Atrial Fibrillation Christopher L. Fellows, MD, FACC, FHRS Virginia Mason Medical Center Seattle, Wa.

Transcription

1 Atrial Fibrillation 2017 Christopher L. Fellows, MD, FACC, FHRS Virginia Mason Medical Center Seattle, Wa.

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

3 1) 2014 AHA/ACC/HRS Guidelines for the Management of AF 2) 2017 Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation

4 AF is common 5-6 Million US patients Expected to double over next 25 years 500,000 new Dx/yr (US) 500,000 Hospitalizations /yr (US) AF adds $26 B/yr to healthcare costs Lifetime risk for adult age >40 = 1/4 Andrade J, Circ Res. 2014;114: Chiang C, Circ Arrhythm Electrophysiol. 2012;5: January CT,. J Am Coll Cardiol. 2014; 64(21):e1-e76.

5 AF is bad 5X increase in stroke (inc w/ age) 2X increase in mortality 2X increase in dementia 3X increase in CHF 2X increase in hospitalizations 3X increase in multiple hospitalizations January CT,. J Am Coll Cardiol. 2014; 64(21):e1-e76.

6 AF is very frustrating, the low back pain of cardiology Causes strokes worst fear Makes pts feel BAD Therapy toxic and ineffective

7 There are 3 reasons to treat AF 1)Prevent stroke 2)Prevent CHF 3)Prevent symptoms

8 Virchow triad, promoting thrombosis Blood stasis Endothelial injury (vwf and inflamatory indicators of endothelial damage) Hypercoagulability ( d-dimer, thrombin complexes, pf4, and other markers of a prothrombotic state) Virchow, R. Gesammelte abhandlungen zur wissenschaftlichen medizin. Frankfurt: Medinger Sohn & Co; pp. 219.

9 Risk stratification 80 s-90 s multiple randomized stroke prevention trials in patients with nonvalvular atrial fibrillation(afasak, BAATAF, SPAF, CAFA and SPINAF) Atrial Fibrillation Investigators (AFI) proposed four independent risk factors for stroke in atrial fibrillation (age, prior stroke,htn, DM) Stroke Prevention in Atrial Fibrillation III (SPAF III)

10 Stroke Rate %per year Stroke Risk in Patients With Nonvalvular AF Not Treated With Anticoagulation According to the CHADS 2 Index CHADS 2 Risk Criteria Score Prior stroke or TIA 2 Age >75 y 1 Hypertension 1 Diabetes mellitus 1 Heart failure 1 20 Patients (N=1733) 15 Adjusted Stroke Rate (%/y) * (95% CI) CHADS 2 Score (1.2 to ) (2.0 to 3.8) (3.1 to 5.1) (4.6 to 7.3) (6.3 to 11.1) (8.2 to 17.5) (10.5 to 27.4) 6 CHADS 2 Score Gage BF JAMA 285: ,2001

11 CHADS2 CHF Hypertension Age > 75 Diabetes Stroke/TIA (2) CHADS2 VASC CHF/LV dysfunction Hypertension Age > 75 (2) Diabetes Stroke/TIA/TE (2) Vasc disease Age > 65 Sex (female) Gage BF JAMA 285: ,2001 Lyp GYH Chest 137: ,2010

12 Stroke risk comparison CHADS2 (n=1733) Stroke rate %/year CHADS2-VASc (n=7329) Stroke rate %/year

13 Tachy-cardiomyopathy 1913 Gossage and Braxton Hicks 1937 I.C. Brill Gossage AM, Braxton Hicks JA Q J Med 1913;6: Brill IC Am Heart J 1937;

14 Tachy-cardiomyopathy Common can occur w/ any arrhythmia Reversible w/ rate control by any means A second episode of tachycardia will quickly deteriorate LV function

15 Mechanisms? High energy phosphate depletion Cellular and mitochondrial Ca++ overload Premature cell death increase in fibrosis and inflamation Adverse electrophysiological changes Vicious cycle continues

16 AF rate control; How slow? <80 resting, avg < 100 (AFFIRM) Lenient rate control (<110 resting HR) (RACE II trial) Symptoms especially with exertion Slow is good, slower is better

17 Heart Rate and Mortality in Healthy Men N= 5713 mean f/u 23 yrs Jouven X, et al. N Engl J Med 2005;352:

18 Heart Rate and Mortality N= 24,913 Mean f/u 14.7 yrs Diaz A. et al. Eur Heart J 2005;26:

19 Prevent Symptoms

20 CLASS I 1. AF catheter ablation is useful for symptomatic paroxysmal AF refractory or intolerant to at least 1 class I or III antiarrhythmic medication (Level of Evidence: A) CLASS IIa 1. AF catheter ablation is reasonable for some patients with symptomatic persistent AF refractory or intolerant to at least 1 class I or III antiarrhythmic medication (Level of Evidence: A) CLASS IIb 1. AF catheter ablation may be considered for symptomatic longstanding persistent AF refractory or intolerant to at least 1 class I or III medication (Level of Evidence: B) 2. AF catheter ablation may be considered before initiation of antiarrhythmic drug therapy with a class I or III antiarrhythmic medication for symptomatic persistent AF when a rhythm-control strategy is desired. (Level of Evidence: C) CLASS III: HARM 1. AF catheter ablation should not be performed in patients who cannot be treated with anticoagulant therapy during and after the procedure. (Level of Evidence: C)

21 Is Sinus Rhythm Important? AFFIRM (Wyse DG, et.al. NEJM 2002;347: ) RACE (Hagens VE, et.al. JACC 2004;43: ) STAF (Carlsson J, et.al. JACC 2003;41: ) All concluded..that there were no mortality differences between rate control and rhythm control strategies in the treatment of AF

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

24 AFFIRM Substudy On treatment analysis NSR= 47% lower risk of death AAD use = 49% increased risk of death AFFIRM investigators. Circ 2004;109:

25 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:

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

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

28 You have AF Take a drug life long to suppress it Have an ablation

29 Catheter MAZE Swartz J, et al. A catheter-based curative approach to atrial fibrillation in humans. Circulation. 1994;90:I-335.

