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Atrial Fibrillation 2014. Christopher L. Fellows, MD, FACC, FHRS Virginia Mason Medical Center Seattle, Wa. 2014 AHA/ACC/HRS Guidelines for the Management of AF 2011 Focused Update on the management of AF
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Atrial Fibrillation 2014 Christopher L. Fellows, MD, FACC, FHRS Virginia Mason Medical Center Seattle, Wa.
2014 AHA/ACC/HRS Guidelines for the Management of AF • 2011 Focused Update on the management of AF • 2012 Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation www.acc.orgwww.hrsonline.org
AF is very frustrating • Causes strokes…strokes are BAD • Makes pts feel BAD • Therapy toxic and ineffective
Stroke Risk in Patients With Nonvalvular AF Not Treated With Anticoagulation According to the CHADS2 Index Stroke Rate %per year CHADS2 Score
CHF Hypertension Age > 75 Diabetes Stroke/TIA (2) CHF/LV dysfunction Hypertension Age > 75 (2) Diabetes Stroke/TIA/TE (2) Vasc disease Age > 65 Sex (female) CHADS2 CHADS2 VASC Gage BF JAMA 285:2864-2870,2001 Lyp GYH Chest 137:263-272,2010
Is Sinus Rhythm Important ? • AFFIRM (Wyse DG, et.al. NEJM 2002;347:1825-31) • RACE (Hagens VE, et.al. JACC 2004;43:241-247.) • STAF (Carlsson J, et.al. JACC 2003;41:1690-1696.) All concluded …..that there were no mortality differences between rate control and rhythm control strategies in the treatment of AF
Sinus Rhythm • AFFIRM type trials excluded highly symptomatic patients • Trials designed to test strategy not therapy • Therapy was very ineffective
AFFIRM Substudy • On treatment analysis • NSR= 47% lower risk of death • AAD use = 49% increased risk of death AFFIRM investigators. Circ 2004;109:1509-1413
“…the failure of AFFIRM, RACE, or STAF in showing any differences between rate and rhythm control is not so much a positive statement for rate control but rather a testimony on the ineffectiveness of the rhythm control methods used.” Verma A, Natale A. Circulation 2005;112:1214-1231.
OK, Sinus rhythm is good but at what price ? • Drugs • Pacer • ICD • Ablation
Antiarrhythmic Drugs Amiodarone Propafenone Sotalol 100 80 60 Sinus Rhythm (%) 40 20 0 0 100 200 300 400 500 600 Time (days) Roy et al. NEJM 2000;342:913-920.
Betablockers Flec/Propaf Sotalol Amio/Dofet Dronedarone Ca blocker Dig Everybody Lone AF Good LV Bad LV Good LV Rate control CHF only AF drugs…my best guess
OK, Sinus rhythm is good but at what price ? • Drugs • Pacer • ICD • Ablation
Kaplan-Meier Curves of Time to Protocol-Defined Treatment Failure, Recurrence of Symptomatic Atrial Arrhythmia, and Recurrence of Any Atrial Arrhythmia by Treatment Group Wilber, D. J. et al. JAMA 2010;303:333-340
“… the success of Pulmonary Vein Antral Isolation can exceed 90%, sometimes requiring 2 procedures, and there is an associated risk of stroke <1%, cardiac perforation <1%, pulmonary vein stenosis <1%, vascular injury <1%, and atrioesophageal fistula 1/1000.”
Results • Worldwide data* (100 centers), 52% efficacy (27% repeats) 6% complications • US data** (92 centers) 66% efficacy *Cappato R, Calkins H, Chen S et.al Circ. 2005;111:1100-1105. **Mickelson S, Dudley B, Treat E, et.al. JICE 2005;12:213-220.
Published Catheter Ablation Success Rates N = 63 studies 6936 pts Success Rates Catheter Ablation Major complications 4.9% Calkins H, et al. Circulation. 2009;2:349-361.
