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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 • 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. Classification of AFib Subtypes Paroxysmal Spontaneous termination usually < 7 days and most often < 48 hours Persistent Does not interrupt spontaneously and needs therapeutic intervention for termination (either pharmacological or electrical cardioversion) Permanent AFib in which cardioversion is attempted but unsuccessful, or successful but immediately relapses, or a form of AFib for which a decision was taken not to attempt cardioversion Levy S, et al. Europace (2003) 5: 119 Prevalence of AFib General population-based prevalence 0.95% 2.5% ATRIA study Olmsted County study Go AS, et al. JAMA (2001) 285: 2370 Miyasaka Y, et al. Circulation (2006) 114: 119 Prevalence of AFib in the General Population in USA and EU ATRIA USA 2.8 million Olmsted 7.4 million ( 300 million inhabitants) EU 4.3 million 11.4 million ( 456 million inhabitants of 25 member states) Prevalence of AFib Projected number of persons with AF (millions) Olmsted County study 15.2 16 15.9 14.3 14 13.1 11.7 12 10.2 10 8.9 11.1 7.7 8 6 5.1 4 5.1 5.9 5.6 9.4 6.7 6.1 6.8 7.5 11.7 12.1 10.3 8.4 2 0 2000 2005 2010 2015 2020 2025 2030 2035 2040 2045 2050 Year Miyasaka Y, et al. Circulation (2006) 114: 119 Incidence of AFib in the General Population – Gender Differences Olmsted County study Observational period: 20 years Men 0.49 % Women 0.28 % Ratio men to women = 1.86 Miyasaka Y, et al. Circulation (2006) 114: 119 Principal Reasons for Increasing Incidence and Prevalence of AFib 1. The population is aging rapidly, increasing the pool of people most at risk of developing AFib 2. Survival from underlying conditions closely associated with AFib, such as hypertension, coronary heart disease and heart failure, is also increasing 3. According to the Olmsted County study, the increase is also related to the increasing population 4. 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 AFib has an Impact on All Aspects of QoL SF-36 quality of life scores in AFib patients and healthy subjects SF-36 scale AFib patients (n=152) Healthy controls (n=47) General health 54 ± 21 78 ± 17* Physical functioning 68 ± 27 88 ± 19* Role physical 47 ± 42 89 ± 28* Vitality 47 ± 21 71 ± 14* Mental health 68 ± 18 81 ± 11* Role emotional 65 ± 41 92 ± 25* Social functioning 71 ± 28 92 ± 14* Bodily pain 69 ± 19 77 ± 15* * p<0.001 Dorian P, et al. J Am Coll Cardiol (2000) 36: 1303 Risk Factors for AFib ATRIA study Characteristic Diagnosed heart failure Hypertension (n=17,974) 29.2% 49.3% Diabetes mellitus 17.1% Previous coronary heart disease 34.6% Baseline characteristics of 17,974 adults with diagnosed AFib, July 1, 1996-December 31, 1997 Go AS, et al. JAMA (2001) 285: 2370 AFib is Responsible for 15-20% of all Strokes Cumulative stroke incidence (%) – AFib is responsible for a 5-fold increase in the risk of ischaemic stroke 12 8 Women AFib+ Men AFib+ Women AFib- Men 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 Increased Risk of Cardiovascular Events Death or hospitalization in individuals with CV event(s) after 20 years Men 100 Women At least one CV event (%) 89 80 66 60 45 40 27 20 0 AFib No AFib AFib No AFib Stewart S, et al. Am J Med (2002) 113: 359 Mortality Associated with AFib Framingham Heart Study, n=5209 Mortality during follow-up (%) 80 60 Men AFib+ Women AFib+ 40 Men AFibWomen AFib20 0 0 1 2 3 4 5 6 7 8 9 10 Follow-up (y) Benjamin EJ, et al. Circulation (1998) 98: 946 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 failure admission +50% +48% Cost of stroke admission +5.1% warfarin use 10% admission +7.4% 10% communitybased care +5.6% Base cost of AF in 2000 0 100 200 300 400 500 600 700 Total health care expenditure (£ million) Base cost of AFib Base cost of associated conditions and procedures Incremental cost of AFib Other costs Stewart S, et al. Heart (2004) 90: 286 Major Costs in Treatment of AFib COCAF Study 8% 9% 2% 6% 52% Hospitalizations Drugs Consultations Further investigations Paramedical procedures Loss of work 23% Le Heuzey JY, et al. Am Heart J (2004) 147:121 Cost of AFib (Europe) FIRE study • 4507 consecutive patients with AFib/flutter admitted to ER enrolled in FIRE study (1.5% admissions) of all ER • 61.9% of AFib/flutter patients were hospitalized (3.3% all hospitalizations) of • Mean hospital stay 7+6 days Santini M, et al. Ital