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How Much Ablation to Eliminate Atrial Fibrillation: Is Less More or Is More More? Roger A. Winkle MD, FHRS

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Cite this article as: Roger A. Winkle MD, FHRS, How Much Ablation to Eliminate Atrial Fibrillation: Is Less More or Is More More?, Heart Rhythm, http://dx.doi.org/ 10.1016/j.hrthm.2015.06.031 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

1 How Much Ablation to Eliminate Atrial Fibrillation: Is Less More or Is More More?

Roger A. Winkle, MD, FHRS

From Silicon Valley Cardiology, E. Palo Alto, CA and Sequoia Hospital, Redwood City, CA

Disclosures: None Corresponding author: Roger A. Winkle, M.D. Silicon Valley Cardiology 1950 University Avenue, Suite 160 E. Palo Alto, CA 94303 (650) 617-8100 (650) 327-2947 Fax E-mail: [email protected]

There has been continual improvement in catheter ablation for symptomatic atrial fibrillation(AF) over the last 15 years. For patients with paroxysmal AF the single procedure success rate increased from approximately 30% in 2003 to 70% in 2010. Single procedure outcomes for persistent AF during that time frame showed less improvement from approximately 30% to 55% and long-standing persistent AF showed virtually no improvement over time and was stuck at about 30-40%(1). When things are

2 not going well, ablationists always seem to want to do more, rather than figure out how to do better with less. When strokes and neurologic events occur in the peri-ablation period, ablationists give more anticoagulation or use uninterrupted anticoagulation, even though we have demonstrated the procedures can be done safely with less anticoagulation(2) and with interrupted anticoagulation(3). Similarly, given the generally poorer outcomes the more persistent the AF, until recently, the trend has been to do more rather than less ablation. For persistent AF, the stepwise approach was introduced approximately 10 years ago(4,5). After pulmonary vein isolation(PVI), continuing to burn until AF organized or preferably broke seemed to improve outcome. It was assumed the better outcome in the patients whose AF organized or broke was due to the additional ablation and substrate modification. However, it is possible that patients whose AF organizes or breaks with ablation have less abnormal substrate and/or an easier to eliminate AF and are going to have a better outcome regardless of what or how much is ablated. After almost 10 years of many, if not most, ablationists doing very extensive ablation for persistent AF, three recently reported randomized trials have questioned the value of such extensive ablation. In the 2C3L study(6) PVI, a left atrial roof line, a mitral isthmus line and a caval tricuspid isthmus line was performed in all patients. They were then randomized to no additional ablation or to extensive ablation of complex atrial fractionated electrograms (CAFÉ) until the arrhythmia broke or they had been ablating for an additional hour. There was a non statistically significant trend in favor of better outcomes with the less extensive ablation strategy. At 12 and 25 months the less extensive ablations resulted in 67% and 57.5% of patients free of AF compared to only 60% and 52.1% for the more extensive strategy(p =

3 0.394). A multicenter trial reported at the recent HRS Late-Breaking Trial Sessions that patients with persistent AF and a more advanced form of paroxysmal AF showed a nonstatistically significant trend in favor of the less extensive strategy of PVI alone compared to PVI plus a line lesion set similar to that done in the 2C3L study(7). At one year, 68% of patients were AF free with PVI alone compared to only 62% with PVI plus lines(p=0.50). Finally, the STAR AF II study(8) in patients with persistent AF also found a non-statistically significant trend in favor of PVI alone with a 65% single procedure one year AF free rate compared to 55% for PVI plus CAFE and 53% for PVI plus lines. Not unexpectedly, all three of these studies showed the less aggressive ablation strategy resulted in reduced procedure times, fluoroscopy times and RF energy delivery. These 3 studies were all done in patients with predominately persistent AF. In this issue of Heart Rhythm, Faustino, et al.(9) report results of a randomized trial of stepwise ablation versus PVI alone for patients with paroxysmal AF. The endpoint of the stepwise ablation was elimination of inducible AF. At one year the authors showed the stepwise ablation approach resulted in 73.3% of patients free of AF compared to only 53.3% for PVI alone. The stepwise approach did require increased procedure times, fluoroscopy times and radiofrequency (RF) energy delivery. It is unclear why this study seems to show that “more is more” in contrast to the 3 studies in persistent AFib where it seems that “less is more.” This may have something to do with the endpoint of eliminating all inducible AF. This study reports a one year success rate for PVI alone that seems somewhat lower than those reported in many other contemporary studies. Even if their one year single procedure AF free rates for PVI alone are the best that could be achieved in the 2007-2013 time frame, recent advances in technology to durably isolate

