Incidence and Disease Burden. Role of Catheter ablation Outcomes Data

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1 Management of Atrial Fibrillation Nitish Badhwar, MD, FACC University of California, San Francisco Risk Appraisal Forum April 23, 2010

2 Incidence and Disease Burden Drug therapy Role of Catheter ablation Outcomes Data

3 Overall and sex-specific trends in age-adjusted incidence of AF between 1980 and 2000 (age adjustment to the 1990 US population) Miyasaka, Y. et al. Circulation 2006;114:

4 Projected Prevalence of Atrial Fibrillation in United States between 2000 and 2050 Miyasaka, Y. et al. Circulation 2006;114:

5 Incidence of Atrial Fibrillation in different age groups Miyasaka, Y. et al. Circulation 2006;114:

6 Hospitalization for Arrhythmias (USA) 6% PSVT Atrial fibrillation accounts for 1/3 of all patient discharges with arrhythmia as principal diagnosis. 4% Atrial Flutter 6% PVCs 8% Conduction Disease 9% SSS 3% SCD 18% Unspecified 34% Atrial Fibrillationill 10% VT 2% VF Bialy D et al. JACC. 1992;19:41A

7 Presence of Heart Disease in Consecutive Outpatients ti t with AF 35% 65% Lone AF Heart di Prystowsky et al. Circulation. 1996;94:I-191

8 Symptom Profile 3 patients (2%) had non-lethal cardiac arrest The most frequent symptoms were: palpitations (96%), dizziness (75%), and shortness of breath (47%) 20% of subjects (33 of 167) reported at least 1 episode of syncope which was preceded by palpitations Symptoms were significantly (p< 0.05) 05) different in the AF/AFL group vs. other types of SVT Despite a low incidence of associated heart disease, and good LV function, there was a high frequency of disabling, potentially life-threatening symptoms associated with episodes of SVT Wood et al., Am J Cardiol. 1997:79(2):145-9.

9 Consequences of Atrial Fibrillation Arrhythmia- associated symptoms LV function, exercise tolerance, and QOL Tachycardia- mediated cardiomyopathy 5- fold in stroke risk Significant burden to healthcare system

10 Classification of Atrial Fibrillation Gallagher MM, Camm AJ. Classification of atrial fibrillation. PACE. 1992;20:

11 Management of Atrial Fibrillation Therapy goals may include: Control of the heart rate (symptom-reduction, rate-control) Restoration and maintenance of normal sinus rhythm (intervention and termination, rhythm-control) Reduction in thrombo-embolic complications (risk reduction for stroke)

12 Incidence and Disease Burden Drug therapy Role of Catheter ablation Role of Imaging

13 Percentage of Strokes Associated with Atrial Fibrillationill Wolf P, Abbott RD, Kannel WB. Arch Intern Med. 1987;147:

14 Risk of Stroke and Bleeding with Warfarin in Atrial Fibrillationill Placebo Warfarin Stroke Bleeding Atrial Fibrillation Investigators. Arch Intern Med. 1994;154:

15 Risk factors for Stroke in Patients with AF High Risk Previous CVA, TIA Rheumatic mitral stenosis Moderate Risk Age > 75 HTN DM CHF, EF < 35% Hyperthyroidism HOCM AF Guidelines

16 Dabigatran vs Warfarin in Atrial Fibrillation Connolly et al. N Eng J Med. 2009;361:

17 Newer Rx for Stroke Prevention Left Atrial Appendage Occluding devices Watchman device Place device Drugs Oral direct thrombin inhibitors (Dabigatran) Direct factor X a inhibitors Parenteral (Fondarinux) Oral (Razaxaban) Odiparcil

18

19 Pharmacological cardioversion Ibutilide Parenteral procainamide, flecainide, propafenone, sotalol l Dofetilide Pill in the pocket (oral) Flecainide (200 / 300 mg) Propafenone (450 / 600 mg) Need AV nodal blockers

20 Newer Drugs for Rhythm Control Dronederone Azimilide Trecetilide Atrial specific Tediasamil RSD 1235 ZP 123 (gap junction enhancer) AVE 0118