Heart J (2004) 5: 205 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 attention and allocation of more resources Section II: Clinical Management of AFib 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 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) Recurrence Following Cardioversion: AFFIRM Study AFFIRM: most recurrences occur within 2 months of cardioversion Patients with AF Recurrence (%) Treatment Arm 100 Rate control Rhythm control 80 60 40 Log rank statistic = 58.62 p<0.0001 20 0 0 1 3 4 5 6 10, 481 (92) 73, 494 (75) 2, 484 (95) 18, 503 (79) Time (years) N, Events (%) Rate control: Rhythm control: 2 563, 3 (0) 729, 2 (0) 167, 383 (69) 96, 440 (80) 42, 472 (87) 344, 356 (50) 250, 422 (60) 143, 470 (69) Raitt MN, et al. Am Heart J (2006) 151: 390 Amiodarone to Prevent Recurrence of AFib CTAF Study: mean follow-up 16 months 100 Patients without AFib (%) p<0.001 80 60 40 Sotalol 20 0 0 Propafenone Amiodarone 100 200 300 400 500 600 Follow-up (days) Roy D, et al. N Engl J Med (2000) 342: 913 Effectiveness of Current AADs • Even with the most effective AAD, such as amiodarone, long-term efficacy is low ~50% or less at 1 year 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 atrial defibrillators 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 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 Section III: Catheter Ablation for the Treatment of AFib 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. Landmarks in Catheter Ablation Techniques Technique Maze reproduction Publication date Schwarz 1994 Right atrial linear lesions Haïssaguerre 1994 Right and left atrial linear lesions Haïssaguerre 1996 PV foci ablation Jaïs / Haïssaguerre 1997/8 Ostial PV isolation Haïssaguerre 2000 Circumferential PV ablation Ablation of non-PV foci Antral PV ablation Double Lasso technique CFAE sites ablation Ostial or circumferential or antral PV ablation plus extra lines (mitral isthmus, posterior wall, roof) Circumferential PV ablation with vagal denervation Pappone 2000 Lin 2003 Maroucche / Natale 2004 Ouyang / Kuck 2004 Nademanee 2004 Jaïs / Hocini 2004/5 Pappone 2004 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 with a 62% success rate (absence of recurrence at 8 6m follow-up) A Combination of Techniques may now be used Depending on the Type of AFib AFib Trigger Ectopic Foci PV & non-PV Foci Ablation, PV Isolation Autonomic Nervous System Vagal Denervation (parasympathetic ganglia ablation) Substrate Atrial tissue CFAEs Ablation Linear Lesions (e.g. mitral isthmus, roof) Cardiac Imaging Techniques • Electroanatomical mapping – CARTO™ / CARTOMERGE™ • Fluoroscopy • Angiography • Intracardiac echography • Cardiac spiral CT • Cardiac MRI CARTO™ System – Localization of catheter to within 1 mm – Increase safety margin during ablation • 3D-electroanatomic maps (CARTO™) showing ablation points encircling PVs PV Antrum Isolation Guided by CARTOMERGE™ Image Integration Software Module RUPV LUPV RMPV LA AC RLPV LLPV Courtesy of Professor Antonio Raviele, Mestre, Italy Catheter Visualization under Fluoroscopic Guidance Ablation catheter LAO LASSO® RAO Efficacy and Safety of Catheter Ablation Meta-analysis of Catheter Ablation Patients Paroxysmal AF SHD Linear 443 75% 26% 33% 55% Focal 508 81% 35% 54% 71% 2,187 83% 36% 62% 75% Circumferential (all) 15,455 68% 37% 64% 74% Circumferential (LACA, WACA) 2,449 65% 37% 59% 72% Circumferential (PVAI) 11,132 68% 42% 67% 76% 559 51% 49% 75% 87% 23,626 61% 55% 63% 75% Ablation method Isolation Substrate ablation (CFAE) TOTAL 6-month cure 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 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 Improved Survival with Ablation vs Drug Treatment • 589 ablated patients compared with 582 on AADs Medical Group Ablation Group Survival probability (%) 100 90 80 Expected Observed 70 60 One-sample log-rank test Obs=36, Exp=31, Z=0.597, p=0.55 0 0 180 360 540 720 900 1080 0 Days of follow-up One-sample log-rank test Obs=79, Exp=341, Z=7.07, p<0.001 180 360 540 720 900 1080 Days of follow-up Pappone C, et al. J Am Coll Cardiol (2003) 42: 185 More AFib-free Patients with Catheter Ablation vs Drug Treatment AFib-free survival probability (%) 100 80 60 40 Ablation Group Medical Group 20 0 0 100 Medical 300 Follow-up (days) No. at risk Ablation 200 589 507 479 379 282 217 135 582 456 354 277 207 141 97 Pappone C, et al. J Am Coll Cardiol (2003) 42: 185 