AIMS: Pulmonary vein isolation (PVI) with cryoenergy delivered through a balloon is a new approach in the treatment of atrial fibrillation (AF), but long-term follow-up is lacking. The aim of this study was to provide insight in the success rate and the incidence of recurrences. METHODS AND RESULTS: Patients with symptomatic AF despite anti-arrhythmic drugs (AADs) were treated with cryoballoon PVI. Daily transtelephonic ECG monitoring, 24 h Holter-ECG, and an arrhythmia-focused questionnaire were used to document AF. One hundred and forty-one patients completed a follow-up of 457 +/- 252 days. Before ablation, Holter-ECG showed AF in 45%, including 16% continuous AF throughout the recording. Event recording revealed a median AF burden of 26%. The questionnaire showed a median of weekly AF complaints lasting for hours. All but one patient had successful PVI with a single procedure. After ablation, AF (defined as lasting for more than 30 s) was seen in 11% of Holter-ECGs, with 1% continuous AF. The event recording showed an AF burden of 9%. The median patient reported no more AF-related symptoms. Recurrence during the first 3 months was predictive for later recurrence. A second procedure was performed in 24 patients. The freedom of AF was 59% without AADs after 1,2 procedures. Four right phrenic nerve paralyses occurred, all resolving within 6 months. No PV stenoses were observed. CONCLUSION: Pulmonary vein isolation with a cryothermal balloon is an effective treatment for paroxysmal AF, resulting in a clinical success rate comparable to studies involving radiofrequency ablation. Temporary right phrenic nerve paralysis is the most important complication.
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