4 pulmonary veins will very likely result in outcomes that exceed those the authors achieved even with their more aggressive stepwise approach. A recent study(9) comparing contact force sensing RF ablation catheters and second generation cryoballoons for ablation of paroxysmal AF ablation showed a 12 month single procedure AF free rate of 83.9% for contact force and 83.6% for the cryoballoon. If such high rates of success can be widely achieved with newer and hopefully more durable pulmonary vein isolation technologies, it would not seem prudent to do extensive biatrial stepwise ablation in patients with paroxysmal or in any type of AF. For paroxysmal AF this more extensive ablation should wait until the improved procedural success shown in the present study is confirmed by others. The best strategy for improving ablation outcomes, might be to do the ablation earlier in the course of the disease. It is likely that a successful outcome from AF ablation is more dependent upon what an ablationist is given to ablate than what they ablate. If patients were referred for ablation at an earlier stage of their disease, before their AF became persistent and they had failed multiple antiarrhythmic drugs(10), the long-term ablation outcomes achieved with less aggressive procedures such as pulmonary vein isolation alone might far exceed any improvement in outcome that could be achieved with more extensive ablation or ablating using newer or future technologies once the AF has progressed to a more advanced stage.

1. Winkle RA, Mead RH, Engel G, Kong MH, Patrawala RA. Trends in atrial fibrillation ablation: have we maximized the current paradigms? J Interv Card Electrophysiol 2012;34:115-123.

5 2. Winkle RA, Mead RH, Engel G, Kong MH, Patrawala PA. Atrial fibrillation ablation using open-irrigated tip radiofrequency: Experience with intraprocedural activated clotting times ≤ 210 seconds. Heart Rhythm 2014;11:963-968. 3. Winkle RA, Mead RH, Engel G, Kong MH, Patrawala PA. Peri-procedural interrupted oral anticoagulation for atrial fibrillation ablation: comparison of aspirin, warfarin, dabigatran, and rivaroxaban. Europace; 2014;16:1443-1449. 4. Jaïs P, O‟Neill MD, Takahashi Y, Jönsson A, Hocini M, Sacher F, Sanders P, Kodali S, Rostock T, Rotter M, Clémenty J, Haïssaguerre M. Stepwise Catheter Ablation of Chronic Atrial Fibrillation: Importance of Discrete Anatomic Sites for Termination. J Cardiovasc Electrophysiol 2006;17: S28-S36, Suppl. 3. 5. Rostock T, Steven D, Hoffman B, Servatius H, Drewitz I, Sydow K, Müllerleile K, Ventura R, Wegscheider K, Meinertz T, Willemas S. Chronic Atrial Fibrillation Is a Biatrial Arrhythmia Data from Catheter Ablation of Chronic Atrial Fibrillation Aiming Arrhythmia Termination Using a Sequential Ablation Approach. Circ Arrhythmia Electrophysiol 2008;1:344-353. 6. Dong JZ, Sang CH, Yu RH, Long DY, Tang RB, Jiang CX, Ning M, Liu N, Liu XP, Du X, Tse HF, Ma CS. Prospective randomized comparison between a fixed „2C3L‟ approach vs. stepwise approach for catheter ablation of persistent atrial fibrillation. Europace doi:10.1093/europace/euv067. 7. Wynn GJ, Panikker S, Morgan M, Hall M, et al. Effect of linear ablation in substrate-based AF: Results of the substrate modification with ablation and antiarrhythmic drugs in non-permanent atrial fibrillation trial. Heart Rhythm 2015;12:1715.

6 8. Verma A, Jiang CY, Betts TR, et al, STAR AF II Investigators. Approaches to Catheter Ablation for Persistent Atrial Fibrillation. N Engl J Med 2015;372:18121822. 9. Faustino M, Pizzi C, Agricola T, Xhyheri B, Costa GM, Flacco ME, Capasso L, Cicolini G, Di Girolamo E, Leonzio L, Manzoli L. Stepwise Approach Ablation Versus Pulmonary Vein Isolation in Patients with Paroxysmal Atrial Fibrillation: Randomized Controlled Trial. Heart Rhythm, doi.org//10.1016/j.hrthm.2015.06.009 10. Winkle RA, Mead RH, Engel G, Kong MH, Patrawala RA. Prior antiarrhythmic drug use and the outcome of atrial fibrillation ablation. Europace 2012;14:646-652.

How much ablation to eliminate atrial fibrillation: Is less more, or is more more?

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