Cryoablation • 1948 (Hass) surgical Cryo lesions in Cardiac surgery using CO2 • 1963 (Cooper) developed liquid nitrogen surgical cryo tools • 1977 (Gallagher) reported AVN ablation using surgical cryoablation • 1991 (Gillette) cryoablation catheter in animals • 1999 (Dubuc) cryocatheter in humans
Cryoablation • Preserves endothelial integrity1 • Decreases risk of thrombus formation1 1 Sarabanda AV, et al. J Am Coll Cardiol. 2005;46:1902-1912. 22
Effectiveness ResultsFreedom from AF after 90 Days Blanked for Detectable AF CRYO 69.9% (114 / 163) Treatment Success OR = 29.5 (12.0 – 72.2) p < 0.001 Blanked for DetectableAF DRUG7.3% (6 / 82) 23
Cryoballoon results 2/11 – 10/14(CF) • N=595 (male 72%) • Ages 29-84 • All symtomatic, documented multiple AF episodes, failed drug therapy. • 82/410 prior failed procedures (8 surgical Maze, 10 multiple RF failures)
Cryoballoon results 2/11 - 12/13 • 124 patients >1 yr f/u 90% NSR, (77% 95/124 NSR off drugs).
Advance Balloon f/u > 12 mo • 50 pts ablated between 6/12 and 11/12 • 47/50 f/u data available • 39/47 cured (no AF no AAD) (83%) • 4/47 brief AF no AAD • 2/47 no AF remain on AAD • 2/47 failures (4%) 96 %
Immediate Lab Complications (18/595 = 3%) • 7 groin hematoma (1.1%) (no intervention required) • 2 hypotension/acidosis • 1 hyperkalemia • 1 phenylepherine IV extravasation • 2 hematuria from foley placement • 1 ileus • 1 temporary pacing overnight for bradycardia • 1 cath/stent • 2 CHF exacerbation
Phrenic nerve palsy (N=595) • 44 Phrenic nerve palsy (7.4%) • 40 transient with full recovery in lab. • 4 persistent at discharge, 3 with full recovery by 3 months, 1 recovery in 12 months.
Late Complications (N=595) • 0 CVA ,TIA,MI, or embolism • 0 Tamponade • 0 EA fistula • 0 Deaths • 0 persistent phrenic nerve palsy (1 yr)
“… the success of Pulmonary Vein Antral Isolation can exceed 90%, sometimes requiring 2 procedures, and there is an associated risk of stroke <1%, cardiac perforation <1%, pulmonary vein stenosis <1%, vascular injury <1%, and atrioesophageal fistula 1/1000.”
Repeat Procedures • 25 %-33% with RF • 34/595 (5.7%) with Cryo
Goals • Improve efficacy • Decrease complications • Decrease repeat procedures • Minimize iatrogenic arrhythmias ( LA flutter) • Decrease lab time or minimize variability
Long-term Outcomes • N= 605 (579 PAF) • 18-48 month f/u ( median 30 month) • 61.6% single procedure • 74.9% multiple procedure • PNP 2% ( last 420 patients 0.7%) Vogt J, et al. JACC 2013;61:1707-12
CRYO Procedure Experience Impacts Treatment Success P < 0.001 by quartile 90% 100% 69% 66% 80% 56% 60% Treatment Success 40% 25 centers n=43 14 centers n=38 10 Centern=42 4 centers n=40 20% 0% 1st and 2nd procedures 6th – 11th procedures 3rd – 5th procedures 12th – 23rd procedures
AF AblationThe “Cure”….where are we ? • The concepts are good • The tools are getting better • Current techniques are becoming more practical for widespread application • Safety remains a concern
AF ablation remains a second line therapy for highly symptomatic patients who fail medical management or cannot /will not take medications (2006) or first line therapy for selected patients (2011)
Things to consider • This is great for symptomaticparoxysmal AF • It is a 2 hour procedure under a general anesthetic • Requires anticoagulation with warfarin • It does not change your CHADS score • It doesn’t work in everybody • There are serious potential complications