Closure of patent foramen ovale defects using GORE® CARDIOFORM septal occluder: Results from a prospective European multicenter study

Stefan E Hardt, Andreas Eicken, Felix Berger, Stephan Schubert, Mario Carminati, Gianfranco Butera, Jochen Grohmann, Rene Höhn, Jens Erik Nielsen-Kudsk, David Hildick-Smith, Magnus Settergren, John D Thomson, Nicolas Geis, Lars Søndergaard

    16 Citationer (Scopus)

    Abstract

    AIMS: The GORE® CARDIOFORM Septal Occluder (GSO) is a novel device designed for rapid and effective closure of patent foramen ovale (PFO) which has distinctive features making it suitable for a broad spectrum of anatomical variations. We report the procedural and 6 months follow-up results of the first prospective, multicenter study using GSO.

    METHODS AND RESULTS: This single-arm study included 150 subjects undergoing closure of PFO in 10 European centers. In 149 out of 150 patients implantation of a GSO device was successful. One patient had a different PFO-closure device implanted. Periprocedural complications were few including one patient with suspected transient ischemic attack, two access site bleedings, and one patient with AV-fistula. No device embolization occurred. During the 6-month follow-up period one patient had a transient asymptomatic thrombus on the device and four patients (2.6%) were diagnosed new onset paroxysmal atrial fibrillation, which were successfully treated. No thrombembolic events occurred. Closure was successful in 94.2% of subjects at discharge evaluation and 96.9% at 6 months follow-up.

    CONCLUSION: This prospective, multicenter study adds to previous published data and suggests that GSO is a versatile device for PFO closure with high procedural and closure success rates and low complication rates through mid-term follow-up. © 2017 Wiley Periodicals, Inc.

    OriginalsprogEngelsk
    TidsskriftCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
    Vol/bind90
    Udgave nummer5
    Sider (fra-til)824-829
    Antal sider6
    ISSN1522-1946
    DOI
    StatusUdgivet - 1 nov. 2017

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