30 Haissaguerre et al.nejm 1998;339:

31 Saito T, Kenji W, Becker A: J Card Electro 2000;11:888-94

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35 Meta-analysis of RF ablation Major complications 4.9% Calkins H, et al. Circulation. 2009;2:

36 How about cold?

37 Cryoablation 1948 (Hass) surgical Cryo lesions in Cardiac surgery using CO (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

38 Cryoadhesion

39 Cryoballoon ablation (FDA approved 12/10) Ablates at the point of balloon contact

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42 STOP AF PAS Interim Results: Efficacy 1-Year Freedom from AF Freedom from AF at 12 months was 89.9% Freedom from AF, and symptomatic AFL/AT at 12 months was 86.4% N=146

43 Single Procedure Success Cryoballoon

44 FIRE AND ICE Trial Primary Endpoints Kuck KH, et al. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016; 374(23):

45 FIRE AND ICE Trial Secondary Analyses: Significant Improvements Favoring Cryoballoon Cryoballoon Demonstrated: 21% Fewer all-cause hospitalizations 33% Fewer Repeat ablations 34% Fewer Cardiovascular hospitalizations 50% Fewer DC cardioversions Kuck, K-H et al. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016; [epub ahead of print]

46 Cryoballoon results 2/11 9/17 (CF) N=1384 (male 71%) Ages ( 29% > 70+ ) 53% Htn, 5% CHF All symtomatic, documented multiple AF episodes, failed drug therapy. 56% paroxysmal 254/1384 prior failed procedures (20 surgical Maze, 112 RF failures, 15 multiple RF failures, 120 failed cryo)

47 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 %

48 Advance Balloon f/u > 12 mo PAF only 80 pts f/u between 7/13 and 5/14 12 month survey data available on 66 54/66 cured (no AF no AAD) (82%) 4/66 better (brief symptoms no AAD or no symptoms w/ AAD (6%) 7/66 redo cryo (10%) 1/66 AVN ablation/pacer 88 %

49 Complications Vascular complications Stroke/ Tia / Embolism Perforation/ Tamponade PV stenosis Phrenic nerve injury Eso-Atrial fistula Misc.

50 Complications (RF) Large data base ( Ca state, N= 4156) 5% All cause hospitalization 38.5% at 1 yr Readmission for AF 21.7% at 1 yr Older age, female Less experienced hospitals Shah,RU, et.al. JACC 2012;59:143-9

51 Second Generation Cryoballoon: STOP AF Post Approval Study Results 5.8% (20/344) adverse event rate 3.2% (11/344) PNI Knight BP, et al. Second-generation Cryoballoon Ablation in Paroxysmal Atrial Fibrillation Patients: 24-month safety and efficacy from the STOP AF Post-Approval Study. Presented at HRS 2017 (Moderated Poster).

52 Meta-analysis of RF ablation Major complications 4.9% Calkins H, et al. Circulation. 2009;2:

53 Adverse Event Details Fire and Ice Total adverse events 7.1% 7.6% Kuck KH, et al. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016; 374(23):

54 Immediate Lab Complications (2.7% N=1384) groin hematoma (1.2%) 2 hypotension/acidosis 4 hematuria from foley placement 1 ileus 1 temporary pacing overnight for bradycardia 2 cath for chest pain (1 stented) 2 CHF exacerbation 1 tamponade

55 Moak,J et al. JICE 2000;4:624-25

56 Moak,J et al. JICE 2000;4:624-25

57 Sachez-Quintana D. Circulation. 2005;112:

58 Phrenic nerve palsy (N=1384) 107 transient phrenic nerve palsy (7.7%) 100 full recovery in lab. 7 ( 0.5 %) persistent at discharge, 5 with full recovery by 3 months, 1 recovery in 12 months, 1 unknown. 0 permanent Phrenic palsy

59 Other Lab Complications (N=1384) 0 CVA*,TIA,MI, or embolism 0 PV stenosis 1 Tamponade 0 E-A fistula 0 Deaths* 0 persistent phrenic nerve palsy (1 yr)

60 Total Lab Time

61 AF Ablation The Cure.where are we? The concepts are good The tools are getting better Safety remains a concern

62 Things to consider Great for symptomatic paroxysmal AF Don t do a trial of rate control It is a 2 hour procedure under a general anesthetic It should be performed only by experienced operators in experienced labs Requires anticoagulation It doesn t work in everybody There are serious potential complications It does not change your CHADS score

63 Post ablation considerations Chest pain (usually mild) Troponin will be elevated Groin hematoma/ecchymosis Blood loss minimal Anti-coagulate for 2 months Serious things to consider ( tamponade, phrenic nerve palsy, E-A fistula, PV stenosis, PNA)