Atrial Fibrillation: GOING ALL IN! · 8/31/2016 2 ©Biosense Webster, Inc. 2014 | Meeting Title | Date THERMOCOOL ®Catheters (including ThermoCool® SmartTouch® catheter) are approved

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©Biosense Webster, Inc. 2014 | Meeting Title | Date

Robert Percell, Jr., MD FACC

Electrophysiologist

Bryan Heart 2016 FallConference

Saturday, October 3, 2016

Atrial Fibrillation:

GOING ALL IN!


THERMOCOOL® Catheters (including ThermoCool® SmartTouch® catheter) are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation,

when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter) #021458

DISCLAIMER

• No company sponsorships were given for this

presentation




Prevalence of Atrial Fibrillation 1

3.1 Million + 1 Million

by 2020 <10%

Mission:

Provide better access to those eligible patients for ablation therapy.

1.Chugh SS, Havmoeller R, Narayanan K, et al . Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47.

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AF is a Progressive Disease

Nieuwlaat R et al. Prognosis, disease progression, and treatment of atrial fibrillation patients during 1 year: follow-up of the Euro Heart Survey on atrial fibrillation.

Eur Heart J. 2008 May;29(9):1181-9. doi: 10.1093/eurheartj/ehn139. Epub 2008 Apr 7.

of patients progress from Paroxysmal to Persistent AF within 1 year of diagnosis1

20% Nieuwlaat R

Typical ProgressionTypical Progression


1. Wolf PA, et al. Atrial Fibrillation risk factor for stroke: the Framingham Study Stroke 1991; 22 (938-988)

AFib and Risk of Stroke

Patients suffering from Atrial Fibrillation have

4-5 times greater risk of stroke 1




Treating AFib as One Team

Primary Care-Cardiology-Electrophysiology Treatment Cycle

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Afib Management1

2

Ablation Procedure3

Agenda

Latest Rhythm Control Strategies


1. Craig T. January, MD, PhD, FACC; L. Samuel Wann, MD, MACC, FAHA; Joseph S. Alpert, MD, FACC, FAHA; Hugh Calkins, MD, FACC, ET AL. 2014 AHA/ACC/HRS Guideline

for the Management of Patients With Atrial Fibrillation: Executive Summary. J Am Coll Cardiol. 2014;64(21):2246-2280

2014 AFib Management Guidelines

The 2014 AHA/ACC/HRS Guidelines for Afib Management provide the highest level

of recommendation (Class: 1; Level of Evidence: A) for catheter ablation as

treatment for drug-refractory, symptomatic paroxysmal Afib.

ClassRECOMMENDATION

THE STRONGEST RECOMENDATION

11 LevelLEVEL OF EVIDENCE

THE HIGHEST LEVEL OF EVIDENCE

AA




Various Mechanisms Contribute to AF

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Sub-types of AF

Paroxysmal

Recurrent, ≥2 episodes

Terminates spontaneously within 7 days

Persistent

Episodes lasting > 7 days

OR

Episodes that require intervention to terminate (medication or electrical cardioversion)

Long-Standing Persistent / Permanent

Continuous AF of > 1 year

Mutual decision between patient and physician has been made to cease further attempts to restore/ maintain normal sinus rhythm by any means, including catheter ablation




Stroke Risk Assessment

Anti-coagulation strategy is guided by several factors, MOST of which are

summed up in the CHA2DS2VASc Score.

CHA2DS2VASc STROKE RISK CRITERIA SCORE

C Congestive Heart Failure 1

H Hypertension 1

A Age ≥ 75 2

D Diabetes mellitus 1

S Stroke/TIA/Embolism 2

V Vascular Disease 1

A Age 65-74 Years 1

S Sex (female) 1


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AF Assessment

During AF assessment, will this therapyE.

Reduce risk of stroke?

Improve quality of life?

Maintain integrity of the left atrium?

Avoid progression of disease?

Avoid development of heart failure?


Rate vs. Rhythm Control

Timeline

AFFIRM StudyNo survival

advantage of Rate vs.

Rhythm control

2002 2006 20142012

Class III

Level C

2001

Class IILevel B

Ionescu Mortality among

patients on rhythm control gradually

decreased relative

to rate control

Class ILevel A*

Ghanbari NSR after RFCA is

associated with 60% reduction in

CV mortality

Society Guidelines for Afib: Ablation

*Class I Level A for PAF with no or minimal heart disease

2010

Wilber RFCA is superior in

efficacy and safety to AAD

2004

Corley (AFFIRM sub-analysis)

NSR associated with 47% reduction

on risk of death

2003

DIAMOND Study

NSR leads to significant

reduction in

mortality

2002




Progression of AF Less Likely with

Rhythm Control Strategy

Rhythm control patients were less likely to

show progression than rate control 1

� 11% rhythm control group showed

AF progression

� 26% rate control group showed AF

progression

Of the patients with AF progression:

� 61% had developed permanent AF

� 39% had developed persistent AF

1. De Vos et al. Progression of atrial fibrillation in the registry on cardiac rhythm disorders assessing the control of atrial fibrillation cohort: Clinical correlates and the effect of rhythm-control therapy. Am

Heart J 2012, 163:887-93

2. Chart information is from Record AF : Worldwide prospective survey of AF management (N=2,137)

2

p

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Afib Management1

2

Ablation Procedure3

Agenda





Efficacy of Catheter Ablation vs ADT

Patients who had catheter ablation have fewer episodes of Afib than

patients who took medication

Patients who had catheter ablation have fewer episodes of Afib than

patients who took medication




Higher Efficacy and Less Complications with Catheter Ablation

1. Smart AF Study

2. Calkins H. et al . Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systematic literature reviews and meta-analyses. Circ Arrhythm Electrophysiol. 2009

Aug;2(4):349-61.

