Comparison of Three Patent Foramen Ovale Closure Devices in a Randomized Trial (Amplatzer Versus CardioSEAL-STARfIex Versus Helex Occluder)

• Published in: The American journal of cardiology 2008-05, Vol.101 (9), p.1253
• Main Authors: Taaffe, Margaret, Fischer, Evelyn, Baranowski, Andreas, Majunke, Nicolas, Heinisch, Corinna, Leetz, Michaela, Hein, Ralph, Bayard, Yves, Büscheck, Franziska, Reschke, Madlen, Hoffmann, Ilona, Wunderlich, Nina, Wilson, Neil, Sievert, Horst
• Format: Article
• Language: English
• Subjects: Cardiology; Clinical outcomes; Clinical trials; Comparative studies; Heart; Medical equipment; Medical treatment; Surgical apparatus & instruments
• ISSN: 0002-9149; 1879-1913

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. [PUBLICATION ABSTRACT]