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Background: Information on comparative outcome between radiofrequency catheter ablation (RFA) and antiarrhythmic drugs (AADs) >1 year after randomization is important for clinical decision-making., Methods and Results: A total of 198 patients (age, 56 ± 10 years) with paroxysmal atrial fibrillation were randomly assigned to RFA (99 patients) or to AADs (99 patients). We evaluated efficacy of RFA or AADs in a comparable 48-month follow-up period according to intention-to-treat analysis. Cardiac rhythm was assessed with daily transtelephonic transmissions. Quality of life was also analyzed. At 4 years, among the 99 patients first assigned to RFA, the procedure was repeated because of recurrent atrial fibrillation/atrial tachycardia in 27 patients (27.3%). Among the 99 patients randomly assigned to AADs, 87 (87.9%) crossed over to undergo RFA and 4 years after random assignment only 12 (12.1%) were in sinus rhythm with AAD alone without ablation. Despite the high level of crossovers, at 4 years the intention-to-treat analysis showed that 72.7% of patients in the ablation arm and 56.5% of those initially randomly assigned to AADs were free of recurrent atrial fibrillation/atrial tachycardia (P=0.017). During the follow-up, 19.2% of AAD patients progressed to persistent atrial fibrillation before switching to RFA. RFA significantly improved quality of life (P<0.001), whereas before crossing over to RFA, patients receiving AADs showed poorer quality of life. Except for new left atrial tachycardia, there were no serious complications caused by RFA., Conclusions: With follow-up extended to 4 years after randomly assigned, ablation remains superior to antiarrhythmic drug in these patients with paroxysmal atrial fibrillation., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00340314.

Objectives: The aim of this study was to describe the natural history of asymptomatic ventricular pre-excitation in children and to determine predictors of potentially life-threatening arrhythmic events., Background: Sudden death can be the first clinical manifestation in asymptomatic children with ventricular pre-excitation, but reduction of its incidence by prophylactic ablation requires the identification of subjects at high risk., Methods: Between 1995 and 2005 we prospectively collected clinical and electrophysiologic data from 184 children (66% male; median age 10 years; range 8 to 12 years) with asymptomatic ventricular pre-excitation on the electrocardiogram. After electrophysiologic testing, subjects were followed as outpatients taking no medications. The primary end point of the study was the occurrence of arrhythmic events. Predictors of potentially life-threatening arrhythmias were analyzed., Results: Over a median follow-up of 57 months (min/max 32/90 months) after electrophysiologic testing, 133 children (mean age 10 years; range 8 to 12 years) did not experience arrhythmic events, remaining totally asymptomatic, while 51 children had within 20 months (min/max 8/60 months) a first arrhythmic event, which was potentially life-threatening in 19 of them (mean age 10 years; range 10 to 14 years). Life-threatening tachyarrhythmias resulted in cardiac arrest (3 patients), syncope (3 patients), atypical symptoms (8 patients), or minimal symptoms (5 patients). Univariate analysis identified tachyarrhythmia inducibility (p < 0.001), anterograde refractory period of accessory pathways (APERP)

Objectives: This study was designed to investigate the potential of circumferential pulmonary vein (PV) ablation for atrial fibrillation (AF) to maintain sinus rhythm (SR) over time, thus reducing mortality and morbidity while enhancing quality of life (QoL)., Background: Circumferential PV ablation is safe and effective, but the long-term outcomes and its impact on QoL have not been assessed or compared with those for medical therapy., Methods: We examined the clinical course of 1,171 consecutive patients with symptomatic AF who were referred to us between January 1998 and March 2001. The 589 ablated patients were compared with the 582 who received antiarrhythmic medications for SR control. The QoL of 109 ablated and 102 medically treated patients was measured with the SF-36 survey., Results: Median follow-up was 900 days (range 161 to 1,508 days). Kaplan-Meier analysis showed observed survival for ablated patients was longer than among patients treated medically (p < 0.001), and not different from that expected for healthy persons of the same gender and calendar year of birth (p = 0.55). Cox proportional-hazards model revealed in the ablation group hazard ratios of 0.46 (95% confidence interval [CI], 0.31 to 0.68; p < 0.001) for all-cause mortality, of 0.45 (95% CI, 0.31 to 0.64; p < 0.001) for morbidities mainly due to heart failure and ischemic cerebrovascular events, and of 0.30 (95% CI, 0.24 to 0.37; p < 0.001) for AF recurrence. Ablated patients' QoL, different from patients treated medically, reached normative levels at six months and remained unchanged at one year., Conclusions: Pulmonary vein ablation improves mortality, morbidity, and QoL as compared with medical therapy. Our findings pave the way for randomized trials to prospect a wider application of ablation therapy for AF.