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 RF Ablation vs Antiarrhythmic Drugs as First-line Therapy • Patients randomised to receive ablation (n=33) or AADs (n=37): AFib-free Survival AFib.free survival 1.0 0.8 0.6 0.4 PVI Group Antiarrhythmic Drug Group 0.2 0 0 100 200 300 Follow-up (days) Wazni OM, et al. JAMA (2005) 293: 2634 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 Medical Group AFib-free survival (%) 100 80 60 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 Randomized Controlled Trial of Amiodarone + Cardioversion + Catheter Ablation Amiodarone & cardioversion (n=69) vs. amiodarone & cardioversion plus PV ablation (n=77) 100 Circumferential pulmonary-vein ablation Control Sinus rhythm (%) 80 60 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 Catheter Ablation is Successful in the Long Term No ERAF ERAF Freedom from Recurrent AFib 1.0 0.8 0.6 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 Complications Reported by Leading Centres Major complications with pulmonary vein ablation in 1039 patients (6 series) Events (n) Rate (%) Range in studies (%) Transient ischaemic attack 4 0.4 0-3 Permanent stroke 1 0.1 0-1 Severe PV stenosis (>70%, symptomatic) 3 0.3 0-3 13 1.3 0-5 Tamponade / perforation 5 0.5 0-3 Severe vascular access complication 3 0.3 0-4 Complication Moderate PV stenosis (40-70%, asymptomatic) Verma A & Natale A Circulation (2005) 112: 1214 Cost Effectiveness Analyses of Catheter Ablation Catheter Ablation May Be More Costeffective than Pharmacological Therapy After 5 years, the cost of RF ablation was below that of medical management and further diverged thereafter 118 patients with symptomatic, drug-refractory AFib 1.52 ± 0.71 ablation procedures 32 weeks Pharmacological treatment Catheter ablation €1590/year €4715 followed by €445/year Weerasooriya R, et al. Pacing Clin Electrophysiol (2003) 26: 292 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 Clinical visits per year 7.4 (2.5) 1.1 (0.6) Emergency room visits per year 1.7 (0.9) 0.03 (0.17) Hospitalization days per year 1.6 (0.8) 0 (0) $1920 (889) $87 (68) Healthcare costs per year Goldberg A, et al. J Interv Card Electrophysiol (2003) 8: 59 Catheter Ablation Cost-Effective in Patients at High Risk of Stroke Model to compare the cost-effectiveness of left atrial catheter ablation (LACA), amiodarone, and rate control therapy in the management of AFib The use of LACA may be cost-effective in patients with AFib at moderate risk for stroke This model did not find it to be cost-effective in low-risk patients. Conclusions Cost-effective in patients at moderate or high risk of stroke Chan DP, et al. J Am Coll Cardiol (2006) 47: 2513 Current Guidelines and Summary Current ACC/AHA/ESC Guidelines Recurrent Paroxysmal AF Minimal or no symptoms Disabling symptoms in AF Anticoagulation and rate control as needed Anticoagulation and rate control as needed No drug for prevention of AF AAD therapy AF ablation if AAD treatment fails ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation J Am Coll Cardiol (2006) 48: 854 Recent Commentary Why Ablation for AFib might be Considered FirstLine Therapy for Some Patients “Current therapies, especially AAM, not only are ineffective but also pose a threat to patient QoL and even longevity. In the hands of experienced operators, AF ablation is an effective, safe, and established treatment for AF that offers an excellent chance for a lasting cure … unlike other therapies, ablation tackles AF at its electrophysiological origin.” Verma A & Natale A Circulation (2005) 112: 1214 Summary of catheter ablation (I) • Catheter ablation for AFib has undergone significant methodological and technical revolution since its initial appearance two decades ago • Discovery that PVs are a major source of ectopic triggers was pivotal in determining efficacy of procedure • Significant technological advances in catheters and imaging are further improving the efficiency of catheter ablation • 3D reconstructions of actual left atrial PV anatomy using CT, MRI, or intracardiac echography enables ever more accurate placement of lesions Summary of catheter ablation • High success rate • Improves survival, cardiac function and freedom from recurrence • New data from RCTs confirm benefits • Safe, with a risk comparable to other low-risk, routine interventions • Cost effective compared to standard pharmacological therapy, at least in patients at moderate thromboembolic risk