Safety and performance of the spider™ patent foramen ovale occluder

Tina Edwards-Lehr, Jennifer Franke, Stefan C. Bertog, Christina Bäcker, Nina Wunderlich, Ilona Hofmann, Neil Wilson, Jean François Piechaud, Horst Sievert

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

Objectives The aim of this clinical trial was to assess safety, efficacy, and technical handling of a novel ceramic-coated double-disc patent foramen ovale (PFO) occluder. Background Though percutaneous PFO closure is performed with increasing frequency worldwide, certain risks such as thrombus formation and incomplete endothelialization remain. The Spider™ PFO occluder was designed to minimize these risks. Methods The Spider™ PFO occluder is a self-expandable double-disc device with a ceramic coated nitinol wire mesh and an integrated expanded polytetrafluoroethylene (ePTFE) membrane on the right atrial side and ceramic coated nitinol anchors and ePTFE patch on the left atrial side. Study patient assessments were conducted at baseline, periprocedure, and discharge and at 1-, 6- and 12-month follow-up. Results Fifty-one patients (mean age 52 ± 14 years; 63% male) were enrolled in the prospective, multicenter clinical trial. Implantation was successful in all patients. Mean procedural time was 30.0 ± 8.6 min. No periprocedural or in-hospital complications occurred. Four patients (8%) had paroxysmal atrial fibrillation (AF) at 1-month follow-up. Otherwise, no procedure or device related adverse events occurred. Importantly, there were no recurrent embolic events. At 1-month follow-up 63% (32/51) of patients had no residual shunt with contrast transesophageal echocardiography during Valsalva maneuver. Of all patients who underwent 6-month echo follow-up to date, 78% (39/50) had no residual shunt during Valsalva maneuver. Conclusion Initial results with the novel Spider™ PFO occluder show that the device is safe and easy to use for percutaneous closure of PFO. The overall complication rate was low. The rate of AF needs further investigation.

Original languageEnglish (US)
Pages (from-to)317-323
Number of pages7
JournalCatheterization and Cardiovascular Interventions
Volume81
Issue number2
DOIs
StatePublished - Feb 2013

Keywords

  • ceramic coating
  • device closure
  • patent foramen ovale
  • spider PFO occluder

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