Safety and performance of the spider™ patent foramen ovale occluder

Authors


  • Conflict of interest: Dr. Sievert reports having ownership interest in Cardiokinetix, Access Closure, Lumen Biomedical and Coherex and serving as a consultant for Access Closure, AGA, Ardian, Arstasis, Atritech, Atirum, Avinger, Bard, Boston Scientific Bridgepoint, CardioKinetix, CardioMEMS, Coherex, Contego, CSI, EndoCross, EndoTex, Epitek, Evalve, ev3, FlowCardia, Gore, Guidant, Lumen Biomedical, HLT, Kensey Nash, Kyoto Medical, Lifetech, Lutonix, Medinol, Medtronic, NDC, NMT, OAS, Occlutech, Osprey, Ovalis, Pathway, PendraCare, Percardia, pfm Medical, Recor, Rox Medical, Sadra, Sorin, Spectranetics, SquareOne, Trireme, Trivascular, Viacor and Veryan. Dr. Wilson is consultant and proctor for WL Gore & Associates. Drs Sievert and Piechaud serve as investigators of the “Spider PFO™ Approval study”. All other authors report no conflict of interest.

Correspondence to: Prof. Dr. med. Horst Sievert, CardioVascular Center, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany. E-mail: horstsievertmd@aol.com

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. © 2012 Wiley Periodicals, Inc.

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