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AFib Management and the Role of Catheter Ablation

AFib Management and the Role of Catheter Ablation. Slide Kit Structure. Section I. AFib Overview Section II. Clinical Management of AFib Section III. Catheter Ablation for the Treatment of AFib. Section I: AFib Overview. Atrial fibrillation.

JasminFlorian
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AFib Management and the Role of Catheter Ablation

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  1. AFib Management and the Role of Catheter Ablation

  2. Slide Kit Structure Section I. AFib Overview Section II. Clinical Management of AFib Section III. Catheter Ablation for the Treatment of AFib

  3. Section I:AFib Overview

  4. Atrial fibrillation • Atrial fibrillation (AFib) is a common disease that causes the upper chambers of the heart (atria) to beat rapidly and in an uncontrolled manner (fibrillation). • Uncoordinated, rapid beating of the atria affects the flow of blood through the heart, causing an irregular pulse and sometimes a sensation of fluttering in the chest.

  5. Classification of AFib Subtypes Levy S, et al. Europace (2003) 5: 119

  6. Prevalence of AFib General population-based prevalence 0.95% ATRIA study 2.5% Olmsted County study Go AS, et al. JAMA (2001) 285: 2370 Miyasaka Y, et al. Circulation (2006) 114: 119

  7. Prevalence of AFib in the General Population in USA and EU ATRIA Olmsted USA 2.8 million 7.4 million ( 300 million inhabitants) EU 4.3 million 11.4 million ( 456 million inhabitants of 25 member states)

  8. Prevalence of AFib • Olmsted County study 15.9 15.2 16 14.3 14 13.1 11.7 12 10.2 12.1 11.7 10 8.9 11.1 Projected number of persons with AF (millions) 7.7 10.3 8 9.4 6.7 5.9 8.4 5.1 6 7.5 6.8 6.1 5.6 4 5.1 2 0 2000 2005 2010 2015 2020 2025 2030 2035 2040 2045 2050 Year Miyasaka Y, et al. Circulation (2006) 114: 119

  9. Incidence of AFib in the General Population – Gender Differences Olmsted County study Observational period: 20 years Men0.49 % Women 0.28 % Ratio men to women = 1.86 Miyasaka Y, et al. Circulation (2006) 114: 119

  10. Principal Reasons for Increasing Incidence and Prevalence of AFib • The population is aging rapidly, increasing the pool of people most at risk of developing AFib • Survival from underlying conditions closely associated with AFib, such as hypertension, coronary heart disease and heart failure, is also increasing • According to the Olmsted County study, the increase is also related to the increasing population • These figures may also be significantly under-estimated because they do not take into account asymptomatic AFib (25% of cases in Olmsted survey) Miyasaka Y, et al. Circulation (2006) 114: 119 Steinberg JS, et al. Heart (2004) 90: 239

  11. AFib has an Impact on All Aspects of QoL SF-36 quality of life scores in AFib patients and healthy subjects Healthy controls(n=47) AFib patients(n=152) SF-36 scale * p<0.001 Dorian P, et al. J Am Coll Cardiol (2000) 36: 1303

  12. Risk Factors for AFib ATRIA study Characteristic (n=17,974) Baseline characteristics of 17,974 adults with diagnosed AFib,July 1, 1996-December 31, 1997 Go AS, et al. JAMA (2001) 285: 2370

  13. AFib is Responsible for 15-20% of all Strokes • AFib is responsible for a 5-fold increase in the risk of ischaemic stroke 12 8 Cumulativestrokeincidence (%) Men AFib+ Women AFib+ Men AFib- Women AFib- 4 0 1 2 3 4 5 1 2 3 4 5 Years of follow-up Wolf PA, et al. Stroke (1991) 22: 983 Go AS, et al. JAMA (2001) 285: 2370 Friberg J, et al. Am J Cardiol (2004) 94: 889

