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Comparison of the Occlutech® Figulla® Septal Occluder and Amplatzer® Septal Occluder for Atrial Septal Defect Device Closure

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Abstract

The Occlutech® Figulla® septal occluder (OFSO) is a later-generation double-disk device with few reports of its success rates and complications compared with the Amplatzer® septal occluder (ASO), which is the worldwide standard device in percutaneous atrial septal defect (ASD) closure. We recruited and compared the results in 149 patients (76.5 % female) who underwent ASD device closure in our center between January 2003 and June 2012. The patients ranged in age from 2.3 to 77.2 years. There were no statistically significant differences between the two groups regarding patient baseline characteristics and procedure variables. The success rate using either device was excellent (ASO 94.4 % and OFSO 97.4 %; p = 0.43). Although the diameter of the ASD and the pulmonary arterial pressure in the OFSO group were slightly higher than in the ASO group, the median fluoroscopic time in the OFSO group was significantly shorter (ASO 13.7 min; OFSO 9.0 min; p < 0.001). The overall median follow-up time was 3.6 years (interquartile range 2.1–9.0 years). There were no significant differences between the major and minor complications when comparing the two devices. Both devices were safe and effective for percutaneous ASD closures. The OFSO had the benefit of a shorter fluoroscopic time.

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Acknowledgments

The Prince of Songkla University Research Fund provided a grant for this study.

Ethical standard

The authors declare that they have no conflict of interest. The study was approved by the Prince of Songkla University Institutional Ethics Committee, and all procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. For this type of study, formal consent is not required.

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Authors and Affiliations

  1. Pediatric Cardiology Unit, Department of Pediatrics, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand

    Supaporn Roymanee, Nakharin Tonklang & Kanjarut Wongwaitaweewong

  2. Pediatric Cardiac Center, Queen Sirikit National Institute of Child Health, College of Medicine, Rangsit University, Bangkok, Thailand

    Worakan Promphan

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  1. Supaporn Roymanee
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  2. Worakan Promphan
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Correspondence to Supaporn Roymanee.

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Roymanee, S., Promphan, W., Tonklang, N. et al. Comparison of the Occlutech® Figulla® Septal Occluder and Amplatzer® Septal Occluder for Atrial Septal Defect Device Closure. Pediatr Cardiol 36, 935–941 (2015). https://doi.org/10.1007/s00246-015-1103-y

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  • DOI: https://doi.org/10.1007/s00246-015-1103-y

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