Document Detail

Patent foramen ovale closure using a bioabsorbable closure device: safety and efficacy at 6-month follow-up.
MedLine Citation:
PMID:  20850098     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: The aim of this study was to assess the mid-term safety and efficacy of percutaneous patent foramen ovale (PFO) closure using a bioabsorbable device (BioSTAR, NMT Medical, Boston, Massachusetts).
BACKGROUND: Closure of PFO in patients with cryptogenic stroke has proven to be safe and effective using different types of permanent devices.
METHODS: All consecutive patients who underwent percutaneous PFO closure with the bioabsorbable closure device between November 2007 and January 2009 were included. Residual shunt was assessed using contrast transthoracic echocardiography.
RESULTS: Sixty-two patients (55% women, mean age 47.7 ± 11.8 years) underwent PFO closure. The in-hospital complications were a surgical device retrieval in 2 patients (3.2%), device reposition in 1 (1.6%), and a minimal groin hematoma in 6 patients (9.7%). The short-term complications at 1-month follow-up (n = 60) were a transient ischemic attack in the presence of a residual shunt in 1 patient and new supraventricular tachycardia in 7 patients (11.3%). At 6-month follow-up (n = 60), 1 patient without residual shunt developed a transient ischemic attack and 1 developed atrial fibrillation. A mild or moderate residual shunt was noted in 51.7%, 33.9%, and 23.7% after 1-day, 1-month, and 6-month follow-up, respectively. A large shunt was present in 8.3%, 3.4%, and 0% after 1-day, 1-month, and 6-month follow-up.
CONCLUSIONS: Closure of PFO using the bioabsorbable device is associated with a low complication rate and a low recurrence rate of embolic events. However, a relatively high percentage of mild or moderate residual shunting is still present at 6-month follow-up.
Ben J Van den Branden; Martijn C Post; Herbert W Plokker; Jurriën M ten Berg; Maarten J Suttorp
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Publication Detail:
Type:  Comparative Study; Journal Article    
Journal Detail:
Title:  JACC. Cardiovascular interventions     Volume:  3     ISSN:  1876-7605     ISO Abbreviation:  JACC Cardiovasc Interv     Publication Date:  2010 Sep 
Date Detail:
Created Date:  2010-09-20     Completed Date:  2011-03-01     Revised Date:  2014-09-05    
Medline Journal Info:
Nlm Unique ID:  101467004     Medline TA:  JACC Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  968-73     Citation Subset:  IM    
Copyright Information:
Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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MeSH Terms
Absorbable Implants*
Cardiac Surgical Procedures / instrumentation*
Follow-Up Studies
Foramen Ovale, Patent / diagnosis,  surgery*
Middle Aged
Radiography, Thoracic
Retrospective Studies
Septal Occluder Device*
Time Factors
Treatment Outcome

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

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