Document Detail

Long-term follow-up of the STARFlex device for closure of secundum atrial septal defect.
MedLine Citation:
PMID:  19156887     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: There is limited published outcome data on the STARFlex device for transcatheter closure of atrial septal defects (ASD). AIM: To contribute to the long term outcomes of ASD device closure with the STARFlex device. METHODS: Results of a prospective FDA approved clinical trial (1999-2001) from a single institution of the STARFlex device for simple ASD was reviewed. The inclusion criteria included age >or=2 years, isolated secundum ASD, evidence of right ventricular volume overload, and maximum stretched diameter <22 mm. A retrospective review of the original study data with most recent follow-up was performed. Clinical success in the trial was defined as complete closure or residual leak <or=2 mm, absence of a severe complication and no need for an additional device or surgery to treat the ASD. RESULTS: Twenty seven (27) patients were prospectively enrolled in the study period with a procedural success in 23 (85%). There were two severe complications, both 40 mm device embolizations that underwent semiurgent surgical intervention for device removal and ASD closure (40 mm device subsequently withdrawn from trial). Device placement was unsuccessful in two patients due to malposition related to an insufficient retro-aortic rim, with elective surgical closure. Unsuccessful procedural outcomes were statistically associated with deficient rims (P < 0.01). Of the 23 long term follow-up device patients, 23 (100%) achieved clinical success: 22 (96%) had complete closure at 1 year and latest echocardiographic follow-up and one case had a small <2 mm residual defect that has persisted. There have been no late complications with normalization of RV volumes in 92% and no deleterious ECG changes. Device fractures occurred in 8/23 (35%) devices and were more common in the larger devices (P < 0.05) but had no sequelae. None required any further intervention to treat the ASD and there were no infectious or thrombotic issues. CONCLUSIONS: In this cohort the STARFlex device for secundum ASD closure provided procedural success in 85% with failures due to surgical referral. All 23 patients with a STARFlex device with available long term follow-up had clinical success. Further long term data is required.
M A Law; J Josey; H Justino; C E Mullins; F F Ing; A W Nugent
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions     Volume:  73     ISSN:  1522-726X     ISO Abbreviation:  Catheter Cardiovasc Interv     Publication Date:  2009 Feb 
Date Detail:
Created Date:  2009-01-28     Completed Date:  2009-03-26     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100884139     Medline TA:  Catheter Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  190-5     Citation Subset:  IM    
Copyright Information:
(c) 2009 Wiley-Liss, Inc.
Department of Pediatrics, Pediatric Cardiology, Texas Children's Hospital, Baylor College of Medicine, Fannin Houston, Texas, USA.
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MeSH Terms
Cardiac Surgical Procedures
Child, Preschool
Device Removal
Echocardiography, Doppler, Color
Equipment Design
Equipment Failure
Follow-Up Studies
Foreign-Body Migration / etiology,  surgery
Heart Catheterization / adverse effects,  instrumentation*
Heart Septal Defects, Atrial / physiopathology,  therapy*,  ultrasonography
Middle Aged
Retrospective Studies
Time Factors
Treatment Outcome
Young Adult
Comment In:
Catheter Cardiovasc Interv. 2009 Feb 1;73(2):196   [PMID:  19156889 ]

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

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