Wahl A, Kunz M, Moschovitis A, Nageh T, Schwerzmann M, Seiler C, Mattle H P, Windecker S, Meier B
Cardiology Department, University Hospital Bern, Switzerland.
Heart. 2008 Mar;94(3):336-41. doi: 10.1136/hrt.2007.118505. Epub 2007 Jul 16.
To carry out long-term follow-up after percutaneous closure of patent foramen ovale (PFO) in patients with cryptogenic stroke.
Prospective cohort study.
Single tertiary care centre.
525 consecutive patients (mean (SD) age 51 (12) years; 56% male).
Percutaneous PFO closure without intraprocedural echocardiography.
Freedom from recurrent embolic events.
A mean (SD) of 1.7 (1.0) clinically apparent embolic events occurred for each patient, and 186 patients (35%) had >1 event. An atrial septal aneurysm was associated with the PFO in 161 patients (31%). All patients were followed up prospectively for up to 11 years. The implantation procedure failed in two patients (0.4%). There were 13 procedural complications (2.5%) without any long-term sequelae. Contrast transoesophageal echocardiography at 6 months showed complete closure in 86% of patients, and a minimal, moderate or large residual shunt in 9%, 3% and 2%, respectively. Patients with small occluders (<30 mm; n = 429) had fewer residual shunts (small 11% vs large 27%; p<0.001). During a mean (SD) follow-up of 2.9 (2.2) years (median 2.3 years; total 1534 patient-years), six ischaemic strokes, nine transient ischaemic attacks (TIAs) and two peripheral emboli occurred. Freedom from recurrent stroke, TIA, or peripheral embolism was 98% at 1 year, 97% at 2 years and 96% at 5 and 10 years, respectively. A residual shunt (hazard ratio = 3.4; 95% CI 1.3 to 9.2) was a risk factor for recurrence.
This study attests to the long-term safety and efficacy of percutaneous PFO closure guided by fluoroscopy only for secondary prevention of paradoxical embolism in a large cohort of consecutive patients.
对不明原因卒中患者经皮闭合卵圆孔未闭（PFO）后进行长期随访。
前瞻性队列研究。
单一三级医疗中心。
525例连续患者（平均（标准差）年龄51（12）岁；56%为男性）。
不进行术中超声心动图检查的经皮PFO闭合术。
无复发性栓塞事件。
每位患者平均（标准差）发生1.7（1.0）次临床明显的栓塞事件，186例患者（35%）发生>1次事件。161例患者（31%）的房间隔瘤与PFO相关。所有患者均进行了长达11年的前瞻性随访。2例患者（0.4%）植入手术失败。有13例手术并发症（2.5%），无任何长期后遗症。6个月时的对比经食管超声心动图显示，86%的患者完全闭合，9%、3%和2%的患者分别有微小、中度或大量残余分流。封堵器较小（<30 mm；n = 429）的患者残余分流较少（微小分流11%对大量分流27%；p<0.001）。在平均（标准差）2.9（2.2）年（中位数2.3年；总计1534患者年）的随访期间，发生了6例缺血性卒中、9例短暂性脑缺血发作（TIA）和2例周围性栓塞。1年时无复发性卒中、TIA或周围性栓塞的比例分别为98%、2年时为97%、5年和10年时为96%。残余分流（风险比 = 3.4；95%置信区间1.3至9.2）是复发的危险因素。
本研究证实了仅在荧光透视引导下经皮PFO闭合术对一大组连续患者进行反常栓塞二级预防的长期安全性和有效性。
