Document Detail

Figulla ASD occluder versus Amplatzer Septal Occluder: a comparative study on validation of a novel device for percutaneous closure of atrial septal defects.
MedLine Citation:
PMID:  19735475     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: Occlutech Figulla ASD Occluder (FSO) is an alternative device to Amplatzer Septal Occluder (ASO) with some structural innovations including increased flexibility, minimizing the amount of material implanted, and absence of the left atrial clamp. We aimed to report our experiences with FSO and compare the outcomes of this novel device versus ASO.
INTERVENTIONS: Between December 2005 and February 2009, 75 patients diagnosed with secundum atrial septal defects underwent transcatheter closure. The FSO device was used in 33 patients, and the ASO was used in 42.
RESULTS: Patient characteristics, stretch size of the defect, device left disc size, procedure, and fluoroscopy time were similar between the groups. However, the difference between device waist size and stretched diameter of the defect was significantly higher, and device delivery sheath was significantly larger in FSO group and device left disc size was significantly lower in the FSO group. In all subjects, the residual shunt was small to trivial during follow-up and the reduction in prevalence of residual shunt with time was similar in both groups (P = 0.68). We found no differences in complication rate between the two devices; however, device embolization to the pulmonary bifurcation in one patient was recorded as major complication in FSO device group.
CONCLUSIONS: Both devices are clinically safe and effective in ASD closure. FSO device has similar outcomes when compared to ASO device. Difficulties in selecting the correct device size in larger defects and larger venous sheath requirement need to be evaluated in further studies.
Aysenur Pac; Tugcin Bora Polat; Ilker Cetin; Mehmet Burhan Oflaz; Sevket Balli
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Publication Detail:
Type:  Comparative Study; Journal Article; Validation Studies     Date:  2009-09-03
Journal Detail:
Title:  Journal of interventional cardiology     Volume:  22     ISSN:  1540-8183     ISO Abbreviation:  J Interv Cardiol     Publication Date:  2009 Dec 
Date Detail:
Created Date:  2009-12-22     Completed Date:  2011-01-31     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8907826     Medline TA:  J Interv Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  489-95     Citation Subset:  IM    
From the Clinic of Pediatric Cardiology, Turkiye Yuksek Ihtisas Education and Research Hospital, Ankara, Turkey.
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MeSH Terms
Balloon Dilation / instrumentation*,  methods
Child, Preschool
Coronary Angiography
Echocardiography, Transesophageal
Equipment Design
Heart Septal Defects, Atrial / therapy*,  ultrasonography
Kaplan-Meier Estimate
Middle Aged
Septal Occluder Device*
Treatment Outcome
Young Adult

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

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