atrial fibrillation: going all in! · 8/31/2016 2 ©biosense webster, inc. 2014 | meeting title |...
Post on 26-Aug-2020
2 Views
Preview:
TRANSCRIPT
8/31/2016
1
©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!
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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.
8/31/2016
2
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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.
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
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
Treating AFib as One Team
Primary Care-Cardiology-Electrophysiology Treatment Cycle
8/31/2016
3
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
Afib Management1
2
Ablation Procedure3
Agenda
Latest Rhythm Control Strategies
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
Various Mechanisms Contribute to AF
8/31/2016
4
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
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
©Biosense Webster, Inc. 2014 | Meeting Title | Date
8/31/2016
5
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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 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?
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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)
2
p
8/31/2016
6
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
Afib Management1
2
Ablation Procedure3
Agenda
Latest Rhythm Control Strategies
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
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
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
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
8/31/2016
7
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
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
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
8/31/2016
8
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
Afib Management1
2
Ablation Procedure3
Agenda
Latest Rhythm Control Strategies
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
Evolution of Afib Technology
8/31/2016
9
©Biosense Webster, Inc. 2014 | Meeting Title | Date
©Biosense Webster, Inc. 2014 | Meeting Title | Date
Stereotaxis
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
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%.
8/31/2016
10
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
Ablation Technology Outcomes
©Biosense Webster, Inc. 2014 | Meeting Title | Date
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
8/31/2016
11
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
Complete Patient Care
Primary Care-Cardiology-Electrophysiology Treatment Cycle
©Biosense Webster, Inc. 2014 | Meeting Title | Date
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
THANK YOU
top related