Department of Cardiology, Hacettepe University Faculty of Medicine, Ankara, Turkey.
Department of Neurology, Hacettepe University Faculty of Medicine, Ankara, Turkey.
Turk Kardiyol Dern Ars. 2021 Jan;49(1):29-39. doi: 10.5543/tkda.2020.06699.
In recent years, percutaneous closure of a patent foramen ovale (PFO) has gained widespread use. This study is an evaluation of the safety and efficacy of the Figulla and Amplatzer devices for PFO closure, including long-term follow-up results.
A total of 305 patients (43.6% male; mean age: 43.25±10.98 years) who underwent percutaneous PFO closure between 2003 and 2019 were enrolled. The Risk of Paradoxical Embolism (RoPE) score was calculated to predict the recurrence risk of cerebrovascular events due to PFO. Transthoracic echocardiography was used during the procedure.
The devices were successfully implanted in all patients. The in-hospital periprocedural complications recorded were atrial fibrillation in 1 patient (0.3%), supraventricular tachycardia in 1 patient (0.3%), and femoral hematoma in 3 patients (1%). The procedure time and fluoroscopy time was 21.92±2.93 minutes and 2.19±0.24 minutes, respectively. Recurrent ischemic stroke or transient ischemic attack (TIA) was observed in 7 (2.2%) patients during the median 85.77 months (25th-75th percentile: 10.21-108.00 months) follow-up. The RoPE score was significantly lower in patients with recurrent ischemic cerebral event (stroke or TIA) compared with asymptomatic patients (p<0.001). Kaplan-Meier curve analysis revealed that there was no significant difference between PFO device types (Amplatzer: 2.4% vs. Figulla: 3.3%) in terms of recurrent ischemic cerebral events during follow-up (log-rank; p=0.642).
Percutaneous PFO closure was safe, feasible, and effective. Our study confirmed the efficacy and safety of transthoracic echocardiogram guidance during percutaneous closure of PFO, which shortens the procedure time. A lower RoPE score was related to the recurrence risk of ischemic cerebrovascular events.
近年来，经皮卵圆孔未闭（PFO）封堵术得到了广泛应用。本研究评估了 Figulla 和 Amplatzer 封堵器治疗 PFO 的安全性和有效性，包括长期随访结果。
共纳入 2003 年至 2019 年间接受经皮 PFO 封堵术的 305 例患者（43.6%为男性；平均年龄：43.25±10.98 岁）。计算风险悖论栓塞（RoPE）评分以预测 PFO 引起的脑血管事件复发风险。术中采用经胸超声心动图。
所有患者均成功植入封堵器。记录的住院围手术期并发症为 1 例（0.3%）患者发生心房颤动，1 例（0.3%）患者发生室上性心动过速，3 例（1%）患者发生股部血肿。手术时间和透视时间分别为 21.92±2.93 分钟和 2.19±0.24 分钟。在中位 85.77 个月（25 至 75 百分位数：10.21 至 108.00 个月）的随访期间，7 例（2.2%）患者出现复发性缺血性卒中和短暂性脑缺血发作（TIA）。与无症状患者相比，复发性缺血性脑事件（卒中和 TIA）患者的 RoPE 评分显著降低（p<0.001）。Kaplan-Meier 曲线分析显示，在随访期间，不同 PFO 封堵器类型（Amplatzer 封堵器：2.4% vs. Figulla 封堵器：3.3%）在复发性缺血性脑事件方面无显著差异（对数秩检验；p=0.642）。
经皮 PFO 封堵术安全、可行、有效。本研究证实了经胸超声心动图引导在经皮 PFO 封堵术中的有效性和安全性，可缩短手术时间。较低的 RoPE 评分与缺血性脑血管事件的复发风险相关。
