Liu W J, Zhang Y S, Cheng G S, Du Y J, He L, Wang X Y, He X M
Department of Structural Heart Disease, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.
Zhonghua Xin Xue Guan Bing Za Zhi. 2017 Jun 24;45(6):485-490. doi: 10.3760/cma.j.issn.0253-3758.2017.06.009.
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. 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. (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), =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), =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(=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. Efficacy and safety are similar for PFO treatment with Cardi-O-fix PFO occluder or Amplatzer PFO occluder in this patient cohort.
比较Cardi-O-fix卵圆孔未闭（PFO）封堵器与Amplatzer PFO封堵器治疗PFO患者的疗效和安全性。2013年5月30日至2015年3月30日，我院前瞻性纳入了246例连续的PFO患者（男性105例，女性141例）。根据疾病的解剖结构和患者意愿进行PFO介入封堵。180例使用Cardi-O-fix PFO封堵器（COF组），其余66例使用Amplatzer PFO封堵器（Amp组）。在12个月的随访期间，比较术后安全性，包括复发性卒中、短暂性脑缺血发作、死亡和完全封堵率，以及疗效，包括不同器械的手术相关并发症。（1）术后12个月，COF组和Amp组的短暂性脑缺血发作率相似（1.1%（2/180）对1.5%（1/66），P = 1.000）。随访12个月期间无复发性卒中和死亡。术后12个月，COF组和Amp组的完全封堵率相似（90.6%（163/180）对86.4%（57/66），P = 0.355）。（2）随访12个月期间，COF组观察到3例（1.7%）阵发性心房颤动，1例患者自发转为窦性心律，2例患者药物转复成功并转为窦性心律。Amp组有1例（1.5%）发生阵发性心房颤动并药物转复为窦性心律。两组阵发性心房颤动发生率无显著差异（P = 1.000）。随访12个月期间，两组均未出现封堵器移位、侵蚀、心包积液及穿刺部位出血等并发症。在该患者队列中，使用Cardi-O-fix PFO封堵器或Amplatzer PFO封堵器治疗PFO的疗效和安全性相似。
