace/euv339

29 Atrial Fibrosis and AF Recurrence After Ablation Single Center, Observational 165 pts. with AF (57% persistent) undergoing ablation CMR with late gadolinium enhancement LGE 35% LGE >35% LGE was independently associated with AF recurrence (HR 1.5 per 10% LGE increase, p<0.001) LGE >35% was associated with: HR 6.5 for persistent AF HR 3.6 for paroxysmal AF LGE 35% LGE >35% Khurram IM et al. JACC Cardiovasc Imaging 2015 (Epub ahead of print)

30 Conclusions AF Ablation in superior to rate control and AADs even in the presence of certain disease states such as heart failure and hypertrophic cardiomyopathy: Improvement in SR maintenance, LVEF, and QOL AF recurrence is commonly due to: PV reconnections, non-pv triggers (LAA), and AF drivers (rotors/focal impulses) New technologies have been designed to improve outcomes of AF ablation: Durable PV isolation (contact force sensing catheters, balloon catheters) Non-PV triggers (LAA isolation, LARIAT) AF drivers (Rotors, Focal impulses)

32 ThermoCool AF: Ablation vs. AADs in Paroxysmal AF Symptomatic AT/AF All AT/AF 70% 63% 19% HR 0.24 (95%CI ,p<0.001) 17% HR 0.29 (95%CI ,p<0.001) Major Treatment-Related Adverse Event Rate (30 day): Ablation 4.9% vs. AADs 8.8% Wilber DJ et al. JAMA 2010;303:333-40

33 ThermoCool AF: Ablation vs. AADs in Paroxysmal AF - QOL SF-36 SF-36 Wilber DJ et al. JAMA 2010;303:333-40

AF Ablation in Patients with LV Dysfunction Study Year Design N Mean Age (Years) Mean LVEF (%) AF Type FU (months ) Chen et al. 2004 Cohort 94 57 36 All 6 Hsu et al.

34 AF Ablation in Patients with LV Dysfunction Study Year Design N Mean Age (Years) Mean LVEF (%) AF Type FU (months ) Chen et al Cohort All 6 Hsu et al Case- Control All 12 Gentlesk et al Cohort PAF, PerAF 3-6 Efremidis et al Cohort PAF, PerAF 9 Lutomsky et al Cohort PAF 6 Khan et al RCT All 6 De Potter et. al 2010 Case- Control Choi et al Case- Control All PAF, PerAF 16 MacDonald et al RCT PerAF 10

35 Hypertrophic Cardiomyopathy: Predictors of AF Recurrence After Ablation Zhao DS et al. Europace 2015;doi: /europace/euv339

36 Targeting Drivers of AF: Rotors & Focal Impulses (FIRM) Narayan SM et al - CONFIRM (Conventional Ablation for Atrial Fibrillation With or Without Focal Impulse and Rotor Modulation) Trial (JACC 2012;60:628-36) 92 pts. randomized (1:2) to FIRM guided vs. conventional RFA FIRM ablation alone terminated AF in 56% & slowed AF by 10% in 30% At median f/u of 273 days, after single procedure, freedom from AF was 82.4% FIRM guided ablation vs. 44.9% conventional (p<0.001) No difference in procedure duration or safety

37 AATAC-AF: Primary Endpoint Impact of Ablation Strategy N AT/AF- Free Outcome* PVI Alone 22 8 (36.4%) PVI, Post Wall, Non-PV Triggers (78.8%) * p < L.Di Biase, P.Mohanty, S.Mohanty, et al. ACC-2015, LBCT Presentation

Ruolo della ablazione della fibrillazione atriale nello scompenso cardiaco

Ruolo della ablazione della fibrillazione atriale nello scompenso cardiaco Matteo Anselmino Division of Cardiology Città della Salute e della Scienza Hospital University of Turin, Italy Disclosure: Honoraria