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HANDS ON How to select patients for atrial fibrillation ablation Hakan Oral, MD, Fred Morady, MD From the Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan. The goals of therapy for atrial fibrillation (AF) are elimination of symptoms and improvement in quality of life; prevention of complications such as thromboembolic events and tachycardia-mediated cardiomyopathy; and, at least in theory, improvement in survival. From an evidence-based perspective, the primary benefit of catheter ablation of AF has been demonstrated to be improvement in symptoms and quality of life. Improvements in left atrial size, left ventricular ejection fraction, and New York Heart Association (NYHA) functional class also have been reported.1–3 Theoretically, maintenance of sinus rhythm after catheter ablation should prevent thromboembolic events due to AF. After catheter ablation of AF, left atrial transport function may decrease by 30% in patients with paroxysmal AF and improve in patients with chronic AF.4 Whether the improved transport function in patients with chronic AF and the residual transport function in patients with paroxysmal AF are sufficient to prevent left atrial thrombus formation is unclear. No studies have demonstrated the long-term safety of discontinuation of anticoagulation in patients with AF who have remained in sinus rhythm after catheter ablation. It is important to keep this in mind when considering the option of catheter ablation in asymptomatic individuals with AF who desire the procedure primarily because they would like to avoid long-term anticoagulation with warfarin. Although the original AFFIRM (Atrial Fibrillation Follow-Up Investigation of Rhythm Management) trial demonstrated equivalent survival in patients randomly assigned to rate-control and rhythm-control strategies, a subsequent post hoc on-treatment analysis demonstrated that sinus rhythm was an independent predictor of improved survival.5,6 Furthermore, a nonrandomized clinical registry from a single center suggested that maintenance of sinus rhythm after catheter ablation is associated with improvement in survival in patients with AF.7 In the AFFIRM trial, sinus rhythm was maintained with antiarrhythmic drug therapy in a relatively small proportion of patients, and the patient population was relatively old (mean age approximately 70 years) and, in general, not very symptomatic. Address reprint requests and correspondence: Dr. Hakan Oral, Division of Cardiovascular Medicine, University of Michigan, TC B1 140D, Electrophysiology, 1500 East Medical Center Drive, Ann Arbor, Michigan 48109-0311. E-mail address: [email protected]. Therefore, the results should not be extrapolated to younger patients whose quality of life is impaired by symptomatic AF. It should be kept in mind that a small annual survival benefit of sinus rhythm over AF would much more likely become clinically significant in younger patients followed for 2 to 3 decades than in older patients followed for 3 to 5 years, as was the case in AFFIRM. Factors influencing patient selection The criteria used to select patients for an invasive procedure are influenced by safety, efficacy, availability, the risk-tobenefit ratio of alternative treatment options, and patient preference. From the societal perspective, the cost of the procedure may influence selection criteria. As the ablation strategies for eliminating AF continue to evolve, the reported efficacy rates remain variable depending on whether AF had been paroxysmal or chronic, the ablation strategy, the definition of a successful outcome, and the methods and duration of surveillance to detect recurrences. These variables may explain the very wide range of 20% to 95% efficacy reported for catheter ablation of AF. The standard definition of a successful outcome has been maintenance of sinus rhythm in the absence of antiarrhythmic drug therapy. However, a marked decrease in AF burden and/or rhythm control with a previously ineffective antiarrhythmic drug also may be clinically meaningful. It should be noted that if extended ECG monitoring is performed, asymptomatic episodes may be detected and the actual efficacy rates may be lower than reported.8 A worldwide survey reported a 6% incidence of major complications for AF ablation procedures performed since 1995.9 A large proportion of the complications consisted of pulmonary vein stenosis. As ablation strategies have evolved toward antral or left atrial ablation away from the ostia of the veins, the incidence