Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
J Am Coll Cardiol. 2018 May 22;71(20):2335-2342. doi: 10.1016/j.jacc.2018.02.046. Epub 2018 Mar 12.
Recent reports showing the favorable role of patent foramen ovale (PFO) closure in patients with cryptogenic stroke have raised the issue of selecting optimal candidates.
This study, DEFENSE-PFO (Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale), evaluated whether the benefits of PFO closure can be determined on the basis of the morphologic characteristics of the PFO, as evaluated by transesophageal echocardiography.
Patients with cryptogenic stroke and high-risk PFO were divided between a transcatheter PFO closure and a medication-only group. High-risk PFO included PFO with atrial septal aneurysm, hypermobility (phasic septal excursion into either atrium ≥10 mm), or PFO size (maximum separation of the septum primum from the secundum) ≥2 mm. The primary endpoint was a composite of stroke, vascular death, or Thrombolysis In Myocardial Infarction-defined major bleeding during 2 years of follow-up.
From September 2011 until October 2017, 120 patients (mean age: 51.8 years) underwent randomization. PFO size, frequency of septal aneurysm (13.3% vs. 8.3%; p = 0.56), and hypermobility (45.0% vs. 46.7%; p > 0.99) were similar between the groups. All PFO closures were successful. The primary endpoint occurred exclusively in the medication-only group (6 of 60 patients; 2-year event rate: 12.9% [log-rank p = 0.013]; 2-year rate of ischemic stroke: 10.5% [p = 0.023]). The events in the medication-only group included ischemic stroke (n = 5), cerebral hemorrhage (n = 1), Thrombolysis In Myocardial Infarction-defined major bleeding (n = 2), and transient ischemic attack (n = 1). Nonfatal procedural complications included development of atrial fibrillation (n = 2), pericardial effusion (n = 1), and pseudoaneurysm (n = 1).
PFO closure in patients with high-risk PFO characteristics resulted in a lower rate of the primary endpoint as well as stroke recurrence. (Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale [DEFENSE-PFO]; NCT01550588).
最近的报告显示卵圆孔未闭（PFO）封堵术在隐源性卒中患者中的有益作用，这引发了选择最佳患者的问题。
本研究，DEFENSE-PFO（卵圆孔未闭封堵与药物治疗隐源性卒中高危卵圆孔未闭患者），通过经食管超声心动图评估 PFO 的形态特征，评估 PFO 封堵术的获益是否可以基于 PFO 的形态特征来确定。
将隐源性卒中且 PFO 高危的患者分为经导管 PFO 封堵组和药物治疗组。高危 PFO 包括房间隔瘤、可移动（隔瓣在任一心房中的相位偏移≥10mm）或 PFO 大小（原发隔与继发隔之间的最大分离≥2mm）。主要终点是 2 年随访期间卒中、血管性死亡或溶栓治疗心肌梗死定义的大出血的复合终点。
2011 年 9 月至 2017 年 10 月，共 120 例患者（平均年龄：51.8 岁）进行了随机分组。PFO 大小、房间隔瘤发生率（13.3% vs. 8.3%；p=0.56）和可移动性（45.0% vs. 46.7%；p＞0.99）在两组间相似。所有 PFO 封堵均成功。主要终点仅发生在药物治疗组（60 例患者中的 6 例；2 年事件发生率：12.9%[对数秩检验 p=0.013]；2 年缺血性卒中发生率：10.5%[p=0.023]）。药物治疗组的事件包括缺血性卒中（n=5）、脑出血（n=1）、溶栓治疗心肌梗死定义的大出血（n=2）和短暂性脑缺血发作（n=1）。非致命性操作相关并发症包括房颤的发生（n=2）、心包积液（n=1）和假性动脉瘤（n=1）。
在具有高危 PFO 特征的患者中进行 PFO 封堵术可降低主要终点事件发生率和卒中复发率。（卵圆孔未闭封堵与药物治疗隐源性卒中高危卵圆孔未闭患者[DEFENSE-PFO]；NCT01550588）。
