Objective: To compare the efficacy and safety of Cardi-O-fix patent foramen ovale (PFO) occluder and Amplatzer PFO occluder for the treatment of patients with PFO. Methods: A total of 246 consecutive patients (105 males and 141 females) with PFO were prospectively enrolled from May 30, 2013 to March 30, 2015 in our hospital. PFO interventional closure was applied according to the anatomical structure of the disease and patients' wishes.Cardi-O-fix PFO occluder was used in 180 cases (COF group), Amplatzer PFO occluder was used in the remaining 66 cases (Amp group). Post-procedure safety including recurrent stroke, transient ischemic attack, death, and complete closure rate, and efficacy including procedure related complications of different devices were compared during the 12 months follow-up. Results: (1) Rate of transient ischemic attack was similar between COF group and Amp group at 12 months after procedure(1.1%(2/180) vs. 1.5%(1/66), P=1.000). There was no recurrent stroke and death during the 12 months follow-up period.Complete closure rate was similar between COF group and Amp group at 12 months after the procedure(90.6%(163/180)vs. 86.4%(57/66), P=0.355). (2) Three cases(1.7%) of paroxysmal atrial fibrillation were observed in COF group during the 12 months follow-up period, 1 patient converted spontaneously to sinus rhythm and 2 patients received successful pharmacologic conversion and converted to sinus rhythm. One patient(1.5%)developed paroxysmal atrial fibrillation and was pharmacologically converted to sinus rhythm in the Amp group. There was no significant difference in rate of paroxysmal atrial fibrillation between the two groups(P=1.000). There was no complications such as occluder translocation, erosion, pericardial effusion and puncture site bleeding in the 2 groups during the 12 months follow-up. Conclusion: Efficacy and safety are similar for PFO treatment with Cardi-O-fix PFO occluder or Amplatzer PFO occluder in this patient cohort.
目的： 比较Cardi－O－fix和Amplatzer卵圆孔未闭(PFO)封堵器治疗PFO的有效性和安全性。 方法： 采用前瞻性研究方法，从2013年5月30日至2015年3月30日连续入选在西安交通大学第一附属医院行介入封堵术的PFO患者246例(其中男性105例，女性141例)。根据病变的解剖结构特点及患者意愿，选用Cardi－O－fix PFO封堵器(COF组，共180例)或Amplatzer PFO封堵器(Amp组，共66例)行PFO介入封堵术。术后随访12个月，比较不同封堵器的有效性(指标包括复发性卒中、短暂性脑缺血发作、死亡和卵圆孔的完全封堵率)和安全性(指标为手术相关并发症)。 结果： (1)术后12个月，COF组与Amp组发生短暂性脑缺血发作的比例差异无统计学意义[1.1%(2/180)比1.5%(1/66)，P＝1.000]。两组均未发生复发性卒中和死亡事件。术后12个月，两组的PFO完全封堵率差异无统计学意义[90.6%(163/180)比86.4%(57/66)，P＝0.355]。(2)术后12个月，COF组发生阵发性心房颤动3例(1.7%)，1例自行转复为窦性心律，另外2例经药物治疗后转复为窦性心律。Amp组发生阵发性心房颤动1例(1.5%)，经药物治疗后转复为窦性心律。两组发生阵发性心房颤动的比例差异无统计学意义(P＝1.000)。两组均无封堵器移位和侵蚀、心包积液和穿刺部位出血等并发症。 结论： Cardi－O－fix PFO封堵器与Amplatzer PFO封堵器治疗PFO的有效性和安全性相似。.
Keywords: Foramen ovale, patent; Septal occluder device; Treatment outcome.