Abstract
BackgroundPersistent atrial fibrillation frequently shows multiple different electrophysiological mechanisms of induction. This heterogeneity causes a low success rate of single procedures of ablation and a high incidence of recurrence. Surgical ablation through bilateral thoracotomy demonstrates better results after a single procedure. Prospective observational studies in inhomogeneous populations without control groups report a remarkable 90% of success with hybrid or staged procedures of surgical ablation coupled with catheter ablation. In this trial, we will examine the hypothesis that a staged approach involving initial minimally invasive surgical ablation of persistent atrial fibrillation, followed by a second percutaneous procedure in case of recurrence, has a higher success rate than repeated percutaneous procedures.Methods/DesignThis is a controlled (2:1) randomized trial comparing use of a percutaneous catheter with minimally invasive transthoracic surgical ablation of persistent atrial fibrillation. The inclusion and exclusion criteria, definitions, and treatment protocols are those reported by the 2012 Expert Consensus Statement on catheter and surgical ablation of atrial fibrillation. Patients will be randomized to either percutaneous catheter (n = 100) or surgical (n = 50) ablation as the first procedure. After 3 months, they are re-evaluated, according to the same guidelines, and receive a second procedure if necessary. Crossover will be allowed and data analyzed on an “intention-to-treat” basis. Primary outcomes are the incidence of sinus rhythm at 6 and 12 months and the proportions of patients requiring a second procedure.DiscussionThe use of a staged strategy combining surgical and percutaneous approaches might be more favorable in treatment of persistent atrial fibrillation than the controversial single percutaneous ablation.Trial registrationISRCTN08035058 Reg 06.20.2013
Highlights
Persistent atrial fibrillation frequently shows multiple different electrophysiological mechanisms of induction
The use of a staged strategy combining surgical and percutaneous approaches might be more favorable in treatment of persistent atrial fibrillation than the controversial single percutaneous ablation
Full list of author information is available at the end of the article isolation (PVI) [3] and the ablation of complex fractioned atrial electrograms (CFAEs) [4] did not result in satisfactory results when used separately during percutaneous catheter ablation procedures (PCAs), whereas the rate of success increased to 74% after combining the two techniques and was 88% when ablation was repeated after 3 months [5]
Summary
PeAf is more complex to treat than the simple paroxysmal AF. Several different percutaneous and surgical techniques have been proposed for its treatment, owing to the difficulties in the standardization of the ablation procedures. The bilateral approach adds time and increases the chances of complications This can be avoided with different devices such as the Estech Cobra Fusion, which is capable of a complete electrical deconnection of the posterior left atrium, delivering bipolar radiofrequency through a single right minimally invasive approach. The staged procedures allow a blank period of evaluation, and two modalities of ablation (surgical and percutaneous) may be used after a predetermined period or only in case of recurrences. In the PCA control group of our study, the choice of the initial technique will be left to the treating cardiologist (PVI, CFAE ablation with or without manipulation of the substrate, or rotor manipulation are frequently used in combination or in staged procedures).
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