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Measuring Success in AF Ablation
Many working groups are currently applying different approaches to
In clinical practice for
PV isolation and using different endpoints to evaluate efficacy. measuring success can
be used only symptoms and perception of QoL.
―Percent success‖ is highly subjective and only measures the percent of patients in whom symptomatic episodes were reduced or eliminated.
End-points/Success of AF Therapy in AF Trials
Symptoms |
Mortality |
Quality of life |
Hospitalizations |
Rhythm control |
Cost |
Stroke |
Adverse events |
|
Composite |
HRS/EHRA/ECAS Expert Consensus
Statement - 2007
«It is important to recognize that the only proven reason to justify an AF ablation procedure at this time is for improvement in quality of life.»
« Although each of the other reasons to perform AF ablation (decreased stroke risk, decreased heart failure risk, and improved survival) may be correct, they have not been systematically evaluated as part of a large randomized clinical trial.»
Heart Rhythm 2007;4(6)
Europace 2007;9:335.
Measuring Success in AF Ablation
―Although the carefully documented absence of recurrent
AF is an objective and meaningful definition of treatment success, patients with occasional AF recurrences may not be considered as treatment failures clinically, if the frequency, duration, and/or severity of the recurrences are markedly changed by the intervention.‖
Calkins H, et al. Circ Arrhythm Electrophysiol 2009;2;349.
Measuring Success in AF Ablation
In 25 pacemaker/ICD pts with AF (7 with persistent AF & 18 with prolonged PAF), AF ablation was done.
After ablation(s), AF burden significantly reduced at 2 mo to 24% (p=0.02), at 6 mo to 14.5% (p=0.002) and at 8 mo to 15.0% (p=0.003)
Only 36% of pts demonstrated no recurrence of arrhythmia during FU.
QoL showed significant improvement after ablation.
Conclusions. AF ablation significantly improves patient symptoms and reduces AF burden after long-term beat-to- beat monitoring by implanted devices. However, AF recurrence is common after these procedures.
Veasey RA, Silberbauer J, Schilling RJ, Morgan JM, Paul V, Furniss SS, Sulke N. The evaluation of
PV isolation and wide-area left atrial ablation to treat AF in patients with implanted permanent pacemakers.
Heart. 2010;96(13):1037-42.
―Atrial fibrillation ablation is very effective in patients with ‗lone‘ or ‗focal‘, paroxysmal AF but can usually not ‘cure’ the arrhythmia (70–85% success rate and 1–3% severe complications)‖.
Success in AF Ablation
The single procedure success rate of catheter ablation of AF off AAD therapy was 57% (50%-64%).
After multiple procedures, the off-AAD success rate increased to 71% (65%-77%).
The ablation success rate was 77% (73%-81%) after multiple procedures in pts on AAD therapy and 72% after a single procedure on AAD therapy.
The mean FU was 14 months (2 - 30 mo).
Calkins H, et al. Meta-analysis of 63 RFA studies.
Circ Arrhythm Electrophysiol 2009;2:349.
The multicentre, randomized trial compared three strategies of AF ablation: ablation of complex fractionated electrograms (CFE) alone, pulmonary vein isolation (PVI) alone, and combined PVI+CFE ablation, using standardized automated mapping software. After one procedure, PVI+CFE had 74% freedom from AF. After two procedures, PVI+CFE had the highest success - 88%; 96% of these patients were off anti- arrhythmics. Complications were two tamponades, no PV stenosis, and no mortality.
Success in AF Ablation
Summary
The results of meta-analyses are reassuring that the safety and efficacy of catheter ablation are remarkably similar to that reported in several randomized controlled clinical trials, including recent STOP-AF, CABANA, THERMOCOOL, and STAR AF trials, and are consistent with clinical practice.
Today it is obvious that catheter ablation is more effective than AAD therapy in treating AF.
Calkins H, et al. Circ Arrhythm Electrophysiol 2009;2;349.
Packer D . STOP-AF, CABANA Trials, ACC09, HRS2010.
Wilber DJ, et al. THERMOCOOL Trial JAMA. 2010;303:333.
Varma A, et al. Eur Heart J 2010;June 11, 31:1344.
Hindricks G, et al. Circ Arrhythm EP. 2010;3:141.
After Successful AF Ablation Should a Patient Undergo Implantation of Cardiac Monitor?
―There are two main potential reasons for accurate arrhythmia monitoring:
In rhythm control trials when freedom from AF is the
outcome parameter.‖ (To learn: long-term efficacy of AFablation, the true impact of short episodes of AF: which episodes of AF can be dangerous?)
In clinical practice to determine the efficacy of rhythm control therapy‖. To treat (by OAT) or not to treat?
EHRA POSITION PAPER. Indications for the use of diagnostic implantable and external ECG loop recorders. Brignole M, et al. Europace (2009) 11, 671–687
Hindricks G, et al. . Circ Arrhythm EP. 2010;3:141
Objectives The aim of this multicenter study was to evaluate the safety of discontinuing oral anticoagulation therapy (OAT) after apparently successful PV isolation.
Methods Studied 3,355 patients, of whom 2,692 discontinued OAT 3 to 6 months after ablation (Off-OAT group) and 663 remained on OAT after this period (On-OAT group).