• 77% of patients free of AF occurrence

• 5% complication rate

CATHETER ABLATION 1

• 52% of patients free of AF occurrence

• 30% complication rate

ANTIARRYTHMIC DRUG

THERAPY 2

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Stroke Reduction: RF Catheter Ablation vs. ADT 1

Significant difference in risk of stroke/TIA:

3.4% RF Catheter Ablation Group vs

5.5% Antiarrhythmic Drug Therapy Group

Significant difference in risk of stroke/TIA:

3.4% RF Catheter Ablation Group vs

5.5% Antiarrhythmic Drug Therapy Group

1. Ionescu-Ittu et. al. Arch Intern Med, 2012; 172: 997-1004


1. Bunch et al. Patients Treated With Catheter Ablation for Atrial Fibrillation Have Long-Term Rates of Death, Stroke and Dementia Similar to Patients Without Atrial Fibrillation. J Cardiovasc

Electrophysiol, Vol. 22, pp. 839-845, August 2011

RF Catheter Ablation Lowers the Risk of Death, Stroke and

Dementia 1




RF Catheter Ablation is Safe and Effective in Octogenarians 1

• Up to 10% of people over 80 years of age have AF

• Up to 25% of strokes in this group are due to AF

• This study compared safety and efficacy of RF ablation in two groups; greater and less than

80 years of age

• Success rates and complications were similar between the two groups

1. Santangeli et al. Catheter Ablation of Atrial Fibrillation in Octogenarians: Safety and Outcomes. J Cardiovasc Electrophysiol, Vol. 23, pp. 687-693, July 2012

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Afib Management1

2

Ablation Procedure3

Agenda





• RF catheter ablation uses high frequency

alternating current to eliminate or alter the

arrhythmogenic substrate

• An ablation catheter is used to apply RF to

the endocardium to produce continuous

lesions (scars) that prevent the abnormal

electrical activation contributing to AF

• The most common lesion sets include

circling of the pulmonary veins (PVs) called

circumferential PV isolation

1. Source: Adapted from Calkins H, Brugada J, Packer DL et al. (2007) HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for

personnel, policy, procedures and follow-up. A report of the HRS Task Force on Catheter and Surgical Ablation of Atrial Fibrillation developed in partnership with the EHRA and the ECAS; in

collaboration with ACC, AHA, and the STS. Endorsed and approved by the governing bodies of the ACC, AHA, ECAS, EHRA, STS, and the HRS. Europace 9(6):335-379.

RF Catheter Ablation Involves Lesion Creation to Prevent Abnormal Activation

1




Evolution of Afib Technology

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Stereotaxis




Latest Treatment Options

STOP AF (Data on 1st gen Cryo Balloon) 1

Adverse events rate 29.8%

Publications on 2d Generation Cryo Balloon do not address any changes of safety data

compared to 1st Gen Cryo Balloon

1 year single procedure freedom of AADs :

49.7%

ThermoCool®SmartTouch®

Catheter 2

Comprehensive treatment option(Atrial Fibrillation, Flutter, Ventricular

Tachycardia)

63-88%3 successful outcomesMulti-center, randomized trials

3.8% complication rate

1 year single procedure freedom of AADs: 65.8%

1. Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: first results of the North American Arctic Front (STOP AF) pivotal trial. J Am Cardiol. 2013 Apr

23;61(16):1713-23

2. SMART AF: Paroxysmal AF Catheter Ablation With a Contact Force Sensing Catheter. J Am Coll Cardiol. 2014;64(7):647-656

3. The THERMOCOOL SMARTTOUCH® Catheter demonstrated up to an 88% success rate in patients with atrial arrhythmia 12 months post procedure - this success rate was seen in a

sub-group analysis of patients within the overall study, for which the main success rate was 77%.

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Ablation Technology Outcomes



Atrial Fibrillation Summary

• AF remains a major public health issue

– Increasing population at risk

– Significant morbidity, mortality and cost$

• Anticoagulants reduce stroke risk

– Warfarin

– NOACs: Rivaroxaban, Apixaban, Dabigatran, and Edoxaban

• Drug Therapy

– Rate Control

– Antiarrhythmics

• Ablation

– AV node and PVI

• Appendage Closure

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Complete Patient Care

Primary Care-Cardiology-Electrophysiology Treatment Cycle




THANK YOU

Documents

Atrial Fibrillation: GOING ALL IN! · 8/31/2016 2 ©Biosense Webster, Inc. 2014 | Meeting Title | Date THERMOCOOL ®Catheters (including ThermoCool® SmartTouch® catheter) are approved