12-year follow-up of catheter ablation for atrial fibrillation. A prospective multi-center, randomized study

Emanuele Bertaglia, Gaetano Senatore, Laura De Michieli, Antonio De Simone, Claudia Amellone, Sonia Ferretto, Vincenzo La Rocca, Marco Giuggia, Domenico Corrado, Franco Zoppo, Giuseppe Stabile

Emanuele Bertaglia
Affiliations
Dipartimento di Scienze Cardiache, Toraciche e Vascolari, Università degli Studi di Padova, via Giustiniani 2 – 35128 Padova (Italy)
Ospedale Civile, via Mariutto, 13 – 3035 Mirano (VE) (Italy)
Correspondence
Address reprint requests and correspondence Emanuele Bertaglia, Via Ca’Rossa, 35, 30173 MESTRE (VE), ITALY. Tel.: +39 3470548576; fax: +39 0498212309.
, MD, PhDcorrespondence

Gaetano Senatore
Affiliations
Ospedale Civile, via Battitore, 7 – 10073 Ciriè (Italy)

Laura De Michieli
Affiliations
Dipartimento di Scienze Cardiache, Toraciche e Vascolari, Università degli Studi di Padova, via Giustiniani 2 – 35128 Padova (Italy)

Antonio De Simone
Affiliations
Casa di Cura San Michele, via Montella, 16 – 81024 Maddaloni (CE) (Italy)

Claudia Amellone
Affiliations
Ospedale Civile, via Battitore, 7 – 10073 Ciriè (Italy)

Sonia Ferretto
Affiliations
Dipartimento di Scienze Cardiache, Toraciche e Vascolari, Università degli Studi di Padova, via Giustiniani 2 – 35128 Padova (Italy)

Vincenzo La Rocca
Affiliations
Casa di Cura San Michele, via Montella, 16 – 81024 Maddaloni (CE) (Italy)

Marco Giuggia
Affiliations
Ospedale Civile, via Battitore, 7 – 10073 Ciriè (Italy)

Domenico Corrado
Affiliations
Dipartimento di Scienze Cardiache, Toraciche e Vascolari, Università degli Studi di Padova, via Giustiniani 2 – 35128 Padova (Italy)

Franco Zoppo
Affiliations
Ospedale Civile, via Mariutto, 13 – 3035 Mirano (VE) (Italy)

Giuseppe Stabile
Affiliations
Casa di Cura San Michele, via Montella, 16 – 81024 Maddaloni (CE) (Italy)
Clinica Mediterranea, via Orazio, 2 – 80122 Napoli (Italy)

Background
Randomized and controlled study have reported the effect of catheter ablation (CA) for atrial fibrillation (AF) over a follow-up of 12-24 months.

Objective
We report on the effect of CA plus antiarrhythmic drugs in comparison with antiarrhythmic drugs alone on the maintenance of sinus rhythm over a 12-year follow-up.

Methods
We extended the follow-up of the 137 patients who were enrolled in the Catheter Ablation for the Cure of Atrial Fibrillation Study between 01st February 2002 and 30th June 2003 and randomized to antiarrhythmic drugs (control group) or antiarrhythmic drugs plus CA (ablation group). The primary end-point was time to first symptomatic or asymptomatic recurrence of atrial arrhythmia lasting > 30 seconds during the follow-up.

Results
During the follow-up 19/68 (27.9%, 95% CI 18.7-39.6%) ablation group patients and 3/69 (4.3%, 95% CI1.49-12.0 %) control group patients did not experienced any relapse of atrial tachyarrhythmia (p< 0.001). The Kaplan-Meier analysis to determine the probability of survival-free from atrial arrhythmias showed a statistical difference in favor of the ablation group (log-rank p <0.001). The effect of CA was consistent with both paroxysmal and persistent AF patients. At the multivariate Cox regression analysis belonging to control group (HR 2.95, IC 95% 1.896-4.726; p<0.001) and longer time since first AF episode (HR 1.004, IC 95% 1.002-1.084; p=0.041) were predictors of atrial tachyarrhythmias recurrence.

Conclusion
In patients with paroxysmal and persistent AF, CA significantly increased time to first recurrence of atrial arrhythmias during a 12-year follow-up.

Clinical Trial Registration
www.isrctn.com. Unique Identifier ISRCTN46898887

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