Comparison of three patent foramen ovale closure devices in a randomized trial (Amplatzer versus CardioSEAL-STARflex versus Helex occluder)

被引：118

作者：

Taaffe, Margaret ^{[1
]}

Fischer, Evelyn ^{[1
]}

Baranowski, Andreas ^{[1
]}

Majunke, Nicolas ^{[1
]}

Heinisch, Corinna ^{[1
]}

Leetz, Michaela ^{[1
]}

Hein, Ralph ^{[1
]}

Bayard, Yves ^{[1
]}

Buescheck, Franziska ^{[1
]}

Reschke, Madlen ^{[1
]}

Hoffmann, Ilona ^{[1
]}

Wunderlich, Nina ^{[1
]}

Wilson, Neil ^{[1
]}

Sievert, Horst ^{[1
,2
]}

机构：

[1] Ctr Cardiovasc, Frankfurt, Germany

[2] Washington Hosp Ctr, Washington, DC 20010 USA

来源：

AMERICAN JOURNAL OF CARDIOLOGY | 2008年 / 101卷 / 09期

关键词：

D O I：

10.1016/j.amjcard.2007.12.040

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

This randomized trial compared procedural complications and 30-day clinical outcomes of 3 patent foramen ovale (PFO) closure devices (Amplatzer, Helex, and CardioSEAL-STARflex). It examined 660 patients (361 men, 299 women, mean age 49.3 +/- 1.9 years), with 220 patients per group. All patients had a history of paradoxical embolism. All PFO closures were successful technically. Exchange of devices for others was most frequently required for the Helex occluder (7 of 220) and 2 of 220 in either of the other groups. Three device embolizations in the Helex group were retrieved and replaced successfully. One patient with a Helex occluder developed a transient ischemic attack and recovered without treatment. A hemopericardium in that group was punctured without affecting the device. One tamponade in the Amplatzer group required surgical device explantation. In 8 of 660 patients in the CardioSEAL-STARflex group, thrombi resolved after anticoagulation. Sixteen patients (11 in the CardioSEAL-STARflex group, 3 in the Amplatzer group, and 2 in the Helex group) had episodes of atrial fibrillation. PFOs were closed completely in 143 of 220 patients (65%) in the Amplatzer group, 116 of 220 patients (52.7%) in the Helex group, and 137 of 220 patients (62.3%) in the CardioSEAL-STARflex group at 30 days with significant differences between the Helex and Amplatzer occluders (p=0.0005) and the Helex and CardioSEAL-STARflex occluders (p=0.0003). PFO closure can be performed safely with each device. In conclusion, the Helex occluder embolized more frequently. Device thrombus formation and paroxysmal atrial fibrillation were more common with the CardioSEAL-STARflex occluder. (c) 2008 Elsevier Inc. All rights reserved.

引用

页码：1353 / 1358

页数：6

共 14 条

[1] Transcatheter closure of patent foramen ovale (PFO) in patients with paradoxical embolism - Periprocedural safety and mid-term follow-up results of three different device occluder systems [J].