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 (2008). Comparison of three patent foramen ovale closure devices in a randomized trial (Amplatzer versus CardioSEAL-STARflex versus Helex occluder). American journal of cardiology, 101(9), pp. 1353-8. New York, N.Y.: Elsevier 10.1016/j.amjcard.2007.12.040
Full text not available from this repository. (Request a copy)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.
Item Type: |
Journal Article (Original Article) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology |
UniBE Contributor: |
Bayard, Yves Laurent |
ISSN: |
0002-9149 |
ISBN: |
18435971 |
Publisher: |
Elsevier |
Language: |
English |
Submitter: |
Factscience Import |
Date Deposited: |
04 Oct 2013 15:02 |
Last Modified: |
05 Dec 2022 14:19 |
Publisher DOI: |
10.1016/j.amjcard.2007.12.040 |
PubMed ID: |
18435971 |
Web of Science ID: |
000255670200024 |
URI: |
https://boris.unibe.ch/id/eprint/26926 (FactScience: 99050) |
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