Abstract：
BACKGROUND: Patent foramen ovale (PFO) affects 20%-34% of adults and is associated with strokes and other disorders. The conventional treatment of 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 divided the 22 patients with both PFO and AF who underwent PVI via cryoablation into 2 groups: standard PVI + atrial septal (AS) cryoablation group (group 1, n = 11) and standard PVI group (group 2, n = 11). The guidewire accesses the left atrium through the PFO without AS puncture during the procedure. 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 The cryoballoon was retracted to the right atrium and inflated against the AS post-PVI.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 2 groups. Neither group had an ischemic stroke report at 1-year follow-up. The PFO closure rate at 6 months in group 1 was significantly higher than that in group 2 (7 [63.6%] vs 1 [9.1%]; P = .002). AF recurrence post ablation was comparable in both groups at 3 months (3 [27.3%] vs 1 [9.1%]; P = .269), 6 months (0 vs 0), and 12 months (2 [18.2%%] vs 1 [9.1%]; P = .534) of follow-up.
CONCLUSIONS: Cryoablation is a safe and effective approach to close PFO in patients with AF undergoing PVI in a single procedure.
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 divided the 22 patients with both PFO and AF who underwent PVI via cryoablation into 2 groups: standard PVI + atrial septal (AS) cryoablation group (group 1, n = 11) and standard PVI group (group 2, n = 11). The guidewire accesses the left atrium through the PFO without AS puncture during the procedure. 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 The cryoballoon was retracted to the right atrium and inflated against the AS post-PVI.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 2 groups. Neither group had an ischemic stroke report at 1-year follow-up. The PFO closure rate at 6 months in group 1 was significantly higher than that in group 2 (7 [63.6%] vs 1 [9.1%]; P = .002). AF recurrence post ablation was comparable in both groups at 3 months (3 [27.3%] vs 1 [9.1%]; P = .269), 6 months (0 vs 0), and 12 months (2 [18.2%%] vs 1 [9.1%]; P = .534) of follow-up.
CONCLUSIONS: Cryoablation is a safe and effective approach to close PFO in patients with AF undergoing PVI in a single procedure.
摘要：
背景：卵圆孔未闭（PFO）影响20-34％的成年人，并与中风和其他疾病有关。PFO相关中风的常规治疗是闭合手术。金属装置与一些不良事件有关。
目的：我们的目的是研究在接受肺静脉隔离术（PVI）的房颤（AF）患者中使用冷冻消融术进行PFO封堵术的有效性和安全性。
方法：我们将22例经冷冻消融术行PVI的PFO和AF患者分为两组：标准PVI+房间隔（AS）冷冻消融术组（第1组，n=11）和标准PVI组（第2组，n=11）。导丝通过PFO进入左心房,在手术过程中没有AS穿刺。通过冷冻消融进行标准PVI。将冷冻球囊缩回至右心房并在PVI后对AS充气。第1组患者冷冻消融120-150秒,而第2组患者接受假消融术.共同的主要终点是PFO闭合率和AF复发和卒中/短暂性脑缺血发作（TIA）事件的复合。
结果：两组间手术相关不良事件无差异。两组在1年随访时都没有缺血性卒中报告。第1组6个月时PFO闭合率明显高于第2组[7(63.6%)vs.1（9.1%），P=0.002]。消融后房颤复发在3个月时两组具有可比性[3（27.3%）与1（9.1%），P=0.269],六个月(0vs.0),和十二个月[2（18.2%）与1（9.1%），随访P=0.534]。
结论：冷冻消融术是一种安全有效的方法，可在接受PVI的房颤患者中通过一次手术关闭PFO。
目的：我们的目的是研究在接受肺静脉隔离术（PVI）的房颤（AF）患者中使用冷冻消融术进行PFO封堵术的有效性和安全性。
方法：我们将22例经冷冻消融术行PVI的PFO和AF患者分为两组：标准PVI+房间隔（AS）冷冻消融术组（第1组，n=11）和标准PVI组（第2组，n=11）。导丝通过PFO进入左心房,在手术过程中没有AS穿刺。通过冷冻消融进行标准PVI。将冷冻球囊缩回至右心房并在PVI后对AS充气。第1组患者冷冻消融120-150秒,而第2组患者接受假消融术.共同的主要终点是PFO闭合率和AF复发和卒中/短暂性脑缺血发作（TIA）事件的复合。
结果：两组间手术相关不良事件无差异。两组在1年随访时都没有缺血性卒中报告。第1组6个月时PFO闭合率明显高于第2组[7(63.6%)vs.1（9.1%），P=0.002]。消融后房颤复发在3个月时两组具有可比性[3（27.3%）与1（9.1%），P=0.269],六个月(0vs.0),和十二个月[2（18.2%）与1（9.1%），随访P=0.534]。
结论：冷冻消融术是一种安全有效的方法，可在接受PVI的房颤患者中通过一次手术关闭PFO。
