RESUMO
BACKGROUND: Patent foramen ovale (PFO) affects 20-34% of adults and is associated with strokes and other disorders. The conventional treatment for PFO-related strokes is a closure procedure. The metal device is associated with some adverse events. OBJECTIVE: Our aim was to investigate the efficacy and safety of PFO closure using cryoablation without implantation in patients with atrial fibrillation (AF) who underwent pulmonary vein isolation (PVI). METHODS: We split the 22 patients with both PFO and AF who underwent PVI via cryoablation into two groups: standard PVI + atrial septum (AS) cryoablation (group 1, n = 11) and standard PVI (group 2, n = 11). The guide wire accesses the left atrium through the PFO without an AS puncture during the procedure. A standard PVI via cryoablation was performed. The cryoballoon was retracted to the right atrium and inflated against the AS post-PVI. Patients in Group 1 had cryoablation for 120-150 seconds, whereas patients in Group 2 received sham ablation. The co-primary end points were the PFO closure rate and a composite of AF recurrence and stroke/transient ischemic attack (TIA) events. RESULTS: There were no differences in procedure-related adverse events between the two groups. Neither group had an ischemic stroke report at 1-year follow-up. PFO closure rate at 6 months in group 1 was significantly higher than group 2 [7 (63.6%) vs. 1 (9.1%), P = 0.002]. AF recurrence after ablation was comparable in both groups at three months [3 (27.3%) vs. 1 (9.1%), P = 0.269], six months (0 vs. 0), and twelve months [2 (18.2%%) vs. 1 (9.1%), P = 0.534] of follow-up. CONCLUSION: Cryoablation is a safe and effective approach to close PFO in AF patients undergoing PVI in a single procedure.
