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Clinical evaluation of a novel occluder device (Occlutech®) for percutaneous transcatheter closure of patent foramen ovale (PFO)

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Abstract

Background

We investigated the safety, feasibility and usefulness for closure of PFO with the new nitinol meshwire PFO-occluder device (Occlutech Figulla®-single layer occluder) with an unique braiding technology which allows a 50% reduction of meshwork material on the left atrial side in combination with a greater flexibility as compared to the Amplatzer® occluder device.

Methods

The retention discs of the new PFO Occlutech Figulla® single layer device (23/25 mm) are connected by a 3 mm waist in the centre with only one right atrial side hub. The left atrial disc is a single flat layer covered by an ultrathin polyethylene terephthalate (PET) patch. We investigated the safety, feasibility and usefulness for closure of PFO in a multicenter clinical trial. Indications for closure included cryptogenic stroke with evidence of a patent foramen ovale in transesophageal echocardiography (PFO max. diameter 13 mm according to sizing balloon). The device was implanted in 36 patients (mean age 57, 18–80 years) by means of fluoroscopy and transesophageal echocardiography (TEE) using a 9 French delivery sheath and employing a femoral vein approach. Both acetylsalicylacid 100 mg/d (6 months) and clopidogrel 75 mg/d (3 months) were administered post interventional. A transthoracal (TTE) and transesophageal echocardiography follow-up examination was performed after 1, 2 and 6 months (TTE day 30 and 180; TEE day 60).

Results

The device was successfully implanted in 36 pts. In one patient PFO implantations was attempted but not crossed with a guide wire. Perioperativly there were no major in-hospital-adverse events or complications thromboembolism, occluder dislodgement, infection or myocardial infarction. One patient had transient atrial fibrillation 2 h after implantation, which terminated medically after 12 h. TEE studies in the remaining 35 pts (one pt was unwilling to further participate) showed a residual shunt in 8.6% (3/35) after 60 days and a left-to-right shunt in 2.6% (1/35) of pts. After 180 days one pt with severe arteriosclerotic heart disease and A.carotic stenosis revealed a stroke without evidence of cardioembolic origin or devices thrombosis.

Conclusions

The novel Occlutech Figulla® PFO N single layer device appears to be safe, feasible and useful for PFO closure despite a 50% reduction of the meshwire, no distal hub and an improved flexibility of the left atrial disc.

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Acknowledgment

The trial was supported by a grant provided by Occlutech Jena®.

Conflict of interest statement Dr. Florian Krizanic and Prof. Dr. H.R. Figulla are consultants of Occlutech ®. Prof. Dr. H.R. Figulla has shares in Occlutech ® Jena. The other authors reported no conflicts of interests.

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Authors and Affiliations

  1. Clinic of Internal Medicine, Department of Cardiology, University Hospital Jena, 07747, Jena, Thuringia, Germany

    Florian Krizanic

  2. Cardiovascular Center, Frankfurt Germany and Washington Hospital Center, Washington, DC, USA

    Horst Sievert

  3. Dept. of Cardiology, University of Leipzig, Leipzig, Germany

    Dietrich Pfeiffer

  4. Dept. of Cardiology, Heart Center Essen, University of Essen, Essen, Germany

    Thomas Konorza

  5. Clinic of Internal Medicine I, University Hospital Jena, Jena, Germany

    Markus Ferrari PhD &  Hans-Reiner Figulla

Authors
  1. Florian Krizanic
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  2. Horst Sievert
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  3. Dietrich Pfeiffer
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  4. Thomas Konorza
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  5. Markus Ferrari PhD
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  6. Hans-Reiner Figulla
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Correspondence to Florian Krizanic.

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Krizanic, F., Sievert, H., Pfeiffer, D. et al. Clinical evaluation of a novel occluder device (Occlutech®) for percutaneous transcatheter closure of patent foramen ovale (PFO). Clin Res Cardiol 97, 872–877 (2008). https://doi.org/10.1007/s00392-008-0699-9

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  • DOI: https://doi.org/10.1007/s00392-008-0699-9

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