Closure of patent forman ovale defects using GORE® CARDIOFORM septal occluder

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

Research output: Contribution to journalArticle

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.

Original languageEnglish
JournalCatheterization and Cardiovascular Interventions
DOIs
Publication statusAccepted/In press - Jan 1 2017

Keywords

  • ASD/PDA/PFO
  • Closure
  • Stroke
  • Structural heart disease intervention

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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