CardioVascular Center Frankfurt, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany.
Eur Heart J. 2013 Nov;34(43):3362-9. doi: 10.1093/eurheartj/eht283. Epub 2013 Jul 9.
Percutaneous patent foramen ovale (PFO) closure for secondary stroke prevention is discussed controversially. Long-term data comparing different closure devices are limited. The objective is the prospective comparison of procedural complications and long-term results after PFO closure in patients with cryptogenic stroke randomized to three different closure devices.
Between January 2001 and December 2004, 660 patients with cryptogenic stroke were randomized to three different closure devices (Amplatzer, CardioSEAL-STARflex, and Helex occluder, 220 patients per group). The primary endpoint was defined as recurrent cerebral ischaemia [stroke, transient ischaemic attacks (TIA), or Amaurosis fugax], death from neurological cause, or any other paradoxical embolism within 5 years after the index procedure. Device implantation was technically successful in all interventions (n = 660; 100%). The procedure was complicated by pericardial tamponade requiring surgery in one patient (Amplatzer group) and device embolization in three patients (all Helex group). Thrombus formation on the device was detected in 12 cases (11 CardioSEALSTARflex, 1 Helex, 0 Amplatzer; P < 0.0001), of which 2 required surgery. Complete closure after single device implantation was more common with the Amplatzer and with the CardioSEAL-STARflex than with the Helex occluder: Amplatzer vs. Helex vs. CardioSEAL-STARflex: n = 217 (98.6%) vs. n = 202 (91.8%) vs. n = 213 (96.8%; P = 0.0012). Within 5 years of follow-up, the primary endpoint occurred in 25 patients (3.8%; 10 TIAs, 12 strokes and 3 cases of cerebral death). Compared with the CardioSEAL-STARflex (6%; 6 TIAs, 6 strokes, 1 cerebral death) and Helex groups (4%; 4 TIAs, 4 stroke, 1 cerebral death), significantly fewer events (P = 0.04) occurred in the Amplatzer group (1.4%; 2 strokes, 1 cerebral death).
Although procedural complications and long-term neurological event rates are low regardless of the device used, the recurrent neurological event rate was significantly lower after Amplatzer than after CardioSEAL-STARflex or Helex implantation. This has important implications regarding the interpretation of trials comparing PFO closure with medical management.
经皮卵圆孔未闭（PFO）封堵术用于二级卒中预防存在争议。比较不同封堵装置的长期数据有限。本研究的目的是前瞻性比较随机分为三组不同封堵装置的隐源性卒中患者的 PFO 封堵术后的手术并发症和长期结果。
2001 年 1 月至 2004 年 12 月，660 例隐源性卒中患者被随机分为三组不同的封堵装置（Amplatzer、CardioSEAL-STARflex 和 Helex 封堵器，每组 220 例）。主要终点定义为 5 年内出现复发性脑缺血[卒中、短暂性脑缺血发作（TIA）或一过性黑矇]、神经源性死亡或任何其他矛盾性栓塞。所有介入治疗（n = 660；100%）均成功植入设备。手术过程中发生心包填塞并发症需手术治疗 1 例（Amplatzer 组），3 例（均为 Helex 组）发生器械栓塞。12 例（11 例 CardioSEAL-STARflex、1 例 Helex、0 例 Amplatzer）发现器械上有血栓形成（P < 0.0001），其中 2 例需要手术治疗。单器械植入后完全闭合更为常见，Amplatzer 和 CardioSEAL-STARflex 优于 Helex 封堵器：Amplatzer 比 Helex 比 CardioSEAL-STARflex：n = 217（98.6%）比 n = 202（91.8%）比 n = 213（96.8%；P = 0.0012）。随访 5 年内，主要终点事件发生 25 例（3.8%；10 例 TIA，12 例卒中，3 例脑死亡）。与 CardioSEAL-STARflex（6%；6 例 TIA，6 例卒中，1 例脑死亡）和 Helex 组（4%；4 例 TIA，4 例卒中，1 例脑死亡）相比，Amplatzer 组的事件发生率明显更低（P = 0.04）（1.4%；2 例卒中，1 例脑死亡）。
尽管无论使用何种装置，手术并发症和长期神经事件发生率均较低，但 Amplatzer 组的复发性神经事件发生率明显低于 CardioSEAL-STARflex 或 Helex 组。这对比较 PFO 封堵术与药物治疗的试验结果具有重要意义。