  14. Increased Risk of Cardiovascular Events • Death or hospitalization in individuals with CV event(s) after 20 years Men Women 100 89 80 66 60 At least one CV event (%) 45 40 27 20 0 AFib No AFib AFib No AFib Stewart S, et al. Am J Med (2002) 113: 359

  15. Mortality Associated with AFib • Framingham Heart Study, n=5209 80 60 Men AFib+ Women AFib+ Mortality during follow-up (%) 40 Men AFib- Women AFib- 20 0 0 1 2 3 4 5 6 7 8 9 10 Follow-up (y) Benjamin EJ, et al. Circulation (1998) 98: 946

  16. Other costs Incremental AFib Healthcare Costs UK costs for AFib in 1995 vs. 2000 • 1995: Direct cost of AFib in the UK between £244 and £531 million (0.6–1.2% of overall health care expenditure) • 2000: £459 million direct cost – double that in 1995 (0.9–2.4% of NHS expenditure) Cost of heart failureadmission +50% Cost of strokeadmission +48% +5.1% ­warfarin use 10%­admission +7.4% 10%­community-based care +5.6% Base cost of AFin 2000 0 100 200 300 400 500 600 700 Total health care expenditure (£ million) Base cost of associated conditions and procedures Incremental cost of AFib Base cost of AFib Stewart S, et al. Heart (2004) 90: 286

  17. Major Costs in Treatment of AFib • COCAF Study 6% 2% 8% 52% Hospitalizations 9% Drugs Consultations Further investigations Paramedical procedures Loss of work 23% Le Heuzey JY, et al. Am Heart J (2004) 147:121

  18. Cost of AFib (Europe) • FIRE study • 4507 consecutive patients with AFib/flutter admitted to ER enrolled in FIRE study (1.5% of all ER admissions) • 61.9% of AFib/flutter patients were hospitalized (3.3% of all hospitalizations) • Mean hospital stay 7+6 days Santini M, et al. Ital Heart J (2004) 5: 205

  19. The Burden of AFib • AFib is responsible for significant economic and healthcare costs • Hospitalization costs • Drug treatment • Treatment of AFib-associated co-morbidities and complications • The health and economic impact will increase with the increasing prevalence and incidence of AFib • AFib, owing to its epidemiology, morbidity, and mortality, represents a significant health problem with important social and economic implications that needs greater attentionand allocation of more resources

  20. Section II:Clinical Management of AFib

  21. Primary Therapeutic Aims in AFib • Restore and maintain sinus rhythm whenever possible • Prevent thromboembolic events In order to: • Reduce symptoms and improve QoL • Minimize impact of AFib on cardiac performance • Reduce risk of stroke • Minimize cardiac remodelling ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation J Am Coll Cardiol (2006) 48: 854

  22. Treatment Options for AFib Cardioversion • Pharmacological • Electrical Drugs to prevent AFib • Antiarrhythmic drugs • Non-antiarrhythmic drugs Drugs to control ventricular rate Drugs to reduce thromboembolic risk Non-pharmacological options • Electrical devices (implantable pacemaker and defibrillator) • AV node ablation and pacemaker implantation (ablate & pace) • Catheter ablation • Surgery (Maze, mini-Maze)

  23. Treatment Arm Rate control Rhythm control Recurrence Following Cardioversion: AFFIRM Study • AFFIRM: most recurrences occur within 2 monthsof cardioversion 100 80 60 Patients with AF Recurrence (%) 40 Log rank statistic = 58.62 p<0.0001 20 0 0 1 2 3 4 5 6 Time (years) N, Events (%) Raitt MN, et al. Am Heart J (2006) 151: 390

  24. Amiodarone to Prevent Recurrence of AFib CTAF Study: mean follow-up 16 months 100 p<0.001 80 60 Patients without AFib (%) 40 Sotalol Propafenone 20 Amiodarone 0 0 100 200 300 400 500 600 Follow-up (days) Roy D, et al.N Engl J Med(2000) 342: 913