21 AFFIRM Atrial Fibrillation Follow-up: Investigation of Rhythm Management Entry Criteria PAF, Persistent AF < 65 w/ risk fx, or >65 w/o 6 hr of AF Treatment Arms Randomized, multicenter Rhythm + anticoag Rate + anticoag Rhythm = AADs or CV, devices & RFA rarely used Rate = ß, & Ca + channel blkrs, digoxin, 5% ablate & pace, 6MWD Outcomes Data Survival Total mortality QoL, cost Disabling stroke, hemorrhage, SCD Study Results N=4060; (~2030 each group) Mean f/u 3.5 yrs Rhythm control offered no survival benefit More adverse events (CVA, death, hospitalizations) in Rhythm arm NEJM 2002;347:

22 Incidence and Disease Burden Drug therapy Role of Catheter ablation Role of Imaging

23 Ablation for Atrial Fibrillation AV nodal ablation for rate control Ablation of precipitating arrhythmia (tachycardia induced tachycardia) Ablation to cure atrial fibrillation

24 AV Junction Ablation Singer: Interventional Electrophysiology. Williams & Wilkins 1997; 328.

25 Ablate (AV Junction) and Pace Clinical improvement Fewer symptoms Better exercise tolerance Improved QOL Improved hemodynamics CO increased Improved EF Small but real incidence of post-procedure SCD PAVE Trial Biventricular pacing post ablation improved EF RV pacing decreased EF

26 Ablation for Atrial Fibrillation AV nodal ablation for rate control Ablation of precipitating arrhythmia (tachycardia induced tachycardia) Ablation to cure atrial fibrillation

27 Tachycardia-Induced Tachycardia One tachycardia degenerates into another Examples: Atrial flutter and atrial tachycardia into AF AV node reentry into AF AV reentry into AF Treating the initiating tachycardia can help prevent future episodes of AF

28 UCSF

29 AVNRT Atrial Fibrillation Sauer et al. Circulation 2006;114:

30 Yang Y et al. AJC 2003;91(1):46-52

31 Ablation for Atrial Fibrillation AV nodal ablation for rate control Ablation of precipitating arrhythmia (tachycardia induced tachycardia) Ablation to cure atrial fibrillation

32 Cut and Sew Maze Procedure Ad, N and Cox, JL. J Card Surg 2004;19:

33 Long term efficacy of Cox Maze III Prasad SM. J Thorac Cardiovasc Surg. 2003;126:

34 Video-assisted bilateral pulmonary vein isolation and left atrial appendage exclusion for atrial fibrillation Wolf et al. J Thorac Cardiovasc Surg.2005;130:

35 Catheter Maze (LA) procedure 42 patients in study, 40 treated 36 initially successful procedures, 4 failures 4 total deaths, all unrelated to procedure 9 severe complications, 2 mild 3 CVA s 1 hemodynamic collapse 1 pericardial effusion / pericardiocentesis 1 infection related 1 ARDS 1 anaphylactic reaction 1 blood loss / transfusion 2 pressure sores

36 Focal Atrial Fibrillation Spontaneous Initiation of Atrial Fibrillation by Ectopic Beats Originating in the Pulmonary Veins Michel Haïssaguerre, M.D., Pierre Jaïs, M.D., Dipen C. Shah, M.D., Atsushi Takahashi, M.D., Mélèze Hocini, i M.D., Gilles Quiniou, i M.D., Stéphane Garrigue, M.D., Alain Le Mouroux, M.D., Philippe Le Métayer, M.D., and Jacques Clémenty, M.D. 1998

37

38 Catheter Ablation for Atrial Fibrillation

39 Evolution of Catheter Ablation Techniques for Atrial Fibrillationill Focal Segmental Circumferential Circumferential + Linear (chronic AF) Electrophysiological substrate (fractionated signals) Spectral analysis of dominant frequency Autonomic o ganglia g a modulation o

40 Location of Left Atrial Ganglionated Plexuses Superior Left GP LPA LSPV RPA RSPV Posterior Surface Anterior Surface LIPV RIPV PA Projection Inferior Left GP Modified from Armour JA, et al The Anatomical Record 1997

41 Autonomic ganglia modulation during catheter ablation for AF

42 Intracardiac ultrasound showing tenting of the inter- atrial septum during transseptal catheterization

43 Phased-Array Intracardiac Echocardiography Monitoring During Pulmonary Vein Isolation in Patients With Atrial Fibrillation Marrouche et al. Circulation.2003;107: ) 2716.)

