20% 10/9/2018. Fluoroless Ablation relinquishing an old habit. Prevalence of Atrial Fibrillation. Atrial Fibrillation is a Progressive Disease

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Griffin Camron Gray
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1 Fluoroless Ablation relinquishing an old habit Robert Percell, MD, FACC Cardiac Electrophysiologist, Bryan Heart Institute Lincoln, NE Prevalence of Atrial Fibrillation 3.1 Million + 1 Million by 2020 <10% Mission: Provide better access to those eligible patients for ablation therapy. Atrial Fibrillation is a Progressive Disease Typical Progression Nieuwlaat R 20% of patients progress from Paroxysmal to Persistent AF within 1 year of diagnosis 1 1

2 1 Afib Management 2 Latest Rhythm Control Strategies 3 Ablation Procedure 2

3 Timeline Rate vs. Rhythm Control AFFIRM Study No survival advantage of Rate vs. Rhythm control DIAMOND Study Corley (AFFIRM NSR leads to sub-analysis) significant NSR associated reduction in with 47% reduction mortality on risk of death Wilber RFCA is superior in efficacy and safety to AAD Ionescu Mortality among Ghanbari patients on rhythm NSR after RFCA is control gradually associated with decreased relative 60% reduction in to rate control CV mortality Class III Level C Class II Level B Society Guidelines for Afib: Ablation Class I Level A* *Class I Level A for PAF with no or minimal heart disease 3

4 Progression of AF less likely with Rhythm Control Strategy Efficacy of Catheter Ablation vs. AAD therapy Catheter Ablation vs. AAD Therapy 4

5 RF Catheter Ablation Lowers the Risk of Death, Stroke and Dementia 1 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 , August Afib Management 2 Latest Rhythm Control Strategies 3 Ablation Procedure RF Catheter Ablation Involves Lesion Creation to Prevent Abnormal Activation RF catheter ablation uses high frequency alternating current to eliminate or alter the arrhythmogenic substrate 1 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):

TactiCath - Integration with the PRECISION Mapping System allows the physician to select, visualize, and manage ablation parameters VS CRYO - No mapping system used.

6 TactiCath - Integration with the PRECISION Mapping System allows the physician to select, visualize, and manage ablation parameters VS CRYO - No mapping system used. Physician is limited to only anatomical approach without ability to diagnose/treat additional arrhythmias Heart Wall Last Week s Case 54 yo man w/ Persistent Atrial fibrillation, Symptomatic, s/p failed CV, propafenone PVI CTI Left Atrium Pre PVI 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) #

$catheter) are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation,$ when used with CARTO Systems (excluding NAVISTAR RMT THERMOCOOL Catheter) #021458 Left Atrium

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

(including ThermoCool SmartTouch when used with CARTO Systems (excluding NAVISTAR RMT THERMOCOOL

7 PVI with Roof and Posterior Floor Line 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) # Left Atrium Post PVI 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) # Left Atrium Pre CryoPVI 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) #

$Left Atrium Post Cryo PVI THERMOCOOL Catheters (including ThermoCool SmartTouch catheter) are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO$

paroxysmal atrial fibrillation, when used with CARTO Systems (excluding NAVISTAR RMT THERMOCOOL Catheter) #021458 Pulmonary Vein Isolation History First PVI in Humans 1994 12 hours 6 hours of X Ray

8 Left Atrium Post Cryo PVI 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) # AVNRT 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) # Pulmonary Vein Isolation History First PVI in Humans hours 6 hours of X Ray Radiation Swartz JF, Pellersels G, Silvers J, Patten L, CervantezD. A catheter-based curative approach to atrial fibrillation in humans (abstract) Circulation.1994;90:I-335. Popularized in hour procedure 4 hours of X Ray Radiation Haïssaguerre M, Jaïs P, Shah DC, et al. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N EnglJ Med1998;339:

independent Harmful Effects of Radiation Local erythema Cataracts Skin desquamation

9 Radiation is NOT your friend Discovered in 1896 Wilhelm Roentgen, a German professor of physics Harmful effects: Deterministic Dose related effects Stochastic Dose independent Harmful Effects of Radiation Local erythema Cataracts Skin desquamation Leukopenia Atrophy of the organs Birth defects Multiple organ and bone cancers. Radiation Exposure 9

10 Radiation Burns Post Ablation Radiation Risks It is estimated that with a single dose of 100 msv There is a 1% chance of developing a solid tumor or leukemia With a dose as low as 10 msv There is a 0.1% chance of developing cancer. Typical EP procedures can deliver between msv and can be as high as 50 msv in a single setting Many EP s obtain pre procedure CT s for PV anatomy Not to mention wearing 20 lb Lead aprons! Radiation Free Ablation? Case Reports and series Pediatrics Pregnancy Near Zero Lowering fluoroscopic dose, frame rates, etc. Lone single randomized trial with PVI for AF Few patients All paroxysmal Experienced operators 10

11 Patient Characteristics Procedure Times 11

12 Safety and Efficacy Efficacy Results at 3 months The Journal of Innovations in Cardiac Rhythm Management Zero Fluoroscopy Radiofrequency Redo Ablation of Atrial Tachycardia after Pulmonary Vein Isolation: A Tale of Two Systems 12

Tachycardia after Pulmonary Vein Isolation: A Tale of

13 The Journal of Innovations in Cardiac Rhythm Management Zero Fluoroscopy Radiofrequency Redo Ablation of Atrial Tachycardia after Pulmonary Vein Isolation: A Tale of Two Systems Local Activation Time mapping Sparkle Mapping 13

SANS FLUORO Ablation numbers SANS FLUORO ABLATIONS PVI SVT ALL 199 157 132 87 105 94 60 54 52 0 2 2 2015 2016 2017 2018 (projected)

14 SANS FLUORO Ablation numbers SANS FLUORO ABLATIONS PVI SVT ALL (projected) Future Directions Super Obese Patients 540 pound patient successful A Flutter ablation SANS FLUORO Lesion Size Index (LSI) Questions? 14

A Cryo Anatomical Procedure to Everyone? Saverio Iacopino, FACC, FESC

A Cryo Anatomical Procedure to Everyone? Saverio Iacopino, FACC, FESC AF Clinical/Referral Challenge Asymptomatic 40% 3 Rx Effective 30% Failed Rx Ablation Atrial fibrillation (AF) is the most common Candidate