Abstract 14068: Prospective Evaluation of Same-Day Discharge After Cryoballoon Ablation of AF: Results of the Easy-PVI Study

Introduction: With advancements in technology and techniques, catheter ablation for the treatment of atrial fibrillation (AF) has become safer with time. Historically, standard-of-care recommended overnight stay after procedure. With improved safety and shorter procedure times, some centers have allowed for same-day discharge (SDD). We report the results of a multi-center, randomized clinical trial investigating the safety of SDD after cryoballoon (CB) ablation of paroxysmal AF. Methods: Patients underwent pulmonary vein isolation (PVI) with the Medtronic Arctic Advance TM cryoballoon at 3 experienced U.S. centers. Six hours after procedure, patients were randomized to either stay overnight or be discharged same-day after meeting study inclusion criteria. Results: A total of 51 patients were enrolled. Two were determined to be screen-fails following ablation of extra-pulmonary foci. Final analysis encompassed the 46 patients who completed randomization and follow-up, with 23 randomized to each group. No significant adverse outcomes were reported in either group, defined as major cardiovascular or cerebrovascular events. Occurrence of any adverse events, including arrhythmia recurrence, vascular complication, ventricular arrhythmia, syncope, pacemaker implant, pulmonary vein stenosis, and persistent phrenic nerve palsy, did not differ significantly between the two groups (p=1.0). Four patients had symptomatic and/or documented recurrence of atrial arrhythmia, three of which were in the same-day discharge group. Two patients developed cough post-operatively, one from each group. One patient from the next-day discharge cohort was diagnosed with pneumonia >2 weeks post-procedure. No patients from either group required emergency room visits due to delayed procedural-related complications. Conclusions: This is the first randomized trial to our knowledge examining the safety of SDD post CB ablation. Based on our results, SDD following CB ablation is a safe option following uncomplicated ablation for PVI. Operators should use their discretion in selecting patients for SDD.