44 Registration of CT derived 3D left atrial model with non contact mapping system Left Pulm Veins Right Pulm Veins Left Pulm Veins Right Pulm Veins Esophagus 3D (Navix) view CT view

45 CT Analysis of the anatomy of Left Atrium and Esophagus Lemola et al.circulation.2004;110:

46 Catheter Ablation within the CT Scan RUPV RUPV LUPV LLPV LAA RLPV Mitral Annulus

47 Role of Digital Enhanced MRI to Assess Left Atrial Structural t Remodeling Normal Moderate Severe Oakes et al. Circulation.2009;119:

48 Remote Navigation (Stereotaxis)

49 Afib incidence and disease burden Role of catheter ablation Role of imaging in ablation Outcomes data

50 Management of Atrial Fibrillation Measurable Outcomes Time to First Recurrence Requires reliable monitoring AF episodes tend to cluster Frequency of Episodes Requires reliable detection for both symptomatic and asymptomatic episodes Duration of Episodes Requires reliable monitoring AF Burden AF Burden Dependent upon accuracy of detection and duration recording

51 Freedom from AF After Circumferential Pulmonary Vein Ablation: Outcomes From a Controlled Nonrandomized Long-Term Study Pappone et al. JACC.2003;42:

52 Quality of Life after Ablation Patients baseline QoL scores were lower than US normative values At baseline, patients t scores with AF & AFL were lowest compared to other arrhythmia pts Patients improved significantly post-procedure procedure Significant decrease in healthcare use & use of AADs in 6 mth following RFA LV function & exercise tolerance significantly improved Wood et al., Circ 2000;101: Bubien et al., Circ 1996; 94(7):

53 Radiofrequency Ablation vs Antiarrhythmic Drugs as First-Line Treatment of Symptomatic Atrial Fibrillation: A Randomized Trial Wazni et al. JAMA.2005;293:

54 Worldwide Survey of the Methods, Efficacy, and Safety of Catheter Ablation for Human Atrial Fibrillation Cappato et al. Circulation.2005;111:

55 Worldwide Survey of the Methods, Efficacy, and Safety of Catheter Ablation for Human Atrial Fibrillation Cappato et al. Circulation.2005;111:

56 Cheema et al. J Interv Card Electrophysiol.2006;15:

57 Success Based on Type of Atrial Fibrillation Cappato et al. Circ Arrhythm Electrophysiol. 2010

58 Complications CVA, TIA, air embolism Left sided atrial arrhythmias Pulmonary vein stenosis AV fistulae, femoral pseudoaneurysm Coronary artery occlusion Death (1/1000) Mechanical Perforation During transseptal puncture- aorta, LA During ablation- LA appendage Atrio Esophageal Fistula Phrenic nerve paralysis Valve damage

59 Who is a candidate for AF Catheter Ablation? Paroxysmal Symptomatic Failed antiarrhythmics Chronic Highly symptomatic Poor hemodynamics Tachycardia induced d cardiomyopathy Failed antiarrhythmics

60 Preprocedure work up Echo, TEE Stress test CT / MRI Anticoagulation for I month prior to procedure Labs TSH Creatinine

61 Future Considerations New ablation techniques Cryoablation Laser balloon, HIFU Robotic + Linear ablation techniques Hybrid procedures (Surgical+catheter) CABANA Trial Drugs vs Ablation, 3000 pts Primary end point total mortality Secondary end point cardiovascular mortality, stroke, MI, serious bleeding, cardiac arrest

62 Summary Chemical Cardioversion Drugs Electrical Cardioversion % % Success Linear Ablation Flutter Ablation Focal AT Ablation PV Quadrant/ Total Isolation

63 Thank you

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