title: Comparison of three patent foramen ovale closure devices in a randomized trial (Amplatzer versus CardioSEAL-STARflex versus Helex occluder).
abstract: 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.
authors.affiliation: CardioVascular Center, Frankfurt, Germany.
authors.forename: Margaret
authors.initials: M
authors.lastname: Taaffe
authors.forename: Evelyn
authors.initials: E
authors.lastname: Fischer
authors.forename: Andreas
authors.initials: A
authors.lastname: Baranowski
authors.forename: Nicolas
authors.initials: N
authors.lastname: Majunke
authors.forename: Corinna
authors.initials: C
authors.lastname: Heinisch
authors.forename: Michaela
authors.initials: M
authors.lastname: Leetz
authors.forename: Ralph
authors.initials: R
authors.lastname: Hein
authors.forename: Yves
authors.initials: Y
authors.lastname: Bayard
authors.forename: Franziska
authors.initials: F
authors.lastname: Büscheck
authors.forename: Madlen
authors.initials: M
authors.lastname: Reschke
authors.forename: Ilona
authors.initials: I
authors.lastname: Hoffmann
authors.forename: Nina
authors.initials: N
authors.lastname: Wunderlich
authors.forename: Neil
authors.initials: N
authors.lastname: Wilson
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
mesh_terms: D000497:Alloys; D006328:Cardiac Catheterization / Q000295:instrumentation*; D016009:Chi-Square Distribution; D005260:Female; D054092:Foramen Ovale, Patent / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011138:Polytetrafluoroethylene; D011183:Postoperative Complications; D019736:Prostheses and Implants; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: D000497:Alloys; C013616:nitinol; D011138:Polytetrafluoroethylene