1. Christopher L. Fellows, MD, FACC, FHRS Virginia Mason Medical Center Seattle, Wa. Cardiac Arrhythmias 2015

2. NEI CHING SU WEN The Yellow Emperor's Classic Textbook of Internal Medicine “When the pulse is irregular and tremulous and the beats occur at intervals, then the impulse of life fades” Huang Ti Circa 2696-2598 BC

3. Hering HE. Das Elektrocardiogramm des Irregularis perpetuus. Deutsches Archiv fur Klinische Medizin. 1908; 94:205-8.

4. 1)2014 AHA/ACC/HRS Guidelines for the Management of AF 2) 2011 Focused Update on the management of AF 3)2012 Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation www.acc.orgwww.acc.org www.hrsonline.orgwww.hrsonline.org

5. National Coverage Determination (NCD). The following indications are covered: 1. Documented non-reversible symptomatic bradycardia due to sinus node dysfunction. 2. Documented non-reversible symptomatic bradycardia due to second degree and/or third degree atrioventricular block. 8/13/2013

6. Basic Arrhythmology Take a good history Document the arrhythmia Symptom/rhythm correlation Evaluate for structural heart disease Precipitating factors (T4, Electrolytes, ETOH)

7. Why treat ? Symptoms (palps to syncope) Prevent Cardiac Arrest Prevent stroke (AF) Prevent worsening of Arrhythmogenic substrate Prevent Arrhythmia induced myopathy

8. Rate related cardiomyopathy

9. Tachy-cardiomyopathy 1913 Gossage and Braxton Hicks described a case of AF in a young man who developed CHF …. “which might very well have been a consequence not a cause of the auricular fibrillation” Gossage AM, Braxton Hicks JA Q J Med 1913;6:435-40.

10. “auricular fibrillation, apart from any other disease of the heart, may cause severe congestive failure and that upon cessation of the arrhythmia the congestive failure may be followed by complete and lasting recovery” I. C. Brill, 1937

11. What tools do we have ? Drugs Pacers ICDs Ablation

12. What tools do we have ? Drugs Pacers ICDs Ablation

13. AF is very frustrating Causes strokes…strokes are BAD Makes pts feel BAD Therapy toxic and ineffective

14. 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

15. Sinus Rhythm AFFIRM type trials excluded highly symptomatic patients Trials designed to test strategy not therapy Therapy was very ineffective

16. 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

17. “…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.

18. OK, Sinus rhythm is good but at what price ? Drugs Pacer ICD Ablation

19. OK, Sinus rhythm is good but at what price ? Drugs Pacer ICD Ablation

20. “… 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.”

21. 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.

22. Published Catheter Ablation Success Rates Success Rates Catheter Ablation Calkins H, et al. Circulation. 2009;2:349-361. N = 63 studies 6936 pts Major complications 4.9%

23. Recent RF study SMART-AF prospective trial (N=161) Contact force catheter Very experienced operators 72.5% 12 month freedom from AF compared to 66% (open irrigated) 4 perforation/tamponade (2.48%) Natale A, et.al, JACC 2014;64:647-56.

24. 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

25. Cryoballoon results 2/11 – 10/14 (CF) N=595 (male 72%) Ages 29-84 All symptomatic, documented multiple AF episodes, failed drug therapy. 82/595 prior failed procedures (8 surgical Maze, 10 multiple RF failures)

26. Cryoballoon results 2/11 - 12/13 124 patients >1 yr f/u 90% NSR, (77% 95/124 NSR off drugs).

27. 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 %

28. Advance Balloon f/u > 12 mo PAF only 62 pts f/u between 6/14 and 8/14 12 month survey data available on all 51/62 cured (no AF no AAD) (82%) 7/62 better (brief symptoms no AAD or no symptoms w/ AAD (11%) 4/62 failures (7%) 93 %

29. 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

30. 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.

31. Late Complications (N=595) 0 CVA,TIA,MI, or embolism 0 Tamponade 0 EA fistula 0 Deaths 0 persistent phrenic nerve palsy (1 yr)

32. “… 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.”

33. Repeat Procedures 25 %-33% with RF 30/595 (5.0%) with Cryo

34. Goals Improve efficacy Decrease complications Decrease repeat procedures Minimize iatrogenic arrhythmias ( LA flutter) Decrease lab time or minimize variability

35. Total Lab Time

36. 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

37. AF Ablation The “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

38. 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)

39. Things to consider This is great for symptomatic paroxysmal 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