of pulmonary vein stenosis should continue to decrease. Pericardial tamponade, retroperitoneal hematoma, groin complications, and phrenic nerve palsy remain major complications; however, these operator-dependent complications should become infrequent as experience increases. Of particular concern are thromboembolic complications and atrioesophageal fistulas. Based on recent reports, the incidence of severe complications ranges from 1% to 2%. Thromboembolic events have become infrequent with the use of aggressive periprocedural anticoagulation regimens. Atrioesophageal fistulas are rare 1547-5271/$ -see front matter © 2006 Heart Rhythm Society. All rights reserved. doi:10.1016/j.hrthm.2006.01.016 616 (⬍0.5%) and should remain very infrequent with increased awareness of the risk of esophageal injury. Various techniques for monitoring the position of the esophagus allow improved safety when ablating along the posterior wall of the left atrium. A study that used a Markov model to assess the costeffectiveness of catheter ablation of AF compared with pharmacologic rate-control or rhythm-control strategies demonstrated that catheter ablation is cost-effective in patients who are at moderate, but not low, risk for thromboembolic events.10 Because catheter ablation of AF may not be cost-effective in many patients, society must be willing to pay for procedures intended primarily to alleviate symptoms and improve quality of life. Specific considerations Symptomatic vs asymptomatic AF Published studies on catheter ablation of AF have included only, or mostly, patients with symptomatic AF, and the role of catheter ablation in improving quality of life has been well established in patients with symptomatic episodes of AF. From an evidence-based perspective, catheter ablation to eliminate AF in asymptomatic patients may not be appropriate until large, randomized, long-term studies become available. However, despite the lack of data, asymptomatic patients can be considered for catheter ablation if they are young and/or have evidence of a possible tachycardia-mediated cardiomyopathy. Failure of prior antiarrhythmic drug therapy vs first-line therapy Failure of two or more antiarrhythmic drugs was a selection criterion in most of the initial reports on catheter ablation of AF. In general, a trial of antiarrhythmic drug therapy usually is considered prior to catheter ablation. Drug therapy may be effective at least in some patients and is noninvasive; therefore, it often is worth trying before considering catheter ablation. However, it may not be necessary to attempt multiple antiarrhythmic drugs prior to ablation. Primarily based on patient preference, it often may be reasonable to proceed with catheter ablation even after failure of one antiarrhythmic drug. In a pilot study, catheter ablation was found to have better efficacy than antiarrhythmic drugs as first-line therapy in 70 drug-naive patients with paroxysmal AF.11 The superior efficacy of ablative therapy also is evident from many studies of patients who already did not respond to multiple antiarrhythmic drugs. The choice of antiarrhythmic drug therapy vs catheter ablation is influenced by a variety Heart Rhythm, Vol 3, No 5, May 2006 of factors and should not simply be based on superior efficacy. Paroxysmal vs chronic AF Initial attempts at focal pulmonary vein ablation and later pulmonary vein isolation had very low clinical efficacy in patients with chronic AF. As ablation strategies evolved to include left atrial ablation to modify the electrophysiologic substrate, clinical efficacy in patients with chronic AF has improved markedly. A recent randomized study that used daily transtelephonic monitoring demonstrated that 74% of patients with chronic AF were in sinus rhythm with significant improvements in quality of life and left ventricular ejection fraction and a decrease in left atrial size during 1-year follow-up.3 Antiarrhythmic drug therapy often has very limited efficacy in patients with chronic AF. Patients with chronic AF may be likely to benefit more from maintenance of sinus rhythm in the long term and should be strongly considered for catheter ablation if they have not responded to drug therapy. Structural heart disease and prior cardiac surgery Catheter ablation of AF has been performed successfully in patients who have hypertensive heart disease, coronary artery disease with or without prior revascularization, and atrial septal defect repair with a pericardial or synthetic patch. The presence of structural heart disease was not an