Catheter ablation is not a class I indication after failed antiarrhythmic drugs

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Catheter ablation is not a class I indication after failed antiarrhythmic drugs Martin Jan Schalij Department of Cardiology Leiden University Medical Center

Disclosure: Research grants from: Boston Scientific Medtronic Biotronik

Introduction A-fib ablation seems to be the ultimate answer to all problems in patients with atrial fibrillation More and more new techniques allowing less experienced operators to perform the procedures Complication rates are acceptable

Atrial fibrillation Progressive disease Modest effectiveness of antiarrhythmic drug Most antiarrhythmic drugs: serious side effects Next step?

Atrial fibrillation begets atrial fibrillation Wijffels MC et al, Circulation 1995 Paroxysmal Persistent Permanent

Roy et al. (N Engl J Med 2000; 342: 913-20) CTAF: Amiodarone to prevent AF recurrence 201 amiodarone 69 % SR 101 propafenon 39 % SR 101 sotalol 39 % SR

Side effects! Cutaneous discoloration with amiodarone use Interstitial pneumonitis due to amiodarone

Dronedarone for Sinus Rhythm Singh et al 2007

Atrial fibrillation Seems logic to perform a catheter ablation after 1-3 failed antiarrhythmic drugs in patients Depending on etiology and presence of structural heart disease many techiques available Results acceptable

Catheter ablation

Effect of Ablation Pappone et al, 2005

Survival Pappone et al, 2005

7 years of A-fib ablation: Patients have become older (47 to 56 years; P < 0.01), with more persistent or permanent AF (17% to 45%; P < 0.01), larger left atrial size (4.0 to 4.4 cm; P < 0.01), and fewer antiarrhythmic drugs used prior to ablation (3.9 to 2.0 drugs; P < 0.01). Gerstenfeld et al. JCE 2007

Catheter ablation Yes a class I after failed medication Becoming easier to perform Results are excellent even in patients with structural heart disease Or not...

Procedural related complications

Potential complications: Systemic embolism Pulmonary vein stenosis Pericardial effusion Cardiac tamponade Phrenic nerve paralysis Silent Cerebral Embolism

Cappoto, Circ 2005

Complications Pappone, circ 2004

Incidence of Silent Cerebral Thromboembolic events Gaita et al, JCE 2011

Total Costs and Atrial Fibrillation Ablation Success or Failure in Medicare-Aged Patients in the United States Michael H. Kim Jay Lin Charles Kreilick Susan H. Foltz Boklage Adv ther 2010

Results: Of 135 patients identified (67% men, age 73 years), ablation was successful in 69 (51.1%); most patients (96%) underwent a single procedure. Patients with successful ablation discontinued antiarrhythmic drug treatment after 54 days. Use of rate-control and anticoagulant drugs decreased after successful ablation, from 87% to 67% and from 86% to 64% of patients, respectively. Among failed ablation patients, 74% versus 70% received rate-control drugs, and 88% versus 82% received anticoagulants preversus postablation.

Conclusion: Outside the clinicaltrial setting, catheter ablation for second-line treatment of AF proved unsuccessful in half of Medicare-aged patients.

Costs The mean cost per ablation procedure was $13,270±$12,139 for patients with successful ablation compared with $16,306±$25,315 for patients with failed ablation (P=0.24)

Catheter Ablation for Atrial Fibrillation Are Results Maintained at 5 Years of Follow-Up? Rukshen Weerasooriya, BMEDSC(HONS), MBBS,* Paul Khairy, MD, PHD, Jean Litalien, MD,* Laurent Macle, MD, Meleze Hocini, MD,* Frederic Sacher, MD,* Nicolas Lellouche, MD,* Sebastien Knecht, MD,* Matthew Wright, PHD, MD,* Isabelle Nault, MD,* Shinsuke Miyazaki, MD,* Christophe Scavee, MD,* Jacques Clementy, MD,* Michel Haissaguerre, MD,* Pierre Jais, MD* JACC 2011

BaselineCharacteristicts (n= 100) Demographic variables Age at inclusion, yrs 55.7 Male sex, % 86 Medical history Type of atrial fibrillation, % Paroxysmal 64 Persistent 22 Long-standing persistent 14 History of atrial fibrillation, months 72 Structural heart disease, % 36 Ischemic 8 Left ventricular hypertrophy 16 Valvular heart disease 5 Idiopathic dilated cardiomyopathy 7 Left ventricular ejection fraction, % 70 Medical therapy Number of ineffective antiarrhythmic drugs 3.5 Failed amiodarone therapy, % 67 Major amiodarone-related complication, % 10

Long term results after 1 ablation procedure Weerasooriya et al, JACC 2011

Multiple procedures Weerasooriya et al, JACC 2011

In selected patients with AF, a catheter ablation strategy with repeat intervention as necessary provides acceptable long-term relief from symptomatic recurrences. Although most recurrences transpire over the first 6 to 12 months, a slow but steady decline in arrhythmia-free survival is noted thereafter, even after 3 or more years of apparent arrhythmia control. Such long-term follow-up data should be openly discussed with patients, factored into management decisions, and incorporated into cost-effectiveness models that assess the merits of an ablation approach. Weerasooriya et al, JACC 2011

Rhythm vs Rate control Van Gelder, NEJM, 2002

Patients Catheter ablation in A-fib patients is becoming more and more a first line treatment modality Results are encouraging but far from perfect Success: 50-90% More patients with structural heart disease More patients with heart failure

Conclusions Atrial fibrillation is a progressive disease Rate control is effective in many patients after failed antiarrhythmic drug therapy Long term results of catheter ablation procedures are extremely poor Especially in patients with large atria To achieve SR at long term follow-up multiple procedures will be necessary in many patients Risk of procedure related complications is high Silent tromboembolic events: may limit the indications even more Consider catheter ablation only in highly symptomatic patients, patients at risk for thromboembolic events, patients without structural heart disease

Catheter ablation is not a class I indication after failed antiarrhythmic drugs