  25. Effectiveness of Current AADs • Even with the most effective AAD, such as amiodarone, long-term efficacy is low ~50% or less at 1 year

  26. Non-Pharmacological Treatment Options for AFib • Pacemakers not curative and must be worn for life • Surgical procedures may be effective but are not a practical solution for the millions of sufferers of AFib • Catheter ablation is potentially curative Devices Electrophysiological Surgery Pacemaker(single or dual chamber) Internal atrialdefibrillators Catheter ablation AV node ablation Maze procedure Modified Maze (mini-Maze) ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation J Am Coll Cardiol (2006) 48: 854

  27. Management of AFib - Summary • Current antiarrhythmic drug therapies are not highly effective in maintaining sinus rhythm and generally have poor outcomes • high recurrence rates • adverse effects and high discontinuation rate • A potentially curative therapy for AFib is desirable

  28. Section III:Catheter Ablation for the Treatment of AFib

  29. Catheter Ablation • Uses a series of long, thin wires (catheters) that are inserted through an artery or a vein and then guided through to the heart. • One of the catheters is then used to localise the source of the abnormal electrical signals and another then delivers high energy waves that neutralise (ablate) abnormal areas. • Using catheters to reach the heart is a common approach to treat a range of heart conditions and is much less invasive than surgical treatments.

  30. Landmarks in Catheter Ablation Techniques Technique Publication date

  31. 1998: Ablation of PV Foci Spontaneous Initiation of Atrial Fibrillation by Ectopic Beats Originating in the Pulmonary Veins Haïssaguerre, M, Jaïs, P, Shah, DC, et al. N Engl J Med (1998) 339: 659 • Pivotal study identifying the pulmonary veins as a major source of ectopic electrical activity • Radiofrequency ablation of ectopic foci was associated witha 62% success rate (absence of recurrence at 8  6m follow-up)

  32. A Combination of Techniques may now be used Depending on the Type of AFib AFib Substrate - Atrial tissue Trigger - Ectopic Foci Autonomic Nervous System CFAEs Ablation Linear Lesions (e.g. mitral isthmus, roof) PV & non-PV Foci Ablation, PV Isolation Vagal Denervation (parasympathetic ganglia ablation)

  33. Cardiac Imaging Techniques • Electroanatomical mapping • CARTO™ / CARTOMERGE™ • Fluoroscopy • Angiography • Intracardiac echography • Cardiac spiral CT • Cardiac MRI

  34. CARTO™ System • Localization of catheter to within 1 mm • Increase safety margin during ablation • 3D-electroanatomic maps (CARTO™) showing ablation points encircling PVs

  35. RUPV RMPV LUPV LA AC RLPV LLPV PV Antrum Isolation Guided by CARTOMERGE™ Image Integration Software Module Courtesy of Professor Antonio Raviele, Mestre, Italy

  36. Catheter Visualization under Fluoroscopic Guidance Ablation catheter LASSO® LAO RAO

  37. Efficacy and Safety of Catheter Ablation

  38. Meta-analysis of Catheter Ablation Paroxysmal AF Patients SHD 6-month cure Ablation method 6-months OK Cure (by each author’s criteria) means no further AFib 6 months after the procedure in the absence of AAD. OK means improvement (fewer episodes, no episodes with previously ineffective AAD). SHD indicates structural heart disease. Fisher JD, et al. PACE (2006) 29: 523

  39. Worldwide Survey on Efficacy and Safety of Catheter Ablation for AFib • Total success rate: 76% • Of 8745 patients: • 27.3% required 1 procedure • 52.0% asymptomatic without drugs • 23.9% asymptomatic with an AAD within <1 yr • Outcome may vary between centres Cappato R, et al. Circulation (2005) 111: 1100

