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- Title
Percutaneous Atrial Shunt Closure Using the Novel Occlutech Figulla Device: 6-Month Efficacy and Safety.
- Authors
Van Den Branden, Ben J. L.; Post, Martijn C.; Plokker, Herbert W. M.; Ten Berg, Jurriën M.; Suttorp, Maarten J.
- Abstract
The Occlutech Figulla Occluder is a new innovative device for percutaneous closure of a patent foramen ovale (PFO) and an atrial septum defect (ASD). We describe the safety and efficacy of this new device at 6-month follow-up. All 82 consecutive patients (51% female, mean age 49.0 ± 13.6 years) who underwent percutaneous PFO (n = 48) or ASD (n = 34) closure between October 2008 and October 2009 were included. Implantation success was 100%. The in-hospital complications were two new onset supraventricular tachycardia (SVT) (2.4%, both ASD patients), nine minimal groin hematoma's (11.0%, 4 PFO and 5 ASD patients), and one transient ST elevation during the procedure (1.2%, ASD patient). During 6 months follow-up (n = 79), no major complications or reoccurrences of cerebral thrombo-embolic events did occur. Seven patients (8.9%, 6 PFO and 1 ASD patient) experienced a new SVT. One patient developed a recurrent cerebral hemorrhage 5 months after ASD closure, which appeared not to be related to the procedure. Using contrast transthoracic echocardiography 6 months after PFO closure (n = 45), a residual shunt was present in 30.2% of the patients (small 25.6%, moderate 4.6%, severe 0%). In the ASD group (n = 34), a residual shunt was observed in 32.5% (small 17.7%, moderate 14.7%, severe 2.9%). The Occlutech Figulla Occluder appears to be easy to use, effective, and safe for percutaneous closure of PFO and ASD. We report a low complication rate but a relative high percentage of small residual shunts 6 months after closure. (J Interven Cardiol 2011;24:264-270)
- Subjects
ATRIAL septal defect treatment; SURGICAL anastomosis; TRANSESOPHAGEAL echocardiography; MEDICAL equipment reliability; TACHYCARDIA; CEREBRAL hemorrhage
- Publication
Journal of Interventional Cardiology, 2011, Vol 24, Issue 3, p264
- ISSN
0896-4327
- Publication type
Article
- DOI
10.1111/j.1540-8183.2010.00619.x