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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
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.
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
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.
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.
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
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
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
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)
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
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
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
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
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
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
• 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. 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%.