University Hospital RWTH Aachen, Department of Cardiology, Aachen, Germany.
J Interv Cardiol. 2009 Dec;22(6):503-10. doi: 10.1111/j.1540-8183.2009.00507.x. Epub 2009 Oct 11.
To identify differences between various occluder types regarding thromboembolic event rates and existence of residual shunts during medium-term follow-up.
Three hundred nine consecutive patients with presumed paradoxical embolism and scheduled for percutaneous closure of patent foramen ovale or atrial septal defect between 1997 and 2006 were considered for this study. Device implantation failed in seven patients (nonstable device position), so 302 patients (46 +/- 12 years, 190 males) formed the study group using Amplatzer (n = 208), Starflex (n = 61), and Cardiastar (n = 33) occluders. Follow-up transesophageal echocardiography was performed 1, 3, and 6 months after implantation.
Periinterventional complications occurred in two patients (cardiac arrhythmias). There were more residual shunts in the Starflex and Cardiastar group than in the Amplatzer group at 6-month follow-up (8/61 vs. 7/33 vs. 8/208, P = 0.0005). Performing logistic regression, the type of occluder device was a significant risk factor for the presence of residual shunt 6 months after implantation (P = 0.0033; Cardiastar vs. Amplatzer OR 6.346, 95% CI 1.998 - 20.156; Starflex vs. Amplatzer OR 4.369, 95% CI 1.444 - 13.222). During mean follow-up of 31 +/- 8 months 16 recurrent thromboembolic events occurred; the annual recurrence was 2.1% for combined end-point stroke, TIA, and peripheral embolism (Amplatzer: 1.3%, Starflex: 3.9%, and Cardiastar: 3.6%, P = 0.0467). The presence of an atrial septal aneurysm was the only significant risk factor (P = 0.0168, OR 3.664, 95% CI 1.263 - 10.630) for the occurrence of thromboembolic events.
Percutaneous closure of patent foramen ovale or atrial septal defect is a safe procedure with little incidence of peri- and postprocedural complications. There is a significant difference between the Amplatzer, Cardiastar, and Starflex occluders in regard to complete closure of the defects and annual recurrence of thromboembolic events.
在中期随访期间，确定不同类型封堵器在血栓栓塞事件发生率和残余分流方面的差异。
1997 年至 2006 年间，我们对 309 例疑似反常栓塞且计划行卵圆孔未闭或房间隔缺损经皮封堵的连续患者进行了研究。7 例患者（器械位置不稳定）手术失败，因此 302 例患者（46 ± 12 岁，190 例男性）使用 Amplatzer（n = 208）、Starflex（n = 61）和 Cardiastar（n = 33）封堵器形成研究组。植入后 1、3 和 6 个月进行经食管超声心动图随访。
2 例患者（心律失常）在围手术期出现并发症。在 6 个月的随访中，Starflex 和 Cardiastar 组的残余分流较 Amplatzer 组多（8/61 比 7/33 比 8/208，P = 0.0005）。进行逻辑回归分析，封堵器类型是植入后 6 个月残余分流的显著危险因素（P = 0.0033；Cardiastar 比 Amplatzer OR 6.346，95%CI 1.998 - 20.156；Starflex 比 Amplatzer OR 4.369，95%CI 1.444 - 13.222）。在平均 31 ± 8 个月的随访中，发生 16 例复发性血栓栓塞事件；卒中、TIA 和外周栓塞的年复发率为 2.1%（Amplatzer：1.3%，Starflex：3.9%，Cardiastar：3.6%，P = 0.0467）。房间隔瘤的存在是血栓栓塞事件发生的唯一显著危险因素（P = 0.0168，OR 3.664，95%CI 1.263 - 10.630）。
卵圆孔未闭或房间隔缺损的经皮封堵是一种安全的手术，围手术期和术后并发症发生率低。Amplatzer、Cardiastar 和 Starflex 封堵器在缺陷完全闭合和血栓栓塞事件的年复发率方面存在显著差异。
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