  40. Medical Group Ablation Group 100 90 Expected 80 Observed Survival probability (%) 70 60 One-sample log-rank testObs=36, Exp=31, Z=0.597, p=0.55 One-sample log-rank testObs=79, Exp=341, Z=7.07, p<0.001 0 0 180 360 540 720 900 1080 0 180 360 540 720 900 1080 Days of follow-up Days of follow-up Improved Survival with Ablation vs Drug Treatment • 589 ablated patients compared with 582 on AADs Pappone C, et al. J Am Coll Cardiol (2003) 42: 185

  41. More AFib-free Patients with Catheter Ablation vs Drug Treatment 100 80 60 AFib-freesurvival probability (%) Ablation Group 40 Medical Group 20 0 0 100 200 300 Follow-up (days) No. at risk 589 507 479 379 282 217 135 Ablation Medical 582 456 354 277 207 141 97 Pappone C, et al. J Am Coll Cardiol (2003) 42: 185

  42. Randomised Clinical Trials of Catheter Ablation RF ablation vs AAD as first-line treatment for AFib • Wazni OM et al. JAMA (2005) 293: 2634-2640 Catheter ablation in drug-refractory AFib • Stabile G et al. Eur Heart J (2006) 27: 216-221 Circumferential PV ablation for chronic AFib • Oral H et al. N Engl J Med (2006) 354: 934-941

  43. RF Ablation vs Antiarrhythmic Drugs as First-line Therapy • Patients randomised to receive ablation (n=33) or AADs (n=37): AFib-free Survival 1.0 0.8 0.6 AFib.free survival PVI Group 0.4 Antiarrhythmic DrugGroup 0.2 0 0 100 200 300 Follow-up (days) Wazni OM, et al. JAMA (2005) 293: 2634

  44. Catheter Ablation vs. AADs Alone in Drug-refractory AFib AADs plus ablation (n=68) or AADs alone (n=69): 1 year follow-up Ablation Group 100 Medical Group 80 60 AFib-freesurvival (%) 40 20 0 0 1 2 3 4 5 6 7 8 9 10 11 12 Months Stabile G, et al. Eur Heart J (2006) 27: 216

  45. Randomized Controlled Trial of Amiodarone + Cardioversion + Catheter Ablation Amiodarone & cardioversion (n=69) vs. amiodarone & cardioversion plus PV ablation (n=77) 100 Circumferentialpulmonary-vein ablation Control 80 60 Sinus rhythm(%) 40 20 0 1 2 3 4 5 6 7 8 9 10 11 12 Months Oral H, et al. N Engl J Med (2006) 354: 9

  46. Catheter Ablation is Successful in the Long Term No ERAF 1.0 ERAF 0.8 0.6 Freedom from Recurrent AFib 0.4 0.2 0 0 2 4 6 8 10 12 Months after PV isolation Oral H, et al. J Am Coll Cardiol (2002) 40: 100

  47. Complications Reported by Leading Centres • Major complications with pulmonary vein ablationin 1039 patients (6 series) Events(n) Rate(%) Range in studies(%) Complication Verma A & NataleA Circulation (2005) 112: 1214

  48. Cost EffectivenessAnalyses of Catheter Ablation

  49. Catheter Ablation May Be More Cost-effective than Pharmacological Therapy • After 5 years, the cost of RF ablation was below that of medical management and further diverged thereafter 118 patientswithsymptomatic,drug-refractory AFib 1.52 ± 0.71 ablationprocedures 32 weeks Pharmacological treatment Catheter ablation €1590/year €4715 followed by €445/year Weerasooriya R, et al. Pacing Clin Electrophysiol (2003) 26: 292

  50. Differences in Hospital Visits and Costs with and without Catheter Ablation • Although the initial cost of ablation is high, after ablation, utilization of healthcare resources is significantly reduced No ablation Catheter ablation Goldberg A, et al. J Interv Card Electrophysiol (2003) 8: 59

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