Document Detail


Outcome after percutaneous closure of a patent foramen ovale using the Intrasept device: a multi-centre study.
MedLine Citation:
PMID:  18324695     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: This multi-centre study reports safety and efficacy of percutaneous patent foramen ovale (PFO) closure, using the fourth generation Intrasept device. BACKGROUND: PFO has been associated with paradoxical embolism and cryptogenic stroke. Percutaneous PFO closure seems to reduce the risk for recurrent paradoxical thrombo-embolism. Currently, different devices are used for PFO closure. METHODS: Patients, who underwent a PFO closure with the Intrasept device (Cardia, Eagan, MN) between July 2002 and September 2006, were included in the study. The primary endpoint was defined as reoccurrence of stroke, transient ischemic attack (TIA), or peripheral thrombo-embolism. Peri-procedural and mid-term complications were reported. RESULTS: Four-hundred thirty patients (mean age 50.7 +/- 13.0 years, 231 men) underwent closure. The indications were cryptogenic stroke (69.8%), TIA (23.5%), peripheral embolism (3.3%), and other (3.5%). The median follow-up time was 0.8 years, range 3.9 years. The primary endpoint occurred in 0.5% for stroke, in 2.5% for TIA, and in none for peripheral embolism. Peri-procedural complications were reported in 11.5% of cases, from which 0.2% was defined as major. No severe complications occurred during mid-term follow-up. A residual shunt was present in 12.5% of patients who did not suffer from a recurrent event, compared to 36.4% of patients who reached the primary endpoint (P = 0.04). CONCLUSION: This multi-centre study suggests that percutaneous closure of a symptomatic PFO with the fourth generation Intrasept device is safe and might be effective to prevent the recurrence of paradoxical thrombo-embolic events.
Authors:
Justin G L M Luermans; Martijn C Post; Rainer Schräder; Thierry Sluysmans; Tom Vydt; Paul Vermeersch; Massimo Chessa; Eustaquio Onorato; Jean-Jacques Goy; Werner I H L Budts
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study    
Journal Detail:
Title:  Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions     Volume:  71     ISSN:  1522-726X     ISO Abbreviation:  Catheter Cardiovasc Interv     Publication Date:  2008 May 
Date Detail:
Created Date:  2008-04-22     Completed Date:  2008-05-29     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100884139     Medline TA:  Catheter Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  822-8     Citation Subset:  IM    
Copyright Information:
2008 Wiley-Liss, Inc.
Affiliation:
Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium.
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MeSH Terms
Descriptor/Qualifier:
Adult
Coronary Circulation
Disease-Free Survival
Embolism, Paradoxical / etiology,  physiopathology,  prevention & control
Equipment Design
Europe
Female
Foramen Ovale, Patent / complications,  physiopathology,  therapy*
Heart Catheterization / adverse effects,  instrumentation*
Humans
Ischemic Attack, Transient / etiology,  physiopathology,  prevention & control*
Kaplan-Meiers Estimate
Male
Middle Aged
Recurrence
Stroke / etiology,  physiopathology,  prevention & control*
Thromboembolism / etiology,  physiopathology,  prevention & control*
Time Factors
Treatment Outcome
Comments/Corrections
Comment In:
Catheter Cardiovasc Interv. 2008 May 1;71(6):829-30   [PMID:  18412080 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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