independent predictor of recurrent AF in any of the published reports. However, these reports often were from a single center and may not have had sufficient power. Data on the safety and efficacy of catheter ablation in patients with congenital heart disease (except for atrial septal defect), particularly in patients with hypertrophic cardiomyopathy, are insufficient. The feasibility and clinical efficacy of left atrial catheter ablation in patients with congestive heart failure (ejection fraction ⬍0.45) have been demonstrated.1 Therefore, these patients also may be considered for catheter ablation. Patients with a prosthetic mitral valve can be particularly challenging. A report from an experienced center demonstrated clinical efficacy of 73% and a complication rate of 2% in 23 patients who previously underwent mitral valve replacement.12 However, caution should be exercised in considering these patients for catheter ablation because of the risk of catheter entrapment. The feasibility and safety of transseptal catheterization in patients who have undergone closure of a patent foramen ovale or atrial septal defect with a percutaneous closure device have not been reported. Age Catheter ablation of AF has been performed in patients as young as 16 years up to those in their 80s. In prior reports, Oral and Morady Selection Criteria for Catheter Ablation of AF age has not been identified as an independent predictor of clinical success. However, it appears that although comparable efficacy often is achieved in older patients, the risk of complications, particularly pericardial tamponade and thromboembolic events, may be higher in elderly patients. In one series, although the efficacy of left atrial catheter ablation was similar among patients with AF who were ⱕ70 years and ⬎70 years, the incidence of tamponade and thromboembolic events was four times higher in patients who were ⬎70 years than in patients who were ⱕ70 years.13 Although the findings of AFFIRM suggest that rate control may be preferable in older patients, it is important to recognize that sinus rhythm could be maintained in only a small group of patients with AF. Furthermore, despite their age, some older patients may lead very active lifestyles and may be debilitated by symptomatic AF even in the presence of adequate rate control. Therefore, therapy should be carefully individualized in older patients, taking into consideration their overall physical health, lifestyle preferences, longevity, and risk of complications.13 Left atrial size and duration of AF Because most reports on catheter ablation of AF included a relatively small number of patients from a single center, multivariate analyses either were not performed or may not have had sufficient power to identify all predictors of a successful outcome after catheter ablation. However, based on a few series, a left atrial diameter ⬍50 to 55 mm predicts a higher probability of a successful outcome. A dilated left atrium is likely to be associated with substantial electroanatomic remodeling, and this may decrease the probability of a successful outcome. A long duration of AF from the time of first diagnosis in patients with chronic AF may be associated with a higher probability of recurrent AF after ablation. A longer duration of AF may result in marked left atrial electroanatomic remodeling and left atrial enlargement. However, a cutoff value for the duration of AF has not been reported. In patients with paroxysmal AF who have not progressed to chronic AF, the duration of AF does not appear to be a predictor of outcome. Surgical ablation In patients with AF who require cardiac surgery for another problem, such as coronary artery disease or mitral valve disease, concomitant intraoperative therapy for AF is appropriate. In patients who do not require concomitant open heart surgery, no data are available on whether surgical ablation should be considered instead of catheter ablation or after one or more failed attempts at catheter ablation. 617 Specific recommendations on how to select patients with AF for catheter ablation Ideal candidate The ideal candidate for catheter ablation of AF has symptomatic episodes of paroxysmal or chronic AF, has not responded to one or more antiarrhythmic drugs, does not have severe comorbid conditions or significant structural heart disease, is younger than 65 to 70 years, has a left atrial diameter ⬍50 to 55 mm, and, for chronic AF, has had AF for ⬍5 years. Relative and absolute contraindications Complications of catheter ablation may have catastrophic outcomes in certain types of patients. They include individuals with severe obstructive carotid artery disease, severe cardiomyopathy with a low ejection fraction, severe aortic stenosis, nonrevascularized left main or three-vessel coronary artery disease, severe pulmonary arterial hypertension, or hypertrophic cardiomyopathy with severe left ventricular outflow tract obstruction. Another relative contraindication may be a history of major lung resection because of the severe impact of pulmonary vein stenosis on a remaining pulmonary vein. Because the risk of thromboembolic events both during the procedure and in the early postoperative period may be prohibitive in the absence of systemic anticoagulation, patients who cannot be anticoagulated both during and for at least 2 months after the ablation procedure should not be considered for catheter ablation of AF. Ablation should not be performed in patients who have a left atrial appendage thrombus or a recently implanted left atrial appendage occlusion device. Surgical intervention can be lifesaving should a severe mechanical complication, such as rupture or massive perforation of the heart or catheter entrapment, occur. Therefore, catheter ablation of AF should not be performed, particularly in higher-risk patients such as the elderly, if surgical backup is not readily available. Catheter ablation of AF should not be performed in patients who are scheduled to undergo cardiac surgery for another indication when surgical ablation of AF also can be performed. Catheter ablation of AF is likely to be of little or no benefit in patients with end-stage cardiomyopathy or massive enlargement of the left atrium (⬎6 cm); or who have severe mitral regurgitation or stenosis and are deemed inappropriate candidates for valvular intervention. Conclusion A variety of ablation strategies have been reported to result in favorable clinical outcomes with a relatively small risk of 618 severe complications, although the vast majority of the published experience comes from high-volume centers. The procedure remains complicated, technically challenging, and lengthy. The criteria used to select patients for catheter ablation should always be individualized because the genesis of AF is multifactorial, AF patients are a heterogeneous population, and the ablation strategies and clinical outcomes vary among centers. Heart Rhythm, Vol 3, No 5, May 2006 7. 8. References 1. Hsu LF, Jais P, Sanders P, Garrigue S, Hocini M, Sacher F, Takahashi Y, Rotter M, Pasquie JL, Scavee C, Bordachar P, Clementy J, Haissaguerre M. Catheter ablation for atrial fibrillation in congestive heart failure. N Engl J Med 2004;351:2373–2383. 2. Lemola K, Sneider M, Desjardins B, Case I, Chugh A, Hall B, Cheung P, Good E, Han J, Tamirisa K, Bogun F, Pelosi F Jr, Kazerooni E, Morady F, Oral H. Effects of left atrial ablation of atrial fibrillation on size of the left atrium and pulmonary veins. Heart Rhythm 2004;1: 576 –581. 3. Oral H, Pappone C, Chugh A, Good E, Bogun F, Pelosi F Jr, Bates E, Lehmann M, Vicedomini G, Augello G, Agricola E, Sala S, Santinelli V, Morady F. Circumferential pulmonary vein ablation for chronic atrial fibrillation. N Engl J Med 2006;354:934 –941. 4. Lemola K, Desjardins B, Sneider M, Case I, Chugh A, Good E, Han J, Tamirisa K, Tsemo A, Reich S, Tschopp D, Igic P, Elmouchi D, Bogun F, Pelosi F Jr, Kazerooni E, Morady F, Oral H. Effect of left atrial circumferential ablation for atrial fibrillation on left atrial transport function. Heart Rhythm 2005;2:923–928. 5. Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, Kellen JC, Greene HL, Mickel MC, Dalquist JE, Corley SD. 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Wazni OM, Marrouche NF, Martin DO, Verma A, Bhargava M, Saliba W, Bash D, Schweikert R, Brachmann J, Gunther J, Gutleben K, Pisano E, Potenza D, Fanelli R, Raviele A, Themistoclakis S, Rossillo A, Bonso A, Natale A. Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation: a randomized trial. JAMA 2005;293:2634 –2640. Lang CC, Santinelli V, Augello G, Ferro A, Gugliotta F, Gulletta S, Vicedomini G, Mesas C, Paglino G, Sala S, Sora N, Mazzone P, Manguso F, Pappone C. Transcatheter radiofrequency ablation of atrial fibrillation in patients with mitral valve prostheses and enlarged atria: safety, feasibility, and efficacy. J Am Coll Cardiol 2005;45:868 – 872. Oral H, Hall B, Chugh A, Cheung P, Lemola K, Good E, Tamirisa K, Han J, Bogun F, Pelosi F Jr, Morady F. Age and catheter ablation for atrial fibrillation (abstr). Circulation 2004;110:348.