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Long-term Efficacy and Safety of Catheter Ablation for AF: What is the Evidence? AHA QCOR Washington DC D. George Wyse MD PhD May 20, 2010. Disclosures*. PHRI – Population Health Research Institute – McMaster University DCRI – Duke Clinical Research Institute; Mayo – Mayo Clinic
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Long-term Efficacy and Safety of Catheter Ablation for AF: What is the Evidence?AHA QCOR Washington DCD. George Wyse MD PhDMay 20, 2010
Disclosures* PHRI – Population Health Research Institute – McMaster University DCRI – Duke Clinical Research Institute; Mayo – Mayo Clinic Axio – Axio Research Corporation U. Penn – University of Pennsylvania * All < $10,000
Outline • Key Patient Characteristics of RCT of LA/PV RFA and AAD • Quantitative “Gradient” between Groups of SR vs. AF in AAD vs. RFA RCT • Goals for Therapy of AF • Reduce Mortality • Prevent Stroke/SE • Preserve/Improve Ventricular Function and Prevent CHF • Relief of Symptoms • RFA of AV Junction and Pacemaker
Age and Duration of Follow-up in RTCof LA/PV Catheter Ablation for RFA AAD RCT: AFFIRM, AF-CHF & ATHENA N = ~ 10,000 Mean Age = 70y Mean FU = 4.5y Table unpublished, courtesy of Win Shen – Mayo University
Quantitative “Gradient”SR vs. AF; AAD vs. RFA Gradient = 70% PABA-CHF – not “prevalence” Gradient = 40% Gradient = 40% AF-CHF AFFIRM New Engl J Med 2002;347:1825 New Engl J Med 2008;358:2667 New Engl J Med 2008;359:1778
Death After RFA for AFShort-term Based on 45, 115 procedures in 35, 569 patients between 1995-2006 = 0.98 per 1,000 JACC 2009;53:1798 Percent Circulation 2005;111:1100
Death After RFA for AFLong-term • 65 ± 9 years • PAF = 69% • No CV Dis = 34% • LVEF = 54 ± 12% • Death in RCT vs. AAD • RR = -0.003 (95% CI • -0.01- 0.02; p = 0.74) • Am Heart J 2009;158:15 + Annual Mortality in AFFIRM ~ 3.5% J Am Coll Cardiol 2003;42:185
Stroke/TIA from RFA for AFShort-term“Yin-Yang” of Anticoagulation Percent Circulation 2005;111:1100
Stroke/SE after RFAShort-term • Stroke in RCT vs. AAD • RR = 0.004 (95% CI • -0.01-0.02; p = 0.54) • Am Heart J 2009;158:15 Circulation 2006;114:759
Impact of Absence of AF on Stroke * Neurology 1993;43:32 & Arch Intern Med 2005:165:1185
Perception of AF after RFA Episodes of AF % Episodes with No Symptoms Circulation 2005;112:307
AF Patterns Before/After AF Ablation with 24/7 Monitoring • “Permanent Cure” after 3 mo blanking = 3/14 J Cardiovasc Electrophysiol 2007;18:818
RFA and LV FunctionA meta analysis of RCT A = RR for reduced LVEF vs. normal LVEF B = Absolute % LVEF after vs. before RFA
SymptomsAblation vs. AAD • Symptomatic AF • Failed at least 1 AAD • No amiodarone in 6 months • LA diameter <5cm • Mean age = 56y • Mean follow-up = 13 months J Am Med Assoc 2010;303:333
Symptoms of AFCCS- SAF Class N = 484 Percent Symptom Class Circ Arrhythmia EP 2009:2;218
Effects of AV Junction Ablation & PaceA Meta Analysis Circulation 2000;101:1138