Long-Term Outcomes After Cryoballoon Pulmonary Vein Isolation Results From a Prospective Study in 605 Patients

Objectives The purpose of this study was to investigate long-term outcomes of freedom from atrial fibrillation (AF) after pulmonary vein (PV) isolation using cryoballoon ablation with balloon-size selection based on individual PV diameters. Background Data are lacking on long-term outcomes from cryoablation and on the most effective balloon size. Methods This was a prospective observational study involving 605 consecutively enrolled patients with symptomatic paroxysmal AF (n = 579) or persistent AF. Cryoballoon size was based on magnetic resonance imaging and/or conventional angiograms. Patients were followed up every 3 months during the first year after discharge and every 6 months in the second year. After 24 months, follow-up was on an outpatient basis with documented AF episodes recorded. Results The PV isolation was achieved without touch-up in 91.1% of patients, using the smaller balloon in 26.7%, the larger balloon in 25.6%, and both balloons in 47.7% of patients. Follow-up data for >12 months (median 30 months; interquartile range 18 to 48 months) were available for 451 patients, 278 (61.6%) of whom were free of AF recurrence with no need for repeat procedures after the 3-month blanking period. Rates of freedom from AF after 1, 2, and 3 repeat procedures (using cryoballoon or radiofrequency ablation with similar success rates) were 74.9%, 76.2%, and 76.9%, respectively. Use of the smaller balloons or both balloons produced the highest rates of long-term freedom from AF. Phrenic nerve palsy occurred in 12 patients (2%), resolving within 3 to 9 months. Conclusions Rates of long-term freedom from AF after cryoballoon ablation are similar to those reported for radiofrequency ablation. A choice between balloons may improve outcomes. (J Am Coll Cardiol 2013;61:1707-12) (C) 2013 by the American College